6th Gene Therapy Analytical Development and CMC Summit

Twelve gene therapies have been approved by the FDA to date to treat a variety of diseases, including the first ever gene edited therapeutic. The CMC package required to effectively demonstrate safety and efficacy of increasingly complex gene therapy products to regulators needs to keep pace.

The 6th Gene Therapy Analytical Development and CMC Summit will unite 250+ analytical development, CMC, QC, and process development experts to showcase innovative analytical and process development methods, assess their readiness, and ultimately guarantee safety, quality, efficacy, and consistency of gene therapies to regulators.

Speakers: Luke Arbogast Director, R and D Eli Lilly, Surya Addepalli Scientist, Gene Therapy Research BioMarin, Steven Berkowitz Consultant Pacira , Chynna Broxton Analytical Development Scientist Spark Therapeutics, Hyosuk Cho Bioassay Analytical Development Scientist Sangamo Therapeutics, Cecilia Della Valle Director, Analytical Science and Technology, Gene Therapy PTC Therapeutics, Sue Duan Head of Analytical Development Astellas Pharma, Charles Feathers Manager, Process Development Tenaya Therapeutics, Faranak Noori Analytical Lead and Scientist BioMarin, Stacey Nash Scientist I Ultragenyx, Partha Mukherjee Senior Director, CMC Therapeutics Matrix Lead and Head of Analytical Development Amicus Therapeutics, Matthew Lotti Senior Associate, Research Ultragenyx, Jing Li Associate Director, Analytical Development, Gene Therapy Ring Therapeutics, Seth Levy Senior Director, Bioprocess Development Modalis Therapeutics, Prasad Kesanakurti NGS Scientist Sanofi, Po-Yi Ho Senior Scientist, Analytical Development Carbon Biosciences, George Opoku Kusi Senior Scientist, Cell and Gene Therapy Regeneron, Binod Pandey Senior Scientist Novartis, Kashyap Pandya Associate Director, Analytical CMC, Gene Therapy PTC Therapeutics, Lauren Paolini Senior Research Associate II Ultragenyx , Jeehae Park Principal Scientist Intellia Therapeutics, Luis Rascon Research Associate II, Analytical Development Astellas Pharma , John Reeves Viral Vector and Process Development Engineer Regeneron Pharmaceuticals, Susan Rutberg Director, Bioassays and Molecular Biology Sanofi, Chen Zhou Principal Research Scientist AbbVie, Wei Zhang Director, CMC Leader Ultragenyx, Katie Zander Director, Standards Education and Outreach Standards Coordinating Body, Cullen Schmid Mason Associate Director, Head of Bioassay Development Biogen, David Schwalb Director, Analytical Development, Cell and Gene Therapies Pacira Bioscicences, Aishwarya Shevade Senior Engineer Regeneron Pharmaceuticals, Will Steeves Senior Research Associate Ultragenyx, Ronald Toth Associate Director, GMU Characterization Sanofi, Susumu Uchiyama Professor Osaka University, Jin Wen Senior Scientist, Analytical Development Spark Therapeutics, Haiqing Yu Senior Scientist Sanofi

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Brochure: https://go.evvnt.com/2481285-3?pid=6581