Minutes May 15, 2024

DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH

NATIONAL ADVISORY COUNCIL FOR BIOMEDICAL IMAGING AND BIOENGINEERING
Summary of Meeting¹
May 15, 2024

The National Advisory Council for Biomedical Imaging and Bioengineering (NACBIB) was convened for its 65th meeting on May 15, 2024, in person at the John Edwards Porter Neuroscience Research Center, Building 35A, Bethesda, MD, and on Zoom 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 9:00 a.m. to 1:06 p.m. for review and discussion of program development, needs, and policy. The meeting was closed to the public from 2:07 p.m. to 2:48 p.m. for the consideration of grant applications.

Council members attending in person:

Dr. Gilda Barabino, Olin College, Needham, MA
Dr. Simon Cherry, University of California, Davis, Davis, CA
Dr. Cynthia McCollough, Mayo Clinic, Rochester, MN
Dr. Kathryn Nightingale, Duke University, Durham, NC
Dr. Daniel Sodickson, New York University Grossman School of Medicine, New York, NY
Dr. Joyce Wong, Boston University, Boston, MA

Council Members attending by Zoom:

Dr. Tejal Desai, Brown University, Providence, RI

NIBIB staff attending by Zoom:

Mr. Ryan Dava
Ms. Pamela Glikman Dr. Karen Olsen

Ex officio member attending:

Dr. Zane Arp (on behalf of Dr. Jeffrey Shuren), U.S. Food and Drug Administration, Silver Spring, MD
Dr. Vincent Ho, Uniformed Services University of the Health Sciences, Bethesda, MD
Dr. Anne Plant, National Institute of Standards and Technology, Gaithersburg, MD

Ex officio members absent:

Mr. Xavier Becerra, Department of Health and Human Services, Washington DC
Dr. Monica M. Bertagnolli, National Institutes of Health, Bethesda, MD
Dr. Sohi Rastegar, National Science Foundation, Arlington, VA
Dr. Jeffrey Shuren, U.S. Food and Drug Administration, Silver Spring, MD

NIH, non-NIBIB members attending:

Dr. Janine Clayton, M.D., NIH Office of Research on Women’s Health
Ms. Sylvia Barnett, NIH Office of Research on Women’s Health

Members of the Public attending:

Dr. Karthick Sankaranarayanan, Purdue University, West Lafayette, IN

Also present:

NIBIB staff present for portions of the meeting:

Chairperson:
Dr. Bruce J. Tromberg

Executive Secretary:
Dr. David T. George

Approximately 245 observers attended the open session, including NIBIB staff and members of the general public.

Call to Order: Dr. David George

Dr. David George called to order the 65th meeting of the National Advisory Council for Biomedical Imaging and Bioengineering. He reminded attendees that the morning session of the meeting was open to the public and welcomed attendees.

¹For 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.

Dr. Clayton began her talk by noting that innovation, technology, and high-return opportunities can advance women’s health and that there are many opportunities to address women’s health in biomedical research that align with NIBIB’s mission areas.

She said that NIBIB’s mission statement complements the NIH sex as a biological variable (SABV) policy, which went into effect in 2016, and recognizes that sex should be considered in research designs, analyses, and reporting of animal and human studies. Dr. Clayton noted that in the past, researchers have over-relied on male cells and male animal models in their work.

In addition, the lack of women enrolled in clinical research has led to medications approved by the U.S. Food and Drug Administration (FDA) that were less effective and more toxic in women than men, along with knowledge gaps about sex differences in disease prevalence, how women experience disease, and how they respond to treatment.

She explained that ORWH’s mission is to expand women's health research at NIH, include minorities in clinical research, and promote the advancement of women in science careers.

Dr. Clayton announced the release of the NIH-wide Strategic Plan for the Research on the Health of Women 2024-2028. The plan complements focus areas in NIBIB’s draft strategic plan: engineered biological systems; sensors and point-of-care diagnostics; biomedical imaging technologies; and data science, modeling, and simulation.

Dr. Clayton said that collaboration with other institutes and centers is key to executing and implementing the new NIH strategic plan for research on women’s health and will be achieved through a coordinating committee and partnerships.

Dr. Clayton highlighted opportunities to invest in women’s health: physical conditions such as endometriosis (a $200 million market in the U.S.), uterine fibroids, and menopause; digital apps that can address fertility and maternal and neonatal health; and menstrual products and gynecological devices. Addressing women’s health gaps could boost the global economy by at least $1 trillion by 2040, she said.

