Wednesday, 08 February 2017 10:37

Ph.D. to the FDA: From a Student to Government Research and Regulatory Review

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Published in Careers

With trained Ph.D. scientists surpassing available academic scientist positions, students want to know what their non-academic career options are in regards to research. While students know about industry research, government research is an option that includes aspects of regulatory review, the process by which products/drugs are approved for human clinical trials and marketing by the U.S. Food and Drug Administration (FDA). We break down how one student transitioned from academia to government, the differences between the two sectors, and how to get involved in regulatory review once inside the FDA. She also goes on to share her passion for getting more women into science.  

Transitioning From Academia to Government 

meAlyxandria Schubert always had a passion for math and science and merged those two subjects by pursuing a BS in bioinformatics from Loyola University Chicago (Loyola). After doing research in a computer science laboratory, she became interested in pursuing graduate school and wanted to use her programming knowledge to improve human health in microbiology. Therefore, she joined the Ph.D. program in Microbiology and Immunology at the University of Michigan, Ann Arbor (UM). For her dissertation, she took a bioinformatics approach to study the microbiome’s influence on the colonization of Clostridium difficile, a gut microbe that causes diarrhea and severe abdominal pain.

Just like some students, while finishing her Ph.D., Alyxandria wasn’t sure if she wanted to stay in research. However, that all changed when a previous UM scientist was building his research program and a core team of people at the FDA and emailed her. He initially wanted Alyxandria to work on C. difficile, but “I didn’t want to work on C. difficile anymore,” Alyxandria remembered telling him. Alyxandria wanted to do something different while still using her bioinformatics skills. He later had funding for a phage therapy project combined with the opportunity to continue to study the microbiome. She decided to take the position as an Oak Ridge Institute for Science and Education (ORISE) Fellow at the FDA because she wanted to try something slightly different than academia and be exposed to new responsibilities within the government. “Being an ORISE fellow at the FDA is kind of like a postdoc but the pay is much better,” she explained. She says that she was also drawn to the potential of the position to have an immediate and obvious impact on public health. For anyone interested in becoming an ORISE fellow, she recommends to directly contact the person who posted the ORISE position with a letter of interest so they are aware of your application. 

Academia vs. Government: What’s the Difference?

In the year that Alyxandria’s been working at the Center for Biologics Evaluation and Research (CBER) at the FDA, she notices differences between academia and government. Unlike academia where you have to apply for grants in order to have funding for a lab, in some government agencies like FDA CBER, funds are allocated for research and the agency’s mission may dictate what type of research and scientific topics you study. She also notices how research at the FDA is focused on safety and efficacy, “The research is used to inform scientists at the FDA [how to judge] investigational products/drugs that come in for regulatory review, which really focuses on the evaluation of safety and efficacy data submitted by manufacturers.” Alyxandria still attends weekly seminars, informal lab meetings, and journal clubs just like she did in graduate school. 

Gaining Regulatory Review Experience

In the beginning of 2016, Alyxandria transitioned into a staff fellow position, which included continuing her research projects and also her involvement in regulatory review (infographic) by evaluating applications for investigational microbiome-based therapeutics. She is training for her new role by co-reviewing applications with her mentor, attending meetings to understand what specific information FDA reviewers look for in an application, and training workshops at the FDA. “I was really nervous at first to ‘regulate drugs’, what if I miss something and it goes to market and I’m responsible, but it’s very much a team effort,” she comments. Many people at the FDA, with different backgrounds and expertise, review different parts of each application to ensure the safety and efficacy of a new product throughout its development and as it moves through clinical trials.  

Women in Science

In addition to her career at the FDA, Alyxandria is passionate about promoting more women in science. At a young age, “I remember how there was no female president and how most of the astronauts were male, and wondered why it was that way,” Alyxandria comments. At Loyola, she also minored in women and gender studies, which opened her eyes to why and in what ways gender differences exist, and that led her to become active with this cause. She helped initiate the first ever discussion (for UM’s Microbiology and Immunology Department) on women’s issues in science on International Women’s Day and taught computer science for Girls Who Code. In the future, she hopes to start a woman in science group at the FDA. She strongly feels that having more women in the scientific workforce brings diversity in ideas and different perspectives. 

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Last modified on Thursday, 06 July 2017 08:52
Shilpa Gadwal

Shilpa Gadwal has been with ASM since March 2015 in her role as a Career Advancement Fellow. She took her passion of career development in trainees and created an online  hub for ASM’s career resources and articles. She received her B.S in the Biological Sciences from the University of Maryland, Baltimore County and Ph.D. in Microbiology and Immunology from the University of Michigan, Ann Arbor.

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