Minutes June 4, 2025

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

PUBLIC HEALTH SERVICE

NATIONAL INSTITUTES OF HEALTH

NATIONAL ADVISORY COUNCIL FOR 

BIOMEDICAL IMAGING AND BIOENGINEERING

Summary of Meeting¹ 

June 4, 2025

The National Advisory Council for Biomedical Imaging and Bioengineering (NACBIB) was convened for its 68th meeting on June 4, 2025, virtually on Teams for the Open Session and Closed Session. Dr. Bruce Tromberg, Director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) presided as Council chairperson. In accordance with Public Law 92-463, the meeting was open to the public from 12:58 p.m. to 4:28 p.m. for review and discussion of program development, needs, and policy. The meeting was closed to the public from 4:47 p.m. to 5:11 p.m. for the consideration of grant applications.

Council members attending in Teams:

Dr. Tamara Baynham, Ingenuity Medical Device Research, LLC, Antioch, TN

Dr. Tejal Desai, Brown University, Providence, RI 

Dr. Wilbur Lam, Emory University School of Medicine, Atlanta, GA

Dr. Raphael Lee, The University of Chicago, Chicago, IL

Dr. Cynthia McCollough, Mayo Clinic, Rochester, MN

Dr. Tyrone Porter, University of Texas at Austin, Austin, TX

Dr. Christine Schmidt, University of Florida, Gainesville, FL

Dr. Daniel Sodickson, New York University Grossman School of Medicine, New York, NY

Dr. Joyce Wong, Boston University, Boston, MA

Ex officio member attending in Teams:

Dr. Nicholas Petrick, U.S. Food and Drug Administration, Silver Spring, MD

Dr. Sohi Rastegar, National Science Foundation, Arlington, VA

Ex officio members absent:

Dr. Jayanta Bhattacharya, National Institutes of Health

Dr. Vincent Ho, Uniformed Services University of the Health Sciences, Bethesda, MD

Robert F. Kennedy, Jr., Department of Health and Human Services, Washington, DC

Also Present:

NIBIB staff present for portions of the meeting:

¹ For the record, it is noted that members absent themselves from the meeting when the Council is discussing applications (a) from their respective institutions or (b) in which a conflict of interest may occur. This procedure only applies to applications that are discussed individually, not to “en bloc” actions.

King, Randy

Merchak, Todd

Mulvaney, Shawn

Nyankale, Mutema

Rampulla, David

Shabestari, Behrouz

Sims, Shaun

Singh, Gagandeep

Sukhareva, Manana

Tornai, Martin

Wang, Shumin

Non-NIBIB NIH staff attending in Teams:

Cozart, Jeffrey

Higgins, David

Chairperson:

Dr. Bruce Tromberg

Executive Secretary:

Dr. Anna Taylor

Approximately 203 observers attended the open session, including NIBIB staff and members of the general public.

Call to Order: Dr. Anna Taylor

Dr. Anna Taylor called to order the 68th meeting of the National Advisory Council for Biomedical Imaging and Bioengineering at 12:58 pm. She reminded attendees that the open session of the meeting was open to the public and welcomed attendees.

Dr. Bruce Tromberg reported on ongoing activities at the NIBIB and at the NIH since the Council last convened in September 2024, covering topics from staffing and personnel changes to grants policy. 

Dr. Tromberg described NIH leadership changes, including the departure of multiple Institute and Center directors as well a proposed reorganization of Institutes under a White House plan. This includes merging NIBIB into a larger National Institute of General Medical Sciences. Various administrative functions are expected to be consolidated, including science policy, communications, legislative affairs, information technology, and Acquisitions, among others.

Dr. Tromberg reported on the centralization of peer review under the Center for Scientific Review (CSR). Going forward, all grant applications will be routed through CSR, eliminating Institutespecific review offices. Dr. Tromberg raised a concern about the loss of institute-specific review given the uniqueness of some NIBIB programs and applications. Dr. Anna Taylor reported on several new and developing grants policies, including policies that impact: the issuance of Notices of Funding Opportunities (NOFOs), indirect cost rates (a proposed 15% cap was paused prior to implementation), and foreign subawards. Throughout the transition, program officers and staff have been adjusting to new administrative requirements and dynamic guidance and helping to translate these changes to the extramural community.

In addition to organization and policy updates, Dr. Tromberg reported on several program developments. He highlighted funding solicitations through the NIBIB-led Point-of-Care Technology Research Network (POCTRN), Design by Biomedical Undergraduate Teams (DEBUT) programs, and the NIH-led Autism Data Science Initiative (ADNI), and Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) projects. Several upcoming NIBIB-led or co-led meetings were featured, including the 6th NIH Synthetic Biology Consortium Meeting, the NCI Workshop on Microsystems Technologies, and the NHLBI-NIBIB vision setting workshop on Emerging Technologies for Coronary Artery Disease Imaging. Lastly, Dr. Tomberg highlighted some recent program outcomes in the RADx Maternal Health Challenge, in the Medical Imaging and Data Resource Center (MIDRC), and in the development of a new RADx funnel for the acceleration of technologies for HIV Viral Load for use in Point of Care settings.

