Darrell Abernethy M.D., Ph.D. is Associate Director for Drug Safety in the Office of Clinical Pharmacology at the Food and Drug Administration.

Dr. Abernethy discussed his transition from academic research to FDA, providing a unique perspective based on his experience in a diverse variety of research environments.

Could you tell me about your job history?

I was trained in internal medicine, clinical pharmacology and geriatric medicine. After a prolonged training period, I was able to start an actual job at the age of 31. That was as a junior faculty member in the departments of psychiatry and medicine at Tufts University School of Medicine. I started my research career there in clinical psychopharmacology, and stayed there for four years. Following that I moved to Baylor College of Medicine for 3 years as an assistant professor and later an associate professor in a clinical pharmacology group in the department of medicine. Our efforts were focused on geriatric pharmacology with a particular interest in cardiovascular drugs. Following that I moved to Brown University, to take the position of Head of Clinical Pharmacology while continuing my research in clinical geriatric pharmacology in addition to doing a substantial amount of teaching medical students. After 8 years at Brown University, I moved to Georgetown University School of Medicine to take an endowed chair and head the division of clinical pharmacology. Here I worked for 5 years and continued my efforts in clinical geriatric pharmacology in addition to further developing the division and mentoring other young scientists. After this time, I moved to the NIH to run a laboratory in the National Institute on Aging (NIA) intramural research program and stayed there for 8 years. At the NIH, running a lab entails running one’s own individual research program, providing support to other investigators and their groups who are members of the laboratory, and managing resources allocated to the laboratory. In this position I focused on more basic pharmacology to better understand how drug responses are affected by RNA splice variants in relevant genes. Running the overall laboratory also entailed mentoring and being a resource for between 20 and 30 other younger investigators and trainees. After this time I transitioned into the position of Chief Science Officer at the U.S. Pharmacopeia (USP) where the efforts focus on development of standards for drugs and processes.  The work was more chemistry based, however the position was a shift toward a largely administrative position. I then moved to the FDA, where I currently work. This position transitioned me back into a mostly research position to develop a predictive drug safety program with a strong focus on systems pharmacology to predict potential adverse drug effects.

Why did you choose this career?

I certainly would not have predicted this would have been my career path, but that does not bother me at all. I ultimately chose this career path, because my mentor and Ph.D. advisor was a well known physician scientist in both clinical pharmacology and internal medicine at the University of Kansas. As with most good mentors, he instilled in me a passion for science and clinical pharmacology and became my role model. I knew from there that I wanted to establish a career in clinical pharmacology, and throughout my work in science my career evolved to the place that it is now.

Describe a typical day in your job.

First of all there is very little that is typical. Some common activities are diverse, but include: compiling diverse kinds of data from different systems and sources to develop a systems pharmacology predictive model, mentoring other young scientists, reviewing biosimilar biologic drug applications, and teaching at Johns Hopkins where I maintain my faculty appointment in geriatric medicine and in the department of pharmacology. This diverse set of roles and responsibilities keeps my work from becoming repetitive and ultimately keeps me interested and excited to pursue this fascinating line of work.

What things do you like most about your job? challenging part in your job?

What I like most about my job is simply learning new things. I’m in a position that allows me to see the most fascinating things everyday. Everyday it seems like we are working with new drugs and drug targets, some of which work and some do not. Then we get to come in and modify the systems pharmacology workflow to better understand future drugs. I also thoroughly enjoy collaborating with people from across disciplines and institutions. We work with difficult problems, and it is incredibly stimulating to work with individuals with diverse expertise and observe how they approach a problem in ways that I may not have thought of. With regard to the most challenging aspect, it is exactly what I just described. We are working with some of the most challenging and complex scientific problems, and the answers are not yet known. These challenges are ultimately what keep me engaged and motivated.

Looking back over the years of job experience in your field, what do you think you should have done differently?

Honestly, there is not much I would have changed. The one thing I think I would do differently was that I likely would not have taken an administrative position that largely involved development of chemical standards. Scientifically that was fine, because my undergraduate degree was in chemistry. However, my true passion is more aligned with clinical pharmacology research, and investigating interesting drug targets.