Dr. Clayton made the case for innovation in women’s health research and discussed the ORWH 2023 innovation opportunity map, which lays out 50 equitable, high-return opportunities to advance global innovation for women’s health. Her office plans to implement a cross-sector approach and engage global stakeholders; prioritize women and include their voices; and develop innovative ideas, research, and science to improve the health of women. When women's health improves, the health of communities and societies improves, which makes this a smart investment for everyone, she said.

Dr. Clayton referred to two landmark pieces of legislation that have advanced women and minorities in research:

• The 1993 NIH Revitalization Act that required researchers to include women in clinical research
• The 21st Century Cures Act that expanded inclusion to individuals of all ages, created a path to include pregnant and lactating women, and required NIH-defined applicable phase III clinical trials to report results disaggregated by sex/gender, race, and ethnicity into ClinicalTrials.gov

Last November, the White House announced an initiative on women's health research. In March, President Biden signed the Executive Order on Advancing Women’s Health Research and Innovation, which is jointly spearheaded by the Office of the First Lady and the White House Gender Policy Council. Dr. Clayton attended the March signing event with NIH Director Dr. Monica Bertagnolli. The President has requested $12 billion to fund this initiative in FY25.

Dr. Clayton noted that NIH will play a critical role in this cross-cutting work that involves HHS and other federal agencies, including the Office of Management and Budget, the U.S. Department of Agriculture, and the U.S. Department of Defense. The President’s order will: prioritize investments in women’s health research, integrate women’s health across the federal research portfolio, galvanize new research on women’s midlife health, and assess unmet needs to support women’s health research.

NIH has taken several actions that align with the executive order:

• Issuing the first Notice of Special Interest on Women’s Health Research (NOT-OD-24-079) that is linked to every NIH parent funding opportunity including Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding opportunities;
• Identifying and developing new common data elements related to women’s health that will help researchers share and combine datasets, promote interoperability, and improve the accuracy of datasets;
• The NIH’s competitive SBIR/STTR programs will increase their investments in research and development on women’s health by 50%;
• NIH is launching its first-ever Pathways to Prevention series on menopause and the management of menopause-related issues; and
• NIH will launch a new initiative led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to fund research on biomarker discovery and validation that can prevent, diagnose, and treat conditions that affect women uniquely.

Dr. Clayton mentioned other key NIH-funded research on sex and gender including:

• The National Institute of Environmental Health Sciences’ intramural program has used artificial intelligence (AI) and machine learning (ML) to effectively detect and diagnose polycystic ovarian syndrome (PCOS),
• The NIH-funded Genotype-Tissue-Expression (GTEx) program discovered sex differences in more than 13,000 genes linked to more than 50 bodily traits and functions, and
• Novel alternative methods that can facilitate drug discoveries and alternative animal models, including these biomedical technologies: gene editing, AI, and induced pluripotent stem cells.

Globally, the World Health Organization (WHO) recently adopted guidelines to promote sex and gender equity in research. Dr. Clayton noted that many journals and publishers have adopted the WHO guidelines. She noted that there is more work to do to attract and keep women in science careers given that men far outnumber women as principal investigators on supported research project grants (RPGs).

Dr. Clayton talked about a “braided river” as a metaphor for women’s career paths that would allow individuals to move in and out of roles and positions in which they consult, start businesses, and hold jobs across disciplines and sectors. This would give them greater flexibility to re-enter or re-integrate after caregiving responsibilities and have experiences in multiple sectors that could bring interdisciplinary solutions to science, said Dr. Clayton.

Discussion: Council congratulated Dr. Clayton on the phenomenal progress ORWH has made and asked how likely the President’s $12 billion request was to be implemented. Dr. Clayton responded that the request will go through the congressional appropriations process in FY25. In the interim, the President’s request has value as a roadmap that, in addition to the NIH strategic plan and other documents, highlights where increased investments could make a difference.

