The Dark Horse Regulatory team will be available to chat at the DHC Lounge (Booth 700), while espresso coffees are being served nearby during the morning break (10:30-11:00 am). Join us on both Wednesday and Thursday for a cappuccino while getting your shot of regulatory strategy advice with our group of regulatory experts. They are:
- Don Fink, DHC Master Practice Expert and ex-CBER OTAT CMC reviewer with 28 years of experience specializing in cell therapy.
- Heath Coats, DHC Senior Practice Expert and ex-DMPQ inspector with expertise in late-stage commercial facility readiness preparations.
- Kevin Whittlesey, DHC Principal and ex-CBER OCTGT CMC reviewer and Commissioner’s Fellow specializing in gene therapy and regen med early-stage development.
- Tal Salz, DHC Practice Expert and ex-CBER OTAT CMC reviewer specializing in gene therapy with specialist experience in comparability.
- Master Principal Kimberly Benton, Ph.D., 22+ years at US FDA CBER, including in senior leadership roles. Most recently, Kim was Associate Director for Regulatory Management in the Office of Tissues and Advanced Therapies (OTAT), having spent the majority of her career directing and managing CMC review as Deputy Director of the Division of Cellular and Gene Therapies, as well as previously acting as Chief of the Cell Therapies Branch.
Any questions, please feel free to email us