Ms. Feldman is an experienced regulatory affairs leader with expertise in rare and neuromuscular disease
WALTHAM, Mass. – Dyne Therapeutics
, a biotechnology company pioneering targeted therapies for patients with serious muscle diseases, today announced the appointment of Debra Feldman as vice president, head of regulatory. Ms. Feldman most recently served as vice president, regulatory affairs at Sage Therapeutics, and brings over 20 years of experience managing regulatory initiatives.
“People with serious muscle diseases and their families urgently need therapies with the potential to address the disease burden they face,” said Ms. Feldman. “I am thrilled to be joining Dyne at a pivotal time in our development, as we advance rapidly toward the clinic.”
“Debra brings significant experience in global regulatory strategy to the Dyne team, including substantial knowledge of the rare disease and neuromuscular spaces,” said Joshua Brumm, president and chief executive officer of Dyne. “Her expertise in navigating regulatory pathways will be invaluable as we rapidly progress our programs toward clinical development, with the aim of developing life-saving therapies for serious muscle diseases.”
Ms. Feldman 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, Ms. Feldman 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. She holds a B.A. from University of Massachusetts, Amherst, a degree in nutritional science from Simmons College and a Master of Public Health from Boston University.
About Dyne Therapeutics
Dyne Therapeutics is pioneering life-transforming therapies for patients with serious muscle diseases. The company’s FORCE™ platform delivers oligonucleotides and other molecules to skeletal, cardiac and smooth muscle with unprecedented precision to restore muscle health. Dyne is advancing treatments for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Dyne was founded by Atlas Venture and is headquartered in Waltham, Mass. For more information, please visit www.dyne-tx.com
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Stephanie Simon, (617) 581-9333