Innovation in Regulatory Science

Grant Recipients


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