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 16, 2023

The National Advisory Council for Biomedical Imaging and Bioengineering (NACBIB) was convened for its 62nd meeting on May 16, 2023, both in-person and online by Zoom for the Open Session and Closed Session. Dr. Bruce J. 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 1:17 p.m. for review and discussion of program development, needs, and policy. The meeting was closed to the public from 2:40 p.m. to 3:14 p.m. for the consideration of grant applications.

Council members present:

Dr. Samuel Achilefu, University of Texas Southwestern, Dallas, TX

Dr. Gilda Barabino, Olin College, Needham, MA

Dr. Jennifer Barton, University of Arizona, Tucson, AZ

Dr. Simon Cherry, University of California, Davis, Davis, CA

Dr. Tejal Desai, Brown University, San Francisco, Providence, RI

Dr. Ranu Jung, University of Arkansas, Fayetteville, AK

Dr. Cynthia McCollough, Mayo Clinic, Rochester, MN

Dr. Kathryn Nightingale, Duke University, Durham, NC

Dr. Daniel Sodickson, New York University, New York, NY

Dr. Joyce Wong, Boston University, Boston, MA

Council member attending by Zoom:

Dr. Amy Herr, University of California, Berkeley, Berkeley, CA

Ex officio member attending:

Dr. Zane Arp (on behalf of Dr. Jeffrey Shuren), U.S. Food and Drug Administration, Silver Spring, MD

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

Ex officio member attending by Zoom:

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

Ex officio members absent:

Mr. Xavier Becerra, Department of Health and Human Services, Washington, DC

Dr. Lawrence Tabak, National Institutes of Health, Bethesda, MD

Dr. Jeffrey Shuren, U.S. Food and Drug Administration, Silver Spring, MD

Dr. Anne Plant, National Institute of Standards and Technology, Gaithersburg, MD

Chairperson:

Dr. Bruce J. Tromberg

Executive Secretary:

Dr. David T. George

Also Present:

NIBIB staff present for portions of the meeting:

Members of the public present for portions of the meeting:

Dr. John Holden, Bethesda, MD

Dr. Rishi Mathura, Food and Drug Administration, Silver Spring, MD

137 observers attended the open-session via live videocast, including NIBIB staff and members of the public.

Call to Order: Dr. David T. George

Dr. David T. George called to order the 62nd 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.

1. NIBIB Staff and Council Member Updates

   Dr. Tromberg welcomed new NIBIB staff: Tuba Fehr, Ph.D., a program director in the Division of Discovery Science and Technology; Feben Zenebe, a program analyst in the Division of Health Informatics Technologies; Jonathan Griffin, a public affairs specialist in the Office of Science Policy and Communications; Yasmine Rahmann, an assistant to the executive officer in the Office of the Director; Whitney Watkins, an executive assistant in the Office of the Director; and Yoon-Young Jang, M.D., Ph.D., a scientific review officer in the Office of Scientific Review.

   Next, Dr. Tromberg announced that, following a national search, David George, Ph.D., has been selected as the NIBIB Associate Director for the Extramural Science Program. Kathy Salaita, Sc.D., will become the acting NIBIB Associate Director for Research Administration, filling Dr. George’s previous position and serving as the Executive Secretary to the National Advisory Council.

   In other NIBIB staff updates, Dr. Tromberg announced that Ann Gawalt, J.D., has been selected as the acting NIBIB Executive Officer. Ms. Gawalt was previously the Director of Office Acquisitions at the National Heart, Lung, and Blood Institute (NHLBI), where she worked with NIBIB to award many complex contracts for the RADx® (for Rapid Acceleration of Diagnostics) Tech and the Medical Imaging and Data Resource Center (MIDRC) programs.

   Finally, Dr. Tromberg acknowledged four departing Council members: Ranu Jung, Ph.D.; Jennifer Barton, Ph.D.; Amy Herr, Ph.D.; and Sam Achilefu, Ph.D.

