Minutes September 14, 2023

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

NATIONAL INSTITUTES OF HEALTH

NATIONAL ADVISORY COUNCIL FOR

BIOMEDICAL IMAGING AND BIOENGINEERING

Summary of Meeting1

September 14, 2023

The National Advisory Council for Biomedical Imaging and Bioengineering (NACBIB) was convened for its 63rd meeting on September 14, 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 12:30 p.m. for review and discussion of program development, needs, and policy. The meeting was closed to the public from 2:05 p.m. to 2:42 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. Amy Herr, University of California, Berkeley, Berkeley, CA

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

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. Cynthia McCollough, Mayo Clinic, Rochester, MN

Council Member not attending:

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

Ex officio members 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. Sohi Rastegar, National Science Foundation, Arlington, VA

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

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

NIH, Non-NIBIB members attending:

Dr. Amy Chase Martin, National Heart, Lung and Blood Institute, NIH, Bethesda, MD

Members of the Public attending:

Dr. Dawn Beraud, American Institute for Medical & Biological Engineering, Washington, DC

Ms. Kiana Newman, Lewis-Burke Associates, Washington, DC

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

Chairperson:

Dr. Bruce J. Tromberg

Executive Secretary:

Dr. Kathy Salaita

Also Present:

NIBIB staff present for portions of the meeting:

Mr. Tareq Al-Shargabi

Ms. Roberta Albert

Dr. Afrouz Anderson

Dr. Kari Ashmont

Dr. Albert Avila

Dr. Moria Bittmann

Dr. Brad Bower

Ms. Jessica Brookes

Mr. Shaquano Brooks

Dr. Jermont Chen

Ms. Mohua Choudhury

Ms. Christine Cooper

Dr. Nichole Daringer

Mr. Ryan Dava

Dr. Qi Duan

Ms. Amber Elia

Dr. Zeynep Erim

Dr. Jessica Falcone

Dr. Tuba Fehr

Dr. Tina Gatlin

Ms. Ann Gawalt

Dr. David George

Ms. Pam Glikman

Mr. Muzzamil Hafeez

Dr. Jill Heemskerk

Ms. Alisha Hopkins

Dr. Kris Kandarpa

Ms. Deborah Kelly

Dr. Randy King

Dr. Alexander Komendantov

Mr. Daniel Koscinski

Mr. Robin Kramer

Dr. Richard Leapman

Mr. Raymond MacDougall

Ms. Jacqueline Martinez-Headen

Ms. Jessica Meade

Mr. Todd Merchak

Dr. Shawn Mulvaney

Ms. Naledi Mullican

Mr. Mutema Nyankale

Dr. Grace Peng

Dr. Manu Platt

Dr. David Rampulla

Dr. Luisa Russell

Dr. Kaitlyn Sadtler

Dr. Behrouz Shabestari

Dr. Manana Sukhareva

Dr. Andrew Weitz

Dr. Michael Wolfson

Dr. Steve Zullo

NIBIB Staff Attending by Zoom:

Dr. Tatjana Atanasijevic

Dr. Tiffani Lash

Dr. Guoying Liu

Dr. Karen Olsen

Dr. Kathy Salaita

Dr. Shumin Wang

Approximately 156 observers attended the open session by videocast, including NIBIB staff and members of the general public.

Call to Order: Dr. Kathy Salaita

Dr. Kathy Salaita called to order the 63rd meeting of the National Advisory Council for Biomedical Imaging and Bioengineering. She reminded attendees that the morning session of the meeting was open to the public and welcomed attendees.


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.

I. Director’s Remarks: Dr. Bruce J. Tromberg

  1. NIBIB Staff Updates

    Dr. Tromberg congratulated Dr. Guoying Liu, who was recently selected as the new director of the Division of Applied Science and Technology (DAST). Dr. Tromberg thanked Dr. Kris Kandarpa for serving as the acting director of DAST for many years.

