DHC Lunch & Learn with the Reg Team
Dark Horse will be convening a panel of our regulatory affairs subject matter experts for a 1-hour panel discussion and Q&A session throughout the lunch breaks of Wednesday 18th, and Thursday 19th. Wednesday’s session will focus specifically on early-stage regulatory strategies and questions. Chaired by our Managing Partners and open to audience participation, the panel will consist of the following:
- 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.
This represents an opportunity to hear what Dark Horse has to say about current regulatory concerns and hear responses to choice topics from our expert panel. After Wednesday’s session on early-stage regulatory considerations, Thursday’s session will focus on late-stage. We look forward to seeing you there!
Any questions, please feel free to email us