2. Budget

   Dr. Tromberg discussed the budget. He noted that the overall appropriation for NIH in FY23 was $47.5B, representing a modest increase from FY22. The appropriation for NIBIB in FY23 was $441M, with $1.7B in supplemental funding for COVID-19 initiatives from FY20-FY22.

   Next, Dr. Tromberg gave an overview of FY22 base appropriation spending, which was $425M. NIBIB received 1,654 competing applications from which 387 awards were made. The NIBIB portfolio also includes 710 non-competing awards, giving an overall total of 1,097 awards managed by NIBIB. These awards included 221 institutions, 2,194 PIs, and supported 6,500 researchers and trainees. The R01 payline was 18% (23% for New Investigators).

3. Funding Opportunities

   Alzheimer’s-focused administrative supplements: Dr. Tromberg spoke of a funding opportunity (NOT-AG- 23-015) that allows NIBIB-funded researchers to apply for a one-year, Alzheimer’s disease-related supplement for NIH grants that are not already focused on Alzheimer’s disease. The due date for this opportunity is October 2, 2023. Dr. Randy King is the NIBIB contact for this effort.

   Bold goals for U.S. biotechnology and biomanufacturing: In response to an executive order on bioeconomy and biomanufacturing, a report led by the White House Office of Science Technology Policy (OSTP) was published in March 2023. Contributing agencies include the Department of Energy, the Department of Agriculture, the Department of Commerce, the Department of Health and Human Services (HHS), and the National Science Foundation. Dr. Tromberg noted that NIBIB staff Drs. David Rampulla and Luisa Russell are key leads and that HHS themes include accessible health monitoring, precision multi-omic medicine, biomanufacturing of cell-based therapies, artificial intelligence (AI)-driven bioproduction of therapeutics, and advanced techniques in gene editing. Dr. Tromberg encouraged Council members to look at the White House OSTP materials.

   NIH synthetic biology for biomedical applications: Dr. Tromberg next spoke of the renewal of NOT-EB-23- 002, a Notice of Special Interest (NOSI) for synthetic biology for biomedical applications. Eight NIH institutes are signed on to this NOSI, and while the first submission due date is today (May 16, 2023), Dr. Tromberg noted that many future due dates are available. Drs. Jermont Chen and Tuba Fehr are the NIBIB contacts for this effort.

   Biomaterials network: Dr. Tromberg reminded Council members of the biomaterials network (RFA-EB-23- 002), which was recently presented by Dr. Russell. The due date for applications for the establishment of a technology development coordinating center is May 31, 2023. The goal of these coordinating centers is to accelerate innovation, development, and dissemination of biomaterials-based technologies and to create connected resources to overcome barriers to clinical translation. Dr. Russell is the NIBIB contact for this effort.

   National Centers for Biomedical Imaging and Bioengineering (P41 Centers): Dr. Tromberg indicated that the P41 program announcement will be reissued as was indicated in a recent Notice of Intent to Publish (NOT- EB-23-007), with the first application due date is September 25, 2023. Dr. Behrouz Shabestari is the NIBIB contact for this effort.

   New NIH diversity funding opportunities: Dr. Tromberg spoke of four funding opportunities related to diversity.

   • Research With Activities Related to Diversity (ReWARD), PAR-23-122: This R01 award supports investigators who are making impactful contributions to diversity, equity, inclusion, and accessibility (DEIA) efforts but who are not currently a primary investigator on an NIH report project plan. The first application due date for this opportunity is June 5, 2023, and the NIBIB contact is Dr. Albert Avila.
   • Instrumentation Grant Program for Resource-limited Institutions, PAR-23-138: This S10 award provides resources to purchase scientific equipment for institutions with limited NIH project grant funding. The first application due date for this opportunity is July 3, 2023, and the NIBIB contact is Dr. Avila.
   • Science Education Partnership Awards (SEPA), PAR-23-137: This award supports STEM education projects for pre-K to grade 12 via partnerships with researchers, teachers, schools, and other educational organizations. The first application receipt date for this opportunity is July 14, 2023, and the NIBIB contact is Dr. Tina Gatlin.
   • NIH Institutional Excellence in DEIA Prize Competition: This opportunity rewards institutions that have designed, implemented, and evaluated interventions to address and improve DEIA within their faculty, postdoctoral scholars, and student bodies. The entry period for this competition ends on September 26, 2023, and the NIBIB contact is Dr. Avila.

