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A Brief History of Myriad Genetics. (1/7) (4:44)
Peter Meldrum, CEO of Myriad gives a brief history of Myriad Genetics. Led in this discussion by JMP Securities analyst Charles Duncan, Peter explains what made him want to start the company, and what differentiated it from all the other companies that sought to build on the genomic revolution. And even though Myriad Genetics has been a pioneer and a leader in the field of molecular diagnostics, it seems there is still a long way to go.
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BRAC Analysis, Myriad Genetics' Primary Revenue Driver. (2/7) (5:55)
Two genes are responsible for the vast majority of hereditary breast and ovarian cancer. The BRAC Analysis diagnostic test can identify these genes and help physicians evaluate the breast and ovarian cancer risks with their patients. Peter Meldrum, discusses the significance of this test, the segments of patient population it serves, and the market size for the test. When Charles Duncan puts forward Myriad's marketing strategy, Peter presents the rationale for his Direct To Consumer (DTC) television advertising, its effectiveness, and the regions of its future expansion.
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Is a European Expansion to be Expected from Myriad Genetics? Checklist and Roadmap. (3/7) (1:21)
Has the European expansion been delayed because of intellectual property or business question? When questioned by Charles Duncan, Peter Meldrum, CEO of Myriad Genetics explains the strategy which has been to establish a significant presence in the US, and then build the infrastructure necessary to capture the European market. We should expect a strong presence in the next 3 years.
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Optimal Chemotherapy Dosing with OnDose, from Myriad Genetics. (4/7) (2:43)
Myriad Genetics' most recent personalized medicine product, OnDose, optimizes chemotherapy dosing for 5-FU regime. Charles Duncan inquires about the safety and efficacy gains from using OnDose vs. Body Surface Area (BSA) dosing. Peter Meldrum explains that OnDose uses pharmacokinetic analysis to measure the exposure each individual gets to the drug. This information can then be used by physicians to tailor the dosing and ensure their patients are in the optimal range. Quoting a Journal of Clinical Oncology study, an 80% reduction in toxic side effects and a doubling of response in terms of tumors shrinking were observed. Additionally, those who receive the OnDose dosing lived on average 6 months longer.
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Myriad Genetics' Latest Diagnostic (PROLARIS) Predicts Prostate Cancer Recurrence. (5/7) (7:02)
On March 2nd, 2010, Myriad Genetics unveiled a diagnostic that can assess the risk of post-prostatectomy recurrence in men with prostate cancer. Charles Duncan asks Peter Meldrum about the clinical utility of the test, and the outlook for a PRE-prostatectomy diagnostic. It does indeed seem that too many prostatectomies are performed in the US (according to a NEJM study). Peter explains that Myriad Genetics just completed a study of its own that showed the diagnostic to be as predictive in pre-prostatectomy as in the post-prostatectomy. The pre-prostatectomy data was submitted to a peer reviewed journal and is expected to be published in the last quarter of 2010. As for reimbursement, PROLARIS has almost 100M lives under coverage, even though it is only a day old.
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Patenting Genes: What if the ACLU Wins the Case Against Myriad Genetics? (6/7) (5:03)
In May of 2009 the ACLU filed a lawsuit against Myriad Genetics, challenging their patents on breast cancer genes. Charles Duncan asks Peter Meldrum of the implications of this case, and the impact on Myriad Genetics' business model if the case is lost. From this point on Charles and Peter continue to discuss the numerous other competitive advantages of the company.
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Financials: How is Myriad Genetics Planning to Return Cash to Investors? (7/7) (2:58)
Myriad Genetics is a profitable company that generates $150M cash per year, and has a great balance sheet. It would seem the lion's share will be reinvested in the development of new products and expansion to new markets. Still, Charles Duncan asks how some of this cash will be returned to shareholders. Peter Meldrum explains the board of directors is currently evaluating sustainable cash dividends and sustainable stock repurchase programs.
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Batman is Back, Busting Clots with Desmoteplase (4:44)
Paion's lead compound is derived from the saliva of the vampire bat, and being tested as an anti-thrombotic in stroke. After an unsuccessful Phase 3 in 2007, a meta analysis revealed 50% of the patients had no clots to bust, and as Wolfgang Soehngen points out in this interview: "if there is no clot to bust, Desmoteplase has no job to do." Batman is back, as it has recently been said, because of Paion's recent turnaround. Desmoteplase is in 2 Phase 3s with Lundbeck, and added new drugs to portfolio. The partnership with Lundbeck includes 100% funding of products development, 63M Euros in upcoming milestones, and double digit royalties.
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Paion De-Risks Pipeline with Acquisition of New Value Driver CNS 7056 (5:40)
The 12.3M Euro acquisition of CeNeS in 2008, and successful Phase 2a development of it's CNS 7056 (short-acting sedative and general anaesthetic) has contributed to more than doubling the value of Paion shares in the second half of 2009. Wolfgang Soehngen explains the rationale was to de-risk Paion's pipeline, and re-gain investor confidence, after the failed Phase 3 for Demostoplase. With the re-licencing of Desmoteplase, CNS 7056 is now Paion's main priority, and Wolfgang expects to partner it within the year. Japanese company ONO Pharmaceutical recently initiated clinical studies for CNS 7056 / ONO-2745 in Japan.
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Paion's Search & Develop Strategy: Get the Proof of Concept Faster and Cheaper than Pharma (7:16)
Taking a product from discovery to market is a challenging proposition, with Wolfgang Soehngen, CEO of Paion addresses with the Search & Develop (S&D) strategy. S&D consists of taking some of Pharma's assets that would otherwise "disappear in the basement" and developing them, knowing that they have already robust toxicology and CMC profiles. Paion's R&D team being fully dedicated to get the proof of concept done can do the work faster and cheaper than Pharma would. Wolfgang suggests that S&D is a much safer way to generate value for shareholders. Wolfgang explains he wants Paion to be viewed as a proof of concept company and be very attractive to big pharma as future partner. In this segment, are also discussed Paion's Phase 3 M6G morphine metabolite, and Wolfgang's favored structure for partnership deals - a good upfront payment, with major coverage of Phase 3 costs.
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Dim That Receptor Activity with Addex's Allosteric Modulation. (5:22)
Ram Selvaraju asks Vincent Mutel, CEO of Addex, about allosteric modulation technology. In essence, it offers regulation of the efficiency of receptors, as opposed to the on / off switch of more traditional drugs. Ram and Vincent discuss the safety profile, and the potential not to induce desensitization. Finally, the business model is reviewed, with Merck and Johnson & Johnson collaborations, and value creation objectives for shareholders through commercialization of their own molecule
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Addex's New Lead Molecule ADX48621, Expected To Be Partnered Soon? (5:56)
ADX48621 is the lead molecule in Addex's pipeline. Ram Selvaraju challenges Vincent Mutel on upcoming clinical news and strategic objectives. With 110+ patients enrolled across 3 completed phase 1 trials, ADX48621 is expected to initialized it's Phase 2B in Q410. Results are expected for late 2011 / early 2012. Vincent plans to partner ADX48621, perhaps in the near term, before getting his Phase 2 data. ADX48621's lead indication is Parkinson's disease levodopa associated dyskinesia (PD-LID), with potential in multiple indications.
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December 2009, A Major Setback for Addex. Use of Cash, and Other Pipeline Molecules (6:58)
The clinical trials for Addex's former lead molecule ADX10059 were brought to halt in December 2009, after findings of hepatotoxicity. Can ADX10059 be salvaged, or is it a "dead horse"? Ram Selvaraju inquires about the future of ADX10059, Addex's cash runway, and projected use of funds, as well the status of other pipeline molecules. In addition to the new lead ADX48621, Addex plans to develop and co=promote a GABA-B positive allosteric modulator for osteoarthritis, and develop and out-license the first fish follicle stimulating hormone receptor (FSHR) negative allosteric modulators first for benign prostatic hyperplasia (BPH), a known precursor to prostate cancer.
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ADDEX Undervalued? What Could Drive Stock Price In The Next 6 Months (4:43)
Finally, Ram Selvaraju and Vincent Mutel discuss the current valuation of Addex. Reviewed are the platform's value and the near term catalysts. With a strong cash position, several partnerships, business development activity, and an expected Phase 2 by the end of the year, Vincent believes in a significant upside for the long term. Additionally, with the obvious product differentiation and innovation, Vincent presents a future for Addex that will undoubtedly be brighter.
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Major Breakthrough in $5bn Osteoporosis Market ()
Everything started with this observation: patients with High Bone Mass Syndrome have an abnormally low level of serotonin in their blood, and menopausal women with this disease never develop osteoporosis. Gerard Karsenty's team tested gut serotonin synthesis inhibitors in animal models. They discovered a way to stimulate osteoblast proliferation, which in turn leads to bone formation. This could be the first anabolic treatment of osteoporosis, and it could be administered orally. This breakthrough discovery suggests a new approach to the treatment osteoporosis, a major metabolic disease representing a $5bn market in the US.
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Inhibiting Serotonin Synthesis in the Gut, Rationale for Treating Osteoporosis ()
Gerard Karsenty studied LP533401 in animal models and found no side effects. This molecule was also tested in early clinical trials, for irritable bowel syndrome, and no side-effects were reported. The next step would be to perform additional animal testing at different doses in different treatment regiments.
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How Does an Anabolic Treatment Compare to Other Approaches in Development for Osteoporosis? ()
Amgen's Denosumab, expected to lead in the treatment of osteoporosis when approved, works by reducing bone resorption. LP533401 stimulates bone formation. This is the first report of gut derived serotonin being used as a target to treat osteporosis. Still, more work is needed to optimize the molecule. This will be the task of the Biotech and Pharma industry, but first they will have to call Columbia University's patent office (212-854-8444 - no pressure, just there if you need it).
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Study of Rare Genetic Disease Leads to New Target for the Treatment of Most Common Bone Disease. ()
If the mandatory human clinical trials confirm the relevance of this new target, a inhibiting the gut serotonin synthesis may lead to a very convenient way to prevent and treat osteoporosis, and to a blockbuster drug.
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Who is Investing in Biotech Today? Kris Jenner (1/3) ()
Marina Bozilenko interviews Dr. Kris Jenner of T. Rowe Price. What is the mood this year at the J.P. Morgan Healthcare Conference? What business models are investors looking for nowadays? How is the tone cautiously optimistic? Who is investing in Biotech today? Are we looking at the "core 100" or has the base expanded?
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Reconsidering Small and Mid Caps, IPOs, and Value Drivers. Kris Jenner (2/3) ()
Are small and mid-cap Biotech companies now being favored by investors? Many IPO have been filed; what will make T. Rowe buy? What will be driving the value of biotechnology stocks in 2010? An interview of Dr. Kris Jenner of T. Rowe Price, by Marina Bozilenko.
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Shareholder Activism in 2010, Good or Bad? Kris Jenner (3/3) ()
Will shareholder activism increase this year? How will that affect Biotech? What are your market predictions for 2010? An interview of Dr. Kris Jenner of T. Rowe Price, by Marina Bozilenko.
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A Transformative Crisis, or Just Another Cycle? Ansbert Gadicke (1/3) ()
Marina Bozilenko interviews Dr. Ansbert Gadicke of MPM Capital. What is different this year at the J.P. Morgan Healthcare Conference? Does it look like we just went through another cycle, or are we seeing transformative change in the industry? From the venture capital perspective, how can this change be characterized? Where are we seeing increased pressure? What are the VCs looking at in new investments?
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Key Issues for Venture Capital Invetments and Fund Raising. Ansbert Gadicke (2/3) ()
What are the key issues for venture capitalists in the current market environment? prediction for new funds trying to raise K? effect on the community? How will it affect early stage technology? An interview of Dr. Ansbert Gadicke of MPM Capital, by Marina Bozilenko.
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Pharma Opportunities, Novel Technologies, and Diseases of the Decade. Ansbert Gadicke (3/3) ()
Will Pharma consolidation create attractive opportunities for Venture Capitalists? What will be the next decade in technology? Which disease therapies will define this coming decade? An interview of Dr. Ansbert Gadicke of MPM Capital, by Marina Bozilenko.
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2010 JP Morgan Healthcare Conference, the Insider Perspective (1/2) ()
Marina Bozilenko interviews Geoff Meacham, Senior Biotechnology Analyst at JP Morgan. What were the companies that gave the tone, and what was the major news that came out during the week? What are the major milestones that could make or break 2010 for biotech? Have the under-served small cap become a good opportunity?
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2010 JP Morgan Healthcare Conference, the Insider Perspective (2/2) ()
At the end of the 2010 JPM conf, what is the best company-profile for a successful IPO? Is it true that Pharma's validation is no longer sought? Is there a new trend in business models for biotech? What is the take home message of the 2010 conference? An interview of Geoff Meacham of JP Morgan, by Marina Bozilenko.
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Accera, 60sec ()
Accera, a privately held biotechnology company, discovers and develops breakthroughs in treating central nervous systems disorders. Accera's new and novel therapeutic approaches positively impact patients with neurodegenerative disorders, who are in need of effective, well-tolerated treatments, and their families. Through its proprietary scientific platform, Accera is developing therapies that address metabolic deficiencies and provide an alternative energy source for brain cells.
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Genetic Technologies, 60sec ()
Genetic Technologies (ASX: GTG, NASDAQ Global Market: GENE) is leading-edge genetic testing and reproductive services business which, together with an extensive range of international patents and allied research activities, aims at uncovering the impact of DNA on health.
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Paion, 60sec ()
The company is specializing in developing and commercializing innovative drugs for the hospital-based treatment of central nervous system (CNS) disorders and thrombotic/cardiovascular diseases, indications for which there is a substantial unmet medical need.
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Epigenomics, 60sec ()
Epigenomics is a molecular diagnostics company focusing on the development and commercialization of in vitro diagnostic tests for cancer.
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Oxford BioMedica, 60sec ()
Gene therapy and immunotherapy have enormous potential to benefit the lives of patients. Oxford BioMedica is one of the leading companies in this field. We have established a platform of highly innovative technologies to deliver genes that code for therapeutic proteins or induce an immune response.
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Wilex, 60sec ()
WILEX’s mission is to develop drugs with a low side effect profile and targeted treatment of different types of cancer as well as diagnostic agents for specific detection of tumours.
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4SC, 60sec ()
4SC AG (Frankfurt, Prime Standard: VSC/ISIN DE0005753818) discovers and develops small-molecules for autoimmune and cancer indications. 4SC-101, a novel autoimmune modulator, is in a Phase IIb study in rheumatoid arthritis as well as a Phase IIa exploratory study in inflammatory bowel disease. The company’s lead oncology compound, resminostat (4SC-201), a pan-histone-deacetylase inhibitor, is in two Phase II trials in hepatocellular carcinoma and Hodgkin’s Lymphoma. Two further oncology compounds 4SC-203 and 4SC-205 are due to commence Phase I trials. Drug candidates are developed until proof-of-concept in order to generate value creating partnerships with the pharmaceutical industry in return for advance and milestone payments as well as royalties.
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Magforce, 60sec ()
MagForce Nanotechnologies AG is the global leader in the field of nanotechnology cancer treatment. This revolutionary technology aims to establish a entirely new form of cancer treatment within the near future, using magnetic particles to treat tumors with very minimal side effects, thus enhancing patient quality of life. The technology and its related equipment are currently in the final phases of clinical trials. Until these have been successfully concluded, the products can only be used in conjunction with clinical trials. The products can only be sold and used in normal clinical practice once they have received regulatory approval from the responsible authorities.
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MediGene, 60sec ()
MediGene's vision is the expansion of the potentials in medicine by means of utilizing biotechnology in a responsible manner. We apply state-of-the-art technologies in the development of innovative drugs for the treatment of cancer and autoimmune diseases. MediGene pursues the strategy of integrating all core areas of a modern biopharmaceuticals company from research to drug development and commercialization.
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Agennix, 60sec ()
Agennix AG is a publicly traded biopharmaceutical company focused on developing novel anti-cancer therapies. The Company was formed by the combination of GPC Biotech AG and Agennix Incorporated. The Company’s most advanced program is talactoferrin, an oral targeted therapy that is in Phase 3 clinical trials in non-small cell lung cancer. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase 1 testing; the oral platinum-based compound satraplatin; and a topical gel form of talactoferrin for wound healing. Agennix is a transatlantic company with sites in Munich, Germany; Princeton, New Jersey and Houston, Texas.
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Algeta, 60sec ()
Algeta is an oncology company developing treatments for bone metastases and disseminated tumor types. The company's lead product Alpharadin is targeting bone metastases which occur frequently in major cancers including hormone-refractory prostate cancer, breast, lung, kidney and thyroid. The treatment of bone metastases represents an area of high unmet medical need.
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Response Biomedical, 60sec ()
Response Biomedical develops, manufactures and markets rapid point-of-care (POC) diagnostic tests for use with our proprietary RAMP® (Rapid Analyte Measurement Platform) System for clinical and environmental applications. RAMP® has set a new performance standard in rapid diagnostic testing by providing lab quality information in minutes.
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RedPoint Bio, 60sec ()
Redpoint is utilizing its knowledge of the biology of taste and its relationship to metabolic processes, satiety and diabetes to focus its research programs on the development of healthier foods and new therapeutic approaches to the treatment of diabetes and obesity.
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2009 in Review, the M&A and Venture Perspectives (1/3) (7:02)
Fred Frank and Dennis Purcell share their perspective on the transformative events of 2009 that are indicative of the future. With 3 mega-deals (Pfizer + Wyeth, Merck + Schering Plough, Roche + Genetech), the pharma landscape is changing - unfavorably for biotech. The follow-on market was strong for large cap, although we've seen less pharma aquiring, and a challenging IPO market. Dennis Purcell comments "we've reset the bar in terms of what you get paid for." Fred Frank notes that while pharma's mega-deals often diminish value and are motivated by fear of patent expiration, the Pfizer Wyeth deal seems to have a more solid strategic rationale. The structure of M&A deals appears to be converging with licensing deals - with smaller upfront and larger milestone payments.
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2010, Where Do We Go From Here? (2/3) (8:26)
Kicking off 2010, Fred Frank advises pharma CEOs to curb those silly stock repurchase programs, and Dennis Purcell advises investors to take capital when it's there and not be overly concerned with dilution. Fred and Dennis continue to discuss consolidation, predominant deal structures, the focus of biotech and pharma, as well as their natural evolution and partnership. Finally, Fred and Dennis share some thoughts on the upcoming biotech IPOs. Many filings are expected but the strength of the post-IPO market is the most critical point to be considered - one which Dennis Purcell says might be victim of an excessive supply from companies trying to raise capital and boutique investment banks pushing them out. Fred remarks that while success breeds success, the later stage companies with approved phase 3 that complete successful IPOs might be encouraging to earlier stage companies, that might not perform as well in the aftermarkets and kill the IPO market. Fred warns that "failure also breeds failure".
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FAST Word Association Game, with Fred Frank and Dennis Purcell (3/3) (1:09)
Fred Frank and Dennis Purcell share with us their spontaneous reaction to key buzz-words, in this classic game presented here by John Mohr and introduced by Needham's Mark Monane. The day's words are : 'Biotech' 'Personalized Medicine' 'Regulatory Environment' 'PharmacoEconomics' 'Innovation' 'Investors'.
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NASDAQ Perspective, Part 1 - Biotech Markets in 2009 (3:12)
While the perspectives might have looked grim early in the year, throughout the year, we've seen numerous signs of recovery and a newfound health in the markets. The Biotech IPO market reopened with Telacris (TLCR) the 4th largest deal of the year, and followed by Cumberland (CPIX) and Nuokang (NKBP) showing signs of an increasingly robust healthcare market, specifically for biotechnology. Since September 15th, the backlog started filling up with a dozen companies filing for IPOs.
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NASDAQ Perspective, Part 2 - Expectations for Biotech in 2010 (4:19)
How will Biotech perform in 2010? With a Q409 setting us up for a positive 2010, the return of the IPO market means new exits for private equity and venture capital investors, who will in turn be able to reinvest in new companies. A dozen Biotech IPOs could be expected in the first 4months of this year. The international outlook is also very positive with Israeli, European, and Chinese companies filing for NASDAQ IPOs. Indicators of success to look for are the strength of the overall market, and the pricing of the issues to come market.
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NASDAQ Perspective, Part 3 - Helping Smaller Biotech Companies Stay Listed (2:38)
It is hard to get listed, and sometimes just as hard to stay listed. Just as we began to understand the magnitude of the financial crisis in September 2008, NASDAQ asked the SEC that companies shouldn't be immediately delisted, if they began trading under $1. This request was shortly thereafter granted, helping keep many companies on the market. Additionally, NASDAQ has been developing the services it provides to issuers (e.g. risk management, corporate governance, investor relations, intelligence on stock trading) in an effort to drive new efficiencies. Finally, we've seen some success with Sarbanes-Oxley, further reducing the cost of trading for Biotechnology companies listed on the NASDAQ.
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Stem Cell Review: Tissue Repair (EP10) (8:20)
Rebuilding tissue with stem cell products requires bioengineering. Bob Langer of MIT helps us understand the bio-engineer's role in (a) the isolation, purification, and expansion of cells (b) the encapsulation - immuno-isolation (c) the creation of scaffolds to guide the cell development, and (d) the monitoring of stem cell activity and clinical benefit. Bob shares clinical stories including heart tissue repair and spinal cord repair. He then touches on the regulatory aspect of stem cells and devices, which together form combination products. In his future outlook, professor Bob Langer describes cellular therapy for tissue repair, having the potential to bring revolutionary treatments to patients, such as rebuilding organs - something traditional drugs could never accomplish.
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Organogenesis' Apligraf: Allogeneic Cell Based Wound Healing; FDA Approved and Shipping! (EP10) (9:03)
Organogenesis CEO Geoff McKay presents one of the leading cell therapy companies today. Built through revenues over the past 5 years, Organogenesis' lead product, Apligraf, is FDA approved, and currently being sold to wound care centers around the world. Organogenesis' pipeline also includes a tendon repair product (in partnership with Integra LifeSciences), as well as the first product approved by the FDA to stimulate soft tissue regeneration in the mouth (receding gum). Finally, Geoff highlights the business model, according to which Organogenesis is responsible for the product from development and manufacturing to commercialization. Organogenesis has it's own commercial team.
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Stem Cell Review: AutoImmune Diseases & Blood Disorders (EP9) ()
What are Hematopoietic Stem Cells (HSCs)? Where can we we find them? Where do they originate? Hanna Mikkola of UCLA helps us understand HSC, the current limitations in cell expansion that are limiting clinical use, as well as the direction of the efforts being made today to overcome this challenge (better harvesting, in vitro expansion, better engraftment, generating HSCs from human embryonic stem cells or induced pluripotent stem cells). Hanna reviews some of the clinical indications in which HSCs are being used, including leukemia, inherited immune deficiencies, aplastic anemia, and autoimmune diseases. New discoveries in the placenta show it is a niche in which HSCs can proliferate without differentiating, one we can study to understand HSCs expansion. Finally, Hanna gives a future outlook for HSCs.
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Celgene Derives Stem Cells from the Placenta (EP9) ()
Celgene Cellular Therapeutics CEO Bob Hariri presents the company's placental derived adherent cells (PDAC). These are stem cells derived from the placenta. The placenta is nature's perfect allograft, as Bob points out. Placental cells have indeed been found to regulate the immune system. That is why Celgene's PDACs are being administered to shut down auto-reactive destructions of the body. Celgene Cellular Therapeutics' (CCT) principal clinical program is in Crohn's Disease. Additionally CCT's cells might be useful in other auto-immune diseases (such as Multiple Sclerosis), CNS, Diabetes, Cardiac, Oncology, Orthopeics, or Wound Healing. The immune advantage that the placenta means there is no need to match donor to recepient, allowing a true allogeneic / pharma business model. Bob Hariri's long term strategy is to apply the understanding of the fundamental biology to specific diseases, and develop cells a regenerative product, with an extremely rigorous manufacturing program.
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Fate Therapeutics Modulates Cell Fate (EP9) ()
Fate Therapeutic's CEO Paul Grayson presents the company's modulation of endogenous stem cells (stem cell fate). Fate can induce proliferation, differentiation, or modification of the function of a cell. Fate is using iPSCs to recapitulate a cell type in discovery, and see how to modulate that stem cell as a therapy for particular diseases. Fate's products are currently in the clinic treating hematological disorders (such as leukemia, lymphoma) with Hematopoietic Stem Cells (HSC) from cord blood. Fate's unique position in stem cell modulation and with iPSCs give it an IP and a competitive advantage. Financially, the company is sound, and backed by top tier VC including Arch Ventures, Venrock, and Polaris.
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Stem Cell Review: Stem Cells & Diabetes (EP8) ()
Alan Lewis of the Juvenile Diabetes Research Foundation distinguishes type 1 and type 2 diabetes, and continues to explain how stem cells are being used today to develop new treatments for type 1 diabetes (a.k.a. juvenile diabetes). Human embryonic stem cells (hESC) are being differentiated to the beta (insulin producing) cells that type 1 diabetics lack, and are being transplanted , in animal models. Since type 1 diabetes is an auto-immune disease, the transplanted cells must be protect from destruction by the immune system. Currently, researchers are working towards that goal with encapsulating technologies and a "gentle" immuno-modulation. In order to treat a diabetic patient, access to an unlimited number of cells is necessary. Alan compares embryonic stem cells, adult stem cells, and iPS as source of cells. And finally, in a future outlook, Alan comments on the FDA's concern for safety, the risk of creating a tumor, artificial pancreas (as an alternative approach), and cell therapy's potential to CURE diseases.
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Novocell Leading Type-1 Diabetes Stem Cell Research (EP8) ()
Novocell CSO Ed Baetge presents the company's pancreatic progenitor cell based approach to the treatment of diabetes type 1. Embryonic stem cells are differentiated into pancreatic progenitor cells and then transplanted in a capsule, where the beta (insulin) cells and islets are formed (invivo). The capsule used must be highly vascularized, and protect the cells from immune destruction. The combination of a cell therapy and a device is how Novocell plans to achieve a superior safety profile in it's future human clinical trials. Ed mentions some of the issues that need to be overcome (including teratoma formation, purity, efficient cell differentiation, encapsulation). Future milestones include the development of a manufacturing for the cells, and a GMP process for the capsules, followed by an FDA pre-registration (expected late 2010), as well as safety, efficacy, and dosing studies for an NDA filing in 2011-2012.