Finally, Dr. Tromberg recognized the departure of two Council members, Dr. Tejal Desai, Dr. Raphael Lee, and ex-officio member, Dr. Anne Plant.

Council Discussion

The Council’s discussion emphasized maintaining community identity, continuing to promote success stories from across the NIBIB ecosystem, and preserving visibility and funding. Council members discussed strategies for communicating the value of the research enterprise, through storytelling, highlighting translational impact, and presenting economic growth metrics tied to public research investment. Council members raised concerns about low morale in the research community, trainee engagement, and the future of American biomedical innovation. There was a consensus that NIBIB must remain a leader in technology and translational innovation, and Council members pledged to continue championing the work of the NIH and the NIBIB.

Dr. Randy King presented a concept clearance to reissue the NIBIB Trailblazer R21 funding opportunity announcement (FOA), citing its strong performance since the program’s inception in 2017. The Trailblazer program supports new investigators proposing high-risk, high-reward projects, offering up to $400,000 over three years with only limited preliminary data (half a page with one figure) permitted. It stands apart from the parent R21 FOA by being more generous and selective, focusing on projects that depart substantially from current thinking. The Trailblazer was originally developed to address two issues: (1) a sharp rise in R21 applications that risked crowding NIBIB R01s, and (2) poor success rates for early-stage investigators (ESIs) under the standard R21. Data showed that ESIs submitted over 60% of R21s but received only 40% of awards. Trailblazer awards now make up a majority of NIBIB’s R21s for new investigators. Between 2015 and 2024, total R21 awards dropped from 85 to 63, while awards to new/ESIs rose from 16 to 40+. The portfolio now favors new investigators at a rate of over 60%—a reversal from pre-Trailblazer trends.

Each Trailblazer submission is screened by NIBIB staff to ensure compliance with the preliminary data restrictions. Applications are assigned to study sections based on topic. Reviewers are briefed on the Trailblazer’s goals to ensure alignment with the FOA. For the proposed reissue, at least four additional NIH ICs (NCI, NICHD, NCRR, and NCCIH) intend to participate in the Trailblazer program, broadening its reach and visibility across NIH. Council members expressed enthusiastic support. Members expressed the importance of promoting Trailblazer awards as prestigious and careerdefining for early investigators. Others shared that their colleges treat Trailblazers as equivalent to career awards. Suggestions were made to promote the award in NIH communications and among tenure and promotion committees. 

The Council supported reissuance of the Trailblazer FOA without substantive changes to structure or eligibility, with encouragement to expand IC participation and brand visibility.

Todd Merchak, Director of the Office of Program Evaluation and Strategic Partnerships at NIBIB, delivered an overview of the RADx initiative, highlighting its evolution into a sustainable technology acceleration platform. RADx was launched during the COVID-19 pandemic to rapidly scale diagnostic testing capacity. The program leveraged NIBIB’s existing POCTRN (Point-of-Care Technologies Research Network) infrastructure to create an "innovation funnel" model. Features of the program include risk assessment, milestone-driven funding, expert project management, validation support, and regulatory acceleration. Structurally, RADx consists of three key centers: Coordination Center which directs project review and evaluation, a Commercialization Center which provides regulatory, manufacturing, and business mentorship, and a Validation Center, which performs independent technical and clinical testing. 

Since the initial launch with COVID-19 diagnostic testing, RADx has evolved to support multiplex flu/COVID tests, as well as mpox, and hepatitis C diagnostics. In addition, the RADx innovation funnel and its Innovation Test Assessment Program have been used to support the Blueprint MedTech Accelerator, which supports early-stage neuroscience device development as well as RADx Challenges, which support prize competitions for maternal health, fetal monitoring, and endometriosis diagnostics. NIBIB is developing a new partnership with the NIH Office of AIDS Research to develop tests to determine HIV viral load. Council members praised RADx’s use of interagency partnerships, project accountability, and in-kind services. They encouraged its continued development as a scalable model for translational acceleration across disease areas.

The open session of the NACBIB meeting was adjourned at 4:28 p.m.

Review of Council Procedures and Regulations: Dr. Anna Taylor 

The grant application review portion of the meeting was closed to the public in accordance with provisions set forth in Section 552b(c)(4) and 552b(c)(6), Title 5, U.S., and section 1009(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. §§ 1001-1014). Members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. 

Members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications which there was a potential conflict of interest, real or apparent.

The National Advisory Council for Biomedical Imaging and Bioengineering considered 5035 research and training applications requesting $7,945,646,260 in total costs. The Council recommended 5035 applications with a total cost of $7,945,646,260.

Adjournment

The closed session was adjourned at 5:11 p.m.