   Training funding opportunities: Dr. Tromberg spoke of three training opportunities.

   • DEBUT Challenge: Dr. Tromberg mentioned that the deadline for submissions for the Design by Biomedical Undergraduate Teams (DEBUT) Challenge is May 31, 2023. He noted that he would like to see applications for this challenge continue to increase and encouraged Council members to contribute ideas to make the application process as easy as possible. Dr. Dave Gutekunst, who is the NIBIB contact for this effort, recently held a webinar about the challenge, which is posted on NIBIB’s website.
   • ESTEEMED (PAR-23-114): The Enhancing Science, Technology, EnginEering, and Math Educational Diversity (ESTEEMED) program supports the development of undergraduate freshmen and sophomores from diverse backgrounds to pursue further studies and careers in bioengineering or STEM fields. For this round of awards, there is a new emphasis on community college partnerships, support for summer research experiences after the freshman year, and budget increases for students and staff. Dr. Tromberg noted that 130 students have been supported since the program started in 2018. There are programs at 14 institutions, with half of these being low-resource institutions. The NIBIB contact for this effort is Dr. Gatlin.
   • RADx Tech DIVE fellowship: Dr. Tromberg noted that 17 fellows have been selected for this program, with topics spanning from business models to regulatory work. The curriculum includes proven methods and mentors from RADx, NIH SBIR (for Small Business Innovation Research), POCTRN (for Point-of-Care Technology Research Network), and CRAASH (for Commercialization Readiness Assessment and Accelerator for Solutions in Healthcare). Dr. Tromberg highlighted that there are travel stipends available. NIBIB contacts for this effort are Drs. Tiffani Lash and Asha Storm.

4. Meetings and Workshops

   NIH HEAL Initiative workshop: Dr. Tromberg discussed a meeting spearheaded by the National Center for Complementary and Integrative Health (NCCIH) titled “Understanding and Restoring Whole Joint Health in Pain Management: An NIH HEAL Initiative Workshop.” This meeting, part of the Helping to End Addiction Long-term (HEAL) Initiative®, will be held virtually on July 25-26, 2023. Drs. Guoying Li and Qi Duan are the NIBIB contacts for this effort.

   2023 IMAG multiscale modeling consortium meeting: After a brief hiatus, the Interagency Modeling and Analysis Group (IMAG) multiscale modeling (MSM) consortium meeting is returning and will be held in person this year on June 28-29, 2023, at the Natcher Conference Center on the NIH main campus. The meeting will celebrate 20 years of IMAG and look back at the progress made over the past two decades. Breakout session topics will include digital twins, new mechanistic machine learning methods, sociobehavioral and social determinant of health models, quantum computing and other technologies for modeling, and translation and incentivization. Dr. Grace Peng is the NIBIB contact for this effort.

   Bridge2AI meeting: There was a Bridge2AI face-to-face leadership meeting held on April 17-19, 2023, which included a number of NIH institute directors. Further, the inaugural Bridge2AI Voice symposium was held on April 19, which engaged 130 stakeholders and focused on voice AI biomarkers of health and disease. Dr. Peng is the NIBIB contact for Bridge2AI.

   HL7 FHIR Connectathon: On May 6-7, 2023, in New Orleans, Dr. Andrew Weitz led a portion of the HL7 (for health level seven) FHIR (for fast healthcare interoperability resources) Connectathon, where participants demonstrated full end-to-end reporting from a diagnostic device to a database. This process included a variety of different steps to obtain, standardize, and transmit the data to several different nodes. Dr. Tromberg said that this is a landmark achievement and that hopefully the lessons learned here can be applied to other fields beyond in vitro diagnostics.