    Dr. Tromberg then welcomed new NIBIB staff: Mohua Choudhury, a program director in the Office of Program Evaluation and Strategic Partnerships; Debanjan Goswami, Ph.D., a scientific review officer in the Office of Scientific Review; Christine Lehmann, a writer-editor in the Office of Science Policy and Communications; and Nichole Daringer, Ph.D., a program director in the Division of Discovery Science and Technology.

  2. Budget and Policy Updates

    Dr. Tromberg discussed the budget. He first highlighted the enacted FY23 budget, which was $47.5B for NIH and $440.6M for NIBIB. The FY24 NIH budget as proposed by the House, Senate, and White House are $43.8B, $47.8B, and $48.8B, respectively. These three proposed budgets maintain flat funding for NIBIB at $440.6M. Dr. Tromberg mentioned that, due to the spending caps from the recent law that increased the federal debt limit, the NIH appropriations will likely be flat in FY24, despite a request from the White House for a higher total. He noted that NIH is preparing for the likelihood of tight funding in FY24 and FY25.

    Dr. Tromberg next reviewed a recent policy notice (NOT-OD-23-149) which prohibits the use of artificial intelligence (AI) during the NIH peer review process. In speaking broadly about AI, Dr. Tromberg brought up a recent white paper from Senator Bill Cassidy, the ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee. Dr. Tromberg highlighted a passage from the white paper, which states that policymakers must weigh the trade-offs inherent with any powerful technology and modify or create the legal framework needed to maximize technologies’ benefits while minimizing risk.

  3. NIBIB Strategic Plan

    Dr. Tromberg reviewed the initial effort to develop an updated strategic plan dating back to 2019. A strategic plan council workgroup was established in May of that year, which included approximately 20 individuals comprised of both Council members and external members. These members and NIBIB staff were assigned to seven working groups to begin development of the plan. Strategic planning efforts were paused at the onset of the COVID-19 pandemic.

    In 2023, the strategic planning process was revisited. Using three major sources of information—data gathered in 2019, the prior NIBIB strategic plan 2012-2016, and experience garnered from the pandemic—a new plan was outlined and shared with the public for comment via a request for information (RFI). Following discussion with Council, the goal is to finalize and distribute an updated strategic plan in early 2024. Dr. Tromberg highlighted several key areas of the 2024-2028 draft strategic plan:

    Updated vision and mission statement: The current NIBIB vision statement reads, “Engineering the future of health.” Similarly, the current NIBIB mission statement reads, “Transform, through engineering, our understanding of disease and its prevention, detection, diagnosis, and treatment.” Based on comments from the RFI and discussions within the community, slight modifications to both the vision and mission statements have been proposed. The proposed vision statement reads, “Technologies to shape the future of health,” while the proposed mission statement reads, “Transform, through technology development, our understanding of disease and its prevention, detection, diagnosis, and treatment.”

    Core values: Dr. Tromberg noted that the updated strategic plan will keep the same basic core values as the previous plan, but the descriptions that accompany these core values will be modified. The updated language can be seen below:

    1. Excellence: We conduct and support cutting-edge science and technology development, serving as a model and resource for researchers around the world.
    2. Innovation: We take risks to readily embrace new approaches, and actively pursue groundbreaking ideas.
    3. Integrity: We act as ethical, transparent, and honest stewards of public trust.
    4. Partnership: We work collaboratively to maximize the beneficial impact on human health.

    Five major technology focus areas: Dr. Tromberg noted that the previous strategic plan did not outline the major technology focus areas of the institute. In order to better communicate NIBIB’s research priorities, five major themes were outlined:

    1. Biomedical imaging technologies
    2. Engineered biological systems
    3. Sensors and point-of-care devices
    4. Therapeutic systems and technologies
    5. Data science, modeling, and computation

    Goals and strategies: While the prior strategic plan included five goals, the current strategic plan condenses these strategies into three major goals that align with NIBIB’s core values. These three goals are as follows:

    1. Develop innovative, enabling, and accessible technologies that drive new discoveries, solve complex problems, and improve human health.
    2. Build purposeful, inclusive, interdisciplinary partnerships with public and private sector stakeholders to expand the impact of biomedical technologies.
    3. Train the next generation of diverse, inclusive, interdisciplinary scientists, engineers, and clinicians to meet critical needs in the biomedical technology research, commercialization, and health care workforce.

