Innovation in Regulatory Science

Application Deadline:

Feb 12, 2021

by

4:00pm

ET

Status:

Now Accepting Applications

Eligibility & Application Process:

For a full explanation of the eligibility requirements, view the Request for Proposals.

Request for Proposals

Grant Recipients

2019

Jessica Myers Franklin, PhD Harvard University Evaluating the validity of real world data for regulatory decision-making through replication of randomized controlled trials

Brigitte Gomperts, MD, PhD University of California-Los Angeles Developing a screen to test the toxicity of new and emerging tobacco products on the airway epithelium

Christoph Hornik, MD, PhD Duke University Real world data to support pediatric drug labeling

Mona Jarrahi, PhD University of California-Los Angeles High-throughput detection of carcinogenic aflatoxins in agricultural food products through terahertz pulsed imaging

Meghan Moran, PhD Johns Hopkins University Innovative methods to inform regulatory action on tobacco product marketing

2017

John W Ayers, PhD University of California-San Diego Increasing citizen participation in e-rulemaking by harnessing social media

Florence T. Bourgeois, MD, MPH Harvard Medical School Pediatric regulatory policy: advancing timely and rigorous evaluation of medicines for children

Merrie Mosedale, PhD University of North Carolina-Chapel Hill Development of an in vitro platform for the evaluation of genetic susceptibility factors associated with adverse drug response

Michael Rosenblum, PhD Johns Hopkins Bloomberg School of Public Health Statistical methods and automated software tool for stress-testing adaptive clinical trial designs

Leslie Wilson, PhD University of California-San Francisco Advancing new methodologies to measure patient preference for regulatory approval of devices

2016

Ray Dorsey, MD University of Rochester Incorporating smartphone research applications into clinical trials

Kevin M. Esvelt, PhD Massachusetts Institute of Technology A model system to evaluate the dynamics and safety of gene drive applications

Christopher Flowers, MD Emory University Microsimulation modeling to evaluate the clinical effectiveness of novel cancer therapies

Andrew Douglas Maidment, PhD University of Pennsylvania VICTRE - Virtual Clinical Trials in The Regulatory Environment

Shoukhrat Mitalipov, PhD Oregon Health and Science University Mitochondrial replacement therapy

2015

Patrick Allard, PhD University of California-Los Angeles Application of novel approaches towards germline toxicity assessment

Darla M. Goeres, PhD Montana State University Methods to assess biofilm prevention on medical devices

Erich S. Huang, MD, PhD Duke University School of Medicine Provenance Laboratory for Auditable Regulatory Science (POLARIS): auditable antibiotic development with the clinical trials transformation initiative

Rustem F. Ismagilov, PhD California Institute of Technology A microfluidic diagnostic platform to advance regulatory science

Sara Lynn Van Driest, MD, PhD Vanderbilt University School of Medicine Leveraging big data for small patients

Joseph C. Wu, MD, PhD Stanford University School of Medicine Accelerating drug discovery with iPS cells and small molecule screen

2014

Brian Alexander, MD Dana Farber Cancer Institute Development of a Biomarker Enriched Adaptive Trial for Patients with Glioblastoma

Randolph Ashton, PhD University of Wisconsin-Madison Organoid Microarrays for pan-Hindbrain and Spinal Cord Screening

J. Matthew Brennan, MD Duke University Medical Center Administrative Claims-based Efficiencies for the Advancement of Regulatory Sciences

Mark Burkard, MD, PhD University of Wisconsin A chemical-genetic library of human cell lines for evaluating pharmacologic inhibition of protein kinases

Mary L’Abbe, PhD University of Toronto Evaluation of nutrient profiling methods for nutrition regulation

2013

Dana Devine, PhD University of British Columbia Refreshing the regulatory approach to ensuring the safety and efficacy of blood transfusion products

Kathleen Giacomini, PhD University of California-San Francisco Systems pharmacology approaches to understanding drug-induced weight gain

Alison Harrill, PhD University of Arkansas for Medical Sciences Advancing regulatory science through translational pharmacogenomics

Calum MacRae, MB, ChB, PhD Brigham and Women’s Hospital Building structure-related prediction algorithms for organ-specific drug toxicity through iterative modeling in novel zebrafish reporter lines

Vishal Vaidya, PhD Brigham and Women’s Hospital Mapping the biology of a damaged kidney cell

Susan Yackee, PhD University of Wisconsin-Madison When politics intrudes on science: regulatory policymaking at the FDA

Award Timeline

Sep 01, 2019

Award Start Date

Feb 12, 2021

Application Deadline

Jul 01, 2021

Notice of Award

Program Contacts

Kelly Rose, PhD

Program Officer

919-991-5120

Melanie Scott

Senior Program Associate

919-991-5107