5. Program Updates

   RADx Tech for maternal health program: Dr. Tromberg highlighted the progress of the RADx Tech for maternal health program, noting that 10 innovators have moved on to the technology assessment phase. These innovators have been awarded $75K and will be in the technology assessment phase for approximately eight months. If certain milestones are met within this phase, the innovators can receive additional awards and advance to the final phase. Dr. Tromberg summarized the 10 technologies that are currently being evaluated, noting that all use digital platforms and infrastructure and that many use in vitro diagnostics. Drs. Taylor Gilliland and Kari Ashmont are leading the NIBIB effort, while Dr. Antonello Pileggi is leading the effort for NICHD (for the Eunice Kennedy Shriver National Institute of Child Health and Human Development).

   MIDRC (Medical Imaging and Data Resource Center): Dr. Tromberg next gave an overview of recent developments from MIDRC. Since the last Council meeting in January 2023, there have been 157K additional studies ingested into the repository, 30.1K additional imaging studies released to the public, and three additional algorithms developed.

   Dr. Tromberg highlighted an effort spearheaded by former Council member Dr. Maryellen Giger to address bias and diversity in AI/machine learning (ML) datasets. In this vein, a recent publication showcases an AI/ML bias awareness tool. Further, another publication under review assesses the demographic representativeness of the MIDRC repository.

   Finally, Dr. Tromberg mentioned the second international MIDRC challenge. The goal of this current challenge is to use AI to predict COVID-19 severity from chest radiographs. Registration for this challenge opens on May 15, 2023. Drs. Brad Bower and Rui Sá are the NIBIB contacts for MIDRC.

   Intramural program updates: To wrap up his report, Dr. Tromberg discussed the intramural research program.

   • MATRICES lab: In addition to leading the BETA (for Biomedical Engineering and Technology Acceleration) Center, Dr. Manu Platt has brought his research to NIBIB and has started work in his new lab, called MATRICES (for Mechanics And Tissue Remodeling Integrating Computational and Experimental Systems). The scope of his research includes computational modeling, software engineering, biochemistry, and more.
   • BETA Center programs and resources: Dr. Tromberg next highlighted some upcoming BETA Center activities. These include listening sessions with intramural researchers across NIH and identifying physical space(s) for the BETA Center, which could include a dedicated maker space along with an area to showcase technology (to both the public and for Congressional visits).
   • BESIP: The BETA Center has already been connected to the biomedical engineering summer internship program (BESIP). The contact for this effort is Dr. Bob Lutz, who started this program more than 20 years ago. This summer, there are 16 interns who have been placed in labs across seven different institutes and centers (with five interns working at NIBIB). The BETA Center, thanks to the leadership of Dr. Platt and Dr. Nicole Morgan, was able to bring in six students, targeting minority- serving institutions.

6. Discussion

   Council members engaged with NIBIB staff on a variety of topics, including the interaction of RADx and ARPA-H (for the Advanced Research Projects Agency for Health), ways to support the P41 program, and disparities in the AI/ML space. NIBIB staff leads for these program areas briefly described to Council the programs, accomplishments to date, and future plans.

Dr. Weitz explained that NITRC will be supported by multiple ICs through NIH Blueprint; however, NIBIB will function as the administering IC. This concept was developed with, has been vetted by, and has support from the other Blueprint IC directors.

NITRC is a free web resource that helps researchers find, develop, and share neuroimaging and neuroinformatics resources. It has been funded by Blueprint since its inception in 2006. Resources and software can be found on the NITRIC homepage and can be sorted by scientific topic and software type.

The three components of the website are:

• Resources Registry which facilitates the distribution, enhancement, and adoption of neuroimaging tools and resources.
• Image Repository which has free neuroimaging datasets meeting global standards.
• Computational Environment which is a freely downloadable or pay-as-you-go virtual computing cloud-based platform.