    Feedback from RFI: Dr. Tromberg noted that the majority of comments from the RFI were either supportive or very supportive of the framework, with a small percentage of respondents (8%) indicating that parts of the framework and goals were unclear. Recommendations have been incorporated into the plan.

  4. Funding Opportunities and Notices

    BEITA at HBCUs: Dr. Tromberg highlighted a notice of intent to publish a funding opportunity announcement for enhancing biomedical engineering, imaging, and technology acceleration (BEITA) at historically black colleges and universities (HBCUs). This announcement (NOT-EB-23-018) provides details of a two-phase program (UG3/UH3 mechanism) with an estimated publication date of January 29, 2024. Dr. Albert Avila is the NIBIB contact for this effort.

    Technology development to reduce health disparities: Dr. Tromberg spoke of a reissuance of a research funding announcement (RFA-EB-21-001). This funding opportunity, in partnership with the National Institute on Minority Health and Health Disparities, is focused on the development of technologies to reduce health disparities and has a due date of January 26, 2024. Dr. Moria Bittmann and Dr. Avila are the NIBIB points of contact for this effort.

    Alzheimer’s-focused administrative supplements: Next, Dr. Tromberg highlighted a notice of special interest (NOT-AG-23-032) in partnership with the National Institute on Aging. This funding opportunity is for the application of Alzheimer's-focused administrative supplements for NIH grants not focused on Alzheimer's disease. Current NIBIB-funded investigators can apply for a supplement to repurpose or redirect their technology for Alzheimer's disease or neurodegenerative disease applications. Dr. Tromberg noted that over the last seven years, nearly $20M has been distributed to NIBIB investigators through this program. The due date for applications is October 2, 2023. Dr. Randy King is the NIBIB point of contact for this effort.

    NIH HEAL Initiative funding opportunity: Dr. Tromberg discussed a funding opportunity (RFA-AT-24-003) in collaboration with the National Center for Complementary and Integrative Health (NCCIH). This funding opportunity is a component of the Helping to End Addiction Long-term (HEAL) Initiative® and is focused on quantitative imaging and other biomarkers for clinical pain management. In FY22, there were seven five-year R61/R33 awards. The application receipt deadline for the current round is October 18, 2023. Dr. Liu is leading the NIBIB effort, while Dr. Alex Tuttle is leading the NCCIH effort.

    NSF-NIH smart & connected health program restructure: The Smart and Connected Health program (NOT-OD-23-165/NSF 23-614), a collaboration between NIH and the National Science Foundation (NSF), has an upcoming application due date on November 9, 2023. There will be a pre-application webinar (NOT-OD-23-167) on September 25, 2023, at 3PM ET. Further, a sub-program, “Smart Health and Biomedical Research in the Era of Artificial Intelligence and Advanced Data Science,” has been restructured to combine successful NSF initiatives and promote goals of the NIH’s strategic plan for data science. Dr. Qi Duan is the NIBIB point of contact for this effort.

    BEAMS Challenge: NIBIB’s Dr. Taylor Gilliland had the idea to crowdsource potential innovations from the institute’s staff, offering the winner the chance to develop their own challenge with a prize of $25,000 to support the challenge project. The winner of this crowdsourcing event was the NIBIB communications team, with Jessica Meade leading the effort. The challenge, named BEAMS (for Biomedical Engineering Adapted for Middle Schoolers), is soliciting lesson plans from middle school teachers and curriculum developers across the country. At the conclusion of the challenge, these lesson plans will be made freely available to teachers. The challenge was launched in June 2023, and the deadline to submit lesson plans is September 30, 2023.

