Innovation in Regulatory Science

Email Updates:


Not Open to Applications

Eligibility & Application Process:

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

Grant Recipients


Russ Altman, MD, PhD Stanford University Artificial intelligence to support pharmacogenetics in under-studied populations

Kim Blenman, PhD Yale University Development of optical and digital microscopy hardware, software, and statistical methods to enable assessment of computational pathology

C. Daniel Mullins, PhD University of Maryland-Baltimore Advancing regulatory science to assure COAs reflect diverse patient experiences

Veronica Rotemberg, MD, PhD Memorial Sloan Kettering Cancer Center Developing an independent audit framework for artificial intelligence in medicine: Using skin lesion analyzers as a use case

Ayako Suzuki, MD, PhD Duke University School of Medicine An innovative approach using real-world data (RWD) for the assessment of risk disparities and clinical risk factors of drug-associated acute liver injury


Amrita Basu, PhD University of California-San Francisco Developing a Toxicity Framework using Patient-Reported Outcomes in Breast Cancer Clinical Trials

John Bridges, PhD Ohio State University College of Medicine and Public Health Advancing methods for measuring patient preferences in regulatory science

Abraham Joy, PhD University of Akron A screening tool for predicting immune response to polymers designed for soft implantable devices

Laine Thomas, PhD Duke University Innovative Biostatistical Methods for Analysis and Assessment of Clinical Trials Augmented by Real World Data

Carole Yauk, PhD University of Ottawa Revolutionizing mutagenicity testing and assessment through the use of a novel error-corrected sequencing technology

Meredith Zozus, PhD University of Texas Health Science Center-San Antonio Unlocking and Evaluating Real-World Data for Use in Regulatory Decision Making


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


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


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


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


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


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

Feb 10, 2023

Application Deadline

Jul 01, 2023

Notice of Award

Sep 01, 2023

Award Start Date

Program Contacts

Tammy Collins, PhD

Program Officer


Melanie Scott

Melanie Scott

Senior Program Associate


Lama Haidar

Program Coordinator