The NITRC site is the go-to site for neuroimaging data and software dissemination and is featured in the majority of the Resource Sharing Plans of current neuroimaging grant proposals. Monthly, there are more than 65K web sessions and 153K page views. Since 2019 the site has had 2.3M users and 54K registered users and has offered more than 1.3K software tools and resource projects. Every month, NITRIC.org is cited on average 200 times in publications.

The proposed scope for this next issuance of NITRIC includes continuation of ongoing and expansion into new activities.

Continuation of ongoing activities includes:

• Content and user maintenance including maintenance and upkeep of the site, resource curation, site moderation functions, and community support services
• Infrastructure maintenance including smooth and secure operation of development, test, stating and production systems, as well as support of core services including software updates and backup strategy
• Content expansion including identifying and adding new software, data, and other resources; tool comparison service; resources from large initiatives; and tools/resources that support the new NIH Policy for Data Management and Sharing
• Outreach documentation, training, education, and support including staffing booths at conferences, including NITRC content in hackathons and academic courses, leveraging social media, the annual State of Neuroimaging survey, quarterly newsletters, and crowdsourcing educational tutorials.

And three areas of expansion includes:

• Tool comparison service: update the tool comparison data with new software and new versions of existing software as they are released
• Resources from large initiatives: maintain outreach to current and past major U.S. neuroscience initiative leadership to better connect these resources with the NITRC community
• Focus on Data Sharing Mandate tools/resources: create and identify tools/resources that facilitate the process of data sharing.

Council Discussion:

Council members were supportive of the concept clearance and asked if there are other areas where this approach has been taken for sharing repositories. Dr. Weitz responded that the National Library of Medicine

(NLM) has a catalogue of all the NIH-supported repositories and there are many types of resources for different scientific domains. Council then asked if there is an NIH-wide understanding of the sustainability of this type of infrastructure given that funding sites like these are expensive. Dr Weitz answered that the best model for sustaining these repositories is for NIH to continue funding them. But continued investment by NIH is justified by the cost savings for researchers by having access to these repositories. He stated that they have not seen success when trying to develop public-private partnerships with major medical imaging companies such as Phillips and Siemens. Council suggested trying Amazon and Google.

In reference to whether NITRIC has gained interest with the recent emergence of AI, Dr. Weitz said it is too early to know, but that resources like the Medical Imaging and Data Resource Center will be needed by the AI community. Finally, Council members expressed concern about the sustainability of the project given that three small companies and one academic institution currently run NITRIC. Dr. Weitz responded that everything is open source so it could, theoretically, be taken over by a new team.

Dr. Thompson began by summarizing her research looking at the effects of inner ear disfunction/balance and gait. She studied injuries in aging and other impaired populations as well as astronauts and athletes. People use three main sensory systems to balance: vestibular, somatosensory, and visual. Ninety million Americans suffer from vertigo, dizziness, or balance disturbances often caused by vestibular dysfunction. In addition, falls in aging individuals are the second leading cause of accidental injury deaths worldwide and 25% of aging population will suffer a fall. Over the past decade there has been a 59% increase in fall-related injuries.

Dr. Thompson then discussed her research on a vestibular prosthesis for balance. The studies were done using non-human primates that had normal, mildly impaired, and severely impaired vestibular states. They found that, among the primates that were severely impaired but wore the prosthesis, there was significant improvement in balance.

At the University of the District of Columbia (UDC), Dr. Thompson’s research team explored whether sensory training could improve balance or balance confidence in aging individuals. They found that in the healthy group, balance confidence coordinates with balance performance; however, among those who had experienced a stroke, there was not a correlation between balance confidence and balance performance. The team hypothesized that this was possibly because the participants were only followed for a short time post- training.