You worked at a number of prestigious universities (Tufts, Baylor, Brown, Georgetown) prior to your work in government. How difficult was it to transition from an established academic career to government? What advice do you have for those looking to make a similar transition?

Difficult is likely not the right word to use here. In an academic career the usual path is to “eat what you kill” or “write your own story”, which can be distilled down to as long as your grants are funded you can choose to do what you want to do and there are few constraints on how you accomplish your goals and continue the funding process. In an NIH government position the research role has very few differences from academia; however, there is a significant difference in administrative structure that took me some time to get accustomed to. This alternate administrative structure is not a negative thing, but rather necessitates the understanding of how you fit into the broader intramural research environment. Transitioning from the NIH to the FDA was also not difficult because the administrative structures are very much similar. What advice do I have for those looking to make a similar transition? First of all, never transition into anything that you do not feel is fun and interesting; don’t worry about any difficulties or differences between the two positions.

What advice do you have for new graduates looking for postdoctoral positions in government research? Should he/she work in a field similar to their PhD work or branch out into a new research area?

Applying to government positions is not all that much different than applying to an academic position. What truly makes an applicant appealing is: (1) they’re really smart, (2) they’re excited about learning new things, (3) they’re hard-working and able to engage in difficult and challenging problems, and (4) they have to know how to effectively collaborate in a cooperative environment. If an applicant meets all of those criteria, they will be highly sought after regardless of where they apply in government. For applicants that honestly feel this way, be sure to be open and honest about it throughout the interview process. Don’t be afraid to show your interest by asking scientific questions. If the applicant is just looking for a job, which many are, it will be more difficult to find a position.

What is the funding structure for someone who does ultimately receive a position within the government? Are there any similarities to the academic funding system?

There are certainly differences in the funding structure, for one both the FDA and NIH intramural programs investigators work on budgets. The structure at the NIH is more similar to academia where you still work on a budget and every four years you’re reviewed by the board of scientific councilors, which is essentially the grant review process. If that review goes well you have earned another four-year budget cycle. At the FDA investigators are on a budget that changes every year based on trends in funding, but there are also limited intramural funds that investigators do compete for in a similar fashion to the grant review process.

What are some entry-level jobs at the FDA? What is the typical background of people who are hired in this entry level jobs?

At the FDA there are postdoctoral-like positions available. We have a particular postdoctoral fellowship program that allows for those type of positions to be available. As with government research, there would be very few differences in the day-to-day research activities of a postdoctoral researcher in government and academic labs. If someone seeks that sort of position they need to be (1) really smart, (2) excited about science (3) hard-working, and (4) collaborative. With these qualities the opportunities to advance within the FDA are pretty good. There is one concern and that is the citizenship status and visa status of a potential employee. If a U.S. citizen, then moving into a regular full-time equivalent (FTE) position is straight forward. If not a U.S. citizen, then the opportunities are more limited. There are some salary lines and positions that would allow a non U.S. citizen to transition into a sort of staff scientist role, but the job status is less secure. My honest advice in this case is to pursue U.S. citizenship if an individual plans to continue working at the FDA.

What major developments do you see in your field over the next 5-10 years? What do you see as the best opportunities for young people entering this field?

Looking at the field of systems pharmacology, I think one of the impending developments will be learning how to effectively integrate numerous large and diverse data sources. This will allow metadata to be effectively leveraged to solve problems in predicting the actions of large complex, yet integrated, biological systems. This solution will require incredibly intelligent people to bridge the knowledge gaps between disciplines. They will need to be conversant with bioinformatics, high-level mathematics, biology, chemistry, and human physiology. This doesn’t require them to be an expert in any of these fields, but rather be able to interact intelligently with cutting-edge experts in the other fields. Ultimately this large challenge presents an enormous possibility for those with the capabilities to understand and integrate multiple sources of data into global hypotheses.

We thank Dr. Abernethy for his time and insights.