Innovation in Regulatory Science Awards Grant

The Burroughs Wellcome Fund's Innovation in Regulatory Science Awards offers up to $500,000 over five years to support academic researchers in developing innovative methodologies in regulatory science. This funding aims to enhance regulatory decision-making by the FDA and promote equitable clinical outcomes. Applications are encouraged from those working to expedite the realization of these outcomes. For more information, refer to the FAQs on the Burroughs Wellcome Fund's website.

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.
Please see FAQs for additional guidelines.

Application Details

(IRSA)
Request for Proposals:

• February 7, 2025 by 3:00 pm (ET)
• 1 INNOVATION IN REGULATORY SCIENCE AWARDS (IRSA)

PROGRAM BACKGROUND
The Burroughs Wellcome Fund (BWF) recognizes Regulatory assess the safety, efficacy, quality, and performance of FDA-
Science as an important yet underfunded area of research. regulated products.”2 Regulatory science has become a
With this initiative, BWF aims to provide research support to centerpiece of the Food and Drug Administration’s (FDA)
stimulate innovation and promote equity in this area. strategy for fostering innovation, and the academic and
of evolving science and technology, and requires that
areas of the FDA’s strategic priorities including but not limited
the science of regulation keep up with the advances in
to: regenerative medicine (including gene therapy), artificial
biomedical science and technology. For example, existing
intelligence and machine learning, digital health, reduction
reports1 have documented the importance of this area
clinical outcomes.
of research to the future of the biomedical enterprise,
it remains inadequately supported. For more information about the FDA’s strategic priorities,
Additionally, individuals from racial, ethnic minority, and
regulatory-science/focus-areas-regulatory-science-report.
geographically underserved regions and other diverse
groups have been historically underrepresented in clinical BWF’s Innovation in Regulatory Science Awards provides
research. As people respond to therapeutics and devices $500,000 over five years to academic researchers
differently based on factors such as genetic ancestry, developing new methodologies or innovative approaches
skin tone differences, etc., a lack of equal representation in regulatory science that will ultimately inform the regulatory
in clinical research contributes to ongoing disparities in decisions FDA and others make. This would necessarily
health outcomes, thus limiting access to safe and effective draw upon the talents of individuals trained in mathematics,
treatments. computer science, applied physics, medicine, engineering,
Regulatory science has been defined as “the science
pharmacology to name a few.
of developing new tools, standards, and approaches to

1. FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology, FDA Science Board, 2007; Innovation or Stagnation:

• Challenge and Opportunity on the Critical Path to New Medical Products, Food and Drug Administration 2004; Building a National Framework for the
• Establishment of Regulatory Science for Drug Development, Institute of Medicine Workshop Report; Advancing Regulatory Science at the FDA, 2011.

1. FDA, 2010. NIH and FDA Announce Collaborative Initiative to Fast-track Innovations to the Public.

have been historically underrepresented in the research
assistant, associate, or full professor level.
enterprise, including but not limited to: women of any
ethnic or racial group; any person identifying as Black or n Citizens and non-citizen permanent and temporary
African American, Latino/a or Hispanic American, Native residents of the U.S. and Canada who are legally
American, Alaska Native, Native Hawaiian, indigenous qualified to work in the U.S. or Canada are eligible.
to the Pacific Islands; persons with disabilities; persons Candidates who are temporary U.S. residents must
from disadvantaged backgrounds (see https://grants.nih. hold a valid U.S. visa (J-1, H1B, F-1 or O-1 visas).
gov/grants/guide/notice-files/NOT-OD-20-031.html for Temporary Canadian residents must hold a valid
examples); and individuals who identify as LGBTQIA+. Canadian visa (Study Permit, C-43, C44, C-10, or
C-20 work permits/visas). If a grant is awarded and
The FAQs may also provide eligibility clarification.
by their visa status. Your institution must verify your
institution where the work will be performed.
immigration status as part of your application.
n Candidates must hold an M.D., Ph.D., D.V.M., D.D.S.,
D.O., D.Phil., Pharm.D., or M.D.-Ph.D. degree. n Postdocs are not eligible.
n Candidates must be based at public or private non- n Candidates who currently hold a BWF award are
not eligible.
academic institutions, research institutes, and teaching
award cycle.
hospitals affiliated with academic degree-granting
institutions. A 501(c)(3) organization is an American n Applications must be submitted by the principal or
tax exempt, nonprofit organization. Candidates should primary investigator (PI). The PI may have up to a total
check with their institutional officials to confirm the of two co-investigators. Co-investigators need not be
institution’s classification. at the same institution; however, one person must be
n Candidates must hold a faculty position, tenure-track
all eligibility requirements.
or non-tenure track, or adjunct faculty position at a
non-profit institution in the United States or Canada; n Candidates must agree to the Terms of Grant.
grants are made to the institutions on behalf of the
award recipients.

