Erin E. Wilhelm, MPH, is Executive Director of the Program for Regulatory Science & Medicine at Georgetown University. Ms. Wilhelm established the key features of the program’s first large effort, a Center of Excellence in Regulatory Science and Innovation (CERSI), supported by the U.S. Food and Drug Administration (FDA). The CERSI is a collaborative effort between the university and the FDA to engage on issues related to regulatory science, including education, professional development, and innovative research. Regulatory science is an interdisciplinary area of research that aims to enhance the development of safe and effective medical products. The discipline relies on a community of scientists from diverse fields to collaborate in new ways, to generate new knowledge that will inform the regulatory decision-making process. Among other responsibilities, Ms. Wilhelm manages the project’s overall operations, including outreach and communications activities, strategic planning and new business development, and managing and mentoring people.
With her experience in regulatory science, Ms. Wilhelm supports the Innovation Center for Biomedical Informatics (ICBI) at Georgetown by serving as primary liaison to FDA for collaborative research projects among ICBI and FDA scientists. Ms. Wilhelm also serves as a project manager and a new business development lead for ICBI, shepherding projects and new proposals from start to completion, and helping to facilitate strategic planning sessions for ICBI faculty and staff.
Ms. Wilhelm has been part of the effort leading the way in establishing regulatory science as an academic discipline. Since 2012, she has led the development of a Georgetown’s online Master of Science concentration in regulatory science. She also served as the co-chair and convener of a national workshop to develop regulatory science curricular guidelines and core competencies in September 2014. With partner organizations, Georgetown offers unique training in the field through a Fellowship in Regulatory Science. Launched in 2014, the fellowship is an opportunity for post-doctoral scientists to conduct research under the direction of seasoned mentors from academia, industry, and government.
Ms. Wilhelm serves as the co-principal investigator for a research study on voluntary data sharing among industry sponsors of medical products. She and her colleagues have published on the subject, recently in the Journal of the American Medical Association in 2014. Additional information about these efforts can be found online at http://regulatoryscience.georgetown.edu.
Ms. Wilhelm is an experienced researcher and writer with a broad background in public health and communications. She has conducted research and written about HIV, disability, traumatic brain injury, and the impact of climate change on human health. She was formerly a staff member at the Institute of Medicine (IOM) of the National Academies, and a guest researcher at Fogarty International Center of the National Institutes of Health (NIH). Ms. Wilhelm’s career began in communications; she held related positions at the Corporate Executive Board, JBS International, Inc., and the St. Petersburg Times. Ms. Wilhelm holds a Master of Public Health in global health from The George Washington University, and dual Bachelor of Arts in mass communications and political science from the University of South Florida.