Council also asked about whether SABV and gender differences were being integrated into the review process at the NIH Center for Scientific Review (CSR), including in orientations for study section members. Dr. Clayton pointed to several resources designed to facilitate their implementation, including educational materials, reviewer guidelines, flowcharts, a SABV primer, and “train the trainer” videos for teaching graduate students. She has also been in conversations with CSR Director Dr. Noni Byrnes about further elevating the visibility of SABV as the simplified review framework goes into effect. In the meantime, Dr. Clayton said that ORWH will continue to elevate this issue through the peer review process, program oversight by reviewing progress reports, and publications.

Council asked whether there are elements of the ORWH agenda that touch on regenerative medicine. Dr. Clayton responded that sex differences in regenerative medicine exist, especially in transplantation, including cardiac transplantation, and that these issues need to be at the forefront of their agenda.

Council asked if Dr. Clayton could address sex differences for women related to race, ethnicity, and socioeconomic status, because some women from underserved health disparity populations are severely impacted by these differential factors that can lead to differential health outcomes. Dr. Clayton responded that ORWH’s Health of Women of Understudied, Underrepresented, and Underreported Populations Databook 2024 was just released and addresses health disparities across various populations of women. The data informs where the needs are and motivates questions for research. ORWH is partnering with ICOs on an administrative supplement that provides support for NIH researchers from a variety of disciplines who are committed to advancing health equity.

Council asked about how women’s health affects families and children beyond pre- and postnatal pregnancy and maternal health. Dr. Clayton responded that exposures during pregnancy and health before pregnancy have a profound impact on the health of the child through epigenetic and other effects. But regarding the social context, important causes of maternal mortality in the U.S. include violence, depression, suicide, and substance abuse, which indicate that not enough is being done to support pregnant people after delivery. She also noted that NICHD is the leading institute at NIH for supporting maternal health and child health research and is linking datasets from mother and children through electronic health records in collaboration with the Office of the National Coordinator.

Dr. Sukhareva gave a brief overview of the NIBIB Office of Scientific Review. She mentioned that all NIBIB reviews a wide variety of NIBIB and NIH programs. She introduced OSR staff members who organize and run these reviews. Dr. Sukhareva indicated that those interested in volunteering to be a reviewer can send a message of interest with a curriculum vitae to NIBIBreviewvolunteer@mail.nih.gov

Dr. Sukhareva said there were two main reasons for simplifying the review framework for RPGs:

• Peer review criteria that had grown too complex, which detracted attention away from the primary role of reviewers to evaluate scientific merit.
• Undue influence of reputation in the NIH peer-review process, which affects judgements of merit when well-known places and/or people are given the benefit of the doubt whereas others are treated with more scrutiny.

The three goals of simplifying the review framework are as follows: enable peer reviewers to better focus on answering the key questions necessary to assess scientific and technical merit; mitigate effects of reputational bias; and reduce reviewer burden.

The changes will apply to all submissions with due dates on or after January 25, 2025 and to these research activity codes: R01, R03, R15, R16, R21, R33, R34, R36, R61, RC1, RC2, RC4, RF1, RL1, RL2, U01, U34, U3R, UA5, UC1, UC2, UC4, UF1, UG3, UH2, UH3, UH5 (including the following phased awards: R21/R33, UH2/UH3, UG3/UH3, R61/R33).

Dr. Sukhareva presented the reorganization of the previous five core criteria into the following three criteria: Factor 1: Importance of the research as assessed by its significance and innovation (scored 1-9) Factor 2: Rigor and feasibility as assessed by their approach (including factors related to the inclusion of human subjects and study timeline for clinical trials) (scored 1-9), and Factor 3: Expertise and resources (not scored) apply to investigators and the environment. This factor will be evaluated as “appropriate” or “gaps identified”; gaps identified will require and explanation from the reviewer.

Reviewers will receive training and guidance materials in spring 2025 before the first review meetings in summer 2025 when they will be applying the simplified peer review framework. More resources can be found on the simplified peer review framework website.

Dr. Sukhareva then discussed the revisions to NIH fellowship applications and review criteria. The three goals are as follows:

1. Better focus reviewer attention on three key assessments: the fellowship candidate’s preparedness and potential, research training plan, and commitment to the candidate.
2. Ensure that a broad range of candidates and research training contexts can be recognized as meritorious by clarifying and simplifying the language in the application and review criteria.
3. Reduce bias in review by emphasizing the commitment to the candidate without undue consideration of sponsor and institutional reputation.

The revised fellowship application (instructions for applicants and application forms) will be shorter, more structured, and aligned with the new review criteria. Section authors will be defined and instructions for the updated reference letter will be explained.

