This is an exciting time for biomedical research as innovation is at an all-time high. To continue this positive trajectory, researchers need training opportunities that embrace team science approaches and cross all stakeholder sectors.
Last year, the Georgetown University Program for Regulatory Science & Medicine (PRSM) joined forces with the Pharmaceutical Research and Manufacturers of America (PhRMA) to create a postgraduate Fellowship in Regulatory Science. The fellowship provides a mentored research experience to guide the next generation of scientists. While the U.S. Food and Drug Administration (FDA) and other organizations offer fellowships in this area, the PRSM-PhRMA program is unique in that it brings together academia, industry and government in one collaborative training package.
Regulatory science—not to be confused with regulatory affairs—is important for the biopharmaceutical field as it draws on evidence-based scientific knowledge to inform decision-making about the safety and benefits of medical products to improve public health. For example, researchers in this emerging, interdisciplinary field may investigate molecular markers in patients with a rare disease to aid in therapeutic discovery and development.
Our first and current PRSM-PhRMA Regulatory Science fellow, Shahla Riazi, MD, Ph.D., has been working with a mentor from our FDA-supported Center of Excellence in Regulatory Science and Innovation (CERSI), on a research effort that marries clinical immunology understanding with biomedical informatics techniques to determine the predictive effect of biomarkers on therapeutic outcomes. In addition to regular meetings with her mentors from Georgetown and industry partner Biogen, Dr. Riazi has had the opportunity to engage with FDA, present her work at several conferences, and spend time at Biogen’s headquarters, experiencing the inner workings of a biopharmaceutical company.
Building on the success of the program, Georgetown and PhRMA are expanding the fellowship this year with a second Fellowship in Pediatric Regulatory Science. We are thrilled to continue this partnership with PhRMA and look forward to working with two new capable fellows. This is an exciting opportunity for fellows to hone research skills and shape their careers. We are now accepting applications, due May 15, 2015. For more information about the program and eligibility, visit our website.
As my colleagues and I reflect on the first year of the program, we recognize the tremendous value of interactions with mentors from academia, industry and government, and we plan to increase and enhance these opportunities for future fellows.
Erin E. Wilhelm, MPH, is the executive director of the Georgetown University Program for Regulatory Science & Medicine.
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest contributors including patients, stakeholders, innovators and others to share their perspectives and point of view. Like in our Conversations series, views represented here may not be those of PhRMA, though they are no less key to a healthy dialogue on issues in health care today.