The UCSF-Stanford Center of Excellence in Regulatory Sciences and Innovation (CERSI) brings together a world-class team of collaborative scientists from two outstanding academic institutions, with the goal of collaboratively supporting the FDA's mission to protect the public's health. Launched in 2014, our CERSI focuses on mission-driven regulatory science?generating new knowledge that helps the FDA in its regulatory decision-making. During our first two years, we have developed a novel and disruptive paradigm for research in regulatory sciences; CERSI research should be collaborative between academic and FDA scientists, and should be evaluated based on its potential to change in regulatory processes, guidances or policies relevant to the approval and monitoring of safe and effective medical products. The goals of this competing renewal application are to advance regulatory sciences through interactive programs in education and research, and to support collaborative interactions between scientists at the FDA and faculty at UCSF and Stanford). The UCSF-Stanford CERSI includes four components, each with a distinct goal: C1. CERSI- Core: The goal of CERSI-Core is to support our education, research and collaborations units by providing management and oversight, and effective communications among the components and between the CERSI and key stakeholders in regulatory sciences. C2. CERSI-Education: The goal of CERSI-Education is to provide state-of-the-art training and educational programs for students, postdoctoral fellows, faculty and scientists in the industry and at FDA. C3. CERSI-Collaborations: The goal of CERSI-Collaborations is to sponsor and support a robust FDA Visiting Scientist program, and conduct workshops and seminars in regulatory sciences at both UCSF and Stanford and at the FDA. C4. CERSI-Research: Through strategic collaborative research efforts, the goal of CERSI-Research is to conduct mission-driven research in innovative regulatory sciences that addresses key scientific issues for advancing FDA's mission in protecting the public health. This proposal also contains a plan (C5) for leveraging the FDA investment and procuring non-federal funds from private donors and industry and through our online course materials. Collectively, the education, research and collaboration components of the UCSF-Stanford CERSI serve to accelerate training and research in innovative regulatory sciences and advance the mission of the FDA in ensuring the public health.

Public Health Relevance

The UCSF-Stanford Center of Excellence in Regulatory Sciences and Innovation (CERSI) will train a new workforce of scientists with expertise in the development of medical products. Scientists in the FDA and in the UCSF-Stanford CERSI will conduct collaborative research in innovative regulatory science, which will enhance the evaluation of safe and effective medical products. Finally, the CERSI will support a Visiting Scientist program to bring FDA scientists to the West Coast to interact with scientists in the highly entrepreneurial environment of the San Francisco Bay Area.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01FD005978-04S1
Application #
10089673
Study Section
Special Emphasis Panel (ZFD1)
Program Officer
Thomas, Audrey
Project Start
2016-09-15
Project End
2021-08-31
Budget Start
2019-09-01
Budget End
2020-08-31
Support Year
4
Fiscal Year
2020
Total Cost
Indirect Cost
Name
University of California San Francisco
Department
Pharmacology
Type
Schools of Pharmacy
DUNS #
094878337
City
San Francisco
State
CA
Country
United States
Zip Code
94118
Wilson, Jennifer L; Altman, Russ B (2018) Biomarkers: Delivering on the expectation of molecularly driven, quantitative health. Exp Biol Med (Maywood) 243:313-322
Mallory, Emily K; Acharya, Ambika; Rensi, Stefano E et al. (2018) Chemical reaction vector embeddings: towards predicting drug metabolism in the human gut microbiome. Pac Symp Biocomput 23:56-67
Irwin, J J; Pottel, J; Zou, L et al. (2017) A Molecular Basis for Innovation in Drug Excipients. Clin Pharmacol Ther 101:320-323
Han, Lichy; Ball, Robert; Pamer, Carol A et al. (2017) Development of an automated assessment tool for MedWatch reports in the FDA adverse event reporting system. J Am Med Inform Assoc 24:913-920
Khuri, Natalia; Zur, Arik A; Wittwer, Matthias B et al. (2017) Computational Discovery and Experimental Validation of Inhibitors of the Human Intestinal Transporter OATP2B1. J Chem Inf Model 57:1402-1413
Peck, Jonathan H; Sing, David C; Nagaraja, Srinidhi et al. (2017) Mechanical performance of cervical intervertebral body fusion devices: A systematic analysis of data submitted to the Food and Drug Administration. J Biomech 54:26-32
Cui, Qi N; Singh, Kuldev; Spaeth, George L (2016) From the Patient's Point of View, How Should Minimally Invasive Glaucoma Surgeries Be Evaluated? Am J Ophthalmol 172:xii-xiv
Hsueh, Chia-Hsiang; Yoshida, Kenta; Zhao, Ping et al. (2016) Identification and Quantitative Assessment of Uremic Solutes as Inhibitors of Renal Organic Anion Transporters, OAT1 and OAT3. Mol Pharm 13:3130-40