Don Fink

Pre-Dark Horse experience?

For my first career, I worked for the U.S. government for 33+ years, more than 27 of which were spent at the FDA Center for Biologics Evaluation and Research (CBER) as a CMC subject matter expert.

And what caused you to decide to join Dark Horse?

I like to joke that retirement is great!, but truly, this is the best post-career gig I can imagine. I’d had work encounters with CEO Anthony Davies in the past and then as luck would have it, he reached out to me right as I was considering stepping down from my government position and contemplating what to do next. I met with him and with COO Katy Spink and the three of us just clicked. I have a history of knowing when the right opportunity crosses my path, and this was an impossibly great one.

We know it’s new, but how has the transition to working in consulting been treating you so far?

It’s so completely different, which has been exhilarating. When you’re on the regulatory side of the ledger, there’s less back and forth: you make a decision, and it stands. Plus, you only see the finished product that arises from countless hours of deliberation…the end point that the sponsors have worked towards. There is so much more spontaneity here because I’m not just seeing a final vetted submission. I get to help access and explain the “why” and be a part of the process. There’s a lot of direct engagement, brainstorming, consideration of all sides of the issues at play. I am loving that sense of partnership with our clients, as well as the internal dynamics with the Dark Horse team itself.

You’re a Master Practice Expert in Regulatory. What does that title mean to you?

To me, it’s an effective description that sums up how one achieves this level of expertise. I’ve experienced the regulatory practice for so many years that the process is second nature to me, and I suppose that’s where the “Master” title comes into play. The title “Master” can be a bit of a misnomer, though, as you never really reach a defining endpoint in this field. You just remain mentally limber and active and engaged in the practice. The more you work at the process, the more equipped you are to guide someone else.

How did you end up working at the FDA?

I started out years ago by following the typical road map laid out: earn a Ph.D., followed by a post-doc with a plan to work in academia, but then I decided that really, academia didn’t feel like the right fit for me. I was at the National Institute of Health at the time of my post-doc. I dutifully went over to the NIH library to flip through job advertisements in Science Magazine (remember, these were the days before internet research!) and there was an ad for the FDA Center for Biologics. The position was literally just a stroll across the Bethesda NIH campus from where I was standing at the time, and by extended good fortune, the opportunity fit my training in neurotrophic factors. As would become my M.O., I jumped at the opportunity. So many things that have come together in my life have been a combination of happenstance and simply working to the best of my ability.

And Cell & Gene Therapy?

I entered it somewhat blindly at first, switching over from therapeutic proteins because the opportunity presented itself and this brand-new field was just so fun and interesting. We were building the regulatory framework right then and there—it was such an exciting time! And eventually I’d been doing it for long enough that I became the point person at the FDA for the industry on developing novel stem cell-based therapies.

Looking back, what is your favorite moment of happenstance?

Professionally, a high point was in 2009 when an editor from Science reached out to me for a perspective on FDA Regulation of Stem Cell-Based Products. I’d always harbored a dream of appearing in this magazine, the back pages of which had given me the chance at my first job in the field. It was a perfect full-circle moment.

Personally, though, my all-time favorite is no contest: meeting my wife, Carolyn. We were both at Northwestern University and to my great fortune I found myself at a birthday party being held across the hall from my dorm room with members of the women’s swim team. This girl walks over, sits down next to me, and starts up a conversation. There she was, the person I was supposed to meet. We had so many things in common (for starters: both growing up in families with physician fathers, a common interest in sports, practicing Presbyterians, all the way down to having a beloved black poodle for a pet) and before you knew it we were married. Here we are, 40+ years later with three grown sons and a lifetime of wonderful memories together. We’ve spent much of the pandemic playing piano duets; our go-to is “I can’t help falling in love with you.” I mean, does it get better than that?

What are some of your hobbies?

A lot of them are performance based: I sing in choral environments, I can play piano and saxophone, and I’m an amateur thespian as well. Once you’ve made an audience laugh, you’re hooked! My longest running non-professional gig, though, was 20 years spent as a youth coach for basketball and lacrosse. It was a wonderful way to build in time with my sons and I found that I just love coaching. We were never in it for the win, but for the experience, the relationships, and the personal growth. My philosophy was that if winning was your only goal, you’d set yourself up for a lifetime of potential disappointment. Instead, I encouraged the kids to focus on building their own skills and enjoying the game itself. One of my favorite things is running into someone I had coached as a young kid, out in the real world, all grown-up. I’ve also always enjoyed mentoring in a work environment—helping someone realize their potential is immensely gratifying.

Donald Fink Coach with team

This picture is from 2015, my final season as a high school boy’s lacrosse coach. I’m standing next to my youngest son, Riley, who was one of my assistant coaches that year.
We were 10-5: it was a great last season!

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