FDA’s Donald Fink to join Dark Horse Consulting Group as Master Practice Expert, Regulatory

January 4, 2021
Dr. Fink, receiving an award from Peter Marks, Director of FDA's CBER.

Walnut Creek, CA—Dark Horse Consulting Group (DHC), the only global consulting practice specializing exclusively in cell and gene therapies, announces renowned FDA expert Donald Fink, Ph.D. as their latest hire.

After 27 years spent at the United States Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER), which followed his six years at the National Institute of Health, Dr. Fink retired last month from his 33+ years of uninterrupted service to the United States Federal government.

His next chapter began at Dark Horse on Monday, where he will bring his decades of experience as a 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, to combination products.

As a Master Practice Expert in Regulatory matters, Dr. Fink will bring to bear his extensive experience in FDA regulation of cellular products. During his decades at the FDA, 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.

To quote Dr. Fink, “I’m elated by the opportunity to support the field of cell and gene therapy by bringing my decades of regulatory experience to DHC’s exceptional team of specialists.”

As part of his distinguished FDA career (during which he received a half-dozen service awards), 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.

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.

Dark Horse Founder and CEO Anthony Davies. Ph.D. said, “We are thrilled to start the year off with a luminary such as Dr. Fink joining our ranks. I am confident that his unmatched regulatory experience will provide our clients with singular guidance.”


About Dark Horse Consulting Group
Dark Horse Consulting—a global company with offices in both California and London—specializes in the development of Cell and Gene Therapy products. Comprised of experts with over two and a half centuries of industry experience, DHC’s collective knowledge spans process development and comparability, device development, manufacturing, quality systems, preclinical development, regulatory, program management, business development, strategy, and financing/investor relations. Dark Horse offers an unmatched understanding of the unique challenges faced by cell and gene therapy developers and are able to apply best practices from this and other industries to address a diverse range of client needs.

Image: Dr. Donald Fink (right), receiving an award from Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research.

Related Posts

Join the Quarter Horse Newsletter

We’ll send you a quarterly newsletter all things DHC!
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.