Tatiana M. Prowell, MD, has held a hybrid government/academic appointment since 2006. She currently serves as a medical officer and breast cancer scientific liaison to the Oncology Center of Excellence at the U.S. Food & Drug Administration (FDA). At Johns Hopkins, she is an assistant professor of oncology in the Breast Cancer Program. An ASCO member since 2002, Dr. Prowell currently serves on the Cancer Research Committee and is the recipient of a 2004 Young Investigator Award from ASCO’s Conquer Cancer Foundation.

How did you initially choose your current career path? Were there any unexpected detours along the way?

TP: My career has taken a number of unexpected turns. I spent almost all of my first 3 years of college taking courses in literature and creative writing. My literature advisor in college was a very sweet, thoughtful man named Clark Rodewald. He had been paraplegic since a motor vehicle accident decades prior and had therefore spent a great deal of his adult life in the company of doctors. When, as a junior, I asked him where he thought I should apply to graduate school in literature, he encouraged me (to my considerable dismay at the time) to consider going to medical school instead. He said, “I just think you were meant to be a doctor.” I had been a fan of a number of authors and poets with medical backgrounds, including John Keats, William Carlos Williams, and Anton Chekhov, so while I always expected that I would teach literature at a college level, I’m pretty sure I also secretly harbored romantic ideas about one day becoming a physician-writer. My mother was diagnosed with lymphoma during my college years, and this undoubtedly planted the seed that ultimately would lead me to a career in oncology.

My father was a PhD scientist who spent his entire career as a federal employee working for the U.S. Geological Survey, but I had never given much thought to working in government myself. When I was an oncology fellow at Johns Hopkins, Dr. Richard Pazdur, now the director of the Oncology Center of Excellence, was leading the newly formed FDA Office of Hematology & Oncology Products and was also adjunct faculty at Johns Hopkins. I met him there through our weekly fellows solid tumor conference, and at the end of the year, he asked me to join the FDA Oncology program once I was done with fellowship. I fully intended to stay in academic medicine, but the truth is that I really disliked writing grants. I loved all the rest of it—caring for patients, identifying important scientific/clinical questions that needed to be addressed, designing trials to answer them, analyzing data, writing, speaking, teaching, you name it—but I simply didn’t want to have to write grants to be able to do all of that.

Dr. Pazdur pointed out that I could do every bit of that if I came to the FDA and continued to see patients at Johns Hopkins, and I would never have to write another grant. I was sold. He hired me in 2006, and I’ve been here happily ever since.

Describe your typical workday.

TP: I can’t say I have a typical workday. Depending on the day, I might be reviewing a first-in-human study to decide if it is safe to conduct, meeting with a company to discuss the design of a phase III breast cancer registration trial, analyzing data to make a decision on whether we should approve a new drug for breast cancer, seeing patients in the second-opinion breast cancer clinic at Johns Hopkins, teaching in the MD/PhD ethics course in the medical school, meeting at ASCO Headquarters to work on a project modernizing eligibility criteria for oncology trials, giving Grand Rounds at an academic center, leading a mini-symposium on breast cancer drug development, or mentoring fellows in one of several programs such as the Vail Methods in Clinical Cancer Research Workshop. The variety of the work from hour to hour and week to week is actually a huge part of why I have stayed, and stayed happy, for as long as I have in this job.

If you have to pick one aspect, what part of your job is your favorite? What part is the most challenging or frustrating?

TP: My favorite part of my job by far is the outreach, which is the hallmark of what the scientific liaisons do. The program was created about 4 years ago and is a very outward-facing role. It provides a mechanism for a subset of the medical officers from FDA Oncology to interact very frequently with academic oncologists, patient advocates, professional societies, community physicians, trainees, and industry. The purpose is for us to benefit from the perspective of all of the stakeholders we serve, and to be able to demystify what we are doing as regulators, in essence to remove regulators from the black box. I am an extrovert through and through and draw a tremendous amount of energy from interacting with others united in service of a common goal of making progress in cancer.

The most challenging part is the sometimes slow pace of progress. I think that’s probably common to every sector of oncology. We all want to see progress for our patients, not in 10 years or even next year, but right now. Clinical research is seldom fast to bear fruit, and government is not the easiest place to make rapid change. So that’s a challenge. But it’s probably useful to be frustrated like that sometimes. It forces me to confront my character flaws, one of which is a legendary degree of impatience.

What do you wish you had known before you chose your career path?

TP: I wish I had known how important it would be for physicians to be well-versed and competent in subjects outside of science and medicine. I have never regretted having majored in languages and literature. To quote my advisor, Clark, when I inquired about changing my major once I decided to go to medical school: “No, stay in languages and literature. You’ll never be sorry you learned to communicate well, no matter what field you end up in, but especially if you end up in medicine.” It is some of the best advice I’ve ever been given. I wish I had also spent time learning about computer science, business, law, and a number of other areas that are increasingly integral to the medical field.

Why would you recommend this career to someone starting out in oncology?

TP: Oncology is a wonderful specialty. There are true joys to be found in every sector. Those in the pharmaceutical industry have the thrill of developing new drugs that transform diseases, those in academia get the privilege of designing and conducting many of the trials to test these drugs, those in practice have the satisfaction of being on the ground in 2018 seeing patients living longer and feeling better, and providing comfort even to those we cannot yet cure. The fun of what we do as regulators is in getting to have a hand in a little bit of all of this. The heart of our mission is to protect and promote public health at the highest level, and it’s humbling to be charged with serving the American people as the “honest broker” in drug development. There really is no greater honor than to be entrusted with people’s lives on such a large scale.

What kind of person thrives in this professional environment?

TP: The professional environment has changed a lot in the 11 years I’ve been at the FDA. When I came in 2006, oncology drug development was struggling. There were a lot of unsuccessful treatments in clinical trials, and the truth is that we spent much of our time trying to prevent harm to patients—putting the brakes on development programs for drugs with limited efficacy and outsized toxicity. In the last several years, there has been a much greater focus on identification of predictive biomarkers that may be targeted successfully in drug development programs enriched for the patients most likely to benefit. As a result, we now spend a lot of our time thinking creatively in collaboration with drug developers, physicians, and patients about how to get highly active drugs developed and to the American people as quickly and ethically as possible without compromising patient safety.

So I guess I would say the most important qualities needed to thrive as a regulator in 2018 would be creativity and adaptability, as well as conscientiousness. As U.S. drug regulators, we serve hundreds of millions of people, so if a mistake is made, the implications are far-reaching. That is always on our minds.

“How I Became” is a series about the numerous and varied career paths in oncology. In each issue, a member will discuss their career journey and give an insider’s view of their profession. Email ascoconnection@asco.org to tell us what career paths you’d like to see covered, or to contribute to this series.