IMPORTANT NOTES
Grants can only be made to non-profit institutions [501(c) Indirect costs may not be charged against BWF grants.
Candidates with questions about their eligibility must
award recipient.
contact BWF in advance of the proposal deadline. BWF
Primary investigators are required to devote no less than will make no exceptions to its policies.
50% of their time to research-related activities.
SELECTION PROCESS
The Regulatory Advisory Committee will review all Innovative & Impactful:

• proposals, select finalists to invite for an interview, and
• n Describes a creative and original approach
• make recommendations for awards to the BWF Board
• of Directors. n Has a high likelihood of benefitting society and
• achieving specific societal outcomes, especially those
• Competitive applications will clearly define realistic, that advance equity in clinical outcomes
• actionable and measurable approaches to advance
• Investigator Leadership and Impact:
• regulatory science research. Proposals will be evaluated
• based on the following categories: n Has depth of regulatory science experience
• n Demonstrates a strong publication history
• Significant & Equitable:
• n Demonstrates respectability within their field by
• n Addresses an important regulatory problem or critical
• providing positive reference letters and personal
• barrier to product development
• statements
• n Advances approaches that promote equity in clinical
• n Has a history of cultivating collaborative and collegial
• outcomes
• relationships
• n Utilizes minority health and health disparities research
• n Provides an impactful and unique voice to the
• best practices
• IRSA community based on characteristics such as
• Implementable: institution, personal experiences, gender, race/ethnicity
• n Presents a clear, timely and implementable strategy or Selected finalists will have the opportunity to present their
• solution to a regulatory problem research during interviews with the advisory committee.
• n Presents a research strategy that is well-reasoned,
• All eligibility requirements must be met.
• organized and appropriate
• Candidates not selected may reapply in the next award
• n Provides evidence of collaboration with regulatory
• cycle, provided they still meet the eligibility requirements.
• officials and/or minority/community-based
• BWF does not provide critiques of unfunded proposals.
• organizations or others to ensure approach is feasible
• and equitable
• n Addresses whether the approach has demographic
• limitations and describes actions to define and/or
• address these limitations
• 5 INNOVATION IN REGULATORY SCIENCE AWARDS (IRSA)

Application Process 3. Bibliography (optional)
Start early—applications must be submitted by the deadline; 4. Organizational Assurances (optional, one-page limit)
no exceptions will be made.

1. Submitted Reprints (three required)
2. Proposals. Interested candidates who meet the

eligibility criteria may submit one online proposal through
ProposalCentral by February 7, 2025 (3:00 pm ET). D. Institutional Signing Official Signature Required (prior to
In brief, the application includes applicant information deadline)
(to be completed within the grant portal), proposal
All communications, including the invitation to interview and
elements (with components to be completed within
declinations, will be made through email.
the grant portal or uploaded as a PDF), plus the letters
of recommendation to be uploaded confidentially by BWF does not provide critiques or written comments of
recommender. unfunded proposals.

1. Interviews. A selected group of finalists will be invited

to interview. Finalists must be available to interview
virtually on June 3-4, 2025 at the Burroughs Wellcome All proposals must be submitted through ProposalCentral,
Fund in Research Triangle Park, North Carolina. Notification a common application system shared by multiple funders.
New users will be required to set-up a profile on
ProposalCentral. Existing users may log-in with their existing
A. To be completed online:

• account.

