# Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI)

> **NIH FDA U01** · JOHNS HOPKINS UNIVERSITY · 2020 · $1,364,159

## Abstract

ABSTRACT
The U.S. Food and Drug Administration's Centers of Excellence in Regulatory Science and Innovation provide
institutions with a valued opportunity to work directly with regulators while simultaneously providing the FDA
opportunities for access and exposure to advanced scientific exchange and training focused on the FDA's
priority areas. As one of the world's leading institutions in higher education, Johns Hopkins University is
pleased to collaborate with the FDA in the development of fundamental new knowledge and tools to advance
regulatory science. Our proposal builds upon a historic alliance between these two vital organizations,
including decades of exchange and partnership in the pursuit of scientific advancement and state-of-the-art
regulation. During the past year alone, our CERSI has engaged in nearly a dozen original scientific
investigations, focusing upon vital areas of regulation ranging from the role of flavorants in
noncombustible tobacco products (Center for Tobacco Products) to the use of patient preference methods to
design upper limb prostheses (Center for Devices and Radiologic Health). The JH-CERSI's investigations,
conducted in close partnership with FDA scientists with stewardship from the Office of Regulatory Science and
Innovation, have advanced the Agency's mission by strengthening the science underpinning its regulatory
activities. Furthermore, these scholarly activities have been conducted while leveraging a variety of additional
governmental and non-profit funding sources, providing the FDA with opportunities to considerably accelerate
and amplify the investments made in the CERSI. Our CERSI also continues to support the training and
professional development of the next generation of leaders in regulation through courses, workshops,
seminars, competitions and certificate, master and doctoral degree programs. In the currently proposed
award, we present more than two dozen scientific investigations focused on: (1) high priority topic areas,
including tobacco, reducing health care associated infections, and addressing opioid use, misuse and
dependence; (2) developing and evaluating new methods to improve the quality and safety of FDA-regulated
products; and (3) creating methods and tools to improve quality and efficiency of clinical and post-approval
evaluation of regulated products. Together, Johns Hopkins University and the U.S. Food and Drug
Administration can continue to ensure that regulatory science flourishes, and in so doing, that the FDA
continues to fulfill its primary charge - to safeguard the health and well-being of the public through the
application of scientifically sound regulatory activities.

## Key facts

- **NIH application ID:** 9976993
- **Project number:** 5U01FD005942-05
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** G. Caleb Alexander
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $1,364,159
- **Award type:** 5
- **Project period:** 2016-09-15 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9976993

## Citation

> US National Institutes of Health, RePORTER application 9976993, Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI) (5U01FD005942-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9976993. Licensed CC0.

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