The reorganized fellowship review criteria will help to better identify promising scientists and how the research project would be used a training vehicle for promising scientists.

These changes apply to all fellowship applications with due dates on or after January 25, 2025, and parent F applications with due dates on or after April 8, 2025.

Discussion: Council praised the effort to simplify the RPG review framework and asked how reviewers were being educated about these changes. Dr. Sukhareva said many training opportunities exist including webinars, training videos, and guidance for scientific review officers. Council asked whether there was a strategy to address when the reviewers’ discussion leads to dramatic changes to their scores and reviewers are asked to change their written comments. Dr. Sukhareva responded that reviewers are guided to communicate their reasons for giving low scores and provide justification.

A. NIBIB Council Updates

Dr. Tromberg began his presentation by recognizing three departing Council members: Kathryn Nightingale, Ph.D.; Simon Cherry, Ph.D.; and Gilda Barabino, Ph.D. Dr. Tromberg presented these Council members with a plaque and thanked them for their service. Dr. George noted that these three Council members have kindly agreed to continue to serve on this Council pending the appointment of the next members.

Dr. Tromberg askowledged Council member Tejal Desai, Ph.D., who was recently named to the National Academy of Engineering. Dr. Desai is honored for her distinguished contributions to engineering “for nanofabricated materials to control biologics delivery, and leadership in the fields of nanotechnology and regenerative medicine.”

B. NIBIB Staff Updates

Dr. Tromberg welcomed new NIBIB staff: Martin Tornai, Ph.D., a program officer in the Division of Applied Science & Technology; Tseday Girma, a team leader in the Office of Grants Management (OGM); Jenna Harrison-Peters, a grants management specialist in OGM; and Josh Elesinmogun, a grants management specialist in OGM.

C. Budget Updates

Dr. Tromberg gave a brief discussion of the budget. The FY24 appropriation for NIH, which was enacted in March, is $48.6B and is essentially the same as the FY23 final allocation ($48.3B, representing a 0.6% increase). The FY24 operating budget for NIBIB is $440.627M, which represents no change from FY23.

The payline for parent R01 announcements is 16% (21% for new investigators and 29% for early-stage investigators (ESIs)). Dr. Tromberg explained that these paylines were restructured to drive two major philosophical points: to sustain the number of competing R01 awards and to protect ESIs. To achieve these paylines, some administrative budget cuts were required. Deeper reductions were made to some competing awards: 24% for R01s to non-ESIs with non-modular budgets; 15% for U01 Bioengineering Partnership with Industry (BPI) awards; 10% for P41s (first year only); and 10% for parent R21 NOFOs. In addition, there is a small reduction (2%) for some non-competing R01s.

Dr. Tromberg finished his discussion of the budget by highlighting some NIH-wide appropriation updates. Programs that receive funding from the 21st Century Cures Act, such as the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative and All of Us, are experiencing large budget cuts. The Advanced Research Projects Agency for Health (ARPA-H) has the same budget as FY23. Other programs, such as the Helping to End Addicting Long Term (HEAL) Initiative, the Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE) Initiative, and those programs related to Alzheimer’s disease and related dementias, are seeing budget increases.

D. Funding Opportunities

White House Initiative on Women’s Health Research: Dr. Tromberg highlighted President Biden’s Executive Order, issued on March 18, 2024, which represents the most comprehensive set of directives ever taken to expand and improve research on women’s health. All NIH institutes, centers, and offices have signed on to the Notice of Special Interest: Women’s Health Research (NOT-OD-24-079), issued by the NIH Office of Research on Women’s Health (ORWH). Further, NIBIB participates in the following ORWH-led supplement opportunities:

- NOT-OD-23-170: Re-entry, reintegration, retraining
- NOT-OD-23-032: Research continuity first-time recipients of research project grants
- NOT-OD-23-031: Research continuity for K award recipients
- NOT-GM-22-005: Women’s health research in IDeA states

Drs. Zeynep Erim, Tina Gatlin, and Dave Gutekunst are the NIBIB contacts for these efforts.