    RADx Tech Fetal Monitoring challenge: Dr. Tromberg wrapped up his discussion about funding opportunities by highlighting a challenge focused on fetal monitoring. The challenge, sponsored by NIBIB, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the Bill and Melinda Gates Foundation, uses a RADx Tech-style innovation funnel to accelerate the development of point-of-care and home-based diagnostic and monitoring technologies for fetal health. The submission deadline is November 17, 2023, with a total prize purse of $2M. Dr. Gilliland is the NIBIB point of contact for this effort.

  5. Program Updates

    2023 training grantees meeting: For the first time since the COVID-19 pandemic, NIBIB held a training grantees meeting. Hosted by the Division of Interdisciplinary Training on June 15-16, 2023, the meeting had over 220 attendees with more than 90% indicating that they had an enjoyable and productive time and would recommend the meeting to their peers. Roughly half of the attendees were T32 trainees.

    2023 IMAG multiscale modeling consortium meeting: On June 28-29, 2023, the Interagency Modeling and Analysis Group (IMAG) multiscale modeling consortium meeting was held. The conference was focused on the successes and memorials from the 20-year history of IMAG and was led by NIBIB’s Dr. Grace Peng. More than 100 attendees convened at the Natcher Conference Center, with 200 attendees viewing the conference online. Highlights of the conference included breakout sessions, poster sessions, and matching early career investigators with mentors. The meeting was featured in the NIH Record and recordings from the conference are available online.

    NIDCD Director’s seminar series: NIBIB recently had the chance to participate in a special symposium held by the National Institute on Deafness and Other Communication Disorders (NIDCD) focused on technologies and marketplace innovations to improve health care access and outcomes. Robert Califf, M.D., the U.S. Food and Drug Administration (FDA) Commissioner, was the invited speaker. He spoke about over-the-counter (OTC) wearable and implantable devices with a particular focus on OTC hearing aids. Institute directors from the National Eye Institute, the National Institute of Dental and Craniofacial Research, the National Library of Medicine, NIDCD, and NIBIB were featured panelists during this symposium. A recording of the meeting can be found online. Dr. Jessica Falcone is the NIBIB point of contact for this effort.

    DEBUT Challenge: This year, The Design by Biomedical Undergraduate Teams (DEBUT) Challenge had 100 submissions from 52 universities across 26 U.S. states and Washington, D.C., engaging 446 students. Prize money totaled $145,000 and included a new prize from the National Institute of Nursing Research focused on technologies to empower nurses in community settings. Dr. Tromberg reviewed the award winners, specifically highlighting the top three NIBIB prizes:

    • The Steven H. Krosnick prize ($20,000): Awarded to a team from Purdue University for their invention called the EpicPen, a low-cost epinephrine auto-injector. Dr. Tromberg shared a short video wherein the winning students described and showcased their technology.
    • The second-place prize ($15,000): Awarded to a team from the University of California-Irvine for their invention called OneSpec, a vaginal speculum designed to improve patient comfort by eliminating painful pressure points, especially during insertion.
    • The third-place prize ($10,000): Awarded to a team from the University of Wisconsin-Madison for their breast magnetic resonance imaging (MRI) biopsy positioning and immobilization device, which solves challenges in obtaining breast biopsy samples.

    Dr. Tromberg noted that the DEBUT awards ceremony will take place at the Biomedical Engineering Society (BMES) Annual Meeting in Seattle on October 13, 2023. Dr. Dave Gutekunst is the contact for the DEBUT program.

    MIDRC: The Medical Imaging and Data Resource Center (MIDRC) continues to expand its impact, releasing more than 150,000 imaging studies and more than 30 algorithms since its inception. Adoption of MIDRC has also increased, engaging nearly 600 registered users and more than 400 collaborating institutions.

    To further engage the imaging community, a second MIDRC challenge was launched. Over 60 teams registered for the challenge, with nine teams submitting final code for evaluation. The ultimate goal is to have the winners work with the MIDRC validation and regulatory working group for mock algorithm submissions to the FDA for regulatory authorization. Drs. Brad Bower and Kris Kandarpa are the NIBIB points of contact for MIDRC.

