Hisani Madison and I met as trainees in the NCI Cancer Prevention Fellowship Program. She recently transitioned from working at the U.S. Food and Drug Administration (FDA) to AstraZeneca. Of course, I was really intrigued about her transition from the FDA to working in pharma. I also thought that maybe our blog readers might be interested in this too! So I asked her to answer some questions for this blog post. Thank you to Hisani for being so generous in sharing her experiences with us!
1. Please compare and contrast the work that you did at the FDA vs. now at AstraZeneca. Are there major differences in your day-to-day activities or schedule?
My day-to-day is so much different now that I am at AstraZeneca compared to the FDA. While my focus on oncology, precision medicine and in vitro diagnostics is consistent, my execution is very different. While at FDA, I largely focused on ensuring that diagnostics used to select patients for oncology medicines were appropriately validated and safe for patient use. By contrast, my job now is to ensure that these diagnostic devices are strategically incorporated into our Phase 3 studies, select the right patient for the right therapeutic and that if required, ready for regulatory approval.
2. What was your motivation for transitioning from the FDA to working in pharma?
I have focused all of the transitions during my career on trying to have the broadest impact to the patient. I moved from a basic science lab to molecular epidemiology, from the NCI to FDA and from FDA to pharma. In each transition, I tried to increase my potential to have a positive impact on cancer patients. After a little over 4 years at FDA, I was ready to explore an opportunity where I could use my skill set to help ensure that the right targeted or “precision medicine” therapeutics are reaching patients who could benefit the most.
3. What were your expectations or impressions of pharma before you started working there? And now that you’re in pharma, were they accurate?
Honestly, as this was my first experience in pharma, I didn’t have a ton of expectations. However, based on talking with friends that I know in pharma, I was aware that the landscape can change pretty frequently due to various factors. This was a pretty accurate generalization. But to my surprise, the strategic goals and rationale behind the AstraZeneca reorganization that I experienced was pretty clear for me and well articulated by the business. So it was a bit less jarring than I initially thought, which was a good thing!
4. What were your main challenges when you started working in pharma? Was there anything you wish you had known before transitioning from the FDA to working in pharma?
I’ve gotten this question a lot since moving to pharma. I always give the same answer: getting used to moving deadlines, priorities and targets. While I was at FDA, my timelines to review and approve diagnostics were federally mandated through MDUFA (Medical Device User Fee and Modernization Act). Thus, if I had a PMA (pre-market approval) application to review, I knew I had 180 days to get the job done. Pharma, on the other hand, requires that I accommodate changing priorities, moving deadlines and a realization that sometimes everything needs to be done today! After almost two years at AstraZeneca, I am still learning how to prioritize my priorities.
5. What do you miss most about working at a government agency?
I miss the people and the structured timelines, but mostly the people. I had an amazing team of individuals that I worked with at FDA. Actually, I am still in contact with many of them. It's always great to return to talk diagnostics with my former team, even if I am seated on the other side of the table.
6. What advice would you give to colleagues about transitioning their careers from government to pharma?
Get flexible and manage your expectations. The pace of pharma can be daunting to some who transition from government. Utilize informational interviews to get a gauge of what people are doing on a day-to-day to see if it would be a fit for you. Do not let a lack of clinical or direct pharmaceutical experience stop you from applying. The unique knowledge and expertise that comes from working in a government agency can be a real asset to pharma. Finally, realistic expectations and an understanding that anything that seems insurmountable can be tackled in bite size pieces will make the transition easier.
Kudos to Hisani for making a seemless transition from working in a regulatory agency to the pharmaceutical industry! Thank you for your advice!
About Hisani Madison, PhD, MPH
Hisani Madison is a Director, Diagnostic Lead in Oncology at AstraZeneca. As a part of the Oncology Companion Diagnostics Unit, Dr. Madison serves as the Global Diagnostic Lead for the lung cancer Global Product Team within the ImmunoOncology Franchise. At AstraZeneca, her focus is ensuring that diagnostic tests are delivered to treat the right patient with the right targeted therapeutic.
Prior to her current position, Dr. Madison was a Senior Scientific Reviewer in the Center for Devices and Radiological Health at the Food and Drug Administration (FDA). While at FDA, Dr. Madison led the review of submissions in the Division of Molecular Genetics and Pathology specializing in the review of devices intended to aid in selection of therapy for patients with solid tumors (companion and complementary diagnostics). Reflective of her work at FDA, Dr. Madison received an FDA Commissioner’s Special Citation Award in 2018 for establishing a pathway for oversight of oncopanels through three groundbreaking submissions and partnerships across the Agency and with external stakeholders.
Dr. Madison completed her postdoctoral training in the Division of Cancer Epidemiology and Genetics at the National Cancer Institute where she conducted molecular epidemiologic research focusing on breast cancer etiology and heterogeneity. She holds a Ph.D. in Pathology from Duke University, an M.P.H. from Johns Hopkins Bloomberg School of Public Health and a B.S. from Hampton University.