RADx® Tech ACT ENDO Challenge: Dr. Tromberg next highlighted the Advancing Cures and Therapies and ending ENDOmetriosis diagnostic delays (ACT ENDO) Challenge (NOT-HD-24-016). This Challenge, led by NICHD, will utilize the Rapid Acceleration of Diagnostics Technology (RADx Tech) “innovation funnel” funding process. Dr. Tromberg noted that precision medicine is informed by diagnostics, and he is hopeful that this type of mechanism will quickly result in solutions in this high-priority area, potentially attracting interest, investment, and commercialization. He anticipates that the official announcement will occur sometime in August. Dr. Taylor Gilliland and Adrianna Aliquo are leading the NIBIB effort.

New approaches for measuring brain changes across longer timespans: Dr. Tromberg next discussed a new initiative that is intended to encourage technological and conceptual innovation to improve repeated measures across longer epochs of the lifespan to better predict outcomes at later ages. Two multi-institute funding opportunities (PAR-24-160 for R01s and PAR-24-161 for R21s) were published in which application are required to include at least two timepoints meaningfully separated in time. Dr. Guoying Liu is the contact for the NIBIB effort.

Supporting the exploration of cloud in NIH-supported research: Dr. Tromberg next focused on a notice (NOT-OD-24-078) that is soliciting competitive revision applications to explore and test potential opportunities for leveraging cloud solutions to enhance existing NIH activities. Available due dates for this notice are June 18, 2024-2026. Dr. Qi Duan is the contact for the NIBIB effort. Dr. Tromberg also mentioned that the NIH Cloud Lab is now open, with the goal of engaging both the intramural and extramural communities. At present, there is a $500 credit for creating an account. Dr. Tromberg added that this resource is an important way for the bioengineering community to come together and give feedback on success stories in the technology development space.

Promoting data reuse for health research: Dr. Tromberg mentioned another supplemental funding opportunity (NOT-OD-24-096) that is soliciting competitive revision applications that focus on data reuse and secondary data analysis in NIH-funded data repositories and knowledge bases to advance scientific inquiry and address health research questions. Available due dates for this funding opportunity in 2024 are July 3 and November 4, and in 2025-2026, March 4, July 3, and November 3. Awards are up to $275,000 direct for up to two years. Dr. Duan is the NIBIB contact for this effort.

Multimodal AI: Dr. Tromberg next highlighted a notice (NOT-24-015) announcing the Advancing Health Research Through Ethical, Multimodal AI Initiative. Expected outcomes of this initiative include new systems-level biomedical research with multimodal AI technology; elucidation of the unique opportunities, risks, and challenges for applying multimodal AI methods; and identification of considerations for the appropriate use of multimodal AI relative to other methodologies. The total program budget is $10M per year for an initial two years (up to 10 awards) with a due date of May 16, 2024. Dr. Tromberg noted that he has participated in several congressional briefings related to AI, noting that there is enormous interest in this topic. Drs. Mohd Anway, Brad Bower, Kris Kandarpa, Rui Pereira de Sá, and Qi Duan are leading the NIBIB effort.

Imaging phantoms administrative supplements: Dr. Tromberg spotlighted the NIBIB/National Institute of Standards and Technology (NIST) imaging phantom library and discussed an administrative supplement opportunity focused on the dissemination of imaging phantoms (NOT-EB-24-009). This effort, in collaboration with the National Eye Institute (NEI), supports the optimization, calibration, and dissemination of imaging phantoms that were developed under NIBIB or NEI grant awards. Benefits of dissemination of the phantoms to the research community include increasing the quality assurance and performance during the technical development of biomedical imaging technologies and the acceleration of innovation, standardization, data sharing, and regulatory clearance. The due date for this funding opportunity is August 1, 2024. Dr. Afrouz Anderson is leading the NIBIB effort.

BEITA at HBCUs: Dr. Tromberg concluded his discussion of funding opportunities by highlighting an NIBIB initiative focused on enhancing biomedical engineering, imaging, and technology acceleration (BEITA) at historically black colleges and universities (HBCUs). This funding opportunity (RFA-EB-23-006) uses a two-phase award (UG3/UH3 mechanism) with the goal to enhance bioengineering and imaging research capacity, technology innovation, education and research training, and opportunities for scientific growth at HBCUs. Dr. Tromberg noted that the first round of applications for this solicitation are currently in review, and upcoming application due dates are September 30 in 2024 and 2025. Dr. Albert Avila is leading the NIBIB effort.