    RADx Tech programs: Dr. Tromberg concluded his overview of NIBIB program highlights by giving an update on two RADx-related items:

    • MakeMyTestCount.Org: Dr. Tromberg noted that voluntary COVID-19 test reporting through MakeMyTestCount.Org has picked up in recent weeks, which has been accompanied by a commensurate increase in COVID-19 positivity. Further, positivity rates for self-tests align with lab and point-of-care tests. The website, which has collected more than 113,000 results to date, now supports the reporting of both COVID-19 and flu test results.
    • Home Test To Treat program: This program, in collaboration with the Administration for Strategic Preparedness & Response and the Centers for Disease Control and Prevention, had a pilot launch in Pennsylvania but has now expanded to Atlanta and Houston. A national launch of the program is planned for the fall. Goals of the program include equity in vulnerable populations, effectiveness of home test-to-treat, and electronic health care records management.

    Dr. Andrew Weitz is the NIBIB point of contact for both of these RADx Tech programs.

  6. Meetings and Workshops

    Alzheimer's disease workshop: This half-day virtual meeting will take place on September 29, 2023. Recipients of Alzheimer's-focused administrative supplements will be given the opportunity to present their work and interact with investigators who concentrate on Alzheimer's disease research. The meeting will feature multiple presentations on imaging, disease monitoring, computational modeling, and emerging technologies. Dr. Randy King is the NIBIB point of contact for this meeting.

    2023 Synthetic Biology Consortium meeting: This two-day meeting will take place both virtually and in-person at the Natcher Conference Center on November 2-3, 2023. Topics will include synthetic biology tools, biomanufacturing case studies, the biomedical regulatory landscape, and biomanufacturing at NIH and other federal agencies. NIBIB points of contact include Drs. Jermont Chen, Tuba Fehr, and Nichole Daringer.

    POCTRN conference and tech showcase: This upcoming conference will focus on the Point-of-Care Technologies Research Network (POCTRN) and will engage POCTRN Center researchers, tech developers, clinicians, regulators, investors, government leaders, non-profit organizations, and industry partners. The focus of the meeting is to accelerate point-of-care/OTC technology innovation, validation, and commercialization. This conference will be held in person on November 28-29, 2023, at the Natcher Conference Center. Dr. Tiffani Lash and Feben Zenebe are the NIBIB points of contact for this effort.

  7. Discussion

    Council discussion largely revolved around the strategic plan. Several topics related to the plan were discussed in detail:

    Dissemination: A point was brought up about innovative ways to disseminate the plan beyond the traditional methods of printing and downloading as a PDF. Dr. Tromberg noted that NIBIB will distribute the plan through multiple channels and that he would like to investigate methods that enhance the online viewing of the document, such as interacting with the images in the plan.

    Wording: A point was made about action words such as ‘building,’ ‘developing,’ and ‘commercializing,’ which indicate late-stage technologies; words that focus on early-stage development such as ‘finding,’ ‘defining,’ ‘identifying,’ ‘discovering,’ and ‘inventing’ should be considered. Dr. Tromberg said that this represents an area of overlap with the mission of the National Institute of General Medical Sciences (NIGMS), which focuses more on fundamental discoveries, while NIBIB focuses more on downstream applications. He noted that NIBIB also supports early-stage research and that this point should be clarified in the strategic plan, but as a whole, NIBIB-supported research is more translational than NIGMS-supported research. He also said that a core emphasis of the strategic plan is NIBIB’s focus on funding projects that NIH has not traditionally supported, such as speed and purpose-driven movement of concepts and ideas from “blackboard to bedside.” One goal of the NIBIB strategic plan is to stand out as the institute that is driving technology, discovery, and innovation.

