VP, Head of Regulatory at Dyne Therapeutics
Debra is an accomplished R&D leader with more than 20 years of regulatory experience in biotech and the life sciences. She has reviewed and authored numerous successful INDs, CTAs, NDAs, MAAs and submissions for breakthrough, fast track, orphan drug and pediatric designations to advance innovative and data-driven science. Prior to joining Dyne, Debra led the regulatory organization at Sage Therapeutics, overseeing regulatory initiatives across a pipeline of products to address neurological and psychiatric disorders. During her time at Sage, she led the company through the approval of ZULRESSO® (brexanolone), the first and only treatment specifically indicated for postpartum depression. Prior to Sage, Ms. Feldman held various regulatory roles focused on multiple therapeutic areas, including rare diseases. Debra holds a B.A. from University of Massachusetts, Amherst, a degree in nutritional science from Simmons College and an M.P.H. from Boston University.