E. Program Updates

MIDRC: Dr. Tromberg next discussed the recent Medical Imaging and Data Repository Center (MIDRC) workshop, a hybrid event held on April 26, 2024, that attracted 40+ in-person attendees and 180+ online participants. He noted that the series of talks at the workshop covered issues and challenges of AI and gave a broad overview of the topic.

Dr. Tromberg explained that MIDRC is part of the ARPA-H Data Fabric Toolbox (BDF). He highlighted the following 4-month deliverables that are on track for completion:

• Meta-index including MIDRC and the Imaging Data Commons in the MIDRC BDF Imaging Hub
• MIDRC diversity calculator for comparing datasets with U.S. Census and Centers for Disease Control and Prevention (CDC) COVID-19 data for population representation
• MIDRC bias awareness tool now includes oncology examples
• MIDRC medical text de-identification tool performs better or on-par with published algorithms
• Indexing schema and data protocol complete for federated learning for edge nodes

Dr. Tromberg concluded his discussion of MIDRC by noting that the U.S. FDA has included a version of MIDRC’s decision tree in their catalog of regulatory science tools. Many different FDA product codes are included (not just those related to COVID-19, which was the impetus for MIDRC’s development).

RADx® Tech: Dr. Tromberg then segued into an update about RADx Tech programs. He noted that there are eight different “RADx-ification” projects that are currently ongoing at NIH. He mentioned a new NIBIB partnership with the Office of AIDS Research (OAR) and the National Institute of Allergy and Infectious Diseases (NIAID) that is seeking to accelerate technologies for HIV viral load for use in point-of-care settings. The goal of this $10M program is to develop quantitative tests that can detect low amounts of viral particles (ideally less than 200 copies per milliliter of blood). Dr. Tromberg noted that people currently being treated for HIV that have a low viral load are considered not contagious. This program is leveraging the Point-of-Care Technology Research Network (POCTRN). In addition to monetary support, the RADx Tech program provides numerous in-kind resources for innovator teams, such as support for test development, manufacturing, and regulatory and commercialization activities. The solicitation for this new “RADx funnel” launched today, May 15, 2024, with responses due by Friday, June 14, 2024. Dr. Shawn Mulvaney is leading the NIBIB effort.

In terms of COVID-19 diagnostics, Dr. Tromberg noted that 100% of the multiplex tests (tests that can detect both COVID-19 and flu A/B) cleared by the FDA for the 2023-2024 season that are currently available on the market received support from the RADx Independent Test Assessment Program (ITAP). The tests, which include both over-the-counter and point-of-care diagnostics, have a current capacity of around 46 million tests per week, with a few more tests in the pipeline.

Dr. Tromberg wrapped up his discussion of RADx impact by discussing the recently concluded Home Test to Treat program. This initiative exceeded its goals in terms of enrollees, telehealth visits, and antiviral prescriptions. Dr. Tromberg highlighted a Forbes news story that expressed concern that the program was ending. Dr. Andrew Weitz, who is the leading the NIBIB effort of this program, noted that Home Test to Treat was always intended to be a pilot program due to limited funding. Further, a major goal of the program was to answer research questions. He said that there is a need for these types of programs and that NIBIB is currently in discussions with CDC about their feasibility. He also noted that findings from the program should be published in the next few months.

F. Training and Dissemination Updates

FY24 NRSA pay level increases: Dr. Tromberg highlighted the recent National Research Service Awards (NRSA) pay level increases (NOT-OD-24-104), which apply to more than 17,000 research trainees. These increases represent the largest year-over-year update since 2017. Predoctoral and postdoctoral scholars will receive a 4% and 8% pay increase, respectively, with postdoctoral salary increasing further based on years of experience. These pay level increases were informed by recommendations from the NIH’s Advisory Committee to the Director (ACD). NIH plans to further increase stipend funding levels over the next three to five years to reach the ACD’s recommended starting pay level of $70,000 annually for postdoctoral NRSAs. There are roughly 17,000 NRSA scholars across NIH, with approximately 180 NRSA scholars at NIBIB. Dr. Tromberg said to contact Drs. Erim, Gatlin, and Gutekunst to understand how these pay level increases will impact investigators.

