Innovation in Regulatory Science

Application Deadline

Feb 07, 2025

Status

Not Open to Applications

Grant Information

BWF’s Innovation in Regulatory Science Awards provides up to $500,000 over five years to academic investigators developing new methodologies or innovative approaches in regulatory science that will ultimately inform the regulatory decisions the Food and Drug Administration (FDA) and others make.  We especially encourage applications from those seeking to advance regulatory science approaches that will expedite the realization of equitable clinical outcomes.

The following videos were recorded in 2020 and 2023 and are being shared for informational purposes because they contain a wealth of information about the IRSA program.  Note that some deadlines within the videos reference past award cycles.

Progress Reporting

Due Date: November 1

Progress and financial reports are required of all BWF grants and are due on the date(s) specified in the award letter or agreement. The Advisory Committee and staff depend heavily upon progress and financial reports to evaluate progress. Late reports inconvenience advisory committee reviewers and impede BWF's evaluation of its programs. Failure to submit progress or financial reports in a timely fashion will result in payments being withheld, and if submissions are missed repeatedly, the award will be terminated.

BWF provides the following progress report guidelines to assist in preparing and submitting progress reports in an acceptable manner. The progress report and financial updates are to be submitted through Proposal Central. You can find the required deliverables listed on the home page after logging in to Proposal Central. Failure to submit any portion of the report by the due date will result in an interruption or cancellation of your funds.

If you need help using Proposal Central, please follow the instructions on their Customer Service webpage to contact their tech support team.

No-Cost Extensions

Awardees may request a no-cost extension (i.e., no additional grant funds to be provided) at least 30 days before the grant end date. To begin a no-cost extension request, please email our Program Associate, Eliza Gary (egary@bwfund.org) with a short description of the purpose for which the extension is requested. The request for a no-cost extension must be copied to the investigator and the appropriate representative of the investigator’s institution. The BWF team will then add an official no-cost extension request to your award on Proposal Central; there, the awardee should include a detailed explanation of the purposes for which the extension is requested. Directions are outlined in the award contract/agreement “General Terms and Conditions” and included in Proposal Central.

In general, extensions do not exceed 24 months. The Fund reserves the right to deny a request in whole or in part. If the request is approved, it will be incumbent upon the named investigator and his/her institution to provide annual progress and expenditure reports each year of the no-cost extension period and final progress and financial reports at the end of the no-cost extension period. BWF will request a return of all no-cost extension funds if progress report requirements and deadlines are unmet.

Progress Reporting for Awardees

Progress Report

The progress report requires the awardee to submit a written report on the progress of the original or approved update to research project aims, an updated biographical sketch, a summary of research progress, and any recent publications. Details regarding each section are in Proposal Central. The progress report must be submitted annually on November 1st.

Financial Report

Awardees are required to update award spending in the Proposal Central budget summary; awardees should report spending in the “expenses” column. Details regarding financial reporting are in Proposal Central. Financial reports are due annually on November 1st.

Report Format

All progress and financial reporting materials should be submitted through Proposal Central. If you have questions, please contact our Program Coordinator, Lama Haidar (lhaidar@bwfund.org).

General

Can I submit more than one application?
No.


Do I need to be nominated by my institution to submit a proposal?
No. You may self-nominate for the proposal. All applications must be approved by an official responsible for sponsored programs at the institution where the work will be performed (generally from the institution’s grants and contracts office, office of research, or sponsored programs office).


Is the BWF application deadline firm?
Yes, the application deadline is firm.


Do I need to submit a preproposal prior to submitting a full application?
No. We are no longer requesting a preproposal for the Innovation in Regulatory Awards program.


Can I submit a paper application?
No. BWF requires that all applications for this program be submitted electronically. Paper applications will not be accepted.


The eligibility requirements mention that the primary investigator must be based at a non-profit institution [501(c3) or equivalent] in the U.S. or Canada. What is a 501(c)(3)?
According to the U.S. Internal Revenue Code, a 501(c)(3) organization is an American tax-exempt, nonprofit organization. Almost all degree-granting institutions are classified as such, as are most research institutes and teaching hospitals. You must check with your institutional officials, usually called the grants and contracts office or the sponsored programs office, etc., to confirm your institution’s classification. BWF cannot make this determination for you.


I am a permanent resident. What documentation is required to verify my residency status?
BWF does not require documentation of your permanent residency for the proposal. Your institution must verify your permanent residency status by certifying the eligibility of your application upon signing the proposal.


Can I include cover letters or supplemental materials with my proposal?
Do not include a cover letter or supplemental materials. If extra materials are included, your proposal will be rejected out of fairness to all applicants.


Can co-investigators be located at different institutions?
Yes. However, the primary investigator must be based at a non-profit institution [501(c3)] in the U.S. or Canada, which will be the administering institution for the award. The primary investigator must meet all eligibility requirements for the program.


Can I change my application once it is submitted?
After a proposal has been submitted, applicants have the option to unsubmit it to make changes, if necessary, only if: 1. The application deadline hasn’t passed; 2. BWF has not already routed the application to a committee for review.

If an applicant needs to edit an application, please review the instructions on page 27 for “Unsubmitting An Application” in the “How to Create an Application Using Proposal Central” guide accessible at this link https://docs.proposalcentral.com/CreateApp.pdf.