The work being done in Dr. Thompson’s lab attracted interest from other agencies, including Walter Reed. As a part of UDC-Walter Reed Educational Partnership Agreement, UDC students and faculty worked to overcome the difficult and time intensive process to create IDEO (Intrepid Dynamic Exoskeletal Orthosis) ankle braces by more efficiently developing them using 3D-printing. The UDC Center for Biomechanical & Rehabilitation Engineering (CBRE) – NASA Johnson Spaceflight Center partnership is investigating how shifting the center of gravity affects balance and postural control while wearing extra-vehicular activity spacesuits.

Dr. Thompson then discussed another aspect of her work: creating new education and research infrastructure. She stated that historically black colleges and universities (HBCUs) make up 3% of the nation’s colleges and universities. They were created to give African Americans a chance at an education, many of them created around the time of the Civil War. They enroll 10% of the nation’s Black students, 20% of Black graduates, and produce 24% of Blacks in science, technology, engineering, and math (STEM) fields and 30% in engineering fields at the bachelor’s level. HBCUs generate $14.8 billion in economic impact.

Dr. Thompson started the bioengineering program at UDC as well as her research laboratory, CBRE. CBRE

has state-of-the-art equipment funded mostly by federal grants. UDC has the first ABET (for Accreditation Board for Engineering and Technology) –accredited Bachelor of Science Biomedical Engineering program at an HBCU. An NIH C06 grant helped Dr. Thompson to create a Specialized, Distinctive & Modernized Technological Center for Assistive Rehabilitation Research (STAR).

Regarding her success, Dr. Thompson credited her training and her ability to go to grant writing workshops early in her career. She recommended that future investment focus on helping trainees learn how to seek grant funds, join grant panels, find mentors who have received grants previously, and develop a short- and long-term vision. She commented that while service projects take time, they are an investment in the future. She also said that she would like to see initiatives to encourage work-life balance and specifically providing sabbaticals especially for women. She concluded with the fact that currently NIH awards less than 1% of contracting dollars to HBCUs and that there is an opportunity for NIH to provide more resources for HBCUs.

Council Discussion

Council expressed excitement and respect for Dr. Thompson’s efforts. Council asked what led Dr. Thompson to join UDC over other institutions that had more resources. She expressed that UDC was attractive based on its location, administration, and opportunity. They discussed what the federal government can do to encourage others to follow a similar path. She restated the importance of grant writing workshops with targeted guidance for young investigators and the opportunity for partnerships with other universities with new biomedical engineering programs. Dr. Thompson emphasized the importance of investing in smaller universities and that funding can go further in smaller institutions. A suggestion was made for increasing HBCU’s role by allowing them to be the lead in collaborations. A new NIH mechanism, Excellence in Innovation, is currently being designed with this concept in mind and will require the HBCU to be the primary as opposed to the secondary institution.

Dr. Albert Avila, Chief Diversity Officer, spoke regarding NIBIB’s Technology Acceleration at HBCUs initiative that will provide awards directly to HBCU institutions and will include grant writing workshops. NIBIB is currently at the stage of deciding which mechanisms will be most effective for this program. Dr. Thompson commented that the C06 doesn’t have funds for personnel and Dr. Avila stated that NIBIB plans to include funding for personnel.

Council asked how HBCUs can hold on to talent. Dr. Thompson stated that it is important for people to have personal motivation to continue the work, otherwise they will be drawn away by offers of more money or bigger labs. Council also commented on the importance of changing mentoring strategies and not only encouraging students to move from one elite institution to another but instead to consider other options for success. She concluded by emphasizing the need for smaller institutions and HBCUs to seek out talent and pursue them.

The open session of the NACBIB meeting was adjourned at 1:17 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. Code, and 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2).

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 1486 research and training applications requesting $2,447,768,170 in total costs. The Council recommended 1486 applications with a total cost of $2,447,768,170.

The closed session was adjourned at 3:14 p.m.

Certification:

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

² These minutes will be approved formally by the Council at the next meeting on September 14, 2023, and corrections or notations will be stated in the minutes of that meeting.