Extension of ESTEEMED and team-based design programs: Dr. Tromberg noted the extension of two training programs. The first program is Enhancing Science, Technology, EnginEering, and Math Educational Diversity (ESTEEMED; NOT-EB-24-007). The next due date is January 17, 2025, plus extension to January 16, 2026. Dr. Gatlin is the NIBIB contact for this effort. The second program is Team-Based Design in Biomedical Engineering Education (NOT-EB-24-008). The next due date is May 30, 2024, plus extension to January 29, 2025. Dr. Gutekunst is the NIBIB contact for this effort.

DEBUT: Dr. Tromberg highlighted the Design by Biomedical Undergraduate Teams (DEBUT) Challenge, which solicits undergraduate teams to develop technology solutions to unmet health needs. The total prize purse for 2024 is $160,000 for 16 winning teams, with many NIH institutes supporting prizes. The submission deadline is May 31, 2024; winners will be announced on August 26, 2024, and the award ceremony will take place on October 25, 2024, at the Biomedical Engineering Society (BMES) annual meeting in Baltimore. Detailed guidelines and submission forms can be found on the VentureWell website. Dr. Gutekunst is leading the NIBIB effort.

Dr. Tromberg spotlighted a 2022 DEBUT Challenge winner, Ali Bisaccia, who developed technology to stabilize skull neurosurgery and later launched a company. Bisaccia participated in the Concept to Clinic: Commercializing Innovation (C3i) program. Now a graduate student at Northeastern, Bisaccia is still working to advance, develop, and commercialize this technology.

NIBIB scholars scientific conference travel award: Dr. Tromberg next discussed a new conference travel award program. The mission of this program is to support the participation of individuals with a demonstrated interest in and/or conducting NIBIB-related research to attend scientific conferences and to meet with NIBIB staff to discuss research career and funding opportunities. Travel award recipients will be reimbursed up to $1,500, with approximately 20-40 awards per year. Individuals from underrepresented groups are highly encouraged to apply. Dr. Tromberg highlighted four major upcoming conferences and their associated application deadlines:

• BMES: October 23-26, 2024; application deadline: July 1, 2024 
• SPIE Photonics West: January 25-30, 2025; application deadline: October 1, 2024
• SPIE Medical Imaging: February 16-20, 2025; application deadline: October 1, 2024 
• Society for Biomaterials (SFB): April 9-12, 2025; application deadline: January 5, 2025

Dr. Tromberg noted that the travel awards are not limited to these conferences, but that these specific meetings are frequently attended by NIBIB program staff. Dr. Avila is the NIBIB contact for this effort.

BESIP: Dr. Tromberg next mentioned the biomedical engineering summer internship program (BESIP), which is now housed in the Biomedical Engineering Technology Acceleration (BETA) Center. More than 200 applications have been received, with 24 interns selected (up from 16 last year). All undergraduate students in BME or other STEM majors are eligible to apply. This year’s program will start on June 3, 2024. Dr. Manu Platt is leading the NIBIB effort.

New NSF-NIBIB/BETA INTERN partnership: Dr. Tromberg next focused on a supplemental funding opportunity that provides graduate students supported by the National Science Foundation (NSF) with experiential learning opportunities at NIH (NSF 24-083). This partnership will fund approximately 8-10 internships in FY24/FY25, providing up to $55,000 per student for a six-month period. Dr. Platt, who is the NIBIB contact for this effort, noted that the intramural research program (IRP) is seeking graduate students with a broad range of expertise, from image analysis to materials synthesis to mathematical modeling.

“Building Bridges” event before BMES conference: Dr. Tromberg then pivoted to discuss a satellite workshop to be hosted by the NIBIB BETA Center on the NIH campus that will take place on October 22, 2024, the day before the BMES annual meeting. The goals of the event include introducing intramural investigators to extramural investigators, facilitating collaborative research connections, and promoting understanding of NIH/federal research resources to extramural investigators. Dr. Platt is leading the NIBIB effort.

Inaugural Bridge2AI open house: Dr. Tromberg next highlighted the first ever Bridge2AI open house, which was held on April 18-19, 2024, and had over 100 attendees. Dr. Grace Peng, who is leading the NIBIB effort, encouraged Council to view recordings from the meeting, which discuss ethical considerations of AI/ML and the release of data. She also mentioned that Bridge2AI has four grand challenges that were selected to address a myriad of issues that are ethical, people-centered, and data-centered.