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Pfizer's Broad Use of Stem Cells, in Search of New Cures (EP8) ()
How is Pfizer involved in stem cell research? Joe Hammang, traces back Pfizer's long history in animal based stem cell research for drug screening, and their current use of embryonic stem cells, adult stem cells, and induced pluripotent stem cells (iPS). Pfizer's focus was initially in tools, but now also includes a significant effort in diabetes, cardiovascular, and ophthalmology, where there is a significant unmet need. Joe explains Pfizer's particular interest in diabetes, and their collaboration with Novocell. Additionally he underscores Pfizer's research and leadership's commitment to finding therapies that can CURE diseases.
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Stem Cell Review: Neural Stem Cells and CNS Disorder (EP7) (12:47)
What is a neural stem cell? How can they help treat neurological disorders such as Alzheimer's disease, Parkinson's disease, spinal cord injury, stroke, ALS (Lou Gehrig's Disease)? Evan Snyder of the Burnham Institute helps define neural stem cells (NSC), explaining that they are relatively inaccessible in the adult patient, but that they seem to benefit from some immunotolerance. It follows that we may be able to use readily available lines of embryonic stem cells for therapy in neurodegenerative disease. Evan reviews current clinical applications for neural stem cells (including as a vehicle for small molecule delivery), and gives his future outlook for neural stem cells. Evan forsees NSCs being used in anti-inflammatory and neuroprotective functions, to deliver tumor killing genes, and to build iPS drug discovery models.
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StemCells Inc. using Neural Stem Cells for their Neuroprotective Effect (EP7) (11:11)
Discover StemCells, Inc (NASDAQ: STEM). A pioneer in the field of neural stem cells, StemCells Inc was founded by the renown Irving Weissman, Fred Gage, and David Anderson. Martin McGlynn, CEO, presents StemCells Inc's use of neural stem cells, and clinical development strategy based on the neuroprotective effect of neural stem cells. Stem Cells Inc is preparing a BLA for NCL (a.k.a. Batten's Disease). Martin reveals the source of the stem cells used, as well as the quantity of cells needed for the treatment of various diseases. StemCells Inc's next clinical trials (PMD, spinal cord, macular degeneration) and milestones are also presented here. We conclude this interview with Martin's comments on successfully dealing with the complexity of regularity matters, beyond FDA approval.
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Q Therapeutics and the Role of Neuronal Support Cells (EP7) (7:03)
Discover the Q cells of Q Therapeutics (Private, Salt Lake City, UT). Deborah Eppstein, CEO presents her company, which is focused on the creation of the support cells for the neurons that make up 90% of the central nervous system (CNS). Q Therapeutic's glial progenitor cells - dubbed Q-Cells - form oligodendrocytes and astrocytes. The Q-Cells are "mini-factories" for neuron support cells that help keep neurons healthy and restore their function before they die. Q Therapeutics is targeting demylenating diseases (multiple sclerosis, transverse myelitis, and cerebral palsy), but also other neurodegenerative diseases and conditions (ALS / Lou Garrig's Disease, Alzheimer's Disease, Parkinson's Disease, and spinal cord injury). Q's clinical trial design is centered around a non-systemic therapy (for safety), and objective measure of improvement (for efficacy). In a competitive universe where most companies are focused on neural regeneration, Q-Cells could come in as a good therapeutic complement.
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Stem Cell Review: Mesenchymal Stem Cells and Connective Disorders (EP6) (9:32)
Gordana Vunjak-Novakovic of Columbia University gives us an explanation of what mesenchymal stem cells are; adult stem cells that are present in many organs and tissues, and that drive tissue repair. The main sources of mesenchymal stem cells are bone marrow and fat (adipose tissue), although they can be found lesser quantities in muscle, blood, heart, liver, and other tissues. Mesenchymal stem cells can be used to regenerate many different types of tissue, but the most promising clinical applications are in bone, cartilage, ligaments, muscle, neural cells, and striated muscles. Mesenchymal stem cells are thought to repair the heart muscles through revascularization and recruitment of repair cells, but the data does not yet show that they can convert into heart muscle. In a future outlook, Gordana shares with us what she thinks is in the near future of mesenchymal stem cells: well defined cells that can be differentiated predictably, understanding the importance of cell origin on clinical outcome, new FDA friendly delivery routes, more effective functional markers and monitoring, and increasing interdisciplinary collaboration.
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Angioblast, Mesoblast, and the Medical Applications of Mesenchymal Precursor Cells (EP6) (9:33)
AngioBlast Systems (Private, NY, USA) and Mesoblast (ASX:MSB), Melbourne, Australia) are the two companies featured in this episode of the Stem Cell Review. Michael Schuster presents the companies' mesenchymal precursor cells isolated from bone marrow, for allogeneic treatment. On the one hand, AngioBlast focuses on cardio vascular indications (heart failure, heart attack) with a phase 2 trial that is 2/3rds of the way, and has an encouraging efficacy profile. On the other hand, Mesoblast is focused on orthopedic indications (mainly bone regeneration and cartilage repair) with an equally promising pilot study in long bone fractures that don't heal over time.
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Auxilium (AUXL) Pfizer Deal, Financials, Business Development, and Upcoming Milestones (4/4) ()
$75M upfront, with a total of $500M in milestones, and double digit royalties. Those are the terms of Auxilium Pharmaceutical's deal with Pfizer. The synergy has increased with Pfizer's recent aquisition of Wyeth. Salveen Kochnover of Collins Stewart and Armando Andio of Auxilium discuss the commercial rights, with an outlook on geography, indications, and other partnership opportunities. Salveen and Armando also review the expected TESTIM revenues for 2009, and the upcoming milestones (Dec 09, data in Dupuytren's; early 2010, submission of XIAFLEX in EU by Pfizer). 5 years from now, Armando expects XIAFLEX will be blockbuster drug.
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XIAFLEX Driving Auxilium's (AUXL) Stock, Dupuytren Indication (1/4) ()
Armando Anido, CEO of Auxilium Pharmaceuticals (AUXL) is interviewed by Salveen Kochnover of Collins Stewart. Salveen asks about the enzyme know as XIAFLEX that breaks down the collagen causing Dupuytren's disease. Armando explains Dupuytren's disease is present in 3-6% of adult caucasian males. Salveen and Armando discuss the clinical data, which has been favorably reviewed by the FDA for safety and efficacy. The results of the XIAFLEX treatment seem to be comparable to those of surgery.
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Auxilium (AUXL) CEO's Strategy to Bring XIAFLEX to the Dupuytren Market (2/4) ()
With upcoming Phase 3 results, Armando Anido, CEO has ramped up Auxilium Pharmaceuticals' commercial infrastructure. The interaction FDA has been positive although they missed their PDUFA date last August. Salveen Kochnover of Collins Stewart inquires about the physician training program and the 5year, 50% recurrence of Dupuytren's disease.
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Auxilium (AUXL) Collagenese XIAFLEX Could be a Pipeline in a Product, Treat Multiple Indications (3/4) ()
XIAFLEX attacks the collagen deposits that cause Dupuytren's contracture (a fixed flexion contracture of the hand where the fingers bend towards the palm and cannot be fully extended), Peyronie's disease (abnormal curvature of the penis), cellulite, keloidal scar, and frozen shoulder (restricting motion and causing chronic pain). Results are expected in Peyronie's in December, with a breaking of the blind and release of top line data. Armando Anido, CEO of Auxilium Pharma is planning an FDA Phase 3 proposal in early 2010. Salveen asks Armando about access to treating physicians for Peyronie's disease (since they are not the same as those treating Dupuytren). Armando explains that Auxilium is well implanted in the urology community with TESTIM, a product that has been treating men with hypogonadism, or low testosterone since Feb 2003. With a Phase 3 approval in Dupuytren, Auxilium will launch new programs, in new indications.
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Stem Cell Review: Looking Forward to 2015 (16:23)
How will stem cells change the way we think about treating diseases? Here is the 5 year forward look at the world of Stem Cells, from some of the greatest experts in the field. What are the diseases we'll be treating, and the tools we'll be using in 2015? Where will we be in terms of clinical trials? What are the dangers in the stem cell hype, and medical tourism? How will stem cells pave the way for personalized medicine, and more rational treatments? How important will stem cells become in the drug discovery process? Discussed in the episode are the eye (macular degeneration), the skin, diabetes (type 1 & 2), blood and autoimmune diseases, glioblastoma, HIV, and more.
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Stem Cell Review: Tools for Drug Screening (EP4) (16:13)
Researchers are using stem cells as tools for disease study, drug screening, clinical trial strategy, and personalized medicine. The induced Pluripotent Stem cell (iPS) is giving us a chance to rethink the way we are developing new drugs. These iPS cells are usually created from somatic cells (such as skin), and not embryos or adult stem cells. In creating iPS from patients' diseased cells, scientists can study the disease in vitro, looking for disease phenotypes, applying microenvironmental stress, and testing new drugs. Compared to animal model testing (e.g. mice), this represents a significant breakthrough, that can be used to validate clinical development strategy and test efficacy in specific groups of patients. iPS is bringing a revolution in drug discovery methodology which is being used to bridge genetics, cell biology, and physiology.
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Stem Cell Review: Biological Processes & Industrial Production (EP3) (22:49)
What are the biological processes that stem cells go through? What are the industrial processes we need to manufacturing? What do we know about cancer stem cells? How do iPS cells fit into the picture vs. embryonic stem cells? In this episode we investigate how the science and research of stem cells is being translated into industrial cell processes to create FDA approvable, and commercializable products. Differentiation, proliferation, migration, retro-differentiation, trans-differentiation, transformation into cancer cells, the role of tumors' micro environments and epigenetics and all reviewed here by the field's foremost experts.
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Can ISIS Pharma's Antisense Turn Drug Discovery on its Head? (1/4) (6:05)
ISIS CEO Dr. Stanley Crooke presents the Antisense platform technology as the natural successor of small molecules and monoclonal antibodies as a drug discovery platform. This platform is fully controlled by ISIS and made available to partners. Needham Analyst Mark Monane and Dr. Crooke discuss the increased speed in drug discovery and reduced risk of failure that Antisense brings. Partnerships and competition are also brought into the discussion. Dr. Crooke affirms a couple billion dollars in partnerships over the past 20 years. With such promising technology, ISIS Pharmaceuticals might strike fear into the hearts of the "old school" biotech companies.
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Genzyme and ISIS Partnership on Lead Product "Mipomersen" for LDL-Cholesterol Reduction (2/4) (9:29)
Dr. Stanley Crooke of ISIS Pharmaceuticals and Mark Monane of Needham & Company discuss ISIS' pipeline, starting with Lead Product Mipomersen, antisense drug being developed with Genzyme, currently in Phase 3 studies in patients who cannot adequately control their cholesterol levels. Mark & Stanley talk through the relationship with Genzyme, the subcutaneous administration of the drug, and the merits of a study in cholesterol, where measurable targets provide an unequivocal test of success or failure. In a 19 product strong pipeline, are many other promising worth discussing. Stanley highlights a few of the next generation drugs in development at ISIS pharmaceuticals.
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ISIS Pharma's Development Strategy, Capital Needs, and Upcoming Milestones to Look Out For (3/4) (6:25)
How does ISIS Pharmaceuticals decide to partner a product or develop it internally? How far in the development will ISIS go? What is ISIS pharma's financial position? What are its growth prospects? What are the important upcoming milestones that will have an impact on the stock? Mark Monane of Needham & Company inquires about all of the above with Dr. Stanley Crooke, CEO of ISIS Pharmaceuticals.
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ISIS Pharmaceuticals CEO Comments on Valuation, Plays the "Word Association" Game with Mark Monane (4/4) (5:59)
With 19 Products in it's pipeline, what may be a groundbreaking proprietary platform technology, and numerous partnerships, ISIS Pharmaceuticals is hard company to value. And Dr. Stanley Crooke, CEO doesn't apologize for it. He then agrees to play Needham Analyst Mark Monane's favorite game, the fun and incisive "Word Association".
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Stem Cell Review: Allogeneic or Autologous? (EP2) (24:56)
Reviewing the technology, business models, intellectual property, regulatory concerns, transplantation and immune rejection. This is the 2nd episode of the Stem Cell Review.
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Stem Cell Review: Stem Cells at a Glance (EP1) (18:37)
What are the different types of stem cells? Potential medical applications? Different business models? Ethical and political constraints? This 1st episode of the Stem Cell Review is a good introductory overview of stem cells.
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Lee Buckler's Cell Therapy '08 Review and '09 Outlook (04:47)
Exciting things we've seen in 2008 are
- the involvement of pharma in cell therapy, investing like they haven't before, developing cell therapy products as drugs, and not just tools (including companies such as Pfizer, GSK, Roche, and Novartis)
- the number of late stage companies in the sector such as Osiris (see: Osteocel / NuVasis, and Prochymal + Chondrogen / Genzyme deals)
- the financing, partnerships and M&A activity with $400M private equity investment, $100M M&A, and $1.8bn non M&A deals.
Things to watch for in 2009 are
- some of the late stage companies (Osiris and Dendrion - i.e. Provange results in April)
- the struggling cell therapy companies and how they will find cash (M&A, Government, VC?)
- the role of the new Obama administration and the public pressure, interest, and enthusiasm for cell therapy -
Harvard Steps Into the Cell Therapy Funding Gap with a Mission for Academic Research to Get to Patients (06:24)
Brock Reeve explains the functioning of the Harvard Stem Cell Institute (HSCI). The HSCI is looking to make the bedside-to-bench and bench-to-bench loop in a way that unequaled anywhere, with the university, its 11 affiliated hospitals, drawing resources from the various schools (law, business, government, divinity). Brock tell us about about the HSCI partnership with GSK, as well as the other relationships they are seeking and building at the moment.
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Roche's Vertes on Big Pharma's Interest in Cell Therapy (03:59)
Alain Vertes of Roche presents the interest of big pharma in the cell therapy. He highlights the main points of his panel presentation:
1. Cell therapy is not a passing fad
2. Cell are not just transplants, they can also be drugs
3. Paradigm shifting applications for cell therapy
4. Protecting intellectual property
5. Potential for stunning efficacy and low risk of side effects -
US and EU Regulatory Synergies, and EMEA Committee for Advanced Therapies (03:34)
Christopher Bravery comments on the new committee for advanced therapies of the EMEA, and its impact on the development of cell therapy in Europe. Christopher also reflects on the similarity between US and European regulatory environments, and the importance of considering that in planning pivotal studies. He also gives us his definition of Cell Therapy and explains the business of ERA Consulting.
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How Would You Define Cell Therapy? (02:28)
We've asked guests and panelists of the 2009 Phacilitate Cell & Gene Therapy forum to answer the following question:
How Would You Define Cell Therapy?
Here are their answers, mashed up by yours truly. -
Are We Going to See New Cell Therapy Products in the Next 2-3 Years? (01:31)
We've asked guests and panelists of the 2009 Phacilitate Cell & Gene Therapy forum to answer the following question:
Are We Going to See New Cell Therapy Products in the Next 2-3 Years?
Here are their answers, mashed up by yours truly. -
How Many Cell Therapy Products Are On the Market Today? (01:27)
We've asked guests and panelists of the 2009 Phacilitate Cell & Gene Therapy forum to answer the following question:
How Many Cell Therapy Products Are On the Market Today?
here are their answers, mashed up by yours truly. -
What Are Some of the Exciting Things Happening in Cell Therapy? (02:06)
We've asked guests and panelists of the 2009 Phacilitate Cell & Gene Therapy forum to answer the following question:
What Are Some of the Exciting Things Happening in Cell Therapy?
Here are their answers, mashed up by yours truly. -
Maxcyte, 60sec Pitch (01:08)
MaxCyte is a clinical-stage cell therapeutics company with a rapidly growing pipeline of product development partnerships in cell-based therapies. The Company's proprietary, non-viral, ex vivo cell loading technology provides safety, scalability and reproducibility capabilities which are fundamental to commercializing successful cell-based therapies. MaxCyte has demonstrated the value of its versatile technology in partnered therapeutic programs in oncology, pulmonary, metabolic and infectious diseases as well as in development collaborations with leading researchers.
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Florida Biologix, 60sec Pitch (01:19)
Florida Biologix® is a biopharmaceutical contract services provider that specializes in developing, manufacturing, purifying, testing and filling Phase I and II cGMP biologic clinical trial material on time and at a reasonable price.
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Athersys Inc., 60sec Pitch (01:09)
Athersys is a developing a pipeline of therapeutic products with “best-in-class” potential. The most advanced product in development is MultiStem, a patented and proprietary stem cell therapy that in the past year has reached clinical stage in 3 areas, including treating cardiovascular disease (acute myocardial infarction), cancer treatment support (leukemia and lymphoma), and ischemic stroke. The company believes MultiStem represents a potential breakthrough in stem cell medicine, since it is the first off-the-shelf stem cell product with each of the following characteristics:
(1) it can be manufactured on an industrial scale far greater than any other stem cell product, and conveniently stored in frozen form;
(2) it can be administered without tissue matching or any immune suppressive drugs, making it analogous to type O blood;
(3) it has the potential to deliver a therapeutic benefit in multiple ways, primarily through the regulated production of multiple factors that control inflammation and immune response, promote tissue repair and healing, protect damaged or injured cells, and deliver other benefits.
MultiStem exhibits a consistent safety profile, and has demonstrated therapeutic effectiveness across a range of disease indications. MultiStem was recently awarded the 2008 Product Innovation of the Year by Frost & Sullivan, who designated it as best-in-class among stem cell and regenerative medicine technologies. In addition to MultiStem, Athersys is developing a portfolio of pharmaceutical candidates for neurologic disease and certain metabolic indications such as obesity. -
Molecular Diagnostics As The Next Major Conceptual Transition (06:05)
Jan Buck welcomes Dr. George Poste onto his show to discuss his uniquely rich view of the life science industry and highlights of his distinguished career. George tells us about his time at SmithKline Beecham, where he witnessed the dramatic transformations driven by molecular biology, genomics, and genetic engineering. Furthermore Jan and George look into molecular diagnostics and how they will allow us to transcend symptoms based empirical approaches and more rigorously characterize the underlying molecular pathologies.
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Mapping the Human Genome, And The Innovator's Dilemma In The Pharma Industry (07:02)
On this latest edition of the Jan Buck Show, Dr. George Poste tells the story of one of the greatest broad-scale industry collaborations, the SNP Consortium (which became the HapMap Project). Aimed to study population genomics in relation with the analysis of susceptibility to disease and responsive to treatment, it harness the power of a large number of companies to create this body of data, furthering the research capabilities of all, while defraying risk and cost. Jan and George continue to discuss radical innovation, the innovator's dilemma, and how it has applied to pharma and it's blockbuster drugs.
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Taking Out A Small Number of Pharmaceutical Manufacturing Plants Could Dislocate Medicine Supply For Large Numbers of the Global Population (05:41)
Dr. George Poste tells the story of his involvement with the Antibioterrorism Task Force and the Office of the Secretary of Defense. When the DoD started looking at global infectious diseases - trying to measure the social, economic and military risk - they brought George in. Jan and George then discuss the post 9/11 era, and securing the medicine production and supply chain.
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The Biodesign Institute, A Radical Experiment To Extract The Low Intensity Signal That May Be Indicative Of Disease (08:14)
Dr. George Poste tells Jan Buck about his beginnings as veterinarian in the south of England, his escape from Europe to the United States in pursuit of greater scientific opportunity, and his recruiting at SmithKlein Beecham, taking genetic engineering technologies into the industry. George and Jan comment on the contribution the pharmaceutical industry has made towards human life. They continue to discuss his role in the creation of the Biodesign Institute of Arizona State University, where the life sciences are integrated with high level engineering, computing, and mathematical analysis. They measure hundreds or thousands of genes simultaneously, defining patterns of expression of multiple markers in the body, that may be indicative of disease.
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A Look to the Future: Personalized Medicine, Consumer Driven Health, Synthetic Biology (07:47)
Jan Buck and Dr. George Poste take a look at the blockbuster based business model of the Pharma industry, and how it might evolve in the years to come. They identify two emerging trends. First, is personalized medicine. Diagnostics and therapy will be increasingly linked. Clinical trials will become smaller, more effective, and cheaper to run. Second is consumer driven health, in which we all take greater responsibility for our own health. Finally, George tells us of his latest governmental responsibility, heading a new task force on synthetic biology - genetically engineering microorganisms to develop a new industrial ecology that can create alternative energy, novel materials, and molecular species that would otherwise be impossible or prohibitively expensive to produce.
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Osiris CEO on the Tremendous Therapeutic and Commercial Applications of Mesenchymal Stem Cells (08:34)
Randy Mills of Osiris and Bill Kirdel discuss the Osiris pipeline and technology. Bill asks Randy about the difference between Osiris' mesenchymal stem cells (MSC) and embryonic stem cells (ESC). Randy explains that MSC are persistent in the human body and that they contribute to our natural healing process. Moreover, the MSC, traditionally associated with connective tissue, have tremendous applicability due to their inflammation regulation, tissue regeneration, and tissue protection abilities. Randy continues to explain Osiris' business development strategy, following the prodigious $1.4 partnering deal with Genzyme for lead compounds in ex-US/Canada markets. Randy and Bill continue to review the execution focused future of Osiris, potential consolidations in the field of cell therapy, and the future of regenerative medicine beyond Osiris.
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Beyond Tests, Lab Service Genoptix (GXDX) Provides Comprehensive Diagnostics, New Efficiencies for Healthcare System. ()
Genoptix CEO, Dr. Tina Nova is interviewed by Adam Feinstein of Barclays Capital. Tina and Adam discuss the origination of the business, and how their comprehensive diagnostics services fit into existing medical paradigms. Tina explains Genoptix holds some of the best hempaths among its ranks, and it focuses on quality diagnostics and quality service. This has been the fuel for its rapid growth. Adam challenges Tina about her plans for managing growth. Given the pricing is fixed, Genoptix will raise its bottom line from increased revenue and greater efficiencies. Tina and Adam continue to discuss the current macro-enviroment and its implications for Genoptix, the impact of President-elect Obama's future healthcare reforms on diagnostics, as well as exciting new developments to come.
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ZelosTherapeutics, Inc. 60sec Pitch ()
Zelos Therapeutics is developing therapeutics for the treatment of osteoporosis and other bone diseases. Our lead compound, ZT-031, is entering Phase 3 registration studies and has the potential to become a leading therapy to treat osteoporosis in the growing PTH market.
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Xoma, Ltd. 60sec Pitch ()
XOMA discovers, develops and manufactures therapeutic antibody agents designed to treat inflammatory, autoimmune, infectious and cancerous diseases and is engaged in more than 16 active development projects. The Company's expanding pipeline includes XOMA 052, an anti-IL-1beta antibody, and XOMA 629, a synthetic antimicrobial peptide compound derived from bactericidal/permeability-increasing protein.
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Vivus Inc. 60sec Pitch ()
VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products. The current portfolio includes investigational products addressing obesity, diabetes and sexual health.
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Vical Incorporated, 60sec Pitch ()
We research and develop biopharmaceutical products based on our patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.
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Osiris Therapeutics, Inc. 60sec Pitch ()
Osiris Therapeutics, Inc. is a leading stem cell therapeutic company focused on developing products to treat medical conditions in the inflammatory, orthopedic and cardiovascular areas. Prochymal is being evaluated in Phase III clinical trials for three indications, including acute and steroid refractory graft versus host disease and also Crohn's disease, and is the only stem cell therapeutic currently designated by FDA as both an Orphan Drug and Fast Track product.
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Newron Pharmaceuticals, SPA, 60sec Pitch ()
Newron Pharmaceuticals S.p.A. is a biopharmaceutical company focused on novel therapies for diseases of the Nervous System and pain.
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MiMedx Group Inc. 60sec Pitch ()
MiMedx Group, Inc., (MDXG) is an integrated developer, manufacturer, and marketer of patent protected, spine and orthopedic implants which represent breakthroughs in the treatment of trauma and disease.
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Mannkind Corporation, 60sec Pitch ()
Mannking Corporation is a biopharmaceutical company focused on the discovery, development and commercialization of therapeutic products for diseases such as diabetes and cancer.
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Dyax Corp. 60sec Pitch ()
Dyax is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on oncology and inflammatory indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development.
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Cynvec, LLC, 60sec Pitch ()
Cynvec is a development stage, NYC based company formed in June 2004 to develop Sindbis-based viral vectors as oncolytic therapeutics, through IP licensed exclusively from NYU.
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Cell Therapeutics, Inc. 60sec Pitch ()
Cell Therapeutics Inc. (CTI) develops, acquires and commercializes novel treatments for cancer. Its goal is to build a leading, vertically-integrated biopharmaceutical company with a diversified portfolio of proprietary cancer drugs. Its research and in-licensing activities are focused on identifying new, less toxic and more effective ways to treat cancer.
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Acucela Inc. 60sec Pitch ()
Acucela Inc. is a clinical-stage biotechnology company focused on developing new drug therapies for blinding eye diseases such as age-related macular degeneration (AMD), Stargardt disease, diabetic retinopathy and retinopathy of prematurity, as well as dry eye.
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Synta Pharmaceuticals Corp. 60sec Pitch ()
Synta Pharmaceuticals Corp. is a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to extend and enhance the lives of patients with severe medical conditions, including cancer and chronic inflammatory diseases.
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Novelos Therapeutics, Inc. 60sec Pitch ()
Novelos Therapeutics, Inc. is a biopharmaceutical company commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis.
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MorphoSys AG, 60sec Pitch ()
MorphoSys is one of the world's leading biotechnology companies focusing on fully human antibodies. With its proprietary technologies, MorphoSys is developing the next generation of antibodies not only for research and diagnostics purposes, but also as highly effective and precise therapeutics. HuCAL® (Human Combinatorial Antibody Library) is a very powerful technology for the rapid and automated production of specific antibodies.
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The Female Health Company, 60sec Pitch ()
The Female Health Company (FHC) owns certain world-wide rights to the Female Condom (FC1 and FC2) – a revolutionary option offering women dual protection against both sexually transmitted diseases, including HIV/AIDS, and unintended pregnancy.
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EyeGate Pharma, 60sec Pitch ()
EyeGate Pharma is a privately held, specialty pharmaceutical company pioneering the use of iontophoresis technology to safely and non-invasively deliver therapeutics to the front and back tissues of the eye. The company’s lead program is EGP-437 being developed for severe uveitis, dry eye and corneal graft rejection.
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Depomed, Inc. 60sec Pitch ()
Depomed, Inc. is a specialty pharmaceutical company with two approved products on the market and other product candidates in its pipeline. The company utilizes its proven, proprietary AcuFormTM drug delivery technology to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract.
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Delcath Systems, Inc. 60sec Pitch ()
Delcath Systems, Inc. is a medical technology company specializing in cancer treatment. The Company has developed a proprietary, patented system which will improve the efficacy of cancer treatment while reducing the considerable, systemic side-effects of chemotherapy.
