Organization of Regulatory and Clinical Associates
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Webinar - Challenges of Outsourcing Gene Therapy Projects
Wednesday, March 6, 2019, 8:15 AM until 10:00 AM
is required before March 5, 2019
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TOPIC: Challenges of Outsourcing Gene Therapy Projects
TOPIC DESCRIPTION: The field of gene therapy is currently in a transition period. The first few therapeutic successes and approved products have led to much excitement and investment, but with associated growing pains. Venture startups expect to be able to outsource similarly to Mab projects, but outsourcing options for gene therapy are not nearly as well developed and are often over capacity. At the same time, the impact of breakthrough therapy designation may be increasing regulatory expectations, which challenges assumptions used for development plans.
SPEAKER: Barbara Thorne
SPEAKER BIOGRAPHY: Barbara Thorne has over 25 years of experience in process development of recombinant proteins, viral vectors, and vaccines, and has worked in small biotech, large pharma, and contract manufacturing organizations (CMO), and is currently an independent consultant (Thorne Bio-Consulting LLC). Previously, she was Executive Director of Product Development at Celladon Corporation, a late-stage clinical biotechnology company developing MYDICAR (AAV1/SERCA2a) to treat heart failure, and director of Process Development at Targeted Genetics Corporation (TGC), Seattle WA where she was responsible for developing manufacturing processes for AAV and adenoviral vectors. She has also held various scientific and process development roles at Bristol Myers Squibb, and consulted for biotechnology and contract manufacturing organizations. She received her PhD in molecular biology from the University of Oregon.
WHO: Clinical, regulatory, quality, manufacturing and legal