    Commercialization: Another point was made about how only a small fraction of pitched technologies actually make it to the commercialization stage. Dr. Tromberg highlighted the success of the RADx Tech program, which resulted in investments and partnerships and has introduced a venture-like process. He noted that NIBIB is prioritizing methods to transfer attributes from the RADx Tech system to extend it beyond in vitro diagnostics.

    The use of AI and ChatGPT: One Council member brought up ChatGPT and what NIBIB’s plans are to leverage this technology. Dr. Tromberg mentioned that many institutes are developing plans for the use of data science and AI, representing an opportunity for the NIBIB Council to take the lead in this area. He noted that NIBIB’s view of AI and its use is distinctly different from most other NIH institutes, but that AI is called out as a central feature in NIBIB’s technology focus areas in the strategic plan. He agreed that AI is an area that requires more organized attention.

    Involvement from early-stage investigators: One Council member asked if members of the younger generation were involved in the development of the plan. Dr. Tromberg noted that the strategic plan is a scaffold and that its main purpose is to capture a big-picture vision of NIBIB’s goals. He noted that the strategies are quite broad and that an early career investigator might have a different perspective from a late-career investigator. He encouraged Council members to engage students and faculty at their institutions to get such conversations started and to bring NIBIB feedback.

    Potential supplement: A point was made that a combined imaging and engineering decadal survey that listed key exciting problems could be a potential supplement to the strategic plan. Dr. Tromberg was agreeable to this idea and noted that it is important to continue to galvanize the community to communicate the impact of these technologies.

    Other feedback: One Council member asked about the best way to contribute to the strategic plan. Dr. Tromberg said that comments from Council were being captured and that Council should review the presented slides and send additional feedback.

    Additional topics of discussion include the following.

    Potential commercialization and deployment of technologies developed during the DEBUT Challenge: Dr. Gutekunst noted that the 2022 winners had the opportunity to join the C3i (for Concept to Clinic: Commercializing Innovation) program and that two teams are going through the first phase of the program now. He also said that most of the winning teams this year will be eligible to participate in the first phase of this program. Further, NIBIB’s partner in the Challenge, VentureWell, is well-connected to the commercialization and business community. Another Council member asked if the Department of Defense could be a potential partner in terms of wearable technology for climate change/excessive heat. Dr. Tromberg said that the National Institute of Environmental Health Sciences received an increase in their FY23 budget to specifically address climate change and the environment, and that this area is a major growth topic.

    Accessibility of imaging devices: The issue of the need for accessible imaging technologies, particularly in “medical deserts” communities was discussed. Dr. Liu noted that both NIBIB and the Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative have been advocating for more accessible imaging, including MRI, to try and make the technology more mobile and portable.

    Training opportunities at the pre-undergraduate level: In responding to this discussion, Dr. Zeynep Erim highlighted NIBIB’s involvement in the UNITE initiative which allows the institute to have more opportunities in this area. She noted that NIBIB has also joined the SEPA (for Science Education Partnership Award) program and that NIBIB has diversity supplements that operate in this area.

    Imaging and sensor forum: a suggestion was made to bring the sensor community and the imaging community together in a joint forum, as they may have shared considerations that may not otherwise be obvious. Dr. Tromberg was agreeable to this idea.

II. Concept Clearances

  1. BRAIN Initiative Concept Clearance: Transformative Discovery to Resolve the Heterogeneity of Brain Cells Through Non-invasive Imaging, by Dr. Shumin Wang

    Dr. Wang started by describing the two current BRAIN Initiative cell census programs: the BRAIN Initiative Cell Census Network, which classifies brain cell types at the single cell level, and the BRAIN Initiative Cell Atlas Network, which maps different cell types and states into brain atlas measurements. The goal of this new concept is to develop a synergistic BRAIN-wide effort to translate the process of identifying and localizing different brain cells into an in vivo, non-invasive process. The desired impact is to pave the way toward new research paradigms, diagnosis, targeted therapy, and treatment management for the brain and beyond.