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BioSpecifics Technologies Corp. 60sec Pitch ()
BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed and licensed injectable collagenase for three clinical indications: Dupuytren's disease, Peyronie's disease and frozen shoulder (adhesive capsulitis).
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Antigenics Inc. 60sec Pitch ()
Antigenics is a biotechnology company working to develop treatments for cancers and infectious diseases.
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Alchemia Limited, 60sec Pitch ()
Alchemia is an Australian biopharmaceutical company employing innovative technologies for the synthesis of complex carbohydrates, the targeting of cancer drugs to tumors and the discovery of medicinal drugs for human use.
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Agile Therapeutics, Inc. 60sec Pitch ()
Agile Therapeutics is a specialty pharmaceutical company focused on developing and commercializing innovative women’s healthcare products that address unmet needs.
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Suven Life Sciences, 60sec Pitch ()
Suven Life Sciences Limited is Hyderabad based life sciences company a pioneer in Contract Research And Manufacturing Services (CRAMS) since 1995. Suven in its endeavor to become collaborative research partner (CRP) for global life science companies has embarked on new business model “Drug Discovery and Development Support Services” (DDDSS) with the onset of Intellectual Property Regime in India since January 2005.
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Stem Cell Therapeutics Corp. 60sec Pitch ()
Stem Cell Therapeutics Corp. is a Canadian biotechnology company (TSX-V: SSS) focused on the development and commercialization of drug-based therapies to treat central nervous system diseases.
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Oncolytics Biotech, Inc. 60sec Pitch ()
Founded in 1998, Oncolytics Biotech Inc. is a public, Canadian-based biotechnology company that is developing a novel,virus-based cancer therapeutic. The reovirus has been shown to selectively kill certain cancer cells without damaging healthy cells and tissues.
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Numoda Corporation, 60sec Pitch ()
As a growth partner to life science companies, Numoda Corporation opens up clients’ options fast, through Improved Norms™, including data lock within hours of the last patient visit. Information services and process management are applied for improved norms in corporate and business development, financial, and product development.
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Neotropix, Inc. 60sec Pitch ()
Neotropix began operations in 2005 to develop and commercialize naturally derived, systemically deliverable oncolytic viruses for the treatment of solid tumors.
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Interleukin Genetics, Inc. 60sec Pitch ()
Interleukin Genetics is a leading, genetics-focused personalized health company that develops preventive consumer products and genetic tests for sale to the emerging personalized health market.
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Infinity Pharmaceuticals, Inc. 60sec Pitch ()
The mission of Infinity Pharmaceuticals, Inc. is to discover, develop, and deliver to patients best-in-class medicines for the treatment of cancer and related conditions.
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Converted Organics, Inc. 60sec Pitch ()
Converted Organics Inc. is transitioning from a development stage company (first reported revenues were in February 2008) to a fully operational company that seeks to construct processing facilities that will use food waste as raw material to manufacture all-natural soil amendment products combining nutritional and disease suppression characteristics.
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Cleveland Biolabs, Inc. 60sec Pitch ()
Cleveland BioLabs, Inc. (Nasdaq:CBLI) is a drug discovery and development company leveraging its proprietary discoveries about programmed cell death to treat cancer and protect normal tissues from exposure to acute stresses.
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Biovest International, 60sec Pitch ()
Biovest International develops personalized immunotherapies for life threatening cancers of the blood system.
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Arana Therapeutics, Inc. 60sec Pitch ()
Arana Therapeutics Limited, created through the merger of Peptech Limited and EvoGenix Limited in August 2007, is a biotechnology company dedicated to developing and providing antibody and peptide-based human therapeutic products for the treatment of cancer and inflammatory diseases.
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Antisoma PLC, 60sec Pitch ()
Antisoma is an oncology-focused biotech company with operations in the UK and the US. Antisoma’s strategy is to acquire promising early-stage drug candidates, develop these through clinical trials, and bring them to market itself or through partnerships.
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Akela Pharma Inc. 60sec Pitch ()
AKELA Pharma Inc. (TSX: AKL) is an integrated drug development company focused on developing therapies for the growing multi-billion dollar inhalation market.
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Cephalon's Growth Drivers and Promising Market Opportunities for Amrix, Treanda. (07:10)
Frank Baldino, CEO of Cephalon gives a quick overview of the company's financial status and comments on Treanda's recent approval for non-Hodgkin lymphoma (NHL). Interviewed by Eric Schmidt, Senior Biotechnology Analyst at Cowen, Frank comments on the high pricing of Treanda, the implication with respect to patients and payors, and the use of Treanda in earlier lines of treatment. Eric also asks Frank about the opportunity for Amrix, how it compares to Flexeril in the musculoskeletal pain market, and what the plans are for marketing the drug Amrix (given Cephalon has limited marketing experience in competitive markets).
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Cephalon's Provigil Cash Cow Running Out of Milk, But Growth Continues With New Products, Indications, and Geographical Markets. (08:12)
Once Provigil reaches the end of it's patent, how will Nuvigil compete against it's mother compound in the wakefulness market? Frank Baldino and Eric Schmidt discuss Nuvigil's improved formula as well as the new markets it plans to reach. Frank and Eric also discuss the management of Cephalon's substantial net earnings in investment vs. EPS. Frank comments on the future reduction of growth in US markets, as healthcare cost are being curbed. However, Cephalon is building an infrastructure to gain rapid access to the Chinese marketplace, which could be a strong growth driver in the years to come.
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CoNCERT's Deuterium Substitution Platform to Create Better, Faster, Cheaper Drugs. (09:08)
Deuterium has the same properties as hydrogen, only it has the power to make molecules more stable. This creates a number of interesting applications for existing drugs. CoNCERT has developed a technological platform that substitutes hydrogen for deuterium, and has applied this process to a number of marketed drugs in the hopes of creating first or best in class drugs. Roger Tung, CEO of CoNCERT is interviewed by Eric Schmidt, Senior Biotech Analyst at Cowen on the properties of the modified drugs, and their patentability. Eric continues to ask Roger about the efficiency drug delivery process and it's starting points. Finally Roger answers questions regarding CoNCERT's cash position, and potential for growth.
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CoNCERT's Leading Portfolio Asset to step into GSK Paroxetine's $3Bn Shoes. (04:52)
CoNCERT's CTP-347 is a Phase 1 treatment for hot flashes that acts as a substitute for GSK's Paroxetine, with the potential added benefit of little to no drug-drug interaction. Roger Tung and Eric Schmidt discuss future studies vs. Paroxetine or placebo. They also review CTP-518, an HIV protease inhibitor that could offer higher tolerability without a combination use with Ritonavir / Norvir (Abbott), simplifying drug use, and reducing cost to payors.
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CoNCERT's IPO, Partnering Strategies and Full Integration for it's Deuterium Substitution Platform & Pipeline Assets (07:31)
The applicability of CoNCERT's pipeline extends beyond what it can accomplish as a small biotech. To what extent is CoNCERT willing to partner its platform and assets? Is full integration a future possibility? As Eric Schmidt interviews Roger Tung, he asks him about taking the company public. Roger and Eric also discuss the use of this platform beyond the current focus in what could a number of spin-outs. Finally, they take a look at the how CoNCERT's technology can help drugs going off patent, and their parent companies that may be staring at the abyss.
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Markets are Down. Is it the Right Time to Invest in Biotech? (07:34)
Most listed biotech companies have lost a considerable part of the market value, what should investors do at the present moment? What is the value of cash, revenues, earnings, and near-term news-flow? What should CEOs do to maximize their chances of success in the years to come, and how much cash do companies need to weather this financial storm? These are just a few of the questions Charles Duncan answers in this program. He also comments on getting the most value of one's pipeline today, as well as the M&A trends in the years to come.
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The Myriad Genetics Split is Official. How Will This Move Unlock Shareholder Value? (04:11)
Charles Duncan comments on the division of Myriad Genetics into a drug development company on the one hand, a personalized medicine company on the other. Why is this a good strategic move? Will the two companies work together? What are the next steps? And how will the assets and balance sheet be divided?
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Ablynx introduces Nanobody Technologies, discusses Pharma Partnering Strategies (08:17)
How does a Small Cap Biotech make it through the current macro environment? Edwin Moses of Ablynx says choice is no longer a luxury but a necessity. Edwin reviews some of Ablynx's partnership agreements, and explains how he brought Pharma in. Beyond the cash, Ablynx is looking for experience and leverage in partners. He continues to explains how Ablynx's Nanobody Technology was discovered in camels, developed in llamas, and how it could potentially offer significant clinical and commercial benefits. Geoff Meacham of JPMorgan continues to ask him about the marketplace differentiation it offers, and the technological challenges that Nanobodies could present in the future. Edwin and Jeff then discuss Pharma's R&D productivity model and partnering models, capturing the entrepreneurial spirit of Biotech, and key drivers of M&A deals today.
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Ablynx's Antithrombotic Safety and Efficacy Profile, Clinical Development Strategy, and Business Development Objectives (05:33)
Edwin Moses tells us what he is most excited about in the pipeline, and where he will focus the company's energy in the years to come. Geoff Meacham asks him about his plans for scaling up Ablynx's clinical development. Edwin and Geoff continue to discuss the target specific and generic based issues that could present a challenge for Ablynx. Finally, they review the antithrombotic's safety and efficacy profile with respect to currently marketed products, and take a look at Ablynx's regulatory approval strategy.
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Ablynx's Pipeline, Technology Advantage over MABs, and Financial Risk (05:50)
Edwin and Jeff discuss the planned evolution of Ablynx's pipeline, taking products to the clinic and improving patient care. Edwin explains everything his team has learned and gained from working with industry partners. Geoff asks about Nanobodies' advantages over Monoclonal AntiBodies (MABs). Finally Edwin and Geoff review Ablynx's $170M cash position and their burn rate, as well as their execution focus for the years to come.
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Portrait of Wall Street's Pioneer Drug Analysts, Fred Frank (08:27)
The first biotech investment banker tells Jan how he got started in the business, as an analyst and a dealmaker, and continued to build the first formal life science focused research program at Lehman Brothers. Fred Frank, Vice-Chairman of Lehman Brothers (Barclays) discusses the tsunamis of change that are affecting the industry, and why Biotech and Pharma form natural partnerships. One is opportunity long and capital short, the other is opportunity short and capital. Fred illustrated this point by comparing the cash and innovation coming from the 100 largest pharma on one hand, and the 100 largest biotech on the other, demonstrating the need they have for one another.
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Fred Frank on Blockbuster Drugs, and the 3 Eras of the Biotech Industry. (12:17)
Fred and Jan review the changing dynamics of the industry (pre-76, 1976 to 2000, and post-2000). They discuss the monumental changes faced by Pharma, the danger of stock buybacks, and the impact of blockbusters on the development of drugs and the valuation of companies. Fred and Jan also discuss some of the more successful business models today, including the Genentech / Roche agreement - although the recent capital acquisition does come under question.
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Fred Frank on the Future of the Industry, and the Lehman / Barclays Deal. (05:10)
Jan Buck asks Fred Frank where the industry is heading, and if we should be expecting radical change in the near future. Fred Frank looks at the assumptions that fueled the growth of the industry from its earliest onset, and their relevance today. He then asks Fred about the Lehman / Barclays transaction. Is it a fit? Will there be a change in activities? What will determine the success of the acquisition?
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Post ASBMR Review: Amgen's Denosumab Lowers Fracture Risk, Makes the News (05:59)
Mike is back from a very exciting American Society for Bone and Mineral Research (ASBMR) meeting in Montreal. Amgen made the news with the results of its phase 3 trial for Denosumab. Mike explains Denosumab sets a new standard for a highly efficacious, safe, and convenient treatment for a disease that has a very high unmet need, despite its prevalence. Mike and Jean-Loup comparison Denosumab to Novartis' Reclast and other Bisphosphonates - looking at safety, tolerability, administration, and convenience.
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Post ASBMR Review: Denosumab to Seize Low Hanging Fruit in Osteoporosis Market, Amgen's Shares could Gain 20 points (10:30)
After reviewing the Denosumab data released at the ASBMR meeting, it looks like Amgen's osteoporosis drug will be a 2nd line treatment. With 50% of osteoporosis patients going off their bisphosphonates in their fisrt year, Mike King thinks there is a low hanging fruit there. Mike also thinks the drug's profile could allow it to quickly become a first line treatment. Jean-Loup and Mike look at the market, Amgen's pricing for the drug, how that may bode with payors, and what impact Denosumab is likely to have on Amgen's share price. Mike has price target of $80 within 1 year. Jean-Loup and Mike also look at other indications and Amgen's clinical development strategy. Finally, Mike compares Denosumab to Enbrel, Avastin, and Tysabri.
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Post ASBMR Review: A quick look Pfizer's Fablyn, and Merck Odanacatib (03:02)
Mike and Jean-Loup take a quick look at some of the other data released at the American Society for Bone and Mineral Research Meeting in Montreal. They review Pfizer's PEARL study for the drug Fablyn, and Merck's phase 2 Odanacatib.
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Targanta's Antibiotic Shows Promise, And Overcomes the Challenges it Faced When Previously Developed at Lilly and InterMune (06:17)
Oritavancin is Targanta's lead compound. Initially developped at Lilly, it was then sold to InterMune, and picked up by Targanta in an equity deal. Mark Leuchtenberger explains the history of the drug, and in doing so faces further probe from Joel Sendek as to the corporate and medical challenges the drug had to face in its earlier days. Mark explains how they were overcome in Targanta's hands, and the true potential of the was drug unlocked.
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Targanta Confident and Prepared for FDA Panel Review of Lead Compound Oritavancin (07:27)
Mark and Joel delve into the clincal trials and regulatory process, around Targanta's Lead compound Oritavancin. Mark describes the current response of the FDA, and completed clinial site audits. He then continues to explain his team is expecting a panel meeting and is fully prepared to assit the panel's review of the drug. This panel could be expected as early as November of this year. When Joel inquires about the release of simplified data, which might differentiate Oritavancin for its competitors, Mark tells him about the drug profile (administration, safety, efficacy), but choses to keep quiet about the release date, telling us he the abstract and data will be revealed at an upcoming, yet undisclosed scientific conference.
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Targanta Attacking $1.2Bn Antibiotic Market with Resistance Adverse Drug, Do-or-Die! (04:08)
Mark and Joel review the competitive landscape for Targanta's Antibiotic and Lead Compound, Oritavancin. Key differentiators include shorter course of treatment, lack of monitoring and dosing adjustment, efficacy and coverage. With a growing $1.2bn market, Mark still sees an unmet medical need in resistance adverse antibiotics, which Targanta is looking to address with focus, passion, and a Do-or-Die attitude. A Phase 3 trial, validating a single dose treatment against a standard of care competitor is expected to run next year.
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Alexza's Staccato: Vaporized Drugs in Multiple Indications, with a Safe and Effective Profile (10:02)
The Staccato system combines drug and device to provide a quick and convenient relief for patients with acute and intermittent conditions. Tom King (Alexza) and Ted Tenthoff (Piper Jaffray) explore the technology, mechanism of action, and safety profile. Tom and Ted to discuss the drugs in the pipeline and the indications, which include acute agitation associated with schizophrenia or bipolar disorders, breakthrough pain, panic attacks, and insomnia. They review the clinical data, and path for regulatory approval, in what Tom King calls a "crisp NDA plan" for early 2010. Tom and Ted also discuss the marketing opportunity and marketing challenges for these drugs and their innovative delivery system.
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Alexza's Eulogistic Symphony Deal, Partnering and Sales Strategies, and Cash 'till the Summer of 2010 (10:39)
Ted Tenthoff asks Tom King of Alexza's partnering strategy. Alexza will develop its own compounds for Psychiatry but will seek to partner in other areas, such as sleep - where Alexza is working with Endo Pharmaceuticals. Tom explains Alexza's strong cash position, and the value of the Symphony transaction, which ultimately led to the development of 3 phase 3 products. Tom and Ted review other financing vehicles used by Alexza, and the production capabilities of the new Mountain View, CA GMP facility. Finally Ted asks Tom about Alexza's discovery process, and method for prioritization of new drug development.
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Making Money in Biotech, the JMP Securities Way - Part I: State of the Industry Mid Year Report (06:09)
The biotech sector is driven by news flow, because it has the power to change the value of companies, and put (more) money in your wallet. Charles Duncan and Jean-Loup discuss the performance of the Biotech industry in 2008 to this day, and the potential impact of news to come in the remainder of this year in the coming months. Despite the very challenging conditions, biotech outperformed. Charles and Jean-Loup also touch on the industry's relative strength in the tough financial markets, and the increased M&A activity.
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Making Money in Biotech, the JMP Securities Way - Part II: Finding the Tipping Point (05:43)
Which companies are likely to have news that can double the value your shares? Charles Duncan looks at the less obvious stock picks that could provide you with the most bang for your buck. His equation for determining the best opportunities incorporates variables such as lack of revenue (yes he means lack of), products that are owned outright and about to get significant clinical data, no FDA risk, and good cash position.
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Making Money in Biotech, the JMP Securities Way - Part III: A few Stock Picks (07:47)
Allos, Cytokinetics, Orexigen, and Sangamo or just a few of JMP Securities stock picks for the end of the year. Charles Duncan explains how they are at a pivotal moment in their growth, and therefore best positioned to generate large returns for investors. Charles gives us some details about the company, the ongoing clinical trials, and the type of news we should expect in the months to come.
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Poniard’s Platinum Compound for Oncology, A Winning Design for its Clinical Trial (08:36)
How does one go about creating value with a platinum compound? In this interview Mike King asks Jerry McMahon of his rather broad use of Picoplatin in Oncology. They review the SPEAR clinical trial in Small Cell Lung Cancer, its design, endpoints, timeline, competitive landscape, and favorability with the FDA.
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Picoplatin in Colorectal, Prostate, Ovarian Cancer and NSCLC, and Poniard’s Cash Position (06:12)
Poniard has begun clinical trials of it’s Picoplatin in combination with other standard of care therapies. Jerry McMahon and Mike King discuss these indications and the different strategies for each one. Jerry tells us about the data presented in these trials at the latest ASCO meetings. Finally they review Poniard’s very attractive cash position, and its plans for partnering in the years to come.
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Nile’s Peptide for Heart Failure to Achieve Superiority through Hemodynamic and Renal Action (05:17)
Peter Strumph describes Nile Therapeutics’ CD-NP peptide for the treatment of Acute Heart Failure, and the competitive landscape. Matt Kaplan asks him about the market size, existing products, and unmet needs. In answering these questions, Peter reviews the mechanisms of action of the peptides on the market and compares their mechanisms of action to Nile’s CDNP which is expected to have more potent Hemodynamic and Renal effects.
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Nile’s CD-NP Phase 3 Strategy, and Secondary Pipeline Products, and 8 Person Team (09:00)
Peter Strumph lines up the milestones to come for Nile’s lead compound CD-NP and gives us a closer look at his strategy for determining the right dosage in Phase 2, in order to adequately prepare his Phase 3. Peter and Matt then discuss CU-NP and 2NTX-99, other pipeline products, Nile’s 8 person team and leverage model, as well as future in-licensing.
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ImClone likely to be Acquired by BMS in the $65-70 range, says Katherine Kim [BoA] (09:28)
Was BMS’ offer to ImClone shareholders to be expected? What was Carl Icahn’s role? How is ImClone’s stock to be valued by BMS and other shareholders? Katherine Kim takes an in-depth look at the drugs, the pipeline, the markets and indications, and benchmark premiums. She believes this deal is very likely to close, and when it does, it will be in the $65-70 range.
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Genentech / Roche, Good Time for a Deal; Talent Unlikely to be Retained, says Katherine Kim [BoA] (05:47)
Genentech is at a turning point, and the time would be right for an acquisition by Roche (if there were any). Her price target is $110 per share. Katherine and Daniel review the value drivers in Genentech, and the willingness of both Roche and Genentech CEOs to make this deal happen.
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Maturing Biotech Sector Likely to see Large Cash Inflow after Genentech & ImClone Deals, says Katherine Kim [BoA] (04:28)
The $60+Bn generated from large cap acquisitions are likely to be reinvested in biotech, specifically in 4 tranches of the sector. Katherine Kim reviews gives us the rationales behind this thinking. She also expects increased M&A activity in the years to come.
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Myriad Genetics, Unique Hybrid Business Model, $48 to $87 Share Price? (10:58)
The story of Myriad Genetics (MYGN) resonated in the investor community as disappointing Phase 3 data was followed by a 40% stock price increase (from $48 on June 27 to $66 on August 20th, day of this interview). Charles Duncan has the longest formal coverage on Myriad. He explains the rationale behind this development, and the $87 price target he has set for the company shares. Charles and Daniel review Myriad’s personalized medicine and drug development hybrid business model, and their prospects for growth as standalone companies. Would spinning of the drug development business further unlock shareholder value? Following increased revenues and a recent $100M licensing with Lundbeck, Myriad’s cash position is quite favorable. Will it acquire? Or could it be acquired?
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Award Winning NeuroBank Team stores your Neuronal Stem Cells (12:28)
NeuroBank was recently awarded the third prize in the Moot Corp Competition dubbed "The Super Bowl of World Business Plan Competition". Their business model relies on a process of extraction, isolation, purification, expansion and storage of adult neural stem cells. Bill Kridel, stem cell expert, interviews the winning team. They discuss Neurobank’s proprietary process, future uses of neuronal stem cells, viability of cryogenically stored cells, cost for and risk to patient, target markets, and customer acquisition.
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Roche and Genentech, Deal Review, with Mike King (06:31)
Mike King and Daniel Teper discuss the Genentech / Roche deal. Genentech’s Board of Directors say $89 per share is inadequate, Roche’s management feels it is more than generous. Genentech shareholders like this stock, and are reluctant to sell for less than $120-135. Why does Roche want the remaining 56% of Genentech? Will Roche be able to retain the innovation that made Genentech so successful? What are the odds of this deal closing?
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BMS and ImClone Deal Review, with Mike King (04:33)
Why is BMS after ImClone, and what will happen next? Carl Icahn’s says the $60 bid is too low. Mike King believes Icahn is waiting for the Genentech Roche transaction to play out, in order to see the valuation metrics that will be used in that transaction. Mike and Daniel continue to discuss the integration of ImClone within BMS, the international rights to Erbitux, and the odds of this transaction closing.
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Impact of Summer Acquisitions on the Biotech Industry, with Mike King (04:10)
With close to $60Bn worth of biotech stock that could be removed from the market, where will this money go? Where will investors be putting their money? Mike thinks it will flow back into the group as there are still some attractive investment opportunities. Mike and Daniel further discuss the disappearance of the large cap leaders, who would take over the leadership position, and the potential for future acquisitions.
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Visionaries: Bill Kridel on the Role of M&A Today. (06:33)
Bill Kridel discusses the strategic and rescue role of M&A today. Many companies leverage M&A for geographic and portfolio reasons - looking at some of the latest deals (Roche and Genentech, Daiichi and Ranbaxy). With the current market conditions M&A propositions from larger companies are becoming increasingly attractive.
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Visionaries: Bill Kridel on Biotech in 20 Years, Regenerative Medicine, Biomarkers, Personalized Medicine. (08:21)
Bill Kridel foresees three great tsunami that are bound to change the biotech industry and the quality of healthcare. These are regenerative medicine, biomarkers and molecular diagnostics, and personalized medicine. Bill also discusses pharma's solutions to increase innovation, and the increased international competitivity.
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Stem Cells Business Models, FDA Initiatives, Companies, and Funds, with Bill Kridel (05:58)
Bill Kridel compares stem cell business models that rely on allogenic vs autologous cells and discusses their market potential. He also touches at the various uses of stem cells, the need for standards of uniformity, FDA Initiatives, companies to focus on, and specialized funds.
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Vivalis uses Embryonic Stem Cell Technology to Enable Vaccine and Antibody Production. (19:04)
Chicken eggs revolutionized the production of vaccines. Could animal stem cells be the new chicken egg? Vivalis has created a technology platform based on embryonic stem cells that enables the production of vaccines and antibodies. Vivalis’ CSO Majid Mehtali is interviewed by Reni Benjamin, analyst at Rodman & Renshaw. The business model is based on technology licensing, with future ambitions for own product development. Majid and Reni review comparables, Vivalis’ cash position, Euronext vs. NASDAQ listing, and the potential for acquisitions.
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Oncology Battlegrounds: Celgene vs. Millenium, with Charles Duncan. (04:55)
The long running face off between Celgene's Revilimid and Millenium's Velcade intensifies with the latest clinical data releases. Charles Duncan, is bullish on Revlimid, he tells us why. Charles looks at the impact of Takeda's new ownership of Millenium on its management and competitivity vs. Celgene. Charles also comments on the JNJ / Takeda relationship.
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Celgene's Revlimid, Markets and Revenues, with Charles Duncan. (03:09)
What are the next areas of growth for Revlimid? Asides from the growth in frontline use for Multiple Myeloma, Charles Duncan tells us about its use in Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). Revlimid is also bound to expand its geographical reach with Europe and Japan. Charles' expectation is that Revlimid will be a $2.8+ billion opportunity drug. Finally, he explains Revlimid's contribution to Celgene's bottom line and stock price. Charles' price target for CELG is $85.
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Oncology Battlegrounds: Genentech vs. ImClone, with Charles Duncan. (05:50)
The data released on Eribitux at the latest ASCO meeting is an indicator of the emergence of personalized medicine. The data itself was not that great of news for ImClone. Nonetheless, it will lift some of the pressure from reimbursement authorities. Charles believes the KRAS mutational status will be on the labels. Genentech remains strong in its growth and earnings. ImClone's new data also affects Genentech indirectly, and in a positive way.
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Small Cap Focus, Full Integration, Personalized Medicine, with Charles Duncan. (10:41)
In today's market, where good clinical data and milestones are shadowed by financing prospects, Charles Duncan recommends having at least 2 years cash. Charles also presents a few of the most promising small and mid caps he's been keeping his eyes on - including Myriad Genetics (MYGN), Sequanom (SQNM), Illumina (ILMN), Invitrogen (IVGN), Genomic Health (GHDX). Charles and Daniel discuss the opportunity for small and mid caps to become fully integrated specialty pharmaceuticals.
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Visionaries: Stelios on Financing, Productivity, and the Cost of Innovation. (09:39)
Stelios Papadopoulos, veteran of the Biotech Industry, looks at the financing environment today, and the "windowless paradigm" we've been operating in since 2003. He emphasizes the importance of changing investor sophistication and investment horizons. Stelios also addresses the cost of innovation and overall sector productivity. Finally Stelios looks back on his expectations for the market today, when he prepared them as an analyst 20 years ago.
