Panelist

Dr. Don Fink is a Master Practice Expert-Regulatory with Dark Horse Consulting (DHC) Group providing support across multiple service areas including strategic regulatory that pertain to cell and gene therapies (CGT) and tissue engineering products. Since joining DHC in 2021, Don has worked with over 100 clients engaged in developing CGT products from initial FDA interactions (INTERACT and pre-IND meetings) through IND, biologics license application (BLA) and post-approval activities. Prior to DHC, Don was an expert Chemistry, Manufacturing and Control (CMC) reviewer in the current FDA Office of Therapeutic Products accumulating over 20-years of experience principally in the cell therapy space.

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