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| SPEAKER |
| Dr Jane Lebkowski |
| Chief Scientific Officer Regenerative Medicine |
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Geron Corporation
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MEETING
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June 2009 |
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| BIOGRAPHY |
Jane Lebkowski joined Geron in 1998 and is Senior Vice President and Chief Scientific Officer of Regenerative Medicine, heading up Geron's human embryonic stem cell programme. Prior to Geron, Dr Lebkowski was VP of Research and Development at Applied Immune Sciences. Following its acquisition by Rhone Poulenc Rorer (RPR, now Sanofi-Aventis) she remained at RPR as VP of Discovery Research, co-ordinating preclinical investigations of gene therapy approaches for treatment of cancer, cardiovascular disease and nervous system disorders. Dr Lebkowski received her PhD in Biochemistry from Princeton University, and completed a postdoctoral fellowship at the Department of Genetics, Stanford University. She has published over 70 peer reviewed papers and has 12 issued US patents. Dr Lebkowski serves as the co-chair of the Industrial Committee of the International Society for Stem Cell Research and is on the editorial boards of several scientific publications.
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| TALK |
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Development of human embryonic stem cells for therapeutic applications
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| DESCRIPTION |
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Human embryonic stem cells (HESC) based regenerative cell therapies require 1) evidence for reliable production and quality control of product manufacturing, 2) rigorous safety testing in preclinical models and 3) the design of clinical trial protocols that assess the safety and benefit of the therapy in appropriate patient populations. GRNOPC1 is a population of allogeneic cells containing oligodendrocyte progenitors derived from characterized, dedicated, human embryonic stem cell banks. GRNOPC1 induces myelination of axons in rats with spinal cord injuries and in Shiverer mice, which lack compact myelin, and also produces numerous neurotrophic factors such as midkine, BDNF and activin. Extensive preclinical studies were performed to determine the distribution of GRNOPC1 as well as any potential toxicities after injection near the thoracic injury epicenter. Based on this IND application, the FDA has granted clearance for Geron to initiate a human clinical trial to assess the safety of GRNOPC1 in patients with subacute, complete ASIA A, thoracic injuries whose last fully preserved neurological level is T3 to T10.
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