Collaboration: FDA Adds Johns Hopkins and UCSF-Stanford to its Centers of Excellence in Regulatory Science and Innovation (CERSIs)

The Food and Drug Administration (FDA) must attempt to match its safety and efficacy regulations with the speed of medical breakthroughs. “Rapid advances in innovative science are bringing fundamental changes to the way FDA-regulated products are developed, evaluated, manufactured, and used,” the FDA states. In order to keep up, FDA has embraced collaboration with academic partners.

In early May, FDA added two institutions to its network of academic partnerships, Centers of Excellence in Regulatory Science and Innovation (CERSIs). FDA selected Johns Hopkins and a joint effort between UC San Francisco and Stanford to support the agency’s ability to evaluate and approve safe and effective new medications. These institutions join the University of Maryland and Georgetown University, the first two centers in the CERSI network, set up in 2011.

Stephen M Ostroff, M.D., FDA’s Acting Chief Scientist recently wrote about the collaboration efforts.

“The specialized, cutting-edge science required for FDA’s increasingly complex mission makes it imperative that we leverage available knowledge and infrastructure from collaborative partners in academia. These partnerships enrich the breadth and depth of FDA expertise, enabling us to base our regulatory decisions on the most current scientific evidence. They also enable FDA to bring its expansive experience to academia, ensuring that the new scientific approaches being developed at these institutions can be applied in a way that increases their usefulness for evaluating FDA-regulated products. And most important of all, patients and consumers will ultimately benefit from the investment.”

FDA developed a “Strategic Plan for Regulatory Science,” which identifies eight priority areas of regulatory science where new or enhanced engagement is essential to the continued success of FDA’s public health and regulatory mission. The priority areas are:

1. Modernize Toxicology to Enhance Product Safety
2. Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes
3. Support New Approaches to Improve Product Manufacturing and Quality
4. Ensure FDA Readiness to Evaluate Innovative Emerging Technologies
5. Harness Diverse Data through Information Sciences to Improve Health Outcomes
6. Implement a New Prevention-Focused Food Safety System to Protect Public Health
7. Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security
8. Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Products

UCSF-Stanford CERSI

Dr. Ostroff notes that the UCSF-Stanford CERSI will target three of the above eight priority areas: (1) transforming toxicology to improve product safety, (2) improving clinical studies and evaluation, and (5) harnessing diverse data through information sciences to improve health outcomes. The links provide more detailed explanations of the FDA initiatives.

This collaboration will also “bring West Coast representation to the CERSI network and enable FDA to access UCSF’s powerhouse in quantitative sciences and pharmacology,” says Dr. Ostroff. “Pre-eminent teams of scientists from both institutions and FDA scientists will be working together to develop and offer courses and workshops in drug development and regulatory science through UCSF’s American Course in Drug Development and Regulatory Sciences (ACDRS).”

Johns Hopkins CERSI

The Johns Hopkins CERSI will also focus on three priority areas of the eight listed above: (2) clinical evaluations, (6) food safety, and (8) social and behavioral science. Dr. Ostroff states: “The university’s internationally recognized faculty in these areas and its geographic proximity to FDA will facilitate intellectual exchange among university faculty, FDA staff, and scientists.” Furthermore, “FDA staff can take advantage of workshops, symposia, courses, certificate programs, and a Master’s degree in Regulatory Science as well as others areas close to FDA’s strategic goals. Johns Hopkins is also known as a leader in innovative approaches to educational and life-long learning, including Internet-based courses that will be available to FDA scientists and staff worldwide.”