Donald Fink, Master Practice Expert, Regulatory

Donald Fink, Ph.D.

MASTER PRACTICE EXPERT, REGULATORY

Chemistry, manufacturing and controls (CMC) subject matter expert with over 25-years of US FDA-regulatory review experience that encompasses the life-cycle of regenerative medicine advanced therapy (RMAT) product development from pre-submission interaction with FDA through filing of market authorization applications. 

ABOUT DON

Prior to joining Dark Horse Consulting Group, Don provided 33+ years of uninterrupted service to the United States Federal government, first as a Pharmacology Research Associate Fellow at the National Institutes of Health followed by over 27 years at the FDA Center for Biologics Evaluation and Research (CBER). While at FDA/CBER, Don served as the CMC reviewer for over 100 files submitted by Sponsors that included INDs, IDEs, 510(k)s, BLAs and a PMA for products ranging from recombinant therapeutic proteins, biologic cellular therapies, and cellular combination products.

Most recently, Don was an Expert Biologist in FDA/CBER’s Office of Tissues and Advanced Therapies (OTAT), Division of Cellular and Gene Therapies, Cell Therapy Branch where he was engaged in regulatory activities pertaining to investigational cellular products comprised or derived from starting populations of stem/progenitor cells. Don was responsible for CMC oversight of an extensive portfolio of applications that included hematopoietic, mesenchymal, cord blood, placenta, and pluripotent (hESC and induced pluripotent)-derived stem cell therapeutic products. 

During his distinguished FDA career, Don organized an FDA advisory committee to address what at the time was the nascent topic of cellular replacement therapies for neurological disorders. The meeting had, as its focus, stem cell-based investigational products. He was also involved with the planning committee for an NIH/FDA co-sponsored workshop highlighting pluripotent stem cell (PSC)-based products in clinical translation. Don established and served as coordinator for an interest group that monitors development of investigational cellular products derived from PSCs giving attention to evolving issues of concern such as the accumulation of mutations during cellular replication that could impact the product safety profile. Don has served as FDA liaison to both the NIH Stem Cell Task Force and the International Society for Stem Cell Research (ISSCR) Task Force for Clinical Translation of Stem Cells. In 2002 Don co-founded and has co-chaired (through 2020) an FDA-NIH interagency working group in partnership with extramural program officers from the National Institute of Neurological Disorders and Stroke that promotes cross-agency dialogue to facilitate clinical translation of cellular and gene transfer-based products.

In addition to his skills as an FDA reviewer of cellular-based products, Don is recognized for his communication capability and knowledge sharing. He has trained and mentored FDA professional staff as well as served on the steering committee and as a faculty member for FDA’s Clinical Investigator Training Course which provides external stakeholders with in-depth information concerning FDA regulations, ethical considerations, and scientific principles that focus on what is important when conducting clinical trials and preparing submissions for FDA review. Don has given numerous outreach presentations and authored or co-authored several book chapters that outline FDA’s approach for the evaluation of stem cell-based therapies.

FDA DISTINGUISHED SERVICE RECOGNITION

  • CBER Honor Award: Outstanding Regulatory Research Project – CBER Human Embryonic Stem Cell Working Group. For outstanding foresight and dedication in public outreach, policy development, and regulatory review related to human embryonic stem cells.
  • FDA Outstanding Service Award. For outstanding leadership and outreach in the approach to regulation of human embryonic stem cells.
  • CBER Honor Award: Outstanding Service Award. For outstanding leadership and outreach in the field of stem cell regulation.
  • FDA Group Recognition Award: Neural Stem Cell Working Group. For significant, exceptional performance and teamwork in planning and executing a public workshop on issues related to regulation of cellular replacement therapies in neurological disorders.
  • FDA Honor Award – Commissioner’s Special Citation: RECELL® (AVITA Medical Americas) PMA Review Team. For outstanding review efforts and collaboration in approval of RECELL®, a novel point-of-care cell harvesting and application device for treatment of burn wounds.
  • CBER Honor Award: Outstanding Service. For outstanding service as a mentor to internal and external FDA stakeholders and as an acting Branch Chief in the Cell Therapies Branch.

SELECTED PUBLICATION

Donald W. Fink, Jr. (2009). FDA Regulation of Stem Cell-Based Products. Science, 324:1662-1663.

CHAPTERS/BOOKS

KE Sung, J Arcidiacono, DW Fink, Jr, A Gray, J Lam, W Tang, I Wu, RK Puri. (2020). The regulatory process from concept to market. In R Lanza, R Langer, JP Vacanti, and A Atala (Eds.), Principles of Tissue Engineering (5th Edition), London, UK; Waltham, MA-USA; and San Diego, CA-USA: Elsevier-Academic Press, pp. 1553-1572.

MH Lee, KJ Whittlesey, JM Dang, M Colehour, J Arcidiacono, E Lazarus, DS Kaplan, DW Fink, CN Durfor, A Batra, S Hilbert, DL Grayeski, R McFarland, and C Witten (2013). Overview of the FDA Regulatory Review Process. In R Lanza and A Atala (Eds), Handbook of Stem Cells, Vol 1: Pluripotent Stem Cells (2nd Edition), London, UK; Waltham, MA-USA; and San Diego, CA-USA: Elsevier-Academic Press, pp. 1001-1019.

DW Fink, Jr., and Bauer, SR. (2009). Stem Cell-based Therapies: FDA Product and Preclinical Considerations. In The Essentials of Stem Cell Biology (2nd edition). Ed. R Lanza, J Gearhart, B Hogan, D Melton, R Pedersen, J Thomson, E Thomas and I Wilmut; Elsevier Academic Press: Burlington, MA, pp. 619-630.

Fink, D.W., Jr. (2004). Human Embryonic Stem Cells: Regulatory Considerations. In [Hand Book of] STEM CELLS: Volume 1- Embryonic Stem Cells. Ed. R Lanza, J Gearhart, B Hogan, D Melton, R Pedersen, J Thomson and M West; Elsevier Academic Press, Boston, MA, San Diego, CA, London, UK, pp. 775-786.

EDUCATION

University of Minnesota
Ph.D. in Pharmacology “Epigenetic Regulation of Neuroblastoma Tumor Growth and Biochemical Differentiation”

Northwestern University 
B.A. with Honors, minor in Biology

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