"Whether it’s to understand how a medical product works and how it’s used, how clinical trials are designed, or how biomarkers are developed, my foundational knowledge in science guides the regulatory work I do." -- Dr. Nina Hunter, Molecular Biologist, Director, Office of Clinical Policy and Programs.
Q. What opportunities does FDA offer you that you couldn’t get elsewhere?
Nina Hunter: For me, what is so fulfilling about working at FDA is that I can see the direct impact that my work has on public health. I’m currently working in FDA’s Office of Clinical Policy and Programs, where I help plan, develop, and execute regulatory and health science-related programs and policies that cut across multiple product centers, from drugs, to devices and biologics. Recently, as part of a team, I worked on a plan to make sure that FDA’s orphan drug designation process is efficient and that our policies in this area continue to be science-based and consistent. This particular initiative is important because orphan drugs are intended to treat rare diseases and FDA’s work in this space would encourage the development of new therapies for these patients. What is also rewarding about FDA is that while scientific work is often competitive, we work collaboratively here and as a team.
Q. How do you use your science degree at FDA?
NH: I have a PhD in Genetics from Harvard Medical School and an AB in Biochemistry and English from Bowdoin College. I also have research experience from NIH. And even though I’m no longer at the bench or involved with primary research, I use my scientific education and analytical skills in my job on a daily basis. Whether it’s to understand how a medical product works and how it’s used, how clinical trials are designed, or how biomarkers are developed, my foundational knowledge in science guides the regulatory work I do.
Q. Why do scientists like you stay at FDA?
NH: One reason is that at FDA we’re really at the forefront of critical medical advancements. Every day I get to learn about and tackle a public health issue resulting from some new discovery or technology or public health need. For example, I've worked on holding a public hearing to discuss the review of medical devices intended for a new use with an approved drug. These medical devices could advance public health by offering new products that might not otherwise be developed.
NH: Another reason is that there are good opportunities here for career advancement and personal development. For example, I joined FDA in 2008 as a scientific reviewer in FDA’s Center for Devices and Radiological Health, where I evaluated diagnostic devices, such as molecular-based companion diagnostics. In that role, I was part of a team that reviewed products like the first molecular-based screening assay for colorectal cancer, which was approved for use. When used correctly, data suggest that this product would save lives. It is extremely gratifying to be a part of the development of these products, starting from the understanding of molecular pathways of various biomarkers to the ultimate impact the product has on public health.
Then in 2015, my role shifted and now I’m developing policy and processes that frame and guide the scientific foundation of the work we do at FDA. For example, I recently worked with a team to launch a modernized process for how combination product submissions are reviewed internally. Because combination products include multiple product types, it is important that we standardize the processes around how we better collaborate with FDA’s different product centers and policies around how we regulate. In addition, I’m helping establish a new function to provide a more transparent and accessible experience for patient communities to interact with FDA.
And on a personal note, I have two young daughters so I really appreciate the flexibility I’m given at FDA, where, as a working mother, I’m able to find a balance between home and work life. If I plan ahead, I can chaperone field trips and stay involved in other important school-related functions. Mostly, I’m fortunate to have the support from my supervisor and mentor, who is a great role model for me. I am both encouraged to develop as a scientist and am recognized for my contributions.
Q. How is science conducted at FDA unique from science conducted at the National Institute of Health (NIH), academia, or industry, for example?
NH: Because FDA’s mission is to protect and promote our nation’s health, we’ve got to keep pace with advances in medicine and related technologies. We have to ensure that our regulatory decisions support medical product innovation and protect the health of patients who depend on those products.
What I enjoy most about FDA is the collaborative work environment. We work with patients and patient groups, with members of other agencies, with academic scientists, and with representatives from industry to ensure that the regulatory decisions we make align with our public health mission. I feel lucky to be able to work in an organization that values the input and perspectives of all of FDA’s different stakeholders.