In today’s cell and gene therapy landscape, there are over 1,400 companies striving to move their products forward into clinic—a critical step in commercializing these groundbreaking treatments. Clinical development is a complex endeavor and the path to market requires careful consideration of factors ranging from chemistry, manufacturing, and controls (CMC) and regulatory strategy to study design, CRO selection, and clinical trial diversity.
On May 11, 2023, Precision ADVANCE, the Center for Breakthrough Medicines, and the Alliance for Regenerative Medicine co-sponsored the second annual Cell & Gene Day, hosted by Endpoint News. Throughout this event, over 25 successful innovators from across the advanced therapy sector shared fresh ideas and insights on overcoming critical challenges in bringing life-saving therapies to patients in need. This white paper is based on a wide-ranging clinical development discussion moderated by Teresa Pokladowski, Regional Vice President of Clinical Business Solutions at Precision for Medicine, and the following panelists immersed in novel technologies:*
- Kanya Rajangam, PhD, Head of Research & Development and Chief Medical Officer, Senti Biosciences
- Robert Ang, MD, CEO, Vor Biopharma
- Albert Seymour, PhD, President and CEO, Homology Medicines
- Cristina Musselli, MD, PhD, Head of Clinical Development, Abata Therapeutics