1. Lay abstract (limit of 3000 characters, including

spaces) Detailed instructions on how to submit a proposal and
the proposal elements are available on the BWF website.

1. Scientific abstract (limit of 3000 characters,

including spaces) Two confidential letters of recommendation are required
for the application. Note that it is the responsibility of

1. Budget

the applicant to ensure that the confidential letters are

1. Personal Statement from primary applicant (limit of

not be considered complete without these confidential

1. Implementation Plan (limit of 4500 characters, recommendation letters. Letters must be requested through

including spaces) the application system and the recommender can upload
the letters to the application confidentially.

1. Facilities and Resources (limit of 5500 characters,

including spaces) Applications are not required to be completed in one sitting.
B. To upload to the application as a PDF:

1. NIH Biosketch (for primary applicant and each

co-investigator)

1. Research Plan (6-page limit, not including

6 INNOVATION IN REGULATORY SCIENCE AWARDS (IRSA)

Submission Process Questions?
Detailed instructions on the submission process are available Please review our online Frequently Asked Questions first.
in the “IRSA Application Guide for ProposalCentral” on the Eligibility inquiries should be directed in advance to BWF
BWF website. program staff by contacting: irsa@bwfund.org
Note:

• Proposals will not be accepted after February 7, 2025. The
• online application system shuts down automatically at the
• deadline and the SUBMIT button will no longer process a
• submission. Plan to submit your application well in advance
• of the grant deadline to allow adequate time to troubleshoot
• any issues. NO EXCEPTIONS OR EXTENSIONS WILL
• BE GRANTED.
• After the deadline, applicants with incomplete proposals
• and those not adhering to instructions will be disqualified
• without prior notice.
• Only proposals submitted through ProposalCentral will be
• accepted.
• It is the responsibility of the applicant to ensure that the
• confidential recommendation letters have been uploaded
• to their application and submitted by the deadline. Late
• submissions will not be accepted.
• 7 INNOVATION IN REGULATORY SCIENCE AWARDS (IRSA)

TERMS OF THE GRANT/USE OF GRANT FUNDS
Indirect costs may not be charged against the grants. During the award period, unused research funds may be
up to $500,000 over five years to academic investigators
(whichever is less) held by institutions when grants expire or
recipients may receive a no-cost extension of up to 24
promoting equitable outcomes.
months; requests explaining why an extension is needed
Grants are made to institutions on behalf of the named must be submitted in writing at least four months prior to
award recipients. The institutions must qualify as 501(c) the end of the award.
(3) or equivalent and the institution’s most current U.S. Tax
for disbursing the funds and for maintaining adequate
writing at least three months prior to the transfer date.
supporting records and receipts of expenditures.
other publications should be sent to BWF along with the
BWF and its program advisory committee.
annual progress report.
Award recipients may obtain funds from other sources for
BWF will not retain any rights to published results, intellectual
under these grants, so long as there is no conflict with
recipients should follow their institutions’ patent, copyright,
meeting the terms of BWF’s award. Award recipients may
and intellectual property policies regarding discoveries that
not hold concurrent BWF awards.
result from research conducted under these awards.
Award recipients are allowed up to $30,000 per year to
Award recipients are expected to adhere to all federal, state,
and local regulations regarding the participation of human
fringe benefits, and $20,000 for any co-investigator’s salary,
including fringe benefits. The remainder of the grant is to
materials, and recombinant DNA in their research projects.
proposed research. BWF does not set or cap the salary
guidelines with regard to scientific misconduct are in place
of the award to be used to cover salary. An institution may
recipients are affiliated.
supplement the grantee’s salary to a level consistent with its
salary scale. There is no limit on use of the award for salary Award recipients should share scientific findings in a timely
support for other laboratory or clinical personnel working manner via the standard means of scientific communication,
with the grantee. Student tuition and fees are not allowed. including publications and/or presentations in scientific
The support allocated for research is under the control of
awardees publish in open access journals.
the award recipient and may be used flexibly for such items
as equipment, consumable supplies, travel to scientific Grants will provide up to $500,000 over a five-year period
meetings, and laboratory personnel working with the award.
an award year, purchases of equipment exceed $20,000
or travel costs exceed $8,000.