P41 webinar series: Dr. Tromberg then discussed a recent NIBIB National Technology Centers Webinar Series focused on the work of magnetic resonance imaging (MRI) centers. The first webinar took place on February 28, 2024, and the second took place on April 2, 2024. Combined, there were 390 attendees from 25 states and three countries, representing 62 participants from academia and 12 from industry. Dr. Tromberg noted that the public awareness generated from these webinars can hopefully help bridge the gap between ongoing research and current clinical practice. Dr. Behrouz Shabestari is the NIBIB contact for this effort.

2024 NIH Synthetic Biology Consortium meeting: Dr. Tromberg then mentioned the upcoming NIH Synthetic Biology Consortium Meeting, scheduled for November 20-22, 2024. The theme of this year’s meeting will be “connecting clinical users and synthetic biology tool makers” with the goal of identifying clinical needs and research gaps. The meeting, which is hosted by the NIH Synthetic Biology Consortium, will also include a synthetic biology tool showcase. Current NIH interest areas in synthetic biology can be found here. Drs. Jermont Chen, Tuba Fehr, and Nichole Daringer are leading the NIBIB effort.

Academy for Radiology and Biomedical Imaging Research event: Dr. Tromberg next highlighted the recent Academy for Radiology and Biomedical Imaging Research meeting, organized around honoring Representative Anna Eshoo, who received their 2024 Gold Medal. Dr. Tromberg mentioned that Rep. Eshoo was one of the key members of Congress who wrote legislation that ultimately led to the creation of NIBIB. Dr. Tromberg spoke at the showcase portion of the event, and NIBIB staff participated in the industry roundtable.

Science educational materials available: Dr. Tromberg then talked about recently available science educational materials spearheaded by the NIBIB Office of Science Policy and Communications (OSPC). First, he mentioned that lessons plans from the Biomedical Engineering Adapted for Middle Schoolers (BEAMS) Challenge are now available. He also highlighted online interactive quizzes and educational content about medical imaging, which include material from NIBIB’s most popular videos.

Science highlights: Dr. Tromberg concluded his Council presentation by mentioning some science highlights developed by NIBIB OSPC:

• - A window into placental development during pregnancy 
  • Photoacoustic imaging technology was used to visualize the mouse placenta and was featured on the cover of Science Advances
• - A golden solution quickly eliminates bacterial infections, no antibiotics required
  • NIBIB story had more than 167,000 page views and was covered by Newsweek and Nanomagazine
• - eC3i program celebrates its 10th anniversary
  • Innovative program has been helping entrepreneurs commercialize biotechnology

G. Discussion

Council discussed collecting longitudinal datasets that cover multiple repeated imaging sessions and potential initiatives to encourage not only data gathering, but also data sharing. Dr. Liu noted that an existing nonprofit organization could aid in some of these challenges and that new tools will need to be developed. It was also mentioned that partnerships—both within NIH, but also with other organizations, like hospitals and medical systems—may be important to realize the full potential of data gathering and sharing. Council noted that Dr. Tromberg made a key omission in his presentation: his own election into the National Academy of Engineering, along with Council member Dr. Desai. Dr. Tromberg thanked Council for the recognition. Council mentioned funding cuts and how this can affect postdoctoral students, which investigators are struggling to recruit. Dr. Tromberg said that he is hoping to highlight K and F awards during the upcoming September council meeting and identify trends in the data. He also encouraged Council to share experiences with postdoc recruiting and challenges and that this topic will be discussed in greater detail in September.

The open session of the NACBIB meeting was adjourned at 1:06 p.m.

Review of Council Procedures and Regulations: Dr. David T. George

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 in which there was a potential conflict of interest, real or apparent.

The National Advisory Council for Biomedical Imaging and Bioengineering considered 1520 research and training applications requesting $811,201,603 in total costs. The Council recommended 1520 applications with a total cost of $811,201,603.

The closed session was adjourned at 2:48 p.m.

Certification:

We certify that, to the best of our knowledge, the foregoing minutes are accurate and complete.²

David T. George, Ph.D.
Executive Secretary
National Advisory Council for Biomedical Imaging and Bioengineering Associate Director for Research Administration
National Institute of Biomedical Imaging and Bioengineering

Bruce Tromberg, Ph.D.
Chairperson, National Advisory Council for Biomedical Imaging and Bioengineering
Director, National Institute of Biomedical Imaging and Bioengineering