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Donald Fink
Dark Horse Consulting
University Park, MD
USA
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Dr. Don Fink is a Regulatory Master Practice Expert with Dark Horse Consulting (DHC) providing strategic support across several DHC service areas pertaining to cell and gene therapies including manufacturing, process development and comparability, analytical testing development, and quality systems. Since joining DHC in 2021, Don has become engaged with over 75 clients in the cell and gene therapy space from early-stage product development (INTERACT and pre-IND meetings) through IND and eventual biologics license application (BLA). Don has shepherded a DHC initiative leading to submission of a proposed draft guidance to FDA on the topic of testing AAV-based gene therapy products for empty capsid composition during product manufacture.
Prior to joining DHC in 2021, Don was an accomplished CMC reviewer in the Division of Cellular and Gene Therapies, current Office of Therapeutic Products (OTP), Center for Biologics Evaluation and Research (CBER), FDA accumulating over 20-years of regulatory experience primarily in the cell therapy space. Don was responsible for review of an extensive portfolio of applications that included hematopoietic, mesenchymal, cord blood, placenta-derived, and pluripotent stem cell-derived cellular products with the latter being an area of focused expertise. While at FDA, Don organized an FDA advisory committee meeting on the topic of cellular replacement therapies for neurological disorders focused on stem cell-based treatments. He served as FDA liaison to the NIH Stem Task Force as well as the International Society for Stem Cell Research Task Force on Clinical Translation of Stem Cells. Don was a co-founder and co-chair of an FDA-NIH interagency working group involving the extramural program office of the National Institute of Neurological Disorders and Stroke which served to promote cross-agency dialogue to facilitate clinical translation of cellular and gene transfer-based treatments. Don has given numerous presentations and authored or co-authored several book chapters describing FDA’s approach for evaluation of stem cell-based therapies.
Prior to joining DHC in 2021, Don was an accomplished CMC reviewer in the Division of Cellular and Gene Therapies, current Office of Therapeutic Products (OTP), Center for Biologics Evaluation and Research (CBER), FDA accumulating over 20-years of regulatory experience primarily in the cell therapy space. Don was responsible for review of an extensive portfolio of applications that included hematopoietic, mesenchymal, cord blood, placenta-derived, and pluripotent stem cell-derived cellular products with the latter being an area of focused expertise. While at FDA, Don organized an FDA advisory committee meeting on the topic of cellular replacement therapies for neurological disorders focused on stem cell-based treatments. He served as FDA liaison to the NIH Stem Task Force as well as the International Society for Stem Cell Research Task Force on Clinical Translation of Stem Cells. Don was a co-founder and co-chair of an FDA-NIH interagency working group involving the extramural program office of the National Institute of Neurological Disorders and Stroke which served to promote cross-agency dialogue to facilitate clinical translation of cellular and gene transfer-based treatments. Don has given numerous presentations and authored or co-authored several book chapters describing FDA’s approach for evaluation of stem cell-based therapies.