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URMC / Education / Graduate Education / URBest Blog / June 2017 / Pursuing a Career in Regulatory Science and Drug Development

Pursuing a Career in Regulatory Science and Drug Development

Career Story by David McMillan, Ph.D., Toxicologist at U.S. Food & Drug Administration

Academia, industry and government: I was always aware of the three career tracks available to biomedical scientists, but as with most fledgling graduate students, I didn’t really know what differentiated them. Pursuit of an academic career was still somewhat en vogue when I started graduate school and it was the only path with which I was familiar. As industry was concerned, I at least understood the distinction between “industry” and “pharma”, but “government” remained elusive. What does it mean to be a government scientist?  Do they do bench research? If so, do they write grants? Who do they report to? How does the government monitor clinical trials for pharmaceuticals and ensure patient safety? Who sets policies on environmental toxicant exposure and how are these policies determined? And what exactly does “regulatory” mean?

After leaving Rochester in 2013, I decided on a post-doc at the University of Vermont in Burlington. I already knew that a life of bench research and grant writing wasn’t for me, but I was certain, perhaps naively, that I should give it another chance. Hindsight is 20/20, though, and while I certainly don’t regret my time in Vermont, I was in need of a change. One can devote several years in academia to answering a very narrow set of questions, and let’s be honest, these questions are usually met with more questions. Don’t get me wrong – research is extremely important and undervalued nowadays, but the discoveries made in cell culture dishes may be decades removed from the patients who need them. Whatever I did, I knew I wanted to work in drug development and be more directly involved in public health. 

The opportunity to work at the U.S. Food & Drug Administration appeared following a networking event within the Society of Toxicology. I hadn’t previously considered the FDA, and I still didn’t really know what they did even up to my interview, but everything I learned intrigued me. The Office of New Drugs, located within the Center from Drug Evaluation and Research, is responsible for reviewing the safety and efficacy of all drugs prior to clinical trials and marketplace approval. The sponsors must submit applications (INDs, pre-INDs and NDAs) containing all information pertaining to manufacturing, efficacy, potential toxicities, pharmacokinetics, and clinical experience to obtain this approval. As a regulatory toxicologist (there’s that word again), I would be responsible for reviewing the preclinical pharmacology and toxicology studies to ensure they are conducted according to the proper regulations and that all toxicities are accounted for. I would be working with medical officers (physicians), virologists, chemists, statisticians, clinical pharmacologists and other toxicologists with various backgrounds, and that the decisions I’d make would directly impact drug development and, by association, the patients. Unlike most pharmaceutical companies, I’d be involved with multiple drugs in various stages of development, and best of all, there’d be no bench work. I knew immediately this was for me. 

What struck me instantly upon working at the FDA is how happy everyone is.  That may sound silly, but it’s true. I’m extremely privileged to work with a number of extremely intelligent, driven and amiable colleagues who are truly dedicated to science and protecting public health. The work itself, while not without its challenges, is fascinating and rewarding, and every day is different. I love my job now and I didn’t think I’d ever say that. Keep your eyes open, consider the roads less traveled, and there’s no telling where your career will take you.

Join me Monday June 26 at noon to learn more about my work at the FDA and how I got there. We'll be in the Medical Center's Northeastern Conference Room (1-9525).

Global Administrator | 6/20/2017

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