Exploring and overcoming the challenges of cell and gene-modified cell therapy CMC

Research and Process Development Lead for early and late phase Gene Therapy (U Penn and Columbia) and Cell Therapy (Legend Biotech and Tmunity). Upstream and Downstream PD lead for Oncolytic Virus (OV) Therapies (Merck) High Throughput (HTP) virus characterization and potency assay development. Analytical Development for stability and release. End-to-end bioprocessing for lentivirus (LVV), retrovirus, adeno-associated virus (AAV), g-deleted rabies (RABVdG) platforms for preclinical to IND and BLA filings. Viral Vector purification, process optimization, process validation for adherent, fixed-bed, microcarrier, and suspension Bioreactors, Clarification (TFDF), Chromatography, TFF, and sterile filtration. Expert in advanced microscopy (Confocal, TIRF, STED, 2-P, SLM and E-Phys setups).Lab Manager and Senior Research Scientist for Dr. Michael P. Sheetz (Lasker Winner); Dr. Charles Rice (Lasker and Nobel Prize winner) and non-tenure-track faculty member at Columbia University as Director of Virology for the Zuckerman Institute.

Larry Bellot is a Scientific Advisor for the Charles River Cell and Gene Therapy CDMO business, having held previous positions as Analytical Sciences and Method Validation Manager and Senior Principal Scientist within the Manufacturing, Science & Technologies (MSAT) group. Prior to Cognate BioServices’ acquisition by Charles River in 2021, Larry also gained experience as MS&T IV, QC Tech Transfer Scientist, and QC Analytical Scientist at the established cell therapy CDMO. A dedicated coach and mentor, Larry received his PhD with honors from The University of Texas Medical Branch at Galveston and has foundational degrees in Industrial Biotechnology and Microbiology and has a vast and varied industrial biotechnology experience.

Karen Doucette currently serves as Cell and Gene Therapy (CGT) Navigator at Charles River Laboratories. Karen plays a critical role in partnering with clients to map the development journey from discovery through commercial manufacturing, with a focus on providing process development guidance to avoid common, time-consuming pitfalls. Karen has over 20 years of experience with biopharmaceutical CROs and CDMOs, spanning pre-clinical and clinical research, development and manufacturing. She has been instrumental in collaboratively driving expansion of CGT service portfolios and aligning research innovation with customer need. Karen received her BS in Animal Science from the University of Delaware and completed her MBA at Goldey-Beacom College.