Eligibility

Can I contact BWF to determine my eligibility?
Applicants are responsible for reading the published guidelines and FAQs to determine eligibility. The FAQs are updated regularly in response to questions received. BWF staff will do their best to respond to every inquiry but will prioritize questions not already clearly addressed in the published guidelines. Please do not contact BWF to ask if we can make an exception to clearly stated guidelines. To ensure a timely response, please email your questions to the program contacts provided.


I do not have a tenure-track position. Am I eligible for this award?
Possibly, as long as you hold a faculty appointment or adjunct faculty appointment at a non-profit institution in the U.S. or Canada, which may include degree-granting institutions, research institutes, and teaching hospitals affiliated with academic degree-granting institutions. You do not need to hold a tenure-track position.


I’m currently a postdoc. Am I eligible for this award?
No.


I am a temporary resident of the United States. Am I eligible for this award?
Possibly. Temporary residents of the U.S. who are legally qualified to work in the U.S. are eligible. Candidates who are temporary U.S. residents must hold a valid U.S. visa (J-1, H1B, F-1 or O-1 visas). If a grant is awarded and your visa does not allow for such a stay, BWF may terminate the grant. BWF will not intercede on behalf of non-citizens whose stay in the U.S. may be limited by their visa status.


I am a temporary resident of Canada. Am I eligible for this award?
Possibly. Temporary residents of Canada who are legally qualified to work in Canada are eligible. Temporary Canadian residents must hold a valid Canadian visa (Study Permit, C-43, C44, C-10, or C-20 work permits/visas). If a grant is awarded and your visa does not allow for such a stay, BWF may terminate the grant. BWF will not intercede on behalf of non-citizens whose stay in the U.S. may be limited by their visa status.


I’m at an independent research institute. Am I eligible for this award?
Possibly. You must be based at a non-profit institution [501(c)(3) or equivalent] in the U.S. or Canada, and hold a faculty appointment, or adjunct faculty appointment, at the institution. If you have such an appointment and your research institute is a non-profit institution [501(c)(3) or equivalent] in the U.S. or Canada, you are eligible. Examples of such institutions may include but are not limited to degree-granting institutions, research institutes, and teaching hospitals affiliated with academic degree-granting institutions.


I’m a past BWF grantee. Am I eligible for this award?
Yes, as long as you meet all the eligibility requirements for the program.

Logistics

What internet browsers are compatible with the BWF Grant Submission System?
Most internet browsers are compatible with the Grant Submission System including, Internet Explorer, Mozilla Firefox, Safari (for Mac), and Google Chrome.


I forgot my user ID/password. What should I do?
For a forgotten password or user ID, access the grant submission system log-in screen and click the forgotten password link.


Do I need to complete an application in one session?
No, you can start an application and return later to complete it. When beginning a new application, you are required to establish a login and password. At any time during the application process, you may click the "save and close" button, exit the application, and return later.

2025

Arezoo Ardekani, PhD Purdue University Physics-Informed Digital Twin for the Delivery of Biotherapeutics

Kari Clase, PhD Purdue University Addressing Regulatory Science Needs in a Global Environment

Michael Lipnick, MD University of California-San Francisco Advancing Methods to Inform Regulatory Action for Equitable Pulse Oximeter Performance

Michelle Rengarajan, MD, PhD Massachusetts General Hospital Developing a Surrogate Biomarker for Dystrophin-Restoring Therapy in Duchenne Muscular Dystrophy

Michael Wells, PhD University of California-Los Angeles “Phase 0” Human Clinical Safety Trials in a Dish

2023

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

2021

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

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

Martha Brumfield, PhD
Special Advisor, Past President and CEO
Critical Path Institute

 

Victoria Chiou, MD
Vice President, Clinical Development
Tempus AI

 

Rachele Hendricks-Sturrup, DHSc, MSc, MA
Research Director, Real World Evidence
Duke-Robert J. Margolis Institute for Health Policy

 

Lisa LaVange, PhD
Professor Emerita and former Chair
Gillings School of Global Public Health
University of North Carolina at Chapel Hill

 

Wendy R. Sanhai, PhD, MBA
Specialist Leader
Deloitte Consulting
Associate Professor
Duke University

 

Christy L. Shaffer, PhD
General Partner, Hatteras Venture Partners
Managing Director, Hatteras Discovery

 

Ann Taylor, MD
Co-Chair, Forum on Drug Discovery, Development and Translation
National Academies of Science, Engineering, and Medicine

 

Jonathan Watanabe, PharmD, PhD
Jere E. Goyan Presidential Chair for the Advancement of Pharmacy
School of Pharmacy
University of California San Francisco

 

Alastair J.J. Wood, M.B., Ch.B, FRCP, FACP (Chair)
Professor of Medicine, Emeritus
Professor of Pharmacology, Emeritus
Vanderbilt University

 

Joseph Wu, MD, PhD
Director, Stanford Cardiovascular Institute
Simon Stertzer Professor of Medicine
Stanford University

 

Additional members may be added to the committee.

Award Timeline

Feb 07, 2025

Application Deadline

Jun 03 - 04, 2025

Finalist Interviews

Jul 31, 2025

Notice of Award

Sep 01, 2025

Award Start Date

Aug 31, 2030

Award End Date

Program Contacts

Tammy Collins, PhD

Program Officer

919-991-5120

Eliza Gary

Program Associate

919-991-5107

Lama Haidar

Program Coordinator

919-991-5115