Bench To Bedside And FDA Submission Strategies For Cell And Gene Therapies

By Dr. Wilson Bryan, director at the Office of Tissues and Advanced Therapies, FDA, Dr. Alison Moore, Chief Technology Officer at Allogene Therapeutics, Dr. Hari Pujar, operating partner at Flagship Pioneering, Dr. Greg Russotti, Chief Technology Officer at Century Therapeutics, Dr. Dolores Baksh, global solutions marketing leader for Cytiva’s cell therapy business

Cell and gene therapies provide curative options for previously incurable diseases, allowing global healthcare to transform its capabilities. However, there are critical issues when it comes to the extensive adoption of these therapies. There are high manufacturing costs and a mainly manual process with complicated logistics and supply chain.

In this Q&A, industry experts share experiences and offer insights on growing trends to accelerate cell and gene therapies. Topics include FDA submissions, commercialization, specifically CMC and other considerations, reducing risk in manufacturing, selecting CDMO, in-house or both, planning and managing Phase I, and working with regulators.

Industry experts:
Dr. Wilson Bryan, director at the Office of Tissues and Advanced Therapies, United States FDA
Dr. Alison Moore, Chief Technology Officer at Allogene Therapeutics
Dr. Hari Pujar, operating partner at Flagship Pioneering
Dr. Greg Russotti, Chief Technology Officer at Century Therapeutics

Dr. Dolores Baksh, global solutions marketing leader for Cytiva’s cell therapy business, moderated the discussion.