June 14, 2012 Program
Guest speaker: Kate Martin, President & Founder, Glenmere Research Inc.
FDA – How to succeed with the Agency today
Glenmere Research is a consulting company providing clinical and editorial services to the pharmaceutical and managed care industries. Kathryn Martin was previously a consultant with Wyeth Pharmaceuticals, and Director of Medical Affairs with Lederle Laboratories.
Introduction: Gottfried Freier, Kaye Scholer (Germany) LLP – analysis of the German life science/biotech market today.
Northwest Biotherapeutics Inc. is a development stage biotechnology company, focused on immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and, through a unique single batch manufacturing process, on a cost-effective affordable basis at leading institutions in the US and Europe. The Company has developed a platform technology, DCVax, which uses activated dendritic cells to mobilize a patient’s own immune system to attack their cancer. The DCVax technology is expected to be applicable to most cancers, and is embodied in several product lines designed for different cancers. The DCVax technology has reached Phase III, late stage clinical trials for two different cancers (brain and prostate), has entered early stage trials for another cancer (ovarian) and has received clearance from the FDA for early stage trials in five other diverse cancers. The Company’s Phase III international clinical trial in brain cancer is under way in the US, Germany (the Fraunhofer Institute), and England (Kings College Hospital), at what will ultimately be over 80 clinical trial sites. The German government is providing a $5.5 million grant to cover half the costs of up to 30 sites in Germany. Under the European regulatory framework, the manufacturing facilities in both Germany and England also will provide vaccine for paying compassionate treatment patients who do not qualify for the clinical trials.
Linda F. Powers, Chief Executive Officer
Linda Powers has served as Chairman of NWBT for the last 4 years, and brings more than 25 years’ experience in corporate transactions and operations, including more than a decade specializing in building biotech companies through Toucan Capital. Ms. Powers is particularly well known for her experience in building biotech companies that are developing cell therapies, including both immune cell therapies (such as NWBT’s DCVax®) and adult stem cell therapies. Such products — consisting of living human cells — require fundamentally different manufacturing, storage, distribution and handling than do pharmaceutical drugs (“pills in bottles”). Such living cell products also involve different clinical and regulatory requirements, and different business and cost/pricing models, than traditional drugs. The cell therapy companies which Ms. Powers has been involved in building over the last decade, both in the US and abroad (in Asia, Europe and Israel), are at the forefront of clinical trials and early commercialization. Ms. Powers has served for years on a number of related boards, including the M2Gen Board of the Moffitt Cancer Center, the Board of the Trudeau Institute (a world leader in immunology research) and others. As Chairman of NWBT, she has brought her lengthy experience to bear in helping to shape NWBT’s overall strategy and programs. As CEO, she will now undertake operational responsibilities in addition to continuing her duties as Chairman.
Les Goldman – Senior Vice President, Business Development
Mr. Les Goldman was a partner at the law firm of Skadden, Arps for over 30 years, specializing in a wide array of advanced technologies and their commercialization. He helped build one of the preeminent global practices in this area. He was responsible for advising on financing, regulatory strategies, and public outreach relating to his clients’ development of numerous cutting edge technologies, bringing to bear a diverse range of deal-making skills. He has taken a special early retirement from Skadden, Arps to enable him to undertake an executive role at NWBT. Mr. Goldman also serves as an advisor to a number of other breakthrough technology companies. In addition, for 8 years, Mr. Goldman has served as Chairman of the Board of a group of TV Stations in 4 mid-size cities across the country. Mr. Goldman is joining NWBT as Senior VP Business Development.
TapImmune Inc. (TPIV.OB) is a biotechnology company specializing in the development of innovative therapeutics and vaccines in the areas of oncology and infectious disease. The company’s lead product, the TAP vaccine performs a key step in moving characteristic markers called antigens to the surfaces of cells. Without TAP, there are no cancer markers, so the immune system fails to spot the rogue cells and the cancerous cells can grow undetected. The Company’s vaccine has shown effective restoration of TAP which restores and augments the marker (antigen) presentation and subsequent recognition and killing of cancer cells by the immune system.
Glynn Wilson, Ph. D. brings an extensive background of success in corporate management and product development with tenures in both major multinational pharmaceutical companies and start-up pharmaceutical/biotech organizations. Dr. Wilson’s former positions include Head of Drug Delivery at SmithKline Beecham Pharmaceuticals, Research Area Head in Advanced Drug Delivery at Ciba-Geigy Pharmaceuticals, and President and co-founder of Auriga Pharmaceuticals. As Executive Vice President of R&D at Tacora Corporation he was responsible for merging the Company with Access Pharmaceuticals. He is a recognized leader in the development of drug delivery systems. Glynn has a Ph.D. in Biochemistry and conducted medical research at The Rockefeller University, New York. He has been on the Board of TapImmune for 5 years.
BioAegis Therapeutics Inc.- Susan L. Levinson, Ph.D. (Chief Executive Officer and Founder)
BioAegis Therapeutics Inc. is a newly-formed clinical stage entity commercializing groundbreaking medical discoveries in inflammation and infection, directed at a portfolio of high value indications. The company has obtained an exclusive worldwide license to a broad range of intellectual property from Harvard Medical School (and other premier institutions), surrounding the diagnostic and therapeutic uses of plasma gelsolin (pGSN), the fourth most prevalent human plasma protein. Recent findings have shown that pGSN is a key component of the body’s innate immunity and possibly the first example of a molecule which both modulates and localizes inflammation and at the same time boosts immune function. BioAegis is developing recombinant human pGSN to restore plasma gelsolin levels in patients where it is depleted.
With over $30 million of previous investment, pGSN is FDA-ready for development in multi-billion dollar indications and is a strong candidate for non-dilutive funding opportunities. BioAegis is in the process of raising its initial funding of $5.5 million.
Susan Levinson is a healthcare executive with life sciences consulting and pharmaceutical experience spanning from the lab bench, through the entire value chain, to marketing. Prior to BioAegis, Dr. Levinson was a Partner in Trivalent Partners, as well as the President of The Strategic Choice, a firm she founded in 2006, after a successful career in the pharmaceutical industry. Most recently, Dr. Levinson held executive positions in Business Strategy and Marketing Planning for Novartis Pharmaceuticals. Here Dr. Levinson led several key initiatives, including the implementation of a new global brand planning model for the US organization and managed the annual strategic and tactical planning process. Prior to this, Dr. Levinson was responsible for New Product Marketing for HRT, osteoporosis and chronic wound markets for the U.S. She began her career at Novartis as Director of Licensing for the former Ciba-Geigy organization, where she led licensing strategy and negotiations within the Bone, Inflammation, Pulmonary and Oncology therapeutic areas. She also led an R&D re-engineering team which designed and implemented a new ‘faster time to market’ model, as well as an R&D project team for US registration. Prior to Ciba-Geigy, Dr. Levinson founded and built a consulting practice for healthcare clients, specializing in technology licensing. She began her career in the industry in Research, where as a Principal Scientist, she managed drug discovery programs at Ortho Pharmaceutical. She is also an award-winning Innocentive Solver. Susan has a B.S in Biochemistry from University of Wisconsin and a Ph.D. in Biomedical Sciences from Mount Sinai School of Medicine.