Team Spotlight: Dr. Frank Casty
Frank Casty, Clinical and Regulatory Expert at PharmApprove

Frank is a pulmonary/critical care physician with over 25 years of experience in the pharmaceutical industry. He has worked across numerous therapeutic areas including allergy, respiratory, cardiovascular, endocrinology and metabolism, and has led several NDA and MAA filings as well as key regulatory meetings. Prior to joining NDA, he worked at large and small companies leading global clinical research and medical affairs organizations, and served as a technical consultant for business development activities.

We recently interviewed Frank to help you get to know him better.

Question: Why did you want to become a doctor?

Answer: I always enjoyed biology and the sciences, and I was curious about how the body works. As you grow older, you realize that there is an opportunity to take care of patients and people in need. During my medical school and my medical training, I volunteered on Native American reservations, where there was a lack of doctors.

Q: How did you wind up in the pharmaceutical industry?

A: I was a medical student and wanted to join academic research when I got a phone call from a clinician at Glaxo. He had seen some of my research publications and thought I might be interested in joining his team. To be honest, I never thought of joining the pharmaceutical sector. Most people don’t (he says with a laugh). In spite of my change in career path, I have kept one foot in healthcare. In fact, right before I joined NDA I was doing some part-time practice. Over the years I’ve done a little bit of practice here and there. I was even in the military for five years as a pulmonary physician. Actually, my experience as a pulmonary physician has been very helpful in the COVID-19 IND submissions NDA is currently supporting.

Q: Question: Why did you join NDA Group?

A: After meeting several people during a visit to the US office in New Jersey, I felt like, “Wow, this is a great organization.” I immediately saw how many seasoned professionals are at the company. People know each other and connect really well. Plus, everyone truly cares about the end game — bringing better medicines to people who need them most.

Q: What is your role at NDA?

A: Right now I’m very busy preparing a client for an FDA Advisory Committee meeting as a member of the PharmApprove team – a specialty practice within NDA Group. Our client is a small company with a treatment for a rare disease. A lot of times, companies may not have any experience with Advisory Committees. They also may not have enough people to really bring presentations together or to manage such a major process. My role when working on a Pharmapprove project is to dive into the data and offer a preliminary diagnosis of a situation, and work with a client to address gaps. I help assess the key scientific messages of a program, anticipate efficacy and safety issues and help guide FDA interactions. That can stand as a framework from which we will write the supporting documentation, develop the slides and so on.

Q: What do you find most interesting about working at NDA/PharmApprove?

A: I like the idea of collaborating with the client on a lot of the key messages and the document review, because to me, getting those right early makes everything go so much smoother. Then you always have a place to come back to, sort of the like the North Star, to anchor your thinking. We do other things, too. For example, when a sponsor does a practice presentation, we can give them feedback on everything from their slides and their script to coaching their presentation skills. The beauty of NDA/PharmApprove is the variety of experts, coaches, slide designers, data and technical people. It’s a team effort and I like that. AdComs aren’t only about a scientific clinical discussion, there’s so much more that has to be coordinated to be successful.

Q: What is the one thing you are most proud of during your career?

A: The idea that I’ve been part of bringing new drugs to the market — better drugs. It sounds corny, but there have been some drugs that patients haven’t had access to, so getting that done in an ethical, science-based way is really a point of pride.

Q: Where did you grow up?

A: In Wilkes-Barre, a small town in Pennsylvania. I went to school in Scranton, around 20 miles away. I live in Pittsburgh now, and we are planning a move to the New Jersey area to be close to NDA’s US headquarters. It’s a funny time to be moving right now so we have to be patient.

Q: How about medical school? Where do you go?

A: I went to medical school in Philadelphia, and then had a residency in internal medicine in Chicago. From there I did my fellowship training in pulmonary and critical care medicine at the University of Vermont.

Q: What do you do in your free time?

A: I enjoy spending time in my backyard — beekeeping and creating wooden furniture for my wife. I’d like to say I’m a novice, because you wouldn’t like to buy my furniture. But I still persist. My wife has a long list of things that she wants me to make for her, but when she sees the quality the list might get smaller (he says with another great laugh).

Q: What’s something your team members at NDA/PharmApprove don’t know about you?

A: (He laughs.) When I was in high school, I wrote an underground newspaper and arranged a walkout because the principal was too strict. He was locking doors and other things like that, and we were protesting.

I’ve become a little more obedient today.


For 20 years we’ve helped innovative life science companies prepare to win at high profile, high stakes meetings such as Advisory Committees, Oral Explanations, expert panels and advisory boards. We’ve coached thousands of professionals and led more than 250 clients through critical junctures to successful outcomes.

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