Don Fink, PhD

Don Fink Headshot Photo square

Englewood, CO, USA

Current Residence
University Park, MD, USA

Graduate Degree
PhD / Pharmacology

Current Position
Master Practice Expert – Regulatory, Dark Horse Consulting, Cell and Gene Therapy Specialists

What has been the trajectory of your career and what do you find most rewarding about your work?

From the formulaic earned PhD and follow-on postdoctoral fellowship, my career path veered without preconception in the direction of serving as a regulatory review scientist in the FDA Center for Biologics Evaluation and Research. As one door closed, another opened. I was tasked with organizing an FDA advisory committee meeting on the topic of the stem cell-based therapies for the treatment of neurological diseases and disorders. This singular event allowed me to become recognized as one of the FDA experts along with other exceptional CBER colleagues on matters related to regulation of stem cell-based investigational products. Having dedicated 27-years to a career as a public servant, I recently retired (December 2020) and have been exceedingly fortunate to be able to leverage my FDA experience in my current position as a private sector consultant. The most rewarding aspect of the work is assisting innovators in the dynamic space of cell-based therapies navigate the regulatory maze that is the FDA whether it be the success of having a first-in-human use investigational new drug application be allowed to proceed or the eventual submission of a biologics license application representing the culmination of many years of commitment and dedication to product development and rigorous clinical testing.  

How would you explain your role to a lay audience?

I have served as both a gatekeeper and an enabler. As a regulatory review scientist with the FDA, I served as an independent quality control monitor of information supplied by innovators seeking to develop novel stem cell-based products. In this role I evaluated the veracity and integrity of information provided to ensure that subjects enrolling in an investigational clinical trial involving a stem-cell based therapy would not be exposed to unreasonable risk. As a consultant, I am able to exercise the experience I gained as an FDA regulatory review scientist to educate and provide guidance to developers of stem cell-based products such that they observe best practices with respect to addressing FDA expectations for new investigational products.  

What is the most exciting aspect of your work?

Having the opportunity to remain at the forefront of technical and scientific innovation as it relates to the development of novel cell-based therapies with the potential to create transformative and curative therapies for conditions for which there is clear, unmet medical need.

What guidance would you share in talking with trainees interested in pursuing a related career path?

Think of working in the product regulation space as an “outside-the-box” opportunity. You have first-hand access to a broad spectrum of innovative investigational therapies that arise from the successful application of cutting-edge science. I found my FDA career to be constantly stimulating, immensely gratifying and imbued with scarcely a higher calling than serving the public. The field of regenerative medicine as defined by cell and gene therapies is expanding rapidly and it is critical that FDA is staffed by personnel with the necessary training and experience to perform the rigorous science-based review required to bring these new and exciting possibility products to the public.

Do you have any mentors or individuals who have inspired you in your stem cell work

Perhaps no two individuals have had a more significant impact on my career in the regulatory arena as it relates to stem cell-based products than James Thomson and Shinya Yamanaka. Bringing to the fore human pluripotent stem cells and the possibility to have self-renewing starting material that could lead to the production of virtually any specialized, differentiated cell type has served to both challenge and shape the regulatory framework for cell-based products. Though expectations have been tempered by the wealth of science-based evidence generated, the boundaries around what may be achievable continue to remain largely undefined.

How do you spend your free time?

Choral singing, noodling on the piano, traveling with my wife of 41-years, Carolyn to visit family, and experimental cooking. Following a recipe is a bit like executing a laboratory protocol with the exception being the opportunity to eat the fruits of your labor.

What is something your peers would be surprised to learn about you? 

I had lunch in the FDA cafeteria, one-on-one, with then serving and current FDA Commissioner nominee, Dr. Robert “Rob” Califf.

What do you most value about your membership with the ISSCR?

I value being part of an organization that has been energetic in its effort to educate the public at large about the potential promise of new treatments being developed as one outcome of rigorous, well-designed experimental laboratory research but also to counsel caution and care with respect to the purveyors of stem cell products that have not been adjudicated by the FDA for evidence of safety and effectiveness as is required.


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