    Dr. Wang identified three gaps or challenges between cell census and molecular imaging:

    • Dimensionality difference: multi-parametric vs. (mostly) single-parametric
    • In non-invasive molecular imaging, there is a scale difference—it can be difficult to identify useful information from various signals from an ensemble of cells whereas single cell approaches have no such ambiguity
    • Tissue accessibility: ex vivo vs. in vivo

    The plan is to start mining BRAIN cell census data to nominate and prioritize imaging targets.

    There will be three emphases of this initiative:

    • Multiplexed acquisition of different non-invasive imaging features, either sequentially or concurrently, that may emulate multi-parametric classification at single-cell level
    • Integrated reconstruction of in vivo/ex vivo information via advanced computational techniques, e.g., regularized reconstruction or AI, for enhanced cell specificity and accuracy
    • The utilization of highly innovative delivery techniques

    The expected outcome of this initiative is to answer the following questions:

    • What non-invasive imaging features could be utilized?
    • What is the best way to integrate multi-faceted information to provide a macroscopic-level picture of cell-type specificity and localization?
    • To what extent can non-invasive imaging features be explored to identify and localize different brain cells?

    The initiative plans to apply the cooperative agreement mechanism to help maximize the outcome and manage the risk.

    Dr. Wang concluded by providing a few examples of potential initiative activities including:

    • Approaches that mine cell census data for nominating single or combination/intersections of signature targets for new reagent development or evaluating the engagement of existing reagents
    • Approaches that exploit chemistries to facilitate blood-brain barrier (BBB) penetration or utilize focal reagent delivery, e.g., focused ultrasound for BBB opening for more selective readouts of cell types/populations and tissue distribution
    • Technology that has minimal or no transformative value to non-invasive imaging-based neuroscience, preclinical, or clinical research
    • Technology that does not have a direct enabling effect on non-invasive identification and mapping of different brain cell types/populations
    • Imaging technology that primarily focuses on abnormal targets resulting from pathology, or benefits specific diagnostic outcomes, or does not have downstream validation of target engagement
    • Development of innovative multivalent probes that could target combinations of endogenous and/or genetic signatures, amplify the signal in certain cells, or be compatible with downstream single-cell analysis
    • Approaches emphasizing efficient and scalable early-stage screening of target engagement that could aid development on a broader and larger scale

    Council members were supportive of the concept and expressed interest in the difference between medical and molecular imaging and the importance of developing new approaches to bridge the gap. They also asked whether the devices and approaches would be able to translate from animal models to humans especially given that there is less concern about safety in animal models, such as taking multiple positron emission tomography (PET) scans. Dr. Wang responded that they believe that while not everything will be directly translatable, the overall strategy developed should be translatable. Council expressed interest in the idea that the knowledge represented in the cell atlases can be translatable into medically relevant information and knowledge if not the technology itself.

  2. B. NIH Center for Biomedical Engineering and Technology Acceleration (BETA), by Dr. Manu Platt

    Dr. Platt introduced NIBIB’s new BETA Center to Council. The BETA Center is an NIH-wide resource housed by the NIBIB Intramural Research Program (IRP) that will serve as a new NIH campus model for accelerating technology-driven interdisciplinary research and clinical translation. Its goal is to bring researchers together with engineering and imaging expertise, including biomedical imaging, biosensing, biomechanics, engineered/synthetic biology, nano/biomaterials, AI, modeling, computation, and informatics. The hope is that this will build an engineering community within NIH as well as recruit new engineering talent.

    Dr. Platt also emphasized that employing evidence-driven approaches to expand diversity, equity, inclusion, and accessibility (DEIA) within NIBIB’s IRP and serving as a model for recruiting diverse biomedical engineering talent to NIH are central to the BETA Center’s mission.

    The BETA team held two separate listening sessions to identify the needs of different NIH institutes and areas where BETA could help. The listening sessions were designed to explore ways to improve the BETA Center and emphasized the importance of building a community of biomedical engineers at NIH to recruit and retain talent. Some of the goals that came out of these listening sessions were:

    • Building bridges between institutes and centers (ICs) and forming