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Visionaries: Stelios on Biotech in 20 Years, Fundamental Science, Personalized Medicine, and Energy. (07:43)
Stelios shares his vision for Biotech in the next 20 years, comparing technical and fundamental problems, how they will be funded and solved. He also addresses the issue of energy, for which he thinks we will find biologically driven solutions. Stelios discusses the relevance of personalized medicine, and his choice of investment today.
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Standardizing Ways to Create New Treatments for Under-served Disease Markets, with Stem Cell Technology (05:13)
Can stem cell technology be used to make under-served disease markets commercially relevant? Professor Marc Peschanski is working with stem cells (embryonic and adult) to create therapeutics for monogenic diseases. His goal and that of his institute are to standardize new ways of creating treatments for monogenic diseases, developing R&D with an emphasis on the technology platform.
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Is Europe attractive for stem cell research? Which countries are the most advanced and have the most favorable legislation? (04:52)
Professor Marc Peschanski discusses the different european legislations, looking at the countries that have taken the lead, and those quickly progressing - including the U.K., Germany, and Spain. He then continues to explain changes in French law that are making stem cell research possible.
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Stem Cell Research Financing, Products, Business Models, and Regulatory Concerns (06:47)
Why is stem cell financing limited, and how does I-STEM finance its research? Professor Marc Peschanski looks at the capital question, and potential applications of stem cell research. He then reviews the concerns of the regulators and compares the FDA and EMEA with respect to stem cells.
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Will Adult Stem Cells Resolve Our Moral Quandaries? Do They Offer The Same Benefits As Embryonic Stem Cells? (05:16)
Is the public opinion antagonistic towards, divided on, or supportive of stem cells? Professor Marc Peschanski explains the state of the debate, now that stem cells can be derived from adult tissue. He also comments on the applicability of human embryonic stem cell technology towards adult stem cell technology.
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ASCO 2008, the take home message with Mike King. (02:17)
What should all investors know about this year’s ASCO? What is the take home message? Mike King tells us it hasn't been a momentous ASCO. ImClone was most affected. Mike and Daniel look at the behavior of stocks before and after the meeting, and reflect on the impact of abstract releases, preceding this year's ASCO.
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ASCO 2008, Focus on Imclone with Mike King. (05:10)
What happened to ImClone's stock after ASCO this year? Mike King tells us about the expectations, the fluctuations, and what he believes was a misinterpretation of the FLEX trial results. Mike foresees a strong market for Erbitux, in the years to come, with positive impact on ImClone's earnings. Also discussed in this interview is the KRAS mutation, its impact on Erbitux's market penetration and on Imclone's earning, as well as the interest doctors and payers have in it.
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ASCO 2008, Focus on Genentech with Mike King. (05:05)
In a Post-ASCO review Mike King reviews Genentech. Can the 2 months Avastin and 5 weeks Erbitux data be compared? Apples and oranges, according to Mike! The subgroups tell a completely different story. Mike is optimistic with regard to Genentech's performance. It has seen a strong growth in Non Small Cell Lung Cancer (NSCLC), and should see growth in Metastatic Breast Cancer too. Mike sets a $92 price target on Genentech's stock; outperform.
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ASCO 2008, Focus on Celgene with Mike King. (04:36)
Celgene in a Post-ASCO review, reveals positive data. Mike King discusses the multiple myeloma survival data and its impact on Revlimid. Mike compares Celgene's Revlimid and (Takeda's) Millenium's Velcade. Is complete response the best predictor of outcome? How do the other parameters of the studies come into play? Mike gives us a projection for the sales of Revlimid and a price target for Celgene at $72. Last he touches upon the question of Celgene's acquisition. Would it make any sense?
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ASCO 2008, Small Cap Focus with Mike King. (05:10)
ASCO can be full of surprises for some of the smaller caps. Mike King from Rodman & Renshaw reviews a few names that include Poiniard, MedRx, and Celldex/Avant.
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New York Success in Biotech, More than Meets the Eye? (07:52)
Is NY a more expensive place to start a Biotech company vs. MA or CA? Nathan Tinker (Executive Director, NYBA) argues it isn't and that NY really presents a great number of opportunities for Biotech Companies. He supports this with example of NY Successes, including ImClone, OSI Pharmaceuticals, and Regeneron. Nathan also discusses VC activity in NY, the NY City vs. NY State dichotomy, and the proximity with NJ Pharma, Nathan also touches on the $.5BN bioscience infrastructure driving RND, as well as the state of phase 2-3 pipelines.
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KSR Demystified, Part 1 - Supreme Court Ruling on Patent Obviousness (08:27)
The Supreme Court’s ruling on intellectual property in the KSR vs. Teleflex case has kept many patent attorneys on the edge of their seat, as Matthew Siegal explains here, and in his Intellectual Property Strategist article (linked below). Matt and his colleague Ian DiBernardo go over the basis for the grant of a patent - the invention has to be new, useful, and non-obvious. They continue to explain how and why the KSR case is changing the non-obviousness requirement, making it more difficult to be fulfilled, and therefore harder for inventors to obtain patents.
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KSR Demystified, Part 2 - Practical Business Implications (03:53)
In theory KSR makes it harder to patent, but the industry is very used to overcoming the non-obviousness clause of patentability, by showing the unexpected benefits. On the bright side of things, this may reduce the quantity of what some consider to be “unworthy patents.” Still Matthew’s advice to the industry remains the same: be prepared, and show improved results.
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Former FDA Commissioner on Obama, Pace of Approval, Stem Cells (04:06)
What will happen to the FDA if Barack Obama gets elected? Dr. Lester Crawford, former Commissioner of the FDA, believes funding will increase, and with it so will the agency morale. This might increase productivity and help increase the pace of approval. The policies, however, are unlikely to change, as the FDA is a body with very few political appointees. When asked about stem cells, Dr. Crawford sees the US, not currently ahead of other nations, but ready to become the leader, as soon as it 'wakes up'. The FDA is also waving certain requirements for stem cell research to further support this effort.
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On Creative Financing: Lionel Leventhal, Paul Capital (05:45)
Lionel gives his outlook on the market, and how to escape its volatility. He advises cautiousness when going public, and explains the other ways a company can bring additional capital in. Lionel continues to explain how Paul Capital (of which he’s a partner) structures its deals. Paul Capital leverages royalties / non-dilutive financing. Lionel then illustrates with 2 'real world' examples of companies they have taken a participation in recently.
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On Creative Financing: Jeff Edelman, Symphony Capital (12:00)
With the capital markets tightened, it has become more difficult for companies to find funding. Some investors have been expanding their creative approach to financing. Jeff Edelman presents a number of options that leverage clinical development capabilities and funding, royalty streams, and optimized development financing - from Novaquest, Paul Capital, and Symphony Capital - of which he's a Principal. Jeff then explains the history of this kind of creative financing in Biotech with Amgen’s Epogen and Nupogen. He continues to illustrate the value created through a “case study” of one of Symphony Capital’s collaboration with Isis, which then led to one of the biggest partnering deals of the year.
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Accelerat(or)ing NYC Biotechs - Investment Vehicle for Emerging Companies. (03:00)
A city with great research and intellectual capital, should welcome a vibrant emerging biotech industry. New York City is not taking advantage of its full potential. Accelerator Corp, a joint investment vehicle for VCs, is putting together resources that are necessary to foster success for Biotechs, here in Manhattan.
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Building Biotech in New York, NYS Economic Development Council (04:57)
Debra Flack tells us about the New York State Economic Development Council and its activities. Debra underlines the strength of New York with respect to Science, Academia, and Finance. She mentions the commitment and grant programs that have been put in place by the state, as well as the lobbying efforts to reduce the tax burden, and the cost of doing business, both in the City and the State.
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BioDefense Funding, Cleveland Biolabs (02:47)
Alan Wolfman tells us about about Cleveland BioLabs, and how it is leveraging its BioDefense funding. He explains the size of, and requirements for the funding, the benefits and dangers of this strategy. Finally, Alan offers his best advice for obtaining government funding: be in very close contact with the agencies you are working with, and hoping to raise funds from.
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Burnham CEO on New Florida Facility ()
Dr. John Reed, President & CEO of the Burnham Institute for Medical Research gives us a brief history of the institute and the discoveries that stemmed from its research. Dr. Reed discusses the ambitions and research focus set forward for the new Florida research facility, and how the the institute collaborates with industry. Stay tuned to watch the Burnham Delegation ring the NASDAQ's opening bell!
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Quest CIO on Healthcare IT, Present and Future ()
What is the current state of Healthcare IT? What is being done to digitize data and clinical information today, to facilitate the access to medical records, by patients and physicians alike, and improve patient care? How can Healthcare IT improve physician and patient collaboration and education? What are some of the solutions Quest has pushed forward? What are the barriers to implementation of this change? What are the industry's concerns? What is your vision for the future of Healthcare IT?
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Manhattan Classic Car Club - Part 2 ()
The second part of our series dedicated to the Manhattan Classic Car Club reveals the inner-workings of the club. Members join, get points, and can drive any car they want - fees and points system explained. Beyond the 'staggeringly stylish' fleet is an exclusive club, a strong community of automobile enthusiats, and a whole lot of fun. We take a ride in Magnum P.I.'s 1989 Ferrari 328 GTS, and take a closer look at the 2003 Ferrari 360 Spider, the 1967 Chevelle SS, the 1966 Mustang Fastback, the seductive 1970 Chevy Cheyenne, and the 1972 de Tomaso Pantera.
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Yelo New York ()
YELO New York is a midtown sanctuary for the sleep-deprived modern warrior. Helping urbanites deal with the pressures of modern life, YELO offers a unique, and soothing, combination of sleep and reflexology therapies.
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Le Parker Meridien ()
Rising 40 stories above Central Park, Le Parker Meridien is one of New York’s most upscale hotels. Steps away from Madison Avenue, MOMA, Carnegie Hall, Broadway theaters and Fifth Avenue’s legendary shopping, Le Parker Merdien is ideally situated for business and pleasure.
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Avant's CEO on Merger with Celldex ()
Dr. Una Ryan discusses Avant's work in infectious diseases, its partnerships with the Gate Foundation and the International Vaccine Institute, and with GSK for Rotarix. Avant announced its merger with Celldex, a spin-off of Medrex. The new combined entity will have an enhanced portfolio and including several clinical stage Oncology products and a novel antibody technology platform.
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Manhattan Classic Car Club - Part 1 ()
Discover the Manhattan Classic Car Club, the premier New York City automobile club, where over 330 members, of all different walks of life, shared the most desirable classic cars, and sports cars. Beyond the staggeringly stylish fleet, is a social club where automobile afficiandos from all walks of life gather, at the club, or any of its numerous functions / trips / events. We take a ride in the club's 'ruthlessly powerful' Ford GT40, and take a closer look at their 1965 Shelby Cobra, 2007 Ferrari F430, and 1965 Convertible Mustang.
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Rodman's John Chambers - Part 1 - Acumen BioFin ()
Meet the man behind Rodman & Renshaw's Life Science division, Acumen BioFin. Find out why Acumen BioFin was established, and how it has been on the forefront of rapidly evolving life science financial markets since its inception. Learn about the PIPES & Register Direct financing opportunities Acumen offers to its clients.
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Rodman's John Chambers - Part 2 - 2007 Recap ()
We recap 2007 with John Chambers 2007, looking at volatility, impact of credit crisis, companies seeking capital, the number of FDA candidates, and the hot trends. John Chambers tells us about the various financing strategies that have been affecting the size and availability of new investment capital for Biotech companies, in the US and abroad. We also discuss the open and shut IPO market, the Follow-On market, the consolidation trends, the Venture piece, and the Biotech finance markets outside the US.
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Rodman's John Chambers - Part 3 - 2008 Outlook ()
John Chambers tells us how adjustable mortgage rates, and election year may affect investor portfolios, and shares his bullish perspective on financing prospects for Biotech in 2008. We discuss the return of IPO market, and its implications in terms of company maturity. We conclude this interview with one general piece of advice for Biotech CEOs, and one for Investors.
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John Allan's ()
John Allan's is a men's grooming club with an old-fashioned clubhouse ambiance. This club not only offers top of the line grooming services. Members can play pool and have a drink with friends or even enjoy a cigar in the lounge area.
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Bottega Del Vino ()
Bottega Del Vino, located in mid-town Manhattan, is one of the most authentic Italian restaurants in New York. This beautiful and unique Italian restaurant offers the best of Veronese cuisine and the most diverse wine list in the country.
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Avicena CEO Interview ()
Dr. Belinda Tsao Nivaggioli is the CEO of Avicena Group (OTCBB: AVCO). She discusses Avicena's cellular energy regulation and optimization technology, in the pipeline, in the latest clinical studies, and how it will create value for shareholders.
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Brasserie 8 1/2 ()
Brasserie 8 1/2 is an upscale brasserie located in the heart of Manhattan. Brasserie 8 1⁄2 achieves a delicate fusion of creativity and comfort, featuring a world-class art collection, adventurous haute French cuisine and a plush atmosphere.
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Forward Integration: from Biotech to Specialty Pharma ()
When should a development stage company take control of its products and build marketing and sales capabilities? Jeff Thomas, Lionel Leventhal, Steve Rauscher, Paul Cayer, and Michel de Rosen share their insight on, and experience with forward integration.
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Sanofi Pasteur looking for R&D Partners ()
What is Sanofi Pasteur looking for in external collaborations? What makes vaccines so attractive to Pharma? How do you expect the increasingly competitive market for vaccines to evolve? What are your thoughts on the recent MedImmune deal?
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Novavax CEO: New Pharma Focus on Vaccines ()
What can you say of the renewed interest for vaccines? Which vaccines have the most attractive development potential? How is risk different with vaccines? How can Pharma be complimentary and how will it affect the entrepreneurial vitality of the vaccines industry? What are your thoughts on valuation after the MedImmune deal?
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Austria: Connecting Europe by Way of Vienna ()
Gisbert Myer explains why Austria is a strategic business location in Europe, as connects its East and West, presents generous cash incentives for R&D, and has attractive corporate tax rates.
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Austria: From Academia to Business ()
Michaela Fritz explains how Austria's strength in academic research - particularly infectious diseases and oncology, has created a new dynamism on the business side. She highlights some of the recent business successes and government programs that are giving Austria a critical mass in European Biotech & Pharma.
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China's Biotech, Rapidly Emerging? ()
James Zhu sees formidable potential for Chinese Biotech and projects its exponential growth as improving IP environment, very sizeable government funding of R&D, and fast growing GDP create numerous opportunities to collaborate with China.
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Dubai: Developing a New Center of Excellence ()
How is Dubai developing its Biotechnology Industry? Dr. Al Khayat tells us about the emirate's ambition to create a center of excellence for the region, the business and science infrastructure it is leveraging, and the incentives that have been put in place to foster the growth of this young industry.
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India: Paradigm Shift, IP, Drug Discovery, and Innovation ()
Nandita Chandavarkar comments on the paradigm shift in intellectual property. India better understands the value of IP as it creates its own. A very clear legislature has been put in place by the government to protect the interests of Bio and Pharma companies.
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Ireland: Commitment to BioPharma and Medical Devices. ()
Marian Byron tells us of the importance of the BioPharma and MedDevices industry to the economy of Ireland. Ireland is totally focused toward BioPharma & MedDevices. Having consolidated a manufacturing base, Ireland is now moving to establish a strong R&D base and putting in place multiple tax incentives and state aids to promote the development of this industry.
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Ireland: Manufacturing, Start Ups, Universities, Research. ()
Dr. Cormack Kilty tells us about his Dublin-based company, Biotrin International, developer novel biomarkers of organ damage. He sees the significant investments in universities and research, as well as the support for start ups and presence of large Pharma groups as the drivers of industry growth.
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Ireland: Success, and Investment for R&D and Innovation. ()
Barry O'Leary highlights the $6bn investment in Ireland that the world's leading companies have made, its huge emphasis on R&D and innovation, and the great talent it contributes to the industry.
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Israel Biotech: Flourishing Research,Innovative Companies. ()
You'll see here Israel Life Science Industry Board Members Zeev Zelig and Yossi Bornstein personify the spirit of the Israel biotechnology industry. Many high tech companies have established R&D facilities in Israel. The research evolves so rapidly that Israel is constantly looking to build collaborations that can help bring these new technologies to market.
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Japan: Services for Foreign Biotech Companies ()
Sato San explains investment promotion is very important to the Japanese government, and that's why it is offering free executive recruiting, marketing services, and office space for foreign companies that are developing their activities on the archipelago.
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Spain: Fast Pace Growth ()
A study a various statistics reveals a higher than 25% growth per year in the Spanish biotechnology industry. External investment is just starting as companies are gaining a critical mass that is now piquing the interest of Venture Capitalists.Spain's growth in BioFuel, AgroFood, and Human Health remains well equilibrated.
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Switzerland: Hidden Champions ()
Great financial markets and increasing VC investments and exits make Switzerland the 9th largest Biotech enterprise in the world. It has a long standing history in pharmaceuticals research and commercialization. In the next 5 years, the SWISS Biotech Association will be focusing on advocacy, building infrastructural offers for expensive Biotech on a national level, and starting to promote itself.
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California: The State's Ambition is to Remain Number One ()
The birthplace of biotechnology is betting on its workforce, research centers, and wonderful environment to attract and retain biotechnology companies. California appreciates the value of biotechnology and wishes to remain the leader in research manufacturing in the United States.
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Florida: Scripps, Building a World Class Research Institute ()
Harry Orf explains the reasoning behind the development of Scripps, and what made Florida a particularly attractive location. He also comments on the peer-to-peer collaborations this biomedical research facility is meant to foster.
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Florida: After Scripps, Torrey Pines sets Research Unit ()
Torrey Pines intends to bring the world class science and entrepreneurial spirit to Florida. Dr Houghten tell us how Torrey Pines fell in love with Port Saint Lucie, and how Torrey Pines combines collaboration and a focus on practical scientific applications to grow rapidly and successfully.
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Maryland: Biotechnology is a Top Priority ()
Maryland is incredibly excited about Biotechnology, and its prospects for improving the human condition and the state's economy. That is why they are investing in research, public private partnerships, and the incubators that are creating the technologies of tomorrow.
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Massachussets: Supercluster, Tremendous Innovation ()
Allan Blair tell us why the state of Massachusetts is known as the "heart and soul" of Biotech. He also presents some of the future challenges for the state, as well incentives for companies to relocate to Massuchusetts (including state-wide, individual region, and site specific)
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North Carolina: Skilled Workforce. ()
NC believes the quality of the workforce is the one greatest determinent of success for biotech and pharma companies. That is why the state is focusing it efforts on workforce training which encompassesfree training for any company moving to region, links to colleges and K-12, and their new science programs.
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Pennsylvania: Innovation, Finance, Infrastructure ()
PA's innovative governor is putting together all kinds of incentive packages to help companies. These include financing through state funds and the strong VC network, as well as a variety of support services such as legal, accounting, partnerships, and site selection.
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Jim Greenwood on Congress and Policy ()
BIO's CEO Jim Greenwood comments on the need for a supportive policy environment for Biotech in the context of the new Democratic Congress, BIO’s new advocacy team and what is expects from the next President of the United States in 2008.
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Maryland: Driving Economic Development through Biotech Investme ()
Dr Mahan discusses the academic and federal research assets that make Maryland a favorite place for Biotech companies. Dr. Mahan also presents Maryland's new tax incentives for corporate and individual Biotech investors.
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Transport's CEO on Drug-Device Convergence ()
Dr Dennis I.Goldberg, on Drug-Device convergence and its application to treatment of dermatological diseases.
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Dyadic's CEO on Bio-Energy ()
Mark Emelfarb, tell us about Dyadic International's cellulose-basd technology and its applications, including Bio-Energy.
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Affymax: the Technology, Timeline, and Success/Risk Factors ()
We asked Arlene Morris what kind of advantage the use of peptide based hematide product presented, what her development timeline looked like, and what critical success and risk factors she perceived as most important.
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Boston Life Sciences's Altropane and Cethrin ()
Ken Rice tells us about Altropane, a molecular imaging agent that can change the treatment of Parkinsons Disease, and Cethrin an enzyme inhibitor for axon regeneration in spinal injurues. He discusses the impact on patient health, the time to market, and the critical success and risk factors.
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War On Bugs: Infectious Diseases and Global Health ()
WarOnBugs bridges the perspective of scientists, physicians and policy makers about recent developments in infectious diseases and global health. Is the risk of an Avian Flu pandemic real? What have learned from the SARS crisis? Can an AIDS vaccine be developed anytime soon? Can we continue to ignore health issues in developing countries?
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Abbott's Tricor: Result of the FIELD Trial ()
The contrasted results of the FIELD trials are explained by the lead investigator, and discussed by several opinion leaders: What are the effects of fenofibrate on the risk of major coronary disease events? How did the use of statins influence the outcome of the study? Will the results have an impact on the guidelines for the treatment of the diabetic populations? How will the findings of these trials influence future studies?
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Portfolio Management and Shareholder Value ()
Bringing together the perspectives of Big Pharma and Biotech: Are Pharma and Biotech competitors or allies? How should expectations be managed for successful partnerships? What is the view of the Street?
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Announcing Ambrilia Biopharma ()
CEO Hans Mader announces at BIO 2006 in Chicago the launch of Ambrilia BioPharma., born of Procyon's acquisition of Cellpep S.A., a French biotechnology company developing therapeutics in oncology and infectious diseases. The merger, along with a concomitant $18.1 million financing was completed on March 1, 2006
A Brief History of Myriad Genetics. (1/7) (4:44)
<stocks>Peter Meldrum, CEO of Myriad gives a brief history of Myriad Genetics. Led in this discussion by JMP Securities analyst Charles Duncan, Peter explains what made him want to start the company, and what differentiated it from all the other companies that sought to build on the genomic revolution. And even though Myriad Genetics has been a pioneer and a leader in the field of molecular diagnostics, it seems there is still a long way to go.
BRAC Analysis, Myriad Genetics' Primary Revenue Driver. (2/7) (5:55)
<stocks>Two genes are responsible for the vast majority of hereditary breast and ovarian cancer. The BRAC Analysis diagnostic test can identify these genes and help physicians evaluate the breast and ovarian cancer risks with their patients. Peter Meldrum, discusses the significance of this test, the segments of patient population it serves, and the market size for the test. When Charles Duncan puts forward Myriad's marketing strategy, Peter presents the rationale for his Direct To Consumer (DTC) television advertising, its effectiveness, and the regions of its future expansion.
BRAC Analysis, Myriad Genetics' Primary Revenue Driver. (2/7)
Is a European Expansion to be Expected from Myriad Genetics? Checklist and Roadmap. (3/7) (1:21)
<stocks>Has the European expansion been delayed because of intellectual property or business question? When questioned by Charles Duncan, Peter Meldrum, CEO of Myriad Genetics explains the strategy which has been to establish a significant presence in the US, and then build the infrastructure necessary to capture the European market. We should expect a strong presence in the next 3 years.
Is a European Expansion to be Expected from Myriad Genetics? Checklist and Roadmap. (3/7)
Optimal Chemotherapy Dosing with OnDose, from Myriad Genetics. (4/7) (2:43)
<stocks>Myriad Genetics' most recent personalized medicine product, OnDose, optimizes chemotherapy dosing for 5-FU regime. Charles Duncan inquires about the safety and efficacy gains from using OnDose vs. Body Surface Area (BSA) dosing. Peter Meldrum explains that OnDose uses pharmacokinetic analysis to measure the exposure each individual gets to the drug. This information can then be used by physicians to tailor the dosing and ensure their patients are in the optimal range. Quoting a Journal of Clinical Oncology study, an 80% reduction in toxic side effects and a doubling of response in terms of tumors shrinking were observed. Additionally, those who receive the OnDose dosing lived on average 6 months longer.
Optimal Chemotherapy Dosing with OnDose, from Myriad Genetics. (4/7)
Myriad Genetics' Latest Diagnostic (PROLARIS) Predicts Prostate Cancer Recurrence. (5/7) (7:02)
<stocks>On March 2nd, 2010, Myriad Genetics unveiled a diagnostic that can assess the risk of post-prostatectomy recurrence in men with prostate cancer. Charles Duncan asks Peter Meldrum about the clinical utility of the test, and the outlook for a PRE-prostatectomy diagnostic. It does indeed seem that too many prostatectomies are performed in the US (according to a NEJM study). Peter explains that Myriad Genetics just completed a study of its own that showed the diagnostic to be as predictive in pre-prostatectomy as in the post-prostatectomy. The pre-prostatectomy data was submitted to a peer reviewed journal and is expected to be published in the last quarter of 2010. As for reimbursement, PROLARIS has almost 100M lives under coverage, even though it is only a day old.
Myriad Genetics' Latest Diagnostic (PROLARIS) Predicts Prostate Cancer Recurrence. (5/7)
Patenting Genes: What if the ACLU Wins the Case Against Myriad Genetics? (6/7) (5:03)
<stocks>In May of 2009 the ACLU filed a lawsuit against Myriad Genetics, challenging their patents on breast cancer genes. Charles Duncan asks Peter Meldrum of the implications of this case, and the impact on Myriad Genetics' business model if the case is lost. From this point on Charles and Peter continue to discuss the numerous other competitive advantages of the company.
Patenting Genes: What if the ACLU Wins the Case Against Myriad Genetics? (6/7)
Financials: How is Myriad Genetics Planning to Return Cash to Investors? (7/7) (2:58)
<stocks>Myriad Genetics is a profitable company that generates $150M cash per year, and has a great balance sheet. It would seem the lion's share will be reinvested in the development of new products and expansion to new markets. Still, Charles Duncan asks how some of this cash will be returned to shareholders. Peter Meldrum explains the board of directors is currently evaluating sustainable cash dividends and sustainable stock repurchase programs.
Financials: How is Myriad Genetics Planning to Return Cash to Investors? (7/7)
Batman is Back, Busting Clots with Desmoteplase (4:44)
<stocks>Paion's lead compound is derived from the saliva of the vampire bat, and being tested as an anti-thrombotic in stroke. After an unsuccessful Phase 3 in 2007, a meta analysis revealed 50% of the patients had no clots to bust, and as Wolfgang Soehngen points out in this interview: "if there is no clot to bust, Desmoteplase has no job to do." Batman is back, as it has recently been said, because of Paion's recent turnaround. Desmoteplase is in 2 Phase 3s with Lundbeck, and added new drugs to portfolio. The partnership with Lundbeck includes 100% funding of products development, 63M Euros in upcoming milestones, and double digit royalties.
Paion De-Risks Pipeline with Acquisition of New Value Driver CNS 7056 (5:40)
<stocks>The 12.3M Euro acquisition of CeNeS in 2008, and successful Phase 2a development of it's CNS 7056 (short-acting sedative and general anaesthetic) has contributed to more than doubling the value of Paion shares in the second half of 2009. Wolfgang Soehngen explains the rationale was to de-risk Paion's pipeline, and re-gain investor confidence, after the failed Phase 3 for Demostoplase. With the re-licencing of Desmoteplase, CNS 7056 is now Paion's main priority, and Wolfgang expects to partner it within the year. Japanese company ONO Pharmaceutical recently initiated clinical studies for CNS 7056 / ONO-2745 in Japan.
Paion De-Risks Pipeline with Acquisition of New Value Driver CNS 7056
Paion's Search & Develop Strategy: Get the Proof of Concept Faster and Cheaper than Pharma (7:16)
<stocks>Taking a product from discovery to market is a challenging proposition, with Wolfgang Soehngen, CEO of Paion addresses with the Search & Develop (S&D) strategy. S&D consists of taking some of Pharma's assets that would otherwise "disappear in the basement" and developing them, knowing that they have already robust toxicology and CMC profiles. Paion's R&D team being fully dedicated to get the proof of concept done can do the work faster and cheaper than Pharma would. Wolfgang suggests that S&D is a much safer way to generate value for shareholders. Wolfgang explains he wants Paion to be viewed as a proof of concept company and be very attractive to big pharma as future partner. In this segment, are also discussed Paion's Phase 3 M6G morphine metabolite, and Wolfgang's favored structure for partnership deals - a good upfront payment, with major coverage of Phase 3 costs.
Paion's Search & Develop Strategy: Get the Proof of Concept Faster and Cheaper than Pharma
Dim That Receptor Activity with Addex's Allosteric Modulation. (5:22)
<stocks>Ram Selvaraju asks Vincent Mutel, CEO of Addex, about allosteric modulation technology. In essence, it offers regulation of the efficiency of receptors, as opposed to the on / off switch of more traditional drugs. Ram and Vincent discuss the safety profile, and the potential not to induce desensitization. Finally, the business model is reviewed, with Merck and Johnson & Johnson collaborations, and value creation objectives for shareholders through commercialization of their own molecule
Dim That Receptor Activity with Addex's Allosteric Modulation.
Addex's New Lead Molecule ADX48621, Expected To Be Partnered Soon? (5:56)
<stocks>ADX48621 is the lead molecule in Addex's pipeline. Ram Selvaraju challenges Vincent Mutel on upcoming clinical news and strategic objectives. With 110+ patients enrolled across 3 completed phase 1 trials, ADX48621 is expected to initialized it's Phase 2B in Q410. Results are expected for late 2011 / early 2012. Vincent plans to partner ADX48621, perhaps in the near term, before getting his Phase 2 data. ADX48621's lead indication is Parkinson's disease levodopa associated dyskinesia (PD-LID), with potential in multiple indications.
Addex's New Lead Molecule ADX48621, Expected To Be Partnered Soon?
December 2009, A Major Setback for Addex. Use of Cash, and Other Pipeline Molecules (6:58)
<stocks>The clinical trials for Addex's former lead molecule ADX10059 were brought to halt in December 2009, after findings of hepatotoxicity. Can ADX10059 be salvaged, or is it a "dead horse"? Ram Selvaraju inquires about the future of ADX10059, Addex's cash runway, and projected use of funds, as well the status of other pipeline molecules. In addition to the new lead ADX48621, Addex plans to develop and co=promote a GABA-B positive allosteric modulator for osteoarthritis, and develop and out-license the first fish follicle stimulating hormone receptor (FSHR) negative allosteric modulators first for benign prostatic hyperplasia (BPH), a known precursor to prostate cancer.
December 2009, A Major Setback for Addex. Use of Cash, and Other Pipeline Molecules
ADDEX Undervalued? What Could Drive Stock Price In The Next 6 Months (4:43)
<stocks>Finally, Ram Selvaraju and Vincent Mutel discuss the current valuation of Addex. Reviewed are the platform's value and the near term catalysts. With a strong cash position, several partnerships, business development activity, and an expected Phase 2 by the end of the year, Vincent believes in a significant upside for the long term. Additionally, with the obvious product differentiation and innovation, Vincent presents a future for Addex that will undoubtedly be brighter.
ADDEX Undervalued? What Could Drive Stock Price In The Next 6 Months
Major Breakthrough in $5bn Osteoporosis Market ()
<hot data>Everything started with this observation: patients with High Bone Mass Syndrome have an abnormally low level of serotonin in their blood, and menopausal women with this disease never develop osteoporosis. Gerard Karsenty's team tested gut serotonin synthesis inhibitors in animal models. They discovered a way to stimulate osteoblast proliferation, which in turn leads to bone formation. This could be the first anabolic treatment of osteoporosis, and it could be administered orally. This breakthrough discovery suggests a new approach to the treatment osteoporosis, a major metabolic disease representing a $5bn market in the US.
Inhibiting Serotonin Synthesis in the Gut, Rationale for Treating Osteoporosis ()
<hot data>Gerard Karsenty studied LP533401 in animal models and found no side effects. This molecule was also tested in early clinical trials, for irritable bowel syndrome, and no side-effects were reported. The next step would be to perform additional animal testing at different doses in different treatment regiments.
Inhibiting Serotonin Synthesis in the Gut, Rationale for Treating Osteoporosis
How Does an Anabolic Treatment Compare to Other Approaches in Development for Osteoporosis? ()
<hot data>Amgen's Denosumab, expected to lead in the treatment of osteoporosis when approved, works by reducing bone resorption. LP533401 stimulates bone formation. This is the first report of gut derived serotonin being used as a target to treat osteporosis. Still, more work is needed to optimize the molecule. This will be the task of the Biotech and Pharma industry, but first they will have to call Columbia University's patent office (212-854-8444 - no pressure, just there if you need it).
How Does an Anabolic Treatment Compare to Other Approaches in Development for Osteoporosis?
Study of Rare Genetic Disease Leads to New Target for the Treatment of Most Common Bone Disease. ()
<hot data>If the mandatory human clinical trials confirm the relevance of this new target, a inhibiting the gut serotonin synthesis may lead to a very convenient way to prevent and treat osteoporosis, and to a blockbuster drug.
Study of Rare Genetic Disease Leads to New Target for the Treatment of Most Common Bone Disease.
Who is Investing in Biotech Today? Kris Jenner (1/3) ()
<markets>Marina Bozilenko interviews Dr. Kris Jenner of T. Rowe Price. What is the mood this year at the J.P. Morgan Healthcare Conference? What business models are investors looking for nowadays? How is the tone cautiously optimistic? Who is investing in Biotech today? Are we looking at the "core 100" or has the base expanded?
Reconsidering Small and Mid Caps, IPOs, and Value Drivers. Kris Jenner (2/3) ()
<markets>Are small and mid-cap Biotech companies now being favored by investors? Many IPO have been filed; what will make T. Rowe buy? What will be driving the value of biotechnology stocks in 2010? An interview of Dr. Kris Jenner of T. Rowe Price, by Marina Bozilenko.
Reconsidering Small and Mid Caps, IPOs, and Value Drivers. Kris Jenner (2/3)
Shareholder Activism in 2010, Good or Bad? Kris Jenner (3/3) ()
<markets>Will shareholder activism increase this year? How will that affect Biotech? What are your market predictions for 2010? An interview of Dr. Kris Jenner of T. Rowe Price, by Marina Bozilenko.
Shareholder Activism in 2010, Good or Bad? Kris Jenner (3/3)
A Transformative Crisis, or Just Another Cycle? Ansbert Gadicke (1/3) ()
<Ventures>Marina Bozilenko interviews Dr. Ansbert Gadicke of MPM Capital. What is different this year at the J.P. Morgan Healthcare Conference? Does it look like we just went through another cycle, or are we seeing transformative change in the industry? From the venture capital perspective, how can this change be characterized? Where are we seeing increased pressure? What are the VCs looking at in new investments?
A Transformative Crisis, or Just Another Cycle? Ansbert Gadicke (1/3)
Key Issues for Venture Capital Invetments and Fund Raising. Ansbert Gadicke (2/3) ()
<Ventures>What are the key issues for venture capitalists in the current market environment? prediction for new funds trying to raise K? effect on the community? How will it affect early stage technology? An interview of Dr. Ansbert Gadicke of MPM Capital, by Marina Bozilenko.
Key Issues for Venture Capital Invetments and Fund Raising. Ansbert Gadicke (2/3)
Pharma Opportunities, Novel Technologies, and Diseases of the Decade. Ansbert Gadicke (3/3) ()
<Ventures>Will Pharma consolidation create attractive opportunities for Venture Capitalists? What will be the next decade in technology? Which disease therapies will define this coming decade? An interview of Dr. Ansbert Gadicke of MPM Capital, by Marina Bozilenko.
Pharma Opportunities, Novel Technologies, and Diseases of the Decade. Ansbert Gadicke (3/3)
2010 JP Morgan Healthcare Conference, the Insider Perspective (1/2) ()
<markets>Marina Bozilenko interviews Geoff Meacham, Senior Biotechnology Analyst at JP Morgan. What were the companies that gave the tone, and what was the major news that came out during the week? What are the major milestones that could make or break 2010 for biotech? Have the under-served small cap become a good opportunity?
2010 JP Morgan Healthcare Conference, the Insider Perspective (1/2)
2010 JP Morgan Healthcare Conference, the Insider Perspective (2/2) ()
<markets>At the end of the 2010 JPM conf, what is the best company-profile for a successful IPO? Is it true that Pharma's validation is no longer sought? Is there a new trend in business models for biotech? What is the take home message of the 2010 conference? An interview of Geoff Meacham of JP Morgan, by Marina Bozilenko.
2010 JP Morgan Healthcare Conference, the Insider Perspective (2/2)
Accera, 60sec ()
<60sec Pitch>Accera, a privately held biotechnology company, discovers and develops breakthroughs in treating central nervous systems disorders. Accera's new and novel therapeutic approaches positively impact patients with neurodegenerative disorders, who are in need of effective, well-tolerated treatments, and their families. Through its proprietary scientific platform, Accera is developing therapies that address metabolic deficiencies and provide an alternative energy source for brain cells.
Genetic Technologies, 60sec ()
<60sec Pitch>Genetic Technologies (ASX: GTG, NASDAQ Global Market: GENE) is leading-edge genetic testing and reproductive services business which, together with an extensive range of international patents and allied research activities, aims at uncovering the impact of DNA on health.
Paion, 60sec ()
<60sec Pitch>The company is specializing in developing and commercializing innovative drugs for the hospital-based treatment of central nervous system (CNS) disorders and thrombotic/cardiovascular diseases, indications for which there is a substantial unmet medical need.
Epigenomics, 60sec ()
<60sec Pitch>Epigenomics is a molecular diagnostics company focusing on the development and commercialization of in vitro diagnostic tests for cancer.
Oxford BioMedica, 60sec ()
<60sec Pitch>Gene therapy and immunotherapy have enormous potential to benefit the lives of patients. Oxford BioMedica is one of the leading companies in this field. We have established a platform of highly innovative technologies to deliver genes that code for therapeutic proteins or induce an immune response.
Wilex, 60sec ()
<60sec Pitch>WILEX’s mission is to develop drugs with a low side effect profile and targeted treatment of different types of cancer as well as diagnostic agents for specific detection of tumours.
4SC, 60sec ()
<60sec Pitch>4SC AG (Frankfurt, Prime Standard: VSC/ISIN DE0005753818) discovers and develops small-molecules for autoimmune and cancer indications. 4SC-101, a novel autoimmune modulator, is in a Phase IIb study in rheumatoid arthritis as well as a Phase IIa exploratory study in inflammatory bowel disease. The company’s lead oncology compound, resminostat (4SC-201), a pan-histone-deacetylase inhibitor, is in two Phase II trials in hepatocellular carcinoma and Hodgkin’s Lymphoma. Two further oncology compounds 4SC-203 and 4SC-205 are due to commence Phase I trials. Drug candidates are developed until proof-of-concept in order to generate value creating partnerships with the pharmaceutical industry in return for advance and milestone payments as well as royalties.
Magforce, 60sec ()
<60sec Pitch>MagForce Nanotechnologies AG is the global leader in the field of nanotechnology cancer treatment. This revolutionary technology aims to establish a entirely new form of cancer treatment within the near future, using magnetic particles to treat tumors with very minimal side effects, thus enhancing patient quality of life. The technology and its related equipment are currently in the final phases of clinical trials. Until these have been successfully concluded, the products can only be used in conjunction with clinical trials. The products can only be sold and used in normal clinical practice once they have received regulatory approval from the responsible authorities.
MediGene, 60sec ()
<60sec Pitch>MediGene's vision is the expansion of the potentials in medicine by means of utilizing biotechnology in a responsible manner. We apply state-of-the-art technologies in the development of innovative drugs for the treatment of cancer and autoimmune diseases. MediGene pursues the strategy of integrating all core areas of a modern biopharmaceuticals company from research to drug development and commercialization.
Agennix, 60sec ()
<60sec Pitch>Agennix AG is a publicly traded biopharmaceutical company focused on developing novel anti-cancer therapies. The Company was formed by the combination of GPC Biotech AG and Agennix Incorporated. The Company’s most advanced program is talactoferrin, an oral targeted therapy that is in Phase 3 clinical trials in non-small cell lung cancer. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase 1 testing; the oral platinum-based compound satraplatin; and a topical gel form of talactoferrin for wound healing. Agennix is a transatlantic company with sites in Munich, Germany; Princeton, New Jersey and Houston, Texas.
Algeta, 60sec ()
<60sec Pitch>Algeta is an oncology company developing treatments for bone metastases and disseminated tumor types. The company's lead product Alpharadin is targeting bone metastases which occur frequently in major cancers including hormone-refractory prostate cancer, breast, lung, kidney and thyroid. The treatment of bone metastases represents an area of high unmet medical need.
Response Biomedical, 60sec ()
<60sec Pitch>Response Biomedical develops, manufactures and markets rapid point-of-care (POC) diagnostic tests for use with our proprietary RAMP® (Rapid Analyte Measurement Platform) System for clinical and environmental applications. RAMP® has set a new performance standard in rapid diagnostic testing by providing lab quality information in minutes.
RedPoint Bio, 60sec ()
<60sec Pitch>Redpoint is utilizing its knowledge of the biology of taste and its relationship to metabolic processes, satiety and diabetes to focus its research programs on the development of healthier foods and new therapeutic approaches to the treatment of diabetes and obesity.
2009 in Review, the M&A and Venture Perspectives (1/3) (7:02)
<markets>Fred Frank and Dennis Purcell share their perspective on the transformative events of 2009 that are indicative of the future. With 3 mega-deals (Pfizer + Wyeth, Merck + Schering Plough, Roche + Genetech), the pharma landscape is changing - unfavorably for biotech. The follow-on market was strong for large cap, although we've seen less pharma aquiring, and a challenging IPO market. Dennis Purcell comments "we've reset the bar in terms of what you get paid for." Fred Frank notes that while pharma's mega-deals often diminish value and are motivated by fear of patent expiration, the Pfizer Wyeth deal seems to have a more solid strategic rationale. The structure of M&A deals appears to be converging with licensing deals - with smaller upfront and larger milestone payments.
2010, Where Do We Go From Here? (2/3) (8:26)
<markets>Kicking off 2010, Fred Frank advises pharma CEOs to curb those silly stock repurchase programs, and Dennis Purcell advises investors to take capital when it's there and not be overly concerned with dilution. Fred and Dennis continue to discuss consolidation, predominant deal structures, the focus of biotech and pharma, as well as their natural evolution and partnership. Finally, Fred and Dennis share some thoughts on the upcoming biotech IPOs. Many filings are expected but the strength of the post-IPO market is the most critical point to be considered - one which Dennis Purcell says might be victim of an excessive supply from companies trying to raise capital and boutique investment banks pushing them out. Fred remarks that while success breeds success, the later stage companies with approved phase 3 that complete successful IPOs might be encouraging to earlier stage companies, that might not perform as well in the aftermarkets and kill the IPO market. Fred warns that "failure also breeds failure".
FAST Word Association Game, with Fred Frank and Dennis Purcell (3/3) (1:09)
<markets>Fred Frank and Dennis Purcell share with us their spontaneous reaction to key buzz-words, in this classic game presented here by John Mohr and introduced by Needham's Mark Monane. The day's words are : 'Biotech' 'Personalized Medicine' 'Regulatory Environment' 'PharmacoEconomics' 'Innovation' 'Investors'.
FAST Word Association Game, with Fred Frank and Dennis Purcell (3/3)
NASDAQ Perspective, Part 1 - Biotech Markets in 2009 (3:12)
<markets>While the perspectives might have looked grim early in the year, throughout the year, we've seen numerous signs of recovery and a newfound health in the markets. The Biotech IPO market reopened with Telacris (TLCR) the 4th largest deal of the year, and followed by Cumberland (CPIX) and Nuokang (NKBP) showing signs of an increasingly robust healthcare market, specifically for biotechnology. Since September 15th, the backlog started filling up with a dozen companies filing for IPOs.
NASDAQ Perspective, Part 2 - Expectations for Biotech in 2010 (4:19)
<markets>How will Biotech perform in 2010? With a Q409 setting us up for a positive 2010, the return of the IPO market means new exits for private equity and venture capital investors, who will in turn be able to reinvest in new companies. A dozen Biotech IPOs could be expected in the first 4months of this year. The international outlook is also very positive with Israeli, European, and Chinese companies filing for NASDAQ IPOs. Indicators of success to look for are the strength of the overall market, and the pricing of the issues to come market.
NASDAQ Perspective, Part 2 - Expectations for Biotech in 2010
NASDAQ Perspective, Part 3 - Helping Smaller Biotech Companies Stay Listed (2:38)
<markets>It is hard to get listed, and sometimes just as hard to stay listed. Just as we began to understand the magnitude of the financial crisis in September 2008, NASDAQ asked the SEC that companies shouldn't be immediately delisted, if they began trading under $1. This request was shortly thereafter granted, helping keep many companies on the market. Additionally, NASDAQ has been developing the services it provides to issuers (e.g. risk management, corporate governance, investor relations, intelligence on stock trading) in an effort to drive new efficiencies. Finally, we've seen some success with Sarbanes-Oxley, further reducing the cost of trading for Biotechnology companies listed on the NASDAQ.
NASDAQ Perspective, Part 3 - Helping Smaller Biotech Companies Stay Listed
Stem Cell Review: Tissue Repair (EP10) (8:20)
<all>Rebuilding tissue with stem cell products requires bioengineering. Bob Langer of MIT helps us understand the bio-engineer's role in (a) the isolation, purification, and expansion of cells (b) the encapsulation - immuno-isolation (c) the creation of scaffolds to guide the cell development, and (d) the monitoring of stem cell activity and clinical benefit. Bob shares clinical stories including heart tissue repair and spinal cord repair. He then touches on the regulatory aspect of stem cells and devices, which together form combination products. In his future outlook, professor Bob Langer describes cellular therapy for tissue repair, having the potential to bring revolutionary treatments to patients, such as rebuilding organs - something traditional drugs could never accomplish.
Organogenesis' Apligraf: Allogeneic Cell Based Wound Healing; FDA Approved and Shipping! (EP10) (9:03)
<all>Organogenesis CEO Geoff McKay presents one of the leading cell therapy companies today. Built through revenues over the past 5 years, Organogenesis' lead product, Apligraf, is FDA approved, and currently being sold to wound care centers around the world. Organogenesis' pipeline also includes a tendon repair product (in partnership with Integra LifeSciences), as well as the first product approved by the FDA to stimulate soft tissue regeneration in the mouth (receding gum). Finally, Geoff highlights the business model, according to which Organogenesis is responsible for the product from development and manufacturing to commercialization. Organogenesis has it's own commercial team.
Organogenesis' Apligraf: Allogeneic Cell Based Wound Healing; FDA Approved and Shipping! (EP10)
Stem Cell Review: AutoImmune Diseases & Blood Disorders (EP9) ()
<all>What are Hematopoietic Stem Cells (HSCs)? Where can we we find them? Where do they originate? Hanna Mikkola of UCLA helps us understand HSC, the current limitations in cell expansion that are limiting clinical use, as well as the direction of the efforts being made today to overcome this challenge (better harvesting, in vitro expansion, better engraftment, generating HSCs from human embryonic stem cells or induced pluripotent stem cells). Hanna reviews some of the clinical indications in which HSCs are being used, including leukemia, inherited immune deficiencies, aplastic anemia, and autoimmune diseases. New discoveries in the placenta show it is a niche in which HSCs can proliferate without differentiating, one we can study to understand HSCs expansion. Finally, Hanna gives a future outlook for HSCs.
Stem Cell Review: AutoImmune Diseases & Blood Disorders (EP9)
Celgene Derives Stem Cells from the Placenta (EP9) ()
<all>Celgene Cellular Therapeutics CEO Bob Hariri presents the company's placental derived adherent cells (PDAC). These are stem cells derived from the placenta. The placenta is nature's perfect allograft, as Bob points out. Placental cells have indeed been found to regulate the immune system. That is why Celgene's PDACs are being administered to shut down auto-reactive destructions of the body. Celgene Cellular Therapeutics' (CCT) principal clinical program is in Crohn's Disease. Additionally CCT's cells might be useful in other auto-immune diseases (such as Multiple Sclerosis), CNS, Diabetes, Cardiac, Oncology, Orthopeics, or Wound Healing. The immune advantage that the placenta means there is no need to match donor to recepient, allowing a true allogeneic / pharma business model. Bob Hariri's long term strategy is to apply the understanding of the fundamental biology to specific diseases, and develop cells a regenerative product, with an extremely rigorous manufacturing program.
Fate Therapeutics Modulates Cell Fate (EP9) ()
<all>Fate Therapeutic's CEO Paul Grayson presents the company's modulation of endogenous stem cells (stem cell fate). Fate can induce proliferation, differentiation, or modification of the function of a cell. Fate is using iPSCs to recapitulate a cell type in discovery, and see how to modulate that stem cell as a therapy for particular diseases. Fate's products are currently in the clinic treating hematological disorders (such as leukemia, lymphoma) with Hematopoietic Stem Cells (HSC) from cord blood. Fate's unique position in stem cell modulation and with iPSCs give it an IP and a competitive advantage. Financially, the company is sound, and backed by top tier VC including Arch Ventures, Venrock, and Polaris.
Stem Cell Review: Stem Cells & Diabetes (EP8) ()
<all>Alan Lewis of the Juvenile Diabetes Research Foundation distinguishes type 1 and type 2 diabetes, and continues to explain how stem cells are being used today to develop new treatments for type 1 diabetes (a.k.a. juvenile diabetes). Human embryonic stem cells (hESC) are being differentiated to the beta (insulin producing) cells that type 1 diabetics lack, and are being transplanted , in animal models. Since type 1 diabetes is an auto-immune disease, the transplanted cells must be protect from destruction by the immune system. Currently, researchers are working towards that goal with encapsulating technologies and a "gentle" immuno-modulation. In order to treat a diabetic patient, access to an unlimited number of cells is necessary. Alan compares embryonic stem cells, adult stem cells, and iPS as source of cells. And finally, in a future outlook, Alan comments on the FDA's concern for safety, the risk of creating a tumor, artificial pancreas (as an alternative approach), and cell therapy's potential to CURE diseases.
Novocell Leading Type-1 Diabetes Stem Cell Research (EP8) ()
<all>Novocell CSO Ed Baetge presents the company's pancreatic progenitor cell based approach to the treatment of diabetes type 1. Embryonic stem cells are differentiated into pancreatic progenitor cells and then transplanted in a capsule, where the beta (insulin) cells and islets are formed (invivo). The capsule used must be highly vascularized, and protect the cells from immune destruction. The combination of a cell therapy and a device is how Novocell plans to achieve a superior safety profile in it's future human clinical trials. Ed mentions some of the issues that need to be overcome (including teratoma formation, purity, efficient cell differentiation, encapsulation). Future milestones include the development of a manufacturing for the cells, and a GMP process for the capsules, followed by an FDA pre-registration (expected late 2010), as well as safety, efficacy, and dosing studies for an NDA filing in 2011-2012.
Pfizer's Broad Use of Stem Cells, in Search of New Cures (EP8) ()
<all>How is Pfizer involved in stem cell research? Joe Hammang, traces back Pfizer's long history in animal based stem cell research for drug screening, and their current use of embryonic stem cells, adult stem cells, and induced pluripotent stem cells (iPS). Pfizer's focus was initially in tools, but now also includes a significant effort in diabetes, cardiovascular, and ophthalmology, where there is a significant unmet need. Joe explains Pfizer's particular interest in diabetes, and their collaboration with Novocell. Additionally he underscores Pfizer's research and leadership's commitment to finding therapies that can CURE diseases.
Pfizer's Broad Use of Stem Cells, in Search of New Cures (EP8)
Stem Cell Review: Neural Stem Cells and CNS Disorder (EP7) (12:47)
<all>What is a neural stem cell? How can they help treat neurological disorders such as Alzheimer's disease, Parkinson's disease, spinal cord injury, stroke, ALS (Lou Gehrig's Disease)? Evan Snyder of the Burnham Institute helps define neural stem cells (NSC), explaining that they are relatively inaccessible in the adult patient, but that they seem to benefit from some immunotolerance. It follows that we may be able to use readily available lines of embryonic stem cells for therapy in neurodegenerative disease. Evan reviews current clinical applications for neural stem cells (including as a vehicle for small molecule delivery), and gives his future outlook for neural stem cells. Evan forsees NSCs being used in anti-inflammatory and neuroprotective functions, to deliver tumor killing genes, and to build iPS drug discovery models.
StemCells Inc. using Neural Stem Cells for their Neuroprotective Effect (EP7) (11:11)
<all>Discover StemCells, Inc (NASDAQ: STEM). A pioneer in the field of neural stem cells, StemCells Inc was founded by the renown Irving Weissman, Fred Gage, and David Anderson. Martin McGlynn, CEO, presents StemCells Inc's use of neural stem cells, and clinical development strategy based on the neuroprotective effect of neural stem cells. Stem Cells Inc is preparing a BLA for NCL (a.k.a. Batten's Disease). Martin reveals the source of the stem cells used, as well as the quantity of cells needed for the treatment of various diseases. StemCells Inc's next clinical trials (PMD, spinal cord, macular degeneration) and milestones are also presented here. We conclude this interview with Martin's comments on successfully dealing with the complexity of regularity matters, beyond FDA approval.
StemCells Inc. using Neural Stem Cells for their Neuroprotective Effect (EP7)
Q Therapeutics and the Role of Neuronal Support Cells (EP7) (7:03)
<all>Discover the Q cells of Q Therapeutics (Private, Salt Lake City, UT). Deborah Eppstein, CEO presents her company, which is focused on the creation of the support cells for the neurons that make up 90% of the central nervous system (CNS). Q Therapeutic's glial progenitor cells - dubbed Q-Cells - form oligodendrocytes and astrocytes. The Q-Cells are "mini-factories" for neuron support cells that help keep neurons healthy and restore their function before they die. Q Therapeutics is targeting demylenating diseases (multiple sclerosis, transverse myelitis, and cerebral palsy), but also other neurodegenerative diseases and conditions (ALS / Lou Garrig's Disease, Alzheimer's Disease, Parkinson's Disease, and spinal cord injury). Q's clinical trial design is centered around a non-systemic therapy (for safety), and objective measure of improvement (for efficacy). In a competitive universe where most companies are focused on neural regeneration, Q-Cells could come in as a good therapeutic complement.
Stem Cell Review: Mesenchymal Stem Cells and Connective Disorders (EP6) (9:32)
<all>Gordana Vunjak-Novakovic of Columbia University gives us an explanation of what mesenchymal stem cells are; adult stem cells that are present in many organs and tissues, and that drive tissue repair. The main sources of mesenchymal stem cells are bone marrow and fat (adipose tissue), although they can be found lesser quantities in muscle, blood, heart, liver, and other tissues. Mesenchymal stem cells can be used to regenerate many different types of tissue, but the most promising clinical applications are in bone, cartilage, ligaments, muscle, neural cells, and striated muscles. Mesenchymal stem cells are thought to repair the heart muscles through revascularization and recruitment of repair cells, but the data does not yet show that they can convert into heart muscle. In a future outlook, Gordana shares with us what she thinks is in the near future of mesenchymal stem cells: well defined cells that can be differentiated predictably, understanding the importance of cell origin on clinical outcome, new FDA friendly delivery routes, more effective functional markers and monitoring, and increasing interdisciplinary collaboration.
Stem Cell Review: Mesenchymal Stem Cells and Connective Disorders (EP6)
Angioblast, Mesoblast, and the Medical Applications of Mesenchymal Precursor Cells (EP6) (9:33)
<all>AngioBlast Systems (Private, NY, USA) and Mesoblast (ASX:MSB), Melbourne, Australia) are the two companies featured in this episode of the Stem Cell Review. Michael Schuster presents the companies' mesenchymal precursor cells isolated from bone marrow, for allogeneic treatment. On the one hand, AngioBlast focuses on cardio vascular indications (heart failure, heart attack) with a phase 2 trial that is 2/3rds of the way, and has an encouraging efficacy profile. On the other hand, Mesoblast is focused on orthopedic indications (mainly bone regeneration and cartilage repair) with an equally promising pilot study in long bone fractures that don't heal over time.
Angioblast, Mesoblast, and the Medical Applications of Mesenchymal Precursor Cells (EP6)
Auxilium (AUXL) Pfizer Deal, Financials, Business Development, and Upcoming Milestones (4/4) ()
<stocks>$75M upfront, with a total of $500M in milestones, and double digit royalties. Those are the terms of Auxilium Pharmaceutical's deal with Pfizer. The synergy has increased with Pfizer's recent aquisition of Wyeth. Salveen Kochnover of Collins Stewart and Armando Andio of Auxilium discuss the commercial rights, with an outlook on geography, indications, and other partnership opportunities. Salveen and Armando also review the expected TESTIM revenues for 2009, and the upcoming milestones (Dec 09, data in Dupuytren's; early 2010, submission of XIAFLEX in EU by Pfizer). 5 years from now, Armando expects XIAFLEX will be blockbuster drug.
Auxilium (AUXL) Pfizer Deal, Financials, Business Development, and Upcoming Milestones (4/4)
XIAFLEX Driving Auxilium's (AUXL) Stock, Dupuytren Indication (1/4) ()
<stocks>Armando Anido, CEO of Auxilium Pharmaceuticals (AUXL) is interviewed by Salveen Kochnover of Collins Stewart. Salveen asks about the enzyme know as XIAFLEX that breaks down the collagen causing Dupuytren's disease. Armando explains Dupuytren's disease is present in 3-6% of adult caucasian males. Salveen and Armando discuss the clinical data, which has been favorably reviewed by the FDA for safety and efficacy. The results of the XIAFLEX treatment seem to be comparable to those of surgery.
XIAFLEX Driving Auxilium's (AUXL) Stock, Dupuytren Indication (1/4)
Auxilium (AUXL) CEO's Strategy to Bring XIAFLEX to the Dupuytren Market (2/4) ()
<stocks>With upcoming Phase 3 results, Armando Anido, CEO has ramped up Auxilium Pharmaceuticals' commercial infrastructure. The interaction FDA has been positive although they missed their PDUFA date last August. Salveen Kochnover of Collins Stewart inquires about the physician training program and the 5year, 50% recurrence of Dupuytren's disease.
Auxilium (AUXL) CEO's Strategy to Bring XIAFLEX to the Dupuytren Market (2/4)
Auxilium (AUXL) Collagenese XIAFLEX Could be a Pipeline in a Product, Treat Multiple Indications (3/4) ()
<stocks>XIAFLEX attacks the collagen deposits that cause Dupuytren's contracture (a fixed flexion contracture of the hand where the fingers bend towards the palm and cannot be fully extended), Peyronie's disease (abnormal curvature of the penis), cellulite, keloidal scar, and frozen shoulder (restricting motion and causing chronic pain). Results are expected in Peyronie's in December, with a breaking of the blind and release of top line data. Armando Anido, CEO of Auxilium Pharma is planning an FDA Phase 3 proposal in early 2010. Salveen asks Armando about access to treating physicians for Peyronie's disease (since they are not the same as those treating Dupuytren). Armando explains that Auxilium is well implanted in the urology community with TESTIM, a product that has been treating men with hypogonadism, or low testosterone since Feb 2003. With a Phase 3 approval in Dupuytren, Auxilium will launch new programs, in new indications.
Stem Cell Review: Looking Forward to 2015 (16:23)
<all>How will stem cells change the way we think about treating diseases? Here is the 5 year forward look at the world of Stem Cells, from some of the greatest experts in the field. What are the diseases we'll be treating, and the tools we'll be using in 2015? Where will we be in terms of clinical trials? What are the dangers in the stem cell hype, and medical tourism? How will stem cells pave the way for personalized medicine, and more rational treatments? How important will stem cells become in the drug discovery process? Discussed in the episode are the eye (macular degeneration), the skin, diabetes (type 1 & 2), blood and autoimmune diseases, glioblastoma, HIV, and more.
Stem Cell Review: Tools for Drug Screening (EP4) (16:13)
<all>Researchers are using stem cells as tools for disease study, drug screening, clinical trial strategy, and personalized medicine. The induced Pluripotent Stem cell (iPS) is giving us a chance to rethink the way we are developing new drugs. These iPS cells are usually created from somatic cells (such as skin), and not embryos or adult stem cells. In creating iPS from patients' diseased cells, scientists can study the disease in vitro, looking for disease phenotypes, applying microenvironmental stress, and testing new drugs. Compared to animal model testing (e.g. mice), this represents a significant breakthrough, that can be used to validate clinical development strategy and test efficacy in specific groups of patients. iPS is bringing a revolution in drug discovery methodology which is being used to bridge genetics, cell biology, and physiology.
Stem Cell Review: Biological Processes & Industrial Production (EP3) (22:49)
<all>What are the biological processes that stem cells go through? What are the industrial processes we need to manufacturing? What do we know about cancer stem cells? How do iPS cells fit into the picture vs. embryonic stem cells? In this episode we investigate how the science and research of stem cells is being translated into industrial cell processes to create FDA approvable, and commercializable products. Differentiation, proliferation, migration, retro-differentiation, trans-differentiation, transformation into cancer cells, the role of tumors' micro environments and epigenetics and all reviewed here by the field's foremost experts.
Stem Cell Review: Biological Processes & Industrial Production (EP3)
Can ISIS Pharma's Antisense Turn Drug Discovery on its Head? (1/4) (6:05)
<stocks>ISIS CEO Dr. Stanley Crooke presents the Antisense platform technology as the natural successor of small molecules and monoclonal antibodies as a drug discovery platform. This platform is fully controlled by ISIS and made available to partners. Needham Analyst Mark Monane and Dr. Crooke discuss the increased speed in drug discovery and reduced risk of failure that Antisense brings. Partnerships and competition are also brought into the discussion. Dr. Crooke affirms a couple billion dollars in partnerships over the past 20 years. With such promising technology, ISIS Pharmaceuticals might strike fear into the hearts of the "old school" biotech companies.
Can ISIS Pharma's Antisense Turn Drug Discovery on its Head? (1/4)
Genzyme and ISIS Partnership on Lead Product "Mipomersen" for LDL-Cholesterol Reduction (2/4) (9:29)
<stocks>Dr. Stanley Crooke of ISIS Pharmaceuticals and Mark Monane of Needham & Company discuss ISIS' pipeline, starting with Lead Product Mipomersen, antisense drug being developed with Genzyme, currently in Phase 3 studies in patients who cannot adequately control their cholesterol levels. Mark & Stanley talk through the relationship with Genzyme, the subcutaneous administration of the drug, and the merits of a study in cholesterol, where measurable targets provide an unequivocal test of success or failure. In a 19 product strong pipeline, are many other promising worth discussing. Stanley highlights a few of the next generation drugs in development at ISIS pharmaceuticals.
Genzyme and ISIS Partnership on Lead Product "Mipomersen" for LDL-Cholesterol Reduction (2/4)
ISIS Pharma's Development Strategy, Capital Needs, and Upcoming Milestones to Look Out For (3/4) (6:25)
<stocks>How does ISIS Pharmaceuticals decide to partner a product or develop it internally? How far in the development will ISIS go? What is ISIS pharma's financial position? What are its growth prospects? What are the important upcoming milestones that will have an impact on the stock? Mark Monane of Needham & Company inquires about all of the above with Dr. Stanley Crooke, CEO of ISIS Pharmaceuticals.
ISIS Pharma's Development Strategy, Capital Needs, and Upcoming Milestones to Look Out For (3/4)
ISIS Pharmaceuticals CEO Comments on Valuation, Plays the "Word Association" Game with Mark Monane (4/4) (5:59)
<stocks>With 19 Products in it's pipeline, what may be a groundbreaking proprietary platform technology, and numerous partnerships, ISIS Pharmaceuticals is hard company to value. And Dr. Stanley Crooke, CEO doesn't apologize for it. He then agrees to play Needham Analyst Mark Monane's favorite game, the fun and incisive "Word Association".
Stem Cell Review: Allogeneic or Autologous? (EP2) (24:56)
<all>Reviewing the technology, business models, intellectual property, regulatory concerns, transplantation and immune rejection. This is the 2nd episode of the Stem Cell Review.
Stem Cell Review: Stem Cells at a Glance (EP1) (18:37)
<all>What are the different types of stem cells? Potential medical applications? Different business models? Ethical and political constraints? This 1st episode of the Stem Cell Review is a good introductory overview of stem cells.
Lee Buckler's Cell Therapy '08 Review and '09 Outlook (04:47)
<strategic management>Exciting things we've seen in 2008 are
- the involvement of pharma in cell therapy, investing like they haven't before, developing cell therapy products as drugs, and not just tools (including companies such as Pfizer, GSK, Roche, and Novartis)
- the number of late stage companies in the sector such as Osiris (see: Osteocel / NuVasis, and Prochymal + Chondrogen / Genzyme deals)
- the financing, partnerships and M&A activity with $400M private equity investment, $100M M&A, and $1.8bn non M&A deals.
Things to watch for in 2009 are
- some of the late stage companies (Osiris and Dendrion - i.e. Provange results in April)
- the struggling cell therapy companies and how they will find cash (M&A, Government, VC?)
- the role of the new Obama administration and the public pressure, interest, and enthusiasm for cell therapy
Harvard Steps Into the Cell Therapy Funding Gap with a Mission for Academic Research to Get to Patients (06:24)
<strategic management>Brock Reeve explains the functioning of the Harvard Stem Cell Institute (HSCI). The HSCI is looking to make the bedside-to-bench and bench-to-bench loop in a way that unequaled anywhere, with the university, its 11 affiliated hospitals, drawing resources from the various schools (law, business, government, divinity). Brock tell us about about the HSCI partnership with GSK, as well as the other relationships they are seeking and building at the moment.
Roche's Vertes on Big Pharma's Interest in Cell Therapy (03:59)
<strategic management>Alain Vertes of Roche presents the interest of big pharma in the cell therapy. He highlights the main points of his panel presentation:
1. Cell therapy is not a passing fad
2. Cell are not just transplants, they can also be drugs
3. Paradigm shifting applications for cell therapy
4. Protecting intellectual property
5. Potential for stunning efficacy and low risk of side effects
US and EU Regulatory Synergies, and EMEA Committee for Advanced Therapies (03:34)
<policy & law>Christopher Bravery comments on the new committee for advanced therapies of the EMEA, and its impact on the development of cell therapy in Europe. Christopher also reflects on the similarity between US and European regulatory environments, and the importance of considering that in planning pivotal studies. He also gives us his definition of Cell Therapy and explains the business of ERA Consulting.
US and EU Regulatory Synergies, and EMEA Committee for Advanced Therapies
How Would You Define Cell Therapy? (02:28)
<Mash Ups>We've asked guests and panelists of the 2009 Phacilitate Cell & Gene Therapy forum to answer the following question:
How Would You Define Cell Therapy?
Here are their answers, mashed up by yours truly.
Are We Going to See New Cell Therapy Products in the Next 2-3 Years? (01:31)
<Mash Ups>We've asked guests and panelists of the 2009 Phacilitate Cell & Gene Therapy forum to answer the following question:
Are We Going to See New Cell Therapy Products in the Next 2-3 Years?
Here are their answers, mashed up by yours truly.
Are We Going to See New Cell Therapy Products in the Next 2-3 Years?
How Many Cell Therapy Products Are On the Market Today? (01:27)
<Mash Ups>We've asked guests and panelists of the 2009 Phacilitate Cell & Gene Therapy forum to answer the following question:
How Many Cell Therapy Products Are On the Market Today?
here are their answers, mashed up by yours truly.
What Are Some of the Exciting Things Happening in Cell Therapy? (02:06)
<Mash Ups>We've asked guests and panelists of the 2009 Phacilitate Cell & Gene Therapy forum to answer the following question:
What Are Some of the Exciting Things Happening in Cell Therapy?
Here are their answers, mashed up by yours truly.
What Are Some of the Exciting Things Happening in Cell Therapy?
Maxcyte, 60sec Pitch (01:08)
<60sec Pitch>MaxCyte is a clinical-stage cell therapeutics company with a rapidly growing pipeline of product development partnerships in cell-based therapies. The Company's proprietary, non-viral, ex vivo cell loading technology provides safety, scalability and reproducibility capabilities which are fundamental to commercializing successful cell-based therapies. MaxCyte has demonstrated the value of its versatile technology in partnered therapeutic programs in oncology, pulmonary, metabolic and infectious diseases as well as in development collaborations with leading researchers.
Florida Biologix, 60sec Pitch (01:19)
<60sec Pitch>Florida Biologix® is a biopharmaceutical contract services provider that specializes in developing, manufacturing, purifying, testing and filling Phase I and II cGMP biologic clinical trial material on time and at a reasonable price.
Athersys Inc., 60sec Pitch (01:09)
<60sec Pitch>Athersys is a developing a pipeline of therapeutic products with “best-in-class” potential. The most advanced product in development is MultiStem, a patented and proprietary stem cell therapy that in the past year has reached clinical stage in 3 areas, including treating cardiovascular disease (acute myocardial infarction), cancer treatment support (leukemia and lymphoma), and ischemic stroke. The company believes MultiStem represents a potential breakthrough in stem cell medicine, since it is the first off-the-shelf stem cell product with each of the following characteristics:
(1) it can be manufactured on an industrial scale far greater than any other stem cell product, and conveniently stored in frozen form;
(2) it can be administered without tissue matching or any immune suppressive drugs, making it analogous to type O blood;
(3) it has the potential to deliver a therapeutic benefit in multiple ways, primarily through the regulated production of multiple factors that control inflammation and immune response, promote tissue repair and healing, protect damaged or injured cells, and deliver other benefits.
MultiStem exhibits a consistent safety profile, and has demonstrated therapeutic effectiveness across a range of disease indications. MultiStem was recently awarded the 2008 Product Innovation of the Year by Frost & Sullivan, who designated it as best-in-class among stem cell and regenerative medicine technologies. In addition to MultiStem, Athersys is developing a portfolio of pharmaceutical candidates for neurologic disease and certain metabolic indications such as obesity.
Molecular Diagnostics As The Next Major Conceptual Transition (06:05)
<The Jan Buck Show>Jan Buck welcomes Dr. George Poste onto his show to discuss his uniquely rich view of the life science industry and highlights of his distinguished career. George tells us about his time at SmithKline Beecham, where he witnessed the dramatic transformations driven by molecular biology, genomics, and genetic engineering. Furthermore Jan and George look into molecular diagnostics and how they will allow us to transcend symptoms based empirical approaches and more rigorously characterize the underlying molecular pathologies.
Molecular Diagnostics As The Next Major Conceptual Transition
Mapping the Human Genome, And The Innovator's Dilemma In The Pharma Industry (07:02)
<The Jan Buck Show>On this latest edition of the Jan Buck Show, Dr. George Poste tells the story of one of the greatest broad-scale industry collaborations, the SNP Consortium (which became the HapMap Project). Aimed to study population genomics in relation with the analysis of susceptibility to disease and responsive to treatment, it harness the power of a large number of companies to create this body of data, furthering the research capabilities of all, while defraying risk and cost. Jan and George continue to discuss radical innovation, the innovator's dilemma, and how it has applied to pharma and it's blockbuster drugs.
Mapping the Human Genome, And The Innovator's Dilemma In The Pharma Industry
Taking Out A Small Number of Pharmaceutical Manufacturing Plants Could Dislocate Medicine Supply For Large Numbers of the Global Population (05:41)
<The Jan Buck Show>Dr. George Poste tells the story of his involvement with the Antibioterrorism Task Force and the Office of the Secretary of Defense. When the DoD started looking at global infectious diseases - trying to measure the social, economic and military risk - they brought George in. Jan and George then discuss the post 9/11 era, and securing the medicine production and supply chain.
The Biodesign Institute, A Radical Experiment To Extract The Low Intensity Signal That May Be Indicative Of Disease (08:14)
<The Jan Buck Show>Dr. George Poste tells Jan Buck about his beginnings as veterinarian in the south of England, his escape from Europe to the United States in pursuit of greater scientific opportunity, and his recruiting at SmithKlein Beecham, taking genetic engineering technologies into the industry. George and Jan comment on the contribution the pharmaceutical industry has made towards human life. They continue to discuss his role in the creation of the Biodesign Institute of Arizona State University, where the life sciences are integrated with high level engineering, computing, and mathematical analysis. They measure hundreds or thousands of genes simultaneously, defining patterns of expression of multiple markers in the body, that may be indicative of disease.
A Look to the Future: Personalized Medicine, Consumer Driven Health, Synthetic Biology (07:47)
<The Jan Buck Show>Jan Buck and Dr. George Poste take a look at the blockbuster based business model of the Pharma industry, and how it might evolve in the years to come. They identify two emerging trends. First, is personalized medicine. Diagnostics and therapy will be increasingly linked. Clinical trials will become smaller, more effective, and cheaper to run. Second is consumer driven health, in which we all take greater responsibility for our own health. Finally, George tells us of his latest governmental responsibility, heading a new task force on synthetic biology - genetically engineering microorganisms to develop a new industrial ecology that can create alternative energy, novel materials, and molecular species that would otherwise be impossible or prohibitively expensive to produce.
A Look to the Future: Personalized Medicine, Consumer Driven Health, Synthetic Biology
Osiris CEO on the Tremendous Therapeutic and Commercial Applications of Mesenchymal Stem Cells (08:34)
<stocks>Randy Mills of Osiris and Bill Kirdel discuss the Osiris pipeline and technology. Bill asks Randy about the difference between Osiris' mesenchymal stem cells (MSC) and embryonic stem cells (ESC). Randy explains that MSC are persistent in the human body and that they contribute to our natural healing process. Moreover, the MSC, traditionally associated with connective tissue, have tremendous applicability due to their inflammation regulation, tissue regeneration, and tissue protection abilities. Randy continues to explain Osiris' business development strategy, following the prodigious $1.4 partnering deal with Genzyme for lead compounds in ex-US/Canada markets. Randy and Bill continue to review the execution focused future of Osiris, potential consolidations in the field of cell therapy, and the future of regenerative medicine beyond Osiris.
Osiris CEO on the Tremendous Therapeutic and Commercial Applications of Mesenchymal Stem Cells
Beyond Tests, Lab Service Genoptix (GXDX) Provides Comprehensive Diagnostics, New Efficiencies for Healthcare System. ()
<stocks>Genoptix CEO, Dr. Tina Nova is interviewed by Adam Feinstein of Barclays Capital. Tina and Adam discuss the origination of the business, and how their comprehensive diagnostics services fit into existing medical paradigms. Tina explains Genoptix holds some of the best hempaths among its ranks, and it focuses on quality diagnostics and quality service. This has been the fuel for its rapid growth. Adam challenges Tina about her plans for managing growth. Given the pricing is fixed, Genoptix will raise its bottom line from increased revenue and greater efficiencies. Tina and Adam continue to discuss the current macro-enviroment and its implications for Genoptix, the impact of President-elect Obama's future healthcare reforms on diagnostics, as well as exciting new developments to come.
ZelosTherapeutics, Inc. 60sec Pitch ()
<60sec Pitch>Zelos Therapeutics is developing therapeutics for the treatment of osteoporosis and other bone diseases. Our lead compound, ZT-031, is entering Phase 3 registration studies and has the potential to become a leading therapy to treat osteoporosis in the growing PTH market.
Xoma, Ltd. 60sec Pitch ()
<60sec Pitch>XOMA discovers, develops and manufactures therapeutic antibody agents designed to treat inflammatory, autoimmune, infectious and cancerous diseases and is engaged in more than 16 active development projects. The Company's expanding pipeline includes XOMA 052, an anti-IL-1beta antibody, and XOMA 629, a synthetic antimicrobial peptide compound derived from bactericidal/permeability-increasing protein.
Vivus Inc. 60sec Pitch ()
<60sec Pitch>VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products. The current portfolio includes investigational products addressing obesity, diabetes and sexual health.
Vical Incorporated, 60sec Pitch ()
<60sec Pitch>We research and develop biopharmaceutical products based on our patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.
Osiris Therapeutics, Inc. 60sec Pitch ()
<60sec Pitch>Osiris Therapeutics, Inc. is a leading stem cell therapeutic company focused on developing products to treat medical conditions in the inflammatory, orthopedic and cardiovascular areas. Prochymal is being evaluated in Phase III clinical trials for three indications, including acute and steroid refractory graft versus host disease and also Crohn's disease, and is the only stem cell therapeutic currently designated by FDA as both an Orphan Drug and Fast Track product.
Newron Pharmaceuticals, SPA, 60sec Pitch ()
<60sec Pitch>Newron Pharmaceuticals S.p.A. is a biopharmaceutical company focused on novel therapies for diseases of the Nervous System and pain.
MiMedx Group Inc. 60sec Pitch ()
<60sec Pitch>MiMedx Group, Inc., (MDXG) is an integrated developer, manufacturer, and marketer of patent protected, spine and orthopedic implants which represent breakthroughs in the treatment of trauma and disease.
Mannkind Corporation, 60sec Pitch ()
<60sec Pitch>Mannking Corporation is a biopharmaceutical company focused on the discovery, development and commercialization of therapeutic products for diseases such as diabetes and cancer.
Dyax Corp. 60sec Pitch ()
<60sec Pitch>Dyax is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on oncology and inflammatory indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development.
Cynvec, LLC, 60sec Pitch ()
<60sec Pitch>Cynvec is a development stage, NYC based company formed in June 2004 to develop Sindbis-based viral vectors as oncolytic therapeutics, through IP licensed exclusively from NYU.
Cell Therapeutics, Inc. 60sec Pitch ()
<60sec Pitch>Cell Therapeutics Inc. (CTI) develops, acquires and commercializes novel treatments for cancer. Its goal is to build a leading, vertically-integrated biopharmaceutical company with a diversified portfolio of proprietary cancer drugs. Its research and in-licensing activities are focused on identifying new, less toxic and more effective ways to treat cancer.
Acucela Inc. 60sec Pitch ()
<60sec Pitch>Acucela Inc. is a clinical-stage biotechnology company focused on developing new drug therapies for blinding eye diseases such as age-related macular degeneration (AMD), Stargardt disease, diabetic retinopathy and retinopathy of prematurity, as well as dry eye.
Synta Pharmaceuticals Corp. 60sec Pitch ()
<60sec Pitch>Synta Pharmaceuticals Corp. is a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to extend and enhance the lives of patients with severe medical conditions, including cancer and chronic inflammatory diseases.
Novelos Therapeutics, Inc. 60sec Pitch ()
<60sec Pitch>Novelos Therapeutics, Inc. is a biopharmaceutical company commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis.
MorphoSys AG, 60sec Pitch ()
<60sec Pitch>MorphoSys is one of the world's leading biotechnology companies focusing on fully human antibodies. With its proprietary technologies, MorphoSys is developing the next generation of antibodies not only for research and diagnostics purposes, but also as highly effective and precise therapeutics. HuCAL® (Human Combinatorial Antibody Library) is a very powerful technology for the rapid and automated production of specific antibodies.
The Female Health Company, 60sec Pitch ()
<60sec Pitch>The Female Health Company (FHC) owns certain world-wide rights to the Female Condom (FC1 and FC2) – a revolutionary option offering women dual protection against both sexually transmitted diseases, including HIV/AIDS, and unintended pregnancy.
EyeGate Pharma, 60sec Pitch ()
<60sec Pitch>EyeGate Pharma is a privately held, specialty pharmaceutical company pioneering the use of iontophoresis technology to safely and non-invasively deliver therapeutics to the front and back tissues of the eye. The company’s lead program is EGP-437 being developed for severe uveitis, dry eye and corneal graft rejection.
Depomed, Inc. 60sec Pitch ()
<60sec Pitch>Depomed, Inc. is a specialty pharmaceutical company with two approved products on the market and other product candidates in its pipeline. The company utilizes its proven, proprietary AcuFormTM drug delivery technology to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract.
Delcath Systems, Inc. 60sec Pitch ()
<60sec Pitch>Delcath Systems, Inc. is a medical technology company specializing in cancer treatment. The Company has developed a proprietary, patented system which will improve the efficacy of cancer treatment while reducing the considerable, systemic side-effects of chemotherapy.
BioSpecifics Technologies Corp. 60sec Pitch ()
<60sec Pitch>BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed and licensed injectable collagenase for three clinical indications: Dupuytren's disease, Peyronie's disease and frozen shoulder (adhesive capsulitis).
Antigenics Inc. 60sec Pitch ()
<60sec Pitch>Antigenics is a biotechnology company working to develop treatments for cancers and infectious diseases.
Alchemia Limited, 60sec Pitch ()
<60sec Pitch>Alchemia is an Australian biopharmaceutical company employing innovative technologies for the synthesis of complex carbohydrates, the targeting of cancer drugs to tumors and the discovery of medicinal drugs for human use.
Agile Therapeutics, Inc. 60sec Pitch ()
<60sec Pitch>Agile Therapeutics is a specialty pharmaceutical company focused on developing and commercializing innovative women’s healthcare products that address unmet needs.
Suven Life Sciences, 60sec Pitch ()
<60sec Pitch>Suven Life Sciences Limited is Hyderabad based life sciences company a pioneer in Contract Research And Manufacturing Services (CRAMS) since 1995. Suven in its endeavor to become collaborative research partner (CRP) for global life science companies has embarked on new business model “Drug Discovery and Development Support Services” (DDDSS) with the onset of Intellectual Property Regime in India since January 2005.
Stem Cell Therapeutics Corp. 60sec Pitch ()
<60sec Pitch>Stem Cell Therapeutics Corp. is a Canadian biotechnology company (TSX-V: SSS) focused on the development and commercialization of drug-based therapies to treat central nervous system diseases.
Oncolytics Biotech, Inc. 60sec Pitch ()
<60sec Pitch>Founded in 1998, Oncolytics Biotech Inc. is a public, Canadian-based biotechnology company that is developing a novel,virus-based cancer therapeutic. The reovirus has been shown to selectively kill certain cancer cells without damaging healthy cells and tissues.
Numoda Corporation, 60sec Pitch ()
<60sec Pitch>As a growth partner to life science companies, Numoda Corporation opens up clients’ options fast, through Improved Norms™, including data lock within hours of the last patient visit. Information services and process management are applied for improved norms in corporate and business development, financial, and product development.
Neotropix, Inc. 60sec Pitch ()
<60sec Pitch>Neotropix began operations in 2005 to develop and commercialize naturally derived, systemically deliverable oncolytic viruses for the treatment of solid tumors.
Interleukin Genetics, Inc. 60sec Pitch ()
<60sec Pitch>Interleukin Genetics is a leading, genetics-focused personalized health company that develops preventive consumer products and genetic tests for sale to the emerging personalized health market.
Infinity Pharmaceuticals, Inc. 60sec Pitch ()
<60sec Pitch>The mission of Infinity Pharmaceuticals, Inc. is to discover, develop, and deliver to patients best-in-class medicines for the treatment of cancer and related conditions.
Converted Organics, Inc. 60sec Pitch ()
<60sec Pitch>Converted Organics Inc. is transitioning from a development stage company (first reported revenues were in February 2008) to a fully operational company that seeks to construct processing facilities that will use food waste as raw material to manufacture all-natural soil amendment products combining nutritional and disease suppression characteristics.
Cleveland Biolabs, Inc. 60sec Pitch ()
<60sec Pitch>Cleveland BioLabs, Inc. (Nasdaq:CBLI) is a drug discovery and development company leveraging its proprietary discoveries about programmed cell death to treat cancer and protect normal tissues from exposure to acute stresses.
Biovest International, 60sec Pitch ()
<60sec Pitch>Biovest International develops personalized immunotherapies for life threatening cancers of the blood system.
Arana Therapeutics, Inc. 60sec Pitch ()
<60sec Pitch>Arana Therapeutics Limited, created through the merger of Peptech Limited and EvoGenix Limited in August 2007, is a biotechnology company dedicated to developing and providing antibody and peptide-based human therapeutic products for the treatment of cancer and inflammatory diseases.
Antisoma PLC, 60sec Pitch ()
<60sec Pitch>Antisoma is an oncology-focused biotech company with operations in the UK and the US. Antisoma’s strategy is to acquire promising early-stage drug candidates, develop these through clinical trials, and bring them to market itself or through partnerships.
Akela Pharma Inc. 60sec Pitch ()
<60sec Pitch>AKELA Pharma Inc. (TSX: AKL) is an integrated drug development company focused on developing therapies for the growing multi-billion dollar inhalation market.
Cephalon's Growth Drivers and Promising Market Opportunities for Amrix, Treanda. (07:10)
<stocks>Frank Baldino, CEO of Cephalon gives a quick overview of the company's financial status and comments on Treanda's recent approval for non-Hodgkin lymphoma (NHL). Interviewed by Eric Schmidt, Senior Biotechnology Analyst at Cowen, Frank comments on the high pricing of Treanda, the implication with respect to patients and payors, and the use of Treanda in earlier lines of treatment. Eric also asks Frank about the opportunity for Amrix, how it compares to Flexeril in the musculoskeletal pain market, and what the plans are for marketing the drug Amrix (given Cephalon has limited marketing experience in competitive markets).
Cephalon's Growth Drivers and Promising Market Opportunities for Amrix, Treanda.
Cephalon's Provigil Cash Cow Running Out of Milk, But Growth Continues With New Products, Indications, and Geographical Markets. (08:12)
<stocks>Once Provigil reaches the end of it's patent, how will Nuvigil compete against it's mother compound in the wakefulness market? Frank Baldino and Eric Schmidt discuss Nuvigil's improved formula as well as the new markets it plans to reach. Frank and Eric also discuss the management of Cephalon's substantial net earnings in investment vs. EPS. Frank comments on the future reduction of growth in US markets, as healthcare cost are being curbed. However, Cephalon is building an infrastructure to gain rapid access to the Chinese marketplace, which could be a strong growth driver in the years to come.
CoNCERT's Deuterium Substitution Platform to Create Better, Faster, Cheaper Drugs. (09:08)
<Ventures>Deuterium has the same properties as hydrogen, only it has the power to make molecules more stable. This creates a number of interesting applications for existing drugs. CoNCERT has developed a technological platform that substitutes hydrogen for deuterium, and has applied this process to a number of marketed drugs in the hopes of creating first or best in class drugs. Roger Tung, CEO of CoNCERT is interviewed by Eric Schmidt, Senior Biotech Analyst at Cowen on the properties of the modified drugs, and their patentability. Eric continues to ask Roger about the efficiency drug delivery process and it's starting points. Finally Roger answers questions regarding CoNCERT's cash position, and potential for growth.
CoNCERT's Deuterium Substitution Platform to Create Better, Faster, Cheaper Drugs.
CoNCERT's Leading Portfolio Asset to step into GSK Paroxetine's $3Bn Shoes. (04:52)
<Ventures>CoNCERT's CTP-347 is a Phase 1 treatment for hot flashes that acts as a substitute for GSK's Paroxetine, with the potential added benefit of little to no drug-drug interaction. Roger Tung and Eric Schmidt discuss future studies vs. Paroxetine or placebo. They also review CTP-518, an HIV protease inhibitor that could offer higher tolerability without a combination use with Ritonavir / Norvir (Abbott), simplifying drug use, and reducing cost to payors.
CoNCERT's Leading Portfolio Asset to step into GSK Paroxetine's $3Bn Shoes.
CoNCERT's IPO, Partnering Strategies and Full Integration for it's Deuterium Substitution Platform & Pipeline Assets (07:31)
<Ventures>The applicability of CoNCERT's pipeline extends beyond what it can accomplish as a small biotech. To what extent is CoNCERT willing to partner its platform and assets? Is full integration a future possibility? As Eric Schmidt interviews Roger Tung, he asks him about taking the company public. Roger and Eric also discuss the use of this platform beyond the current focus in what could a number of spin-outs. Finally, they take a look at the how CoNCERT's technology can help drugs going off patent, and their parent companies that may be staring at the abyss.
Markets are Down. Is it the Right Time to Invest in Biotech? (07:34)
<markets>Most listed biotech companies have lost a considerable part of the market value, what should investors do at the present moment? What is the value of cash, revenues, earnings, and near-term news-flow? What should CEOs do to maximize their chances of success in the years to come, and how much cash do companies need to weather this financial storm? These are just a few of the questions Charles Duncan answers in this program. He also comments on getting the most value of one's pipeline today, as well as the M&A trends in the years to come.
Markets are Down. Is it the Right Time to Invest in Biotech?
The Myriad Genetics Split is Official. How Will This Move Unlock Shareholder Value? (04:11)
<stocks>Charles Duncan comments on the division of Myriad Genetics into a drug development company on the one hand, a personalized medicine company on the other. Why is this a good strategic move? Will the two companies work together? What are the next steps? And how will the assets and balance sheet be divided?
The Myriad Genetics Split is Official. How Will This Move Unlock Shareholder Value?
Ablynx introduces Nanobody Technologies, discusses Pharma Partnering Strategies (08:17)
<stocks>How does a Small Cap Biotech make it through the current macro environment? Edwin Moses of Ablynx says choice is no longer a luxury but a necessity. Edwin reviews some of Ablynx's partnership agreements, and explains how he brought Pharma in. Beyond the cash, Ablynx is looking for experience and leverage in partners. He continues to explains how Ablynx's Nanobody Technology was discovered in camels, developed in llamas, and how it could potentially offer significant clinical and commercial benefits. Geoff Meacham of JPMorgan continues to ask him about the marketplace differentiation it offers, and the technological challenges that Nanobodies could present in the future. Edwin and Jeff then discuss Pharma's R&D productivity model and partnering models, capturing the entrepreneurial spirit of Biotech, and key drivers of M&A deals today.
Ablynx introduces Nanobody Technologies, discusses Pharma Partnering Strategies
Ablynx's Antithrombotic Safety and Efficacy Profile, Clinical Development Strategy, and Business Development Objectives (05:33)
<stocks>Edwin Moses tells us what he is most excited about in the pipeline, and where he will focus the company's energy in the years to come. Geoff Meacham asks him about his plans for scaling up Ablynx's clinical development. Edwin and Geoff continue to discuss the target specific and generic based issues that could present a challenge for Ablynx. Finally, they review the antithrombotic's safety and efficacy profile with respect to currently marketed products, and take a look at Ablynx's regulatory approval strategy.
Ablynx's Pipeline, Technology Advantage over MABs, and Financial Risk (05:50)
<stocks>Edwin and Jeff discuss the planned evolution of Ablynx's pipeline, taking products to the clinic and improving patient care. Edwin explains everything his team has learned and gained from working with industry partners. Geoff asks about Nanobodies' advantages over Monoclonal AntiBodies (MABs). Finally Edwin and Geoff review Ablynx's $170M cash position and their burn rate, as well as their execution focus for the years to come.
Ablynx's Pipeline, Technology Advantage over MABs, and Financial Risk
Portrait of Wall Street's Pioneer Drug Analysts, Fred Frank (08:27)
<The Jan Buck Show>The first biotech investment banker tells Jan how he got started in the business, as an analyst and a dealmaker, and continued to build the first formal life science focused research program at Lehman Brothers. Fred Frank, Vice-Chairman of Lehman Brothers (Barclays) discusses the tsunamis of change that are affecting the industry, and why Biotech and Pharma form natural partnerships. One is opportunity long and capital short, the other is opportunity short and capital. Fred illustrated this point by comparing the cash and innovation coming from the 100 largest pharma on one hand, and the 100 largest biotech on the other, demonstrating the need they have for one another.
Fred Frank on Blockbuster Drugs, and the 3 Eras of the Biotech Industry. (12:17)
<The Jan Buck Show>Fred and Jan review the changing dynamics of the industry (pre-76, 1976 to 2000, and post-2000). They discuss the monumental changes faced by Pharma, the danger of stock buybacks, and the impact of blockbusters on the development of drugs and the valuation of companies. Fred and Jan also discuss some of the more successful business models today, including the Genentech / Roche agreement - although the recent capital acquisition does come under question.
Fred Frank on Blockbuster Drugs, and the 3 Eras of the Biotech Industry.
Fred Frank on the Future of the Industry, and the Lehman / Barclays Deal. (05:10)
<The Jan Buck Show>Jan Buck asks Fred Frank where the industry is heading, and if we should be expecting radical change in the near future. Fred Frank looks at the assumptions that fueled the growth of the industry from its earliest onset, and their relevance today. He then asks Fred about the Lehman / Barclays transaction. Is it a fit? Will there be a change in activities? What will determine the success of the acquisition?
Fred Frank on the Future of the Industry, and the Lehman / Barclays Deal.
Post ASBMR Review: Amgen's Denosumab Lowers Fracture Risk, Makes the News (05:59)
<markets>Mike is back from a very exciting American Society for Bone and Mineral Research (ASBMR) meeting in Montreal. Amgen made the news with the results of its phase 3 trial for Denosumab. Mike explains Denosumab sets a new standard for a highly efficacious, safe, and convenient treatment for a disease that has a very high unmet need, despite its prevalence. Mike and Jean-Loup comparison Denosumab to Novartis' Reclast and other Bisphosphonates - looking at safety, tolerability, administration, and convenience.
Post ASBMR Review: Amgen's Denosumab Lowers Fracture Risk, Makes the News
Post ASBMR Review: Denosumab to Seize Low Hanging Fruit in Osteoporosis Market, Amgen's Shares could Gain 20 points (10:30)
<markets>After reviewing the Denosumab data released at the ASBMR meeting, it looks like Amgen's osteoporosis drug will be a 2nd line treatment. With 50% of osteoporosis patients going off their bisphosphonates in their fisrt year, Mike King thinks there is a low hanging fruit there. Mike also thinks the drug's profile could allow it to quickly become a first line treatment. Jean-Loup and Mike look at the market, Amgen's pricing for the drug, how that may bode with payors, and what impact Denosumab is likely to have on Amgen's share price. Mike has price target of $80 within 1 year. Jean-Loup and Mike also look at other indications and Amgen's clinical development strategy. Finally, Mike compares Denosumab to Enbrel, Avastin, and Tysabri.
Post ASBMR Review: A quick look Pfizer's Fablyn, and Merck Odanacatib (03:02)
<markets>Mike and Jean-Loup take a quick look at some of the other data released at the American Society for Bone and Mineral Research Meeting in Montreal. They review Pfizer's PEARL study for the drug Fablyn, and Merck's phase 2 Odanacatib.
Post ASBMR Review: A quick look Pfizer's Fablyn, and Merck Odanacatib
Targanta's Antibiotic Shows Promise, And Overcomes the Challenges it Faced When Previously Developed at Lilly and InterMune (06:17)
<stocks>Oritavancin is Targanta's lead compound. Initially developped at Lilly, it was then sold to InterMune, and picked up by Targanta in an equity deal. Mark Leuchtenberger explains the history of the drug, and in doing so faces further probe from Joel Sendek as to the corporate and medical challenges the drug had to face in its earlier days. Mark explains how they were overcome in Targanta's hands, and the true potential of the was drug unlocked.
Targanta Confident and Prepared for FDA Panel Review of Lead Compound Oritavancin (07:27)
<stocks>Mark and Joel delve into the clincal trials and regulatory process, around Targanta's Lead compound Oritavancin. Mark describes the current response of the FDA, and completed clinial site audits. He then continues to explain his team is expecting a panel meeting and is fully prepared to assit the panel's review of the drug. This panel could be expected as early as November of this year. When Joel inquires about the release of simplified data, which might differentiate Oritavancin for its competitors, Mark tells him about the drug profile (administration, safety, efficacy), but choses to keep quiet about the release date, telling us he the abstract and data will be revealed at an upcoming, yet undisclosed scientific conference.
Targanta Confident and Prepared for FDA Panel Review of Lead Compound Oritavancin
Targanta Attacking $1.2Bn Antibiotic Market with Resistance Adverse Drug, Do-or-Die! (04:08)
<stocks>Mark and Joel review the competitive landscape for Targanta's Antibiotic and Lead Compound, Oritavancin. Key differentiators include shorter course of treatment, lack of monitoring and dosing adjustment, efficacy and coverage. With a growing $1.2bn market, Mark still sees an unmet medical need in resistance adverse antibiotics, which Targanta is looking to address with focus, passion, and a Do-or-Die attitude. A Phase 3 trial, validating a single dose treatment against a standard of care competitor is expected to run next year.
Targanta Attacking $1.2Bn Antibiotic Market with Resistance Adverse Drug, Do-or-Die!
Alexza's Staccato: Vaporized Drugs in Multiple Indications, with a Safe and Effective Profile (10:02)
<stocks>The Staccato system combines drug and device to provide a quick and convenient relief for patients with acute and intermittent conditions. Tom King (Alexza) and Ted Tenthoff (Piper Jaffray) explore the technology, mechanism of action, and safety profile. Tom and Ted to discuss the drugs in the pipeline and the indications, which include acute agitation associated with schizophrenia or bipolar disorders, breakthrough pain, panic attacks, and insomnia. They review the clinical data, and path for regulatory approval, in what Tom King calls a "crisp NDA plan" for early 2010. Tom and Ted also discuss the marketing opportunity and marketing challenges for these drugs and their innovative delivery system.
Alexza's Staccato: Vaporized Drugs in Multiple Indications, with a Safe and Effective Profile
Alexza's Eulogistic Symphony Deal, Partnering and Sales Strategies, and Cash 'till the Summer of 2010 (10:39)
<stocks>Ted Tenthoff asks Tom King of Alexza's partnering strategy. Alexza will develop its own compounds for Psychiatry but will seek to partner in other areas, such as sleep - where Alexza is working with Endo Pharmaceuticals. Tom explains Alexza's strong cash position, and the value of the Symphony transaction, which ultimately led to the development of 3 phase 3 products. Tom and Ted review other financing vehicles used by Alexza, and the production capabilities of the new Mountain View, CA GMP facility. Finally Ted asks Tom about Alexza's discovery process, and method for prioritization of new drug development.
Making Money in Biotech, the JMP Securities Way - Part I: State of the Industry Mid Year Report (06:09)
<markets>The biotech sector is driven by news flow, because it has the power to change the value of companies, and put (more) money in your wallet. Charles Duncan and Jean-Loup discuss the performance of the Biotech industry in 2008 to this day, and the potential impact of news to come in the remainder of this year in the coming months. Despite the very challenging conditions, biotech outperformed. Charles and Jean-Loup also touch on the industry's relative strength in the tough financial markets, and the increased M&A activity.
Making Money in Biotech, the JMP Securities Way - Part I: State of the Industry Mid Year Report
Making Money in Biotech, the JMP Securities Way - Part II: Finding the Tipping Point (05:43)
<markets>Which companies are likely to have news that can double the value your shares? Charles Duncan looks at the less obvious stock picks that could provide you with the most bang for your buck. His equation for determining the best opportunities incorporates variables such as lack of revenue (yes he means lack of), products that are owned outright and about to get significant clinical data, no FDA risk, and good cash position.
Making Money in Biotech, the JMP Securities Way - Part II: Finding the Tipping Point
Making Money in Biotech, the JMP Securities Way - Part III: A few Stock Picks (07:47)
<markets>Allos, Cytokinetics, Orexigen, and Sangamo or just a few of JMP Securities stock picks for the end of the year. Charles Duncan explains how they are at a pivotal moment in their growth, and therefore best positioned to generate large returns for investors. Charles gives us some details about the company, the ongoing clinical trials, and the type of news we should expect in the months to come.
Making Money in Biotech, the JMP Securities Way - Part III: A few Stock Picks
Poniard’s Platinum Compound for Oncology, A Winning Design for its Clinical Trial (08:36)
<stocks>How does one go about creating value with a platinum compound? In this interview Mike King asks Jerry McMahon of his rather broad use of Picoplatin in Oncology. They review the SPEAR clinical trial in Small Cell Lung Cancer, its design, endpoints, timeline, competitive landscape, and favorability with the FDA.
Poniard’s Platinum Compound for Oncology, A Winning Design for its Clinical Trial
Picoplatin in Colorectal, Prostate, Ovarian Cancer and NSCLC, and Poniard’s Cash Position (06:12)
<stocks>Poniard has begun clinical trials of it’s Picoplatin in combination with other standard of care therapies. Jerry McMahon and Mike King discuss these indications and the different strategies for each one. Jerry tells us about the data presented in these trials at the latest ASCO meetings. Finally they review Poniard’s very attractive cash position, and its plans for partnering in the years to come.
Picoplatin in Colorectal, Prostate, Ovarian Cancer and NSCLC, and Poniard’s Cash Position
Nile’s Peptide for Heart Failure to Achieve Superiority through Hemodynamic and Renal Action (05:17)
<stocks>Peter Strumph describes Nile Therapeutics’ CD-NP peptide for the treatment of Acute Heart Failure, and the competitive landscape. Matt Kaplan asks him about the market size, existing products, and unmet needs. In answering these questions, Peter reviews the mechanisms of action of the peptides on the market and compares their mechanisms of action to Nile’s CDNP which is expected to have more potent Hemodynamic and Renal effects.
Nile’s Peptide for Heart Failure to Achieve Superiority through Hemodynamic and Renal Action
Nile’s CD-NP Phase 3 Strategy, and Secondary Pipeline Products, and 8 Person Team (09:00)
<stocks>Peter Strumph lines up the milestones to come for Nile’s lead compound CD-NP and gives us a closer look at his strategy for determining the right dosage in Phase 2, in order to adequately prepare his Phase 3. Peter and Matt then discuss CU-NP and 2NTX-99, other pipeline products, Nile’s 8 person team and leverage model, as well as future in-licensing.
Nile’s CD-NP Phase 3 Strategy, and Secondary Pipeline Products, and 8 Person Team
ImClone likely to be Acquired by BMS in the $65-70 range, says Katherine Kim [BoA] (09:28)
<markets>Was BMS’ offer to ImClone shareholders to be expected? What was Carl Icahn’s role? How is ImClone’s stock to be valued by BMS and other shareholders? Katherine Kim takes an in-depth look at the drugs, the pipeline, the markets and indications, and benchmark premiums. She believes this deal is very likely to close, and when it does, it will be in the $65-70 range.
ImClone likely to be Acquired by BMS in the $65-70 range, says Katherine Kim [BoA]
Genentech / Roche, Good Time for a Deal; Talent Unlikely to be Retained, says Katherine Kim [BoA] (05:47)
<markets>Genentech is at a turning point, and the time would be right for an acquisition by Roche (if there were any). Her price target is $110 per share. Katherine and Daniel review the value drivers in Genentech, and the willingness of both Roche and Genentech CEOs to make this deal happen.
Genentech / Roche, Good Time for a Deal; Talent Unlikely to be Retained, says Katherine Kim [BoA]
Maturing Biotech Sector Likely to see Large Cash Inflow after Genentech & ImClone Deals, says Katherine Kim [BoA] (04:28)
<markets>The $60+Bn generated from large cap acquisitions are likely to be reinvested in biotech, specifically in 4 tranches of the sector. Katherine Kim reviews gives us the rationales behind this thinking. She also expects increased M&A activity in the years to come.
Myriad Genetics, Unique Hybrid Business Model, $48 to $87 Share Price? (10:58)
<stocks>The story of Myriad Genetics (MYGN) resonated in the investor community as disappointing Phase 3 data was followed by a 40% stock price increase (from $48 on June 27 to $66 on August 20th, day of this interview). Charles Duncan has the longest formal coverage on Myriad. He explains the rationale behind this development, and the $87 price target he has set for the company shares. Charles and Daniel review Myriad’s personalized medicine and drug development hybrid business model, and their prospects for growth as standalone companies. Would spinning of the drug development business further unlock shareholder value? Following increased revenues and a recent $100M licensing with Lundbeck, Myriad’s cash position is quite favorable. Will it acquire? Or could it be acquired?
Myriad Genetics, Unique Hybrid Business Model, $48 to $87 Share Price?
Award Winning NeuroBank Team stores your Neuronal Stem Cells (12:28)
<stocks>NeuroBank was recently awarded the third prize in the Moot Corp Competition dubbed "The Super Bowl of World Business Plan Competition". Their business model relies on a process of extraction, isolation, purification, expansion and storage of adult neural stem cells. Bill Kridel, stem cell expert, interviews the winning team. They discuss Neurobank’s proprietary process, future uses of neuronal stem cells, viability of cryogenically stored cells, cost for and risk to patient, target markets, and customer acquisition.
Award Winning NeuroBank Team stores your Neuronal Stem Cells
Roche and Genentech, Deal Review, with Mike King (06:31)
<markets>Mike King and Daniel Teper discuss the Genentech / Roche deal. Genentech’s Board of Directors say $89 per share is inadequate, Roche’s management feels it is more than generous. Genentech shareholders like this stock, and are reluctant to sell for less than $120-135. Why does Roche want the remaining 56% of Genentech? Will Roche be able to retain the innovation that made Genentech so successful? What are the odds of this deal closing?
BMS and ImClone Deal Review, with Mike King (04:33)
<markets>Why is BMS after ImClone, and what will happen next? Carl Icahn’s says the $60 bid is too low. Mike King believes Icahn is waiting for the Genentech Roche transaction to play out, in order to see the valuation metrics that will be used in that transaction. Mike and Daniel continue to discuss the integration of ImClone within BMS, the international rights to Erbitux, and the odds of this transaction closing.
Impact of Summer Acquisitions on the Biotech Industry, with Mike King (04:10)
<markets>With close to $60Bn worth of biotech stock that could be removed from the market, where will this money go? Where will investors be putting their money? Mike thinks it will flow back into the group as there are still some attractive investment opportunities. Mike and Daniel further discuss the disappearance of the large cap leaders, who would take over the leadership position, and the potential for future acquisitions.
Impact of Summer Acquisitions on the Biotech Industry, with Mike King
Visionaries: Bill Kridel on the Role of M&A Today. (06:33)
<strategic management>Bill Kridel discusses the strategic and rescue role of M&A today. Many companies leverage M&A for geographic and portfolio reasons - looking at some of the latest deals (Roche and Genentech, Daiichi and Ranbaxy). With the current market conditions M&A propositions from larger companies are becoming increasingly attractive.
Visionaries: Bill Kridel on Biotech in 20 Years, Regenerative Medicine, Biomarkers, Personalized Medicine. (08:21)
<strategic management>Bill Kridel foresees three great tsunami that are bound to change the biotech industry and the quality of healthcare. These are regenerative medicine, biomarkers and molecular diagnostics, and personalized medicine. Bill also discusses pharma's solutions to increase innovation, and the increased international competitivity.
Stem Cells Business Models, FDA Initiatives, Companies, and Funds, with Bill Kridel (05:58)
<markets>Bill Kridel compares stem cell business models that rely on allogenic vs autologous cells and discusses their market potential. He also touches at the various uses of stem cells, the need for standards of uniformity, FDA Initiatives, companies to focus on, and specialized funds.
Stem Cells Business Models, FDA Initiatives, Companies, and Funds, with Bill Kridel
Vivalis uses Embryonic Stem Cell Technology to Enable Vaccine and Antibody Production. (19:04)
<stocks>Chicken eggs revolutionized the production of vaccines. Could animal stem cells be the new chicken egg? Vivalis has created a technology platform based on embryonic stem cells that enables the production of vaccines and antibodies. Vivalis’ CSO Majid Mehtali is interviewed by Reni Benjamin, analyst at Rodman & Renshaw. The business model is based on technology licensing, with future ambitions for own product development. Majid and Reni review comparables, Vivalis’ cash position, Euronext vs. NASDAQ listing, and the potential for acquisitions.
Vivalis uses Embryonic Stem Cell Technology to Enable Vaccine and Antibody Production.
Oncology Battlegrounds: Celgene vs. Millenium, with Charles Duncan. (04:55)
<stocks>The long running face off between Celgene's Revilimid and Millenium's Velcade intensifies with the latest clinical data releases. Charles Duncan, is bullish on Revlimid, he tells us why. Charles looks at the impact of Takeda's new ownership of Millenium on its management and competitivity vs. Celgene. Charles also comments on the JNJ / Takeda relationship.
Oncology Battlegrounds: Celgene vs. Millenium, with Charles Duncan.
Celgene's Revlimid, Markets and Revenues, with Charles Duncan. (03:09)
<stocks>What are the next areas of growth for Revlimid? Asides from the growth in frontline use for Multiple Myeloma, Charles Duncan tells us about its use in Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). Revlimid is also bound to expand its geographical reach with Europe and Japan. Charles' expectation is that Revlimid will be a $2.8+ billion opportunity drug. Finally, he explains Revlimid's contribution to Celgene's bottom line and stock price. Charles' price target for CELG is $85.
Celgene's Revlimid, Markets and Revenues, with Charles Duncan.
Oncology Battlegrounds: Genentech vs. ImClone, with Charles Duncan. (05:50)
<stocks>The data released on Eribitux at the latest ASCO meeting is an indicator of the emergence of personalized medicine. The data itself was not that great of news for ImClone. Nonetheless, it will lift some of the pressure from reimbursement authorities. Charles believes the KRAS mutational status will be on the labels. Genentech remains strong in its growth and earnings. ImClone's new data also affects Genentech indirectly, and in a positive way.
Oncology Battlegrounds: Genentech vs. ImClone, with Charles Duncan.
Small Cap Focus, Full Integration, Personalized Medicine, with Charles Duncan. (10:41)
<stocks>In today's market, where good clinical data and milestones are shadowed by financing prospects, Charles Duncan recommends having at least 2 years cash. Charles also presents a few of the most promising small and mid caps he's been keeping his eyes on - including Myriad Genetics (MYGN), Sequanom (SQNM), Illumina (ILMN), Invitrogen (IVGN), Genomic Health (GHDX). Charles and Daniel discuss the opportunity for small and mid caps to become fully integrated specialty pharmaceuticals.
Small Cap Focus, Full Integration, Personalized Medicine, with Charles Duncan.
Visionaries: Stelios on Financing, Productivity, and the Cost of Innovation. (09:39)
<strategic management>Stelios Papadopoulos, veteran of the Biotech Industry, looks at the financing environment today, and the "windowless paradigm" we've been operating in since 2003. He emphasizes the importance of changing investor sophistication and investment horizons. Stelios also addresses the cost of innovation and overall sector productivity. Finally Stelios looks back on his expectations for the market today, when he prepared them as an analyst 20 years ago.
Visionaries: Stelios on Financing, Productivity, and the Cost of Innovation.
Visionaries: Stelios on Biotech in 20 Years, Fundamental Science, Personalized Medicine, and Energy. (07:43)
<strategic management>Stelios shares his vision for Biotech in the next 20 years, comparing technical and fundamental problems, how they will be funded and solved. He also addresses the issue of energy, for which he thinks we will find biologically driven solutions. Stelios discusses the relevance of personalized medicine, and his choice of investment today.
Visionaries: Stelios on Biotech in 20 Years, Fundamental Science, Personalized Medicine, and Energy.
Standardizing Ways to Create New Treatments for Under-served Disease Markets, with Stem Cell Technology (05:13)
<New Technologies>Can stem cell technology be used to make under-served disease markets commercially relevant? Professor Marc Peschanski is working with stem cells (embryonic and adult) to create therapeutics for monogenic diseases. His goal and that of his institute are to standardize new ways of creating treatments for monogenic diseases, developing R&D with an emphasis on the technology platform.
Is Europe attractive for stem cell research? Which countries are the most advanced and have the most favorable legislation? (04:52)
<New Technologies>Professor Marc Peschanski discusses the different european legislations, looking at the countries that have taken the lead, and those quickly progressing - including the U.K., Germany, and Spain. He then continues to explain changes in French law that are making stem cell research possible.
Stem Cell Research Financing, Products, Business Models, and Regulatory Concerns (06:47)
<New Technologies>Why is stem cell financing limited, and how does I-STEM finance its research? Professor Marc Peschanski looks at the capital question, and potential applications of stem cell research. He then reviews the concerns of the regulators and compares the FDA and EMEA with respect to stem cells.
Stem Cell Research Financing, Products, Business Models, and Regulatory Concerns
Will Adult Stem Cells Resolve Our Moral Quandaries? Do They Offer The Same Benefits As Embryonic Stem Cells? (05:16)
<New Technologies>Is the public opinion antagonistic towards, divided on, or supportive of stem cells? Professor Marc Peschanski explains the state of the debate, now that stem cells can be derived from adult tissue. He also comments on the applicability of human embryonic stem cell technology towards adult stem cell technology.
ASCO 2008, the take home message with Mike King. (02:17)
<markets>What should all investors know about this year’s ASCO? What is the take home message? Mike King tells us it hasn't been a momentous ASCO. ImClone was most affected. Mike and Daniel look at the behavior of stocks before and after the meeting, and reflect on the impact of abstract releases, preceding this year's ASCO.
ASCO 2008, Focus on Imclone with Mike King. (05:10)
<stocks>What happened to ImClone's stock after ASCO this year? Mike King tells us about the expectations, the fluctuations, and what he believes was a misinterpretation of the FLEX trial results. Mike foresees a strong market for Erbitux, in the years to come, with positive impact on ImClone's earnings. Also discussed in this interview is the KRAS mutation, its impact on Erbitux's market penetration and on Imclone's earning, as well as the interest doctors and payers have in it.
ASCO 2008, Focus on Genentech with Mike King. (05:05)
<stocks>In a Post-ASCO review Mike King reviews Genentech. Can the 2 months Avastin and 5 weeks Erbitux data be compared? Apples and oranges, according to Mike! The subgroups tell a completely different story. Mike is optimistic with regard to Genentech's performance. It has seen a strong growth in Non Small Cell Lung Cancer (NSCLC), and should see growth in Metastatic Breast Cancer too. Mike sets a $92 price target on Genentech's stock; outperform.
ASCO 2008, Focus on Celgene with Mike King. (04:36)
<stocks>Celgene in a Post-ASCO review, reveals positive data. Mike King discusses the multiple myeloma survival data and its impact on Revlimid. Mike compares Celgene's Revlimid and (Takeda's) Millenium's Velcade. Is complete response the best predictor of outcome? How do the other parameters of the studies come into play? Mike gives us a projection for the sales of Revlimid and a price target for Celgene at $72. Last he touches upon the question of Celgene's acquisition. Would it make any sense?
ASCO 2008, Small Cap Focus with Mike King. (05:10)
<stocks>ASCO can be full of surprises for some of the smaller caps. Mike King from Rodman & Renshaw reviews a few names that include Poiniard, MedRx, and Celldex/Avant.
New York Success in Biotech, More than Meets the Eye? (07:52)
<BioClusters>Is NY a more expensive place to start a Biotech company vs. MA or CA? Nathan Tinker (Executive Director, NYBA) argues it isn't and that NY really presents a great number of opportunities for Biotech Companies. He supports this with example of NY Successes, including ImClone, OSI Pharmaceuticals, and Regeneron. Nathan also discusses VC activity in NY, the NY City vs. NY State dichotomy, and the proximity with NJ Pharma, Nathan also touches on the $.5BN bioscience infrastructure driving RND, as well as the state of phase 2-3 pipelines.
KSR Demystified, Part 1 - Supreme Court Ruling on Patent Obviousness (08:27)
<policy & law>The Supreme Court’s ruling on intellectual property in the KSR vs. Teleflex case has kept many patent attorneys on the edge of their seat, as Matthew Siegal explains here, and in his Intellectual Property Strategist article (linked below). Matt and his colleague Ian DiBernardo go over the basis for the grant of a patent - the invention has to be new, useful, and non-obvious. They continue to explain how and why the KSR case is changing the non-obviousness requirement, making it more difficult to be fulfilled, and therefore harder for inventors to obtain patents.
KSR Demystified, Part 1 - Supreme Court Ruling on Patent Obviousness
KSR Demystified, Part 2 - Practical Business Implications (03:53)
<policy & law>In theory KSR makes it harder to patent, but the industry is very used to overcoming the non-obviousness clause of patentability, by showing the unexpected benefits. On the bright side of things, this may reduce the quantity of what some consider to be “unworthy patents.” Still Matthew’s advice to the industry remains the same: be prepared, and show improved results.
Former FDA Commissioner on Obama, Pace of Approval, Stem Cells (04:06)
<policy & law>What will happen to the FDA if Barack Obama gets elected? Dr. Lester Crawford, former Commissioner of the FDA, believes funding will increase, and with it so will the agency morale. This might increase productivity and help increase the pace of approval. The policies, however, are unlikely to change, as the FDA is a body with very few political appointees. When asked about stem cells, Dr. Crawford sees the US, not currently ahead of other nations, but ready to become the leader, as soon as it 'wakes up'. The FDA is also waving certain requirements for stem cell research to further support this effort.
Former FDA Commissioner on Obama, Pace of Approval, Stem Cells
On Creative Financing: Lionel Leventhal, Paul Capital (05:45)
<markets>Lionel gives his outlook on the market, and how to escape its volatility. He advises cautiousness when going public, and explains the other ways a company can bring additional capital in. Lionel continues to explain how Paul Capital (of which he’s a partner) structures its deals. Paul Capital leverages royalties / non-dilutive financing. Lionel then illustrates with 2 'real world' examples of companies they have taken a participation in recently.
On Creative Financing: Jeff Edelman, Symphony Capital (12:00)
<markets>With the capital markets tightened, it has become more difficult for companies to find funding. Some investors have been expanding their creative approach to financing. Jeff Edelman presents a number of options that leverage clinical development capabilities and funding, royalty streams, and optimized development financing - from Novaquest, Paul Capital, and Symphony Capital - of which he's a Principal. Jeff then explains the history of this kind of creative financing in Biotech with Amgen’s Epogen and Nupogen. He continues to illustrate the value created through a “case study” of one of Symphony Capital’s collaboration with Isis, which then led to one of the biggest partnering deals of the year.
Accelerat(or)ing NYC Biotechs - Investment Vehicle for Emerging Companies. (03:00)
<markets>A city with great research and intellectual capital, should welcome a vibrant emerging biotech industry. New York City is not taking advantage of its full potential. Accelerator Corp, a joint investment vehicle for VCs, is putting together resources that are necessary to foster success for Biotechs, here in Manhattan.
Accelerat(or)ing NYC Biotechs - Investment Vehicle for Emerging Companies.
Building Biotech in New York, NYS Economic Development Council (04:57)
<BioClusters>Debra Flack tells us about the New York State Economic Development Council and its activities. Debra underlines the strength of New York with respect to Science, Academia, and Finance. She mentions the commitment and grant programs that have been put in place by the state, as well as the lobbying efforts to reduce the tax burden, and the cost of doing business, both in the City and the State.
Building Biotech in New York, NYS Economic Development Council
BioDefense Funding, Cleveland Biolabs (02:47)
<strategic management>Alan Wolfman tells us about about Cleveland BioLabs, and how it is leveraging its BioDefense funding. He explains the size of, and requirements for the funding, the benefits and dangers of this strategy. Finally, Alan offers his best advice for obtaining government funding: be in very close contact with the agencies you are working with, and hoping to raise funds from.
Burnham CEO on New Florida Facility ()
<strategic management>Dr. John Reed, President & CEO of the Burnham Institute for Medical Research gives us a brief history of the institute and the discoveries that stemmed from its research. Dr. Reed discusses the ambitions and research focus set forward for the new Florida research facility, and how the the institute collaborates with industry. Stay tuned to watch the Burnham Delegation ring the NASDAQ's opening bell!
Quest CIO on Healthcare IT, Present and Future ()
<stocks>What is the current state of Healthcare IT? What is being done to digitize data and clinical information today, to facilitate the access to medical records, by patients and physicians alike, and improve patient care? How can Healthcare IT improve physician and patient collaboration and education? What are some of the solutions Quest has pushed forward? What are the barriers to implementation of this change? What are the industry's concerns? What is your vision for the future of Healthcare IT?
Manhattan Classic Car Club - Part 2 ()
<executive lifestyle>The second part of our series dedicated to the Manhattan Classic Car Club reveals the inner-workings of the club. Members join, get points, and can drive any car they want - fees and points system explained. Beyond the 'staggeringly stylish' fleet is an exclusive club, a strong community of automobile enthusiats, and a whole lot of fun. We take a ride in Magnum P.I.'s 1989 Ferrari 328 GTS, and take a closer look at the 2003 Ferrari 360 Spider, the 1967 Chevelle SS, the 1966 Mustang Fastback, the seductive 1970 Chevy Cheyenne, and the 1972 de Tomaso Pantera.
Yelo New York ()
<executive lifestyle>YELO New York is a midtown sanctuary for the sleep-deprived modern warrior. Helping urbanites deal with the pressures of modern life, YELO offers a unique, and soothing, combination of sleep and reflexology therapies.
Le Parker Meridien ()
<executive lifestyle>Rising 40 stories above Central Park, Le Parker Meridien is one of New York’s most upscale hotels. Steps away from Madison Avenue, MOMA, Carnegie Hall, Broadway theaters and Fifth Avenue’s legendary shopping, Le Parker Merdien is ideally situated for business and pleasure.
Avant's CEO on Merger with Celldex ()
<stocks>Dr. Una Ryan discusses Avant's work in infectious diseases, its partnerships with the Gate Foundation and the International Vaccine Institute, and with GSK for Rotarix. Avant announced its merger with Celldex, a spin-off of Medrex. The new combined entity will have an enhanced portfolio and including several clinical stage Oncology products and a novel antibody technology platform.
Manhattan Classic Car Club - Part 1 ()
<executive lifestyle>Discover the Manhattan Classic Car Club, the premier New York City automobile club, where over 330 members, of all different walks of life, shared the most desirable classic cars, and sports cars. Beyond the staggeringly stylish fleet, is a social club where automobile afficiandos from all walks of life gather, at the club, or any of its numerous functions / trips / events. We take a ride in the club's 'ruthlessly powerful' Ford GT40, and take a closer look at their 1965 Shelby Cobra, 2007 Ferrari F430, and 1965 Convertible Mustang.
Rodman's John Chambers - Part 1 - Acumen BioFin ()
<markets>Meet the man behind Rodman & Renshaw's Life Science division, Acumen BioFin. Find out why Acumen BioFin was established, and how it has been on the forefront of rapidly evolving life science financial markets since its inception. Learn about the PIPES & Register Direct financing opportunities Acumen offers to its clients.
Rodman's John Chambers - Part 2 - 2007 Recap ()
<markets>We recap 2007 with John Chambers 2007, looking at volatility, impact of credit crisis, companies seeking capital, the number of FDA candidates, and the hot trends. John Chambers tells us about the various financing strategies that have been affecting the size and availability of new investment capital for Biotech companies, in the US and abroad. We also discuss the open and shut IPO market, the Follow-On market, the consolidation trends, the Venture piece, and the Biotech finance markets outside the US.
Rodman's John Chambers - Part 3 - 2008 Outlook ()
<markets>John Chambers tells us how adjustable mortgage rates, and election year may affect investor portfolios, and shares his bullish perspective on financing prospects for Biotech in 2008. We discuss the return of IPO market, and its implications in terms of company maturity. We conclude this interview with one general piece of advice for Biotech CEOs, and one for Investors.
John Allan's ()
<executive lifestyle>John Allan's is a men's grooming club with an old-fashioned clubhouse ambiance. This club not only offers top of the line grooming services. Members can play pool and have a drink with friends or even enjoy a cigar in the lounge area.
Bottega Del Vino ()
<executive lifestyle>Bottega Del Vino, located in mid-town Manhattan, is one of the most authentic Italian restaurants in New York. This beautiful and unique Italian restaurant offers the best of Veronese cuisine and the most diverse wine list in the country.
Avicena CEO Interview ()
<stocks>Dr. Belinda Tsao Nivaggioli is the CEO of Avicena Group (OTCBB: AVCO). She discusses Avicena's cellular energy regulation and optimization technology, in the pipeline, in the latest clinical studies, and how it will create value for shareholders.
Brasserie 8 1/2 ()
<executive lifestyle>Brasserie 8 1/2 is an upscale brasserie located in the heart of Manhattan. Brasserie 8 1⁄2 achieves a delicate fusion of creativity and comfort, featuring a world-class art collection, adventurous haute French cuisine and a plush atmosphere.
Forward Integration: from Biotech to Specialty Pharma ()
<strategic management>When should a development stage company take control of its products and build marketing and sales capabilities? Jeff Thomas, Lionel Leventhal, Steve Rauscher, Paul Cayer, and Michel de Rosen share their insight on, and experience with forward integration.
Sanofi Pasteur looking for R&D Partners ()
<stocks>What is Sanofi Pasteur looking for in external collaborations? What makes vaccines so attractive to Pharma? How do you expect the increasingly competitive market for vaccines to evolve? What are your thoughts on the recent MedImmune deal?
Novavax CEO: New Pharma Focus on Vaccines ()
<markets>What can you say of the renewed interest for vaccines? Which vaccines have the most attractive development potential? How is risk different with vaccines? How can Pharma be complimentary and how will it affect the entrepreneurial vitality of the vaccines industry? What are your thoughts on valuation after the MedImmune deal?
Austria: Connecting Europe by Way of Vienna ()
<BioClusters>Gisbert Myer explains why Austria is a strategic business location in Europe, as connects its East and West, presents generous cash incentives for R&D, and has attractive corporate tax rates.
Austria: From Academia to Business ()
<BioClusters>Michaela Fritz explains how Austria's strength in academic research - particularly infectious diseases and oncology, has created a new dynamism on the business side. She highlights some of the recent business successes and government programs that are giving Austria a critical mass in European Biotech & Pharma.
China's Biotech, Rapidly Emerging? ()
<BioClusters>James Zhu sees formidable potential for Chinese Biotech and projects its exponential growth as improving IP environment, very sizeable government funding of R&D, and fast growing GDP create numerous opportunities to collaborate with China.
Dubai: Developing a New Center of Excellence ()
<BioClusters>How is Dubai developing its Biotechnology Industry? Dr. Al Khayat tells us about the emirate's ambition to create a center of excellence for the region, the business and science infrastructure it is leveraging, and the incentives that have been put in place to foster the growth of this young industry.
India: Paradigm Shift, IP, Drug Discovery, and Innovation ()
<BioClusters>Nandita Chandavarkar comments on the paradigm shift in intellectual property. India better understands the value of IP as it creates its own. A very clear legislature has been put in place by the government to protect the interests of Bio and Pharma companies.
Ireland: Commitment to BioPharma and Medical Devices. ()
<BioClusters>Marian Byron tells us of the importance of the BioPharma and MedDevices industry to the economy of Ireland. Ireland is totally focused toward BioPharma & MedDevices. Having consolidated a manufacturing base, Ireland is now moving to establish a strong R&D base and putting in place multiple tax incentives and state aids to promote the development of this industry.
Ireland: Manufacturing, Start Ups, Universities, Research. ()
<BioClusters>Dr. Cormack Kilty tells us about his Dublin-based company, Biotrin International, developer novel biomarkers of organ damage. He sees the significant investments in universities and research, as well as the support for start ups and presence of large Pharma groups as the drivers of industry growth.
Ireland: Success, and Investment for R&D and Innovation. ()
<BioClusters>Barry O'Leary highlights the $6bn investment in Ireland that the world's leading companies have made, its huge emphasis on R&D and innovation, and the great talent it contributes to the industry.
Israel Biotech: Flourishing Research,Innovative Companies. ()
<BioClusters>You'll see here Israel Life Science Industry Board Members Zeev Zelig and Yossi Bornstein personify the spirit of the Israel biotechnology industry. Many high tech companies have established R&D facilities in Israel. The research evolves so rapidly that Israel is constantly looking to build collaborations that can help bring these new technologies to market.
Japan: Services for Foreign Biotech Companies ()
<BioClusters>Sato San explains investment promotion is very important to the Japanese government, and that's why it is offering free executive recruiting, marketing services, and office space for foreign companies that are developing their activities on the archipelago.
Spain: Fast Pace Growth ()
<BioClusters>A study a various statistics reveals a higher than 25% growth per year in the Spanish biotechnology industry. External investment is just starting as companies are gaining a critical mass that is now piquing the interest of Venture Capitalists.Spain's growth in BioFuel, AgroFood, and Human Health remains well equilibrated.
Switzerland: Hidden Champions ()
<BioClusters>Great financial markets and increasing VC investments and exits make Switzerland the 9th largest Biotech enterprise in the world. It has a long standing history in pharmaceuticals research and commercialization. In the next 5 years, the SWISS Biotech Association will be focusing on advocacy, building infrastructural offers for expensive Biotech on a national level, and starting to promote itself.
California: The State's Ambition is to Remain Number One ()
<BioClusters>The birthplace of biotechnology is betting on its workforce, research centers, and wonderful environment to attract and retain biotechnology companies. California appreciates the value of biotechnology and wishes to remain the leader in research manufacturing in the United States.
Florida: Scripps, Building a World Class Research Institute ()
<BioClusters>Harry Orf explains the reasoning behind the development of Scripps, and what made Florida a particularly attractive location. He also comments on the peer-to-peer collaborations this biomedical research facility is meant to foster.
Florida: After Scripps, Torrey Pines sets Research Unit ()
<BioClusters>Torrey Pines intends to bring the world class science and entrepreneurial spirit to Florida. Dr Houghten tell us how Torrey Pines fell in love with Port Saint Lucie, and how Torrey Pines combines collaboration and a focus on practical scientific applications to grow rapidly and successfully.
Maryland: Biotechnology is a Top Priority ()
<BioClusters>Maryland is incredibly excited about Biotechnology, and its prospects for improving the human condition and the state's economy. That is why they are investing in research, public private partnerships, and the incubators that are creating the technologies of tomorrow.
Massachussets: Supercluster, Tremendous Innovation ()
<BioClusters>Allan Blair tell us why the state of Massachusetts is known as the "heart and soul" of Biotech. He also presents some of the future challenges for the state, as well incentives for companies to relocate to Massuchusetts (including state-wide, individual region, and site specific)
North Carolina: Skilled Workforce. ()
<BioClusters>NC believes the quality of the workforce is the one greatest determinent of success for biotech and pharma companies. That is why the state is focusing it efforts on workforce training which encompassesfree training for any company moving to region, links to colleges and K-12, and their new science programs.
Pennsylvania: Innovation, Finance, Infrastructure ()
<BioClusters>PA's innovative governor is putting together all kinds of incentive packages to help companies. These include financing through state funds and the strong VC network, as well as a variety of support services such as legal, accounting, partnerships, and site selection.
Jim Greenwood on Congress and Policy ()
<policy & law>BIO's CEO Jim Greenwood comments on the need for a supportive policy environment for Biotech in the context of the new Democratic Congress, BIO’s new advocacy team and what is expects from the next President of the United States in 2008.
Maryland: Driving Economic Development through Biotech Investme ()
<BioClusters>Dr Mahan discusses the academic and federal research assets that make Maryland a favorite place for Biotech companies. Dr. Mahan also presents Maryland's new tax incentives for corporate and individual Biotech investors.
Maryland: Driving Economic Development through Biotech Investme
Transport's CEO on Drug-Device Convergence ()
<Companies>Dr Dennis I.Goldberg, on Drug-Device convergence and its application to treatment of dermatological diseases.
Dyadic's CEO on Bio-Energy ()
<Companies>Mark Emelfarb, tell us about Dyadic International's cellulose-basd technology and its applications, including Bio-Energy.
Affymax: the Technology, Timeline, and Success/Risk Factors ()
<Companies>We asked Arlene Morris what kind of advantage the use of peptide based hematide product presented, what her development timeline looked like, and what critical success and risk factors she perceived as most important.
Boston Life Sciences's Altropane and Cethrin ()
<Companies>Ken Rice tells us about Altropane, a molecular imaging agent that can change the treatment of Parkinsons Disease, and Cethrin an enzyme inhibitor for axon regeneration in spinal injurues. He discusses the impact on patient health, the time to market, and the critical success and risk factors.
War On Bugs: Infectious Diseases and Global Health ()
<medicine>WarOnBugs bridges the perspective of scientists, physicians and policy makers about recent developments in infectious diseases and global health. Is the risk of an Avian Flu pandemic real? What have learned from the SARS crisis? Can an AIDS vaccine be developed anytime soon? Can we continue to ignore health issues in developing countries?
Abbott's Tricor: Result of the FIELD Trial ()
<hot data>The contrasted results of the FIELD trials are explained by the lead investigator, and discussed by several opinion leaders: What are the effects of fenofibrate on the risk of major coronary disease events? How did the use of statins influence the outcome of the study? Will the results have an impact on the guidelines for the treatment of the diabetic populations? How will the findings of these trials influence future studies?
Portfolio Management and Shareholder Value ()
<strategic management>Bringing together the perspectives of Big Pharma and Biotech: Are Pharma and Biotech competitors or allies? How should expectations be managed for successful partnerships? What is the view of the Street?
Announcing Ambrilia Biopharma ()
<stocks>CEO Hans Mader announces at BIO 2006 in Chicago the launch of Ambrilia BioPharma., born of Procyon's acquisition of Cellpep S.A., a French biotechnology company developing therapeutics in oncology and infectious diseases. The merger, along with a concomitant $18.1 million financing was completed on March 1, 2006
