The Center of Excellence in Regulatory Science and Innovation (M-CERSI) is funded by the U.S. Food and Drug Administration. The center focuses on modernizing and improving the ways drugs and medical devices are reviewed and evaluated. This center is a collaborative partnership between the University of Maryland, College Park, and the University of Maryland, Baltimore. Researchers from both campuses work with FDA staff to support the development of new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.
The M-CERSI focuses on four key FDA priorities:
- improving pre-clinical assessments of the safety and efficacy of new drugs and devices;
- ensuring readiness to evaluate innovative and emerging technologies; and
- harnessing diverse data through information sciences to improve health outcomes;
- addressing minority health and health disparities.
Through M-CERSI, researchers are addressing pre-clinical assessment focusing on membrane transporters in drug development. Membrane transporters allow nutrients and drugs to move throughout the body. However, these doorways can be the basis for drug-to-drug interactions. Ensuring readiness to evaluate innovative and emerging technologies will contribute to the scientific underpinning of two device-related product areas: laser-based therapeutic devices and tissue engineering constructs. Harnessing diverse data through information sciences to improve health outcomes is an important goal, as well as focusing on patient prescriber agreements (PPAs) of prescription opioid analgesic drugs. PPAs are contracts between prescribers and their patients to identify expectations of the prescriber and the patient.
The Center also sponsors seminars and workshops, as well as an open public forum to promote regulatory science exchange, bringing together a network of experts from academia, industrial consortia and FDA scientists.
The center’s co-principal investigators are Dr. William Bentley, UMD Fischell Department of Bioengineering Professor and Director of the Robert E. Fischell Institute for Biomedical Devices, and Dr. James Polli, the Shangraw/Noxell Endowed Chair in Pharmaceutical Sciences at the University of Maryland’s School of Pharmacy.
Learn more about M-CERSI here or reach out via email a cersi@umd.edu.
This well-established fellowship has helped students transition multiple medical device ideas into prototypes and commercial ventures while earning their Master of Engineering (M.Eng.) degrees.
Award Details:
- Sponsored project(s) utilize technology developed at the University of Maryland, College Park or University of Maryland, Baltimore.
- The sponsored project(s) can be a continuation of a senior capstone project.
- Funding is awarded for one or two year
The fellowship is open to students graduating from engineering, pharmacy, or related STEM programs.
Benefits include:
- Tuition remission for M.Eng. courses and a fellowship stipend
- Access to dedicated lab space and material support for prototype development
- Connections with industry and regulatory professionals
- Guidance in commercializing a device with the Fischell Foundry
Please note that 2025 applications is due January 25 at 11:59 p.m.
Learn more about fellowship here or reach out via email at fischellinstitute@umd.edu.
The Robert E. Fischell Institute for Biomedical Devices Summer Research Internship program started in 2023 to provide passionate undergraduate and graduate students the opportunity to work in Fischell Institute PI affliated labs. Over 100 students apply, and only a select few are chosen to work on several unique projects and gain hands-on lab research experience. This paid experience was able to help students secure future opportunities, as well as, gain mentorship and guidance for their careers.
Please note that the Intern(s) hours and duration will be determined by their assigned PI. There may also be an opportunity to extend the internship during the following academic year.
If you are applying, you must be an engineering, chemistry, physics, biology, computer science, materials science, or biochemistry major.
Please note priority review will occur with applications submitted by the deadline. As of right the summer 2025 deadline is being determined.
Learn more about the internship program here or reach via email to Commuications and Program Specialist Ambi Narula for questions.
CIMER provides resources for organizations and institutions to improve research mentoring relationships.
Effective research mentoring relationships are critical to developing the next generation of researchers. You'll learn how to improve these relationships at all career stages and promote cultural change that values excellence in research mentoring as a critical aspect of diversifying the research workforce.
Please note that these training sessions are only available to grad students and post-docs. Facilitating these sessions will be Drs. Martha Wang, Jenna Mueller, Katharina Maisel, and Alisa Clyne.
Attending all 4 sessions will earn you a Mentor Training Certificate!
For details please view this page and please contact enteringmentoringtraining@umd.edu for questions