Cambridge Healthtech Institute’s 3rd Annual
Gene Therapy CMC and Analytics
Regulation and Analysis of Vector-Based Gene Therapies
August 14-15, 2019
Gene therapy is an extremely promising technique for the treatment of incurable diseases such as cancer and genetic disorders such as hemophilia. However, the analysis, characterization and delivery of these unique products remain a key issue.
Cambridge Healthtech Institute’s Gene Therapy CMC and Analytics meeting uncovers the practical challenges facing vector-based gene therapy analytics, assay development, quality control, vector development and delivery.
REGULATION OF CMC OF VECTOR-BASED GENE THERAPIES
USP Standards Development Activities to Support Gene Therapies
Jim Robertson, PhD, Senior Scientific Liaison, USP
Developing CMC Strategies to Advance a Gene Therapy Pipeline
Rajiv Gangurde, PhD, Director, CMC, Voyager Therapeutics
CHARACTERIZATION AND ANALYSIS
Comparative Studies on the Empty/Full AAV Capsid Using Multiple Analytical Methods
Dong Xu, PhD, Senior Scientist, Analytical Development, Biogen, Inc.
Talk Title to be Announced
Anthony Leyme, PhD, Scientist II, Technical Development, Analytical Bioassay Development, Biogen
Plasmid Control Strategy for Triple Transfection AAV Production
Lawrence Thompson, PhD, Principal Scientist, Analytical Research & Development, BioTherapeutics Pharm Sciences, Pfizer
The Application of Process Analytical Technologies for Advanced Viral Manufacture
Damian Marshall, PhD, Head, Analytical Development, Non-Clinical Operations, Cell & Gene Therapy Catapult UK
Bioassay Development for AAV Gene Therapy Products
Aisleen McColl-Carboni, PhD, Senior Scientist, sanofi
Strategies and Advances in AAV Vector Characterization: Product-Related Impurities
Christine Le Bec, Head of CMC Analytical, Technology Development, Genethon
Panel Discussion: Analytical Strategies for Gene Therapies
Xiaohui Lu, PhD, Director, AAV, Production, CRISPR Therapeutics
Bo Yan, PhD, Senior Scientist, Analytical Development, Beam Therapeutics
Wei-Chiang Chen, PhD, Senior Scientist, Analytical, Solid Bioscience
Quality Control of Gene Therapies
Sebastiaan Van Zalen, PhD, Quality Manager, Clinical Vector Core, Children’s Hospital of Philadelphia
* The program is subject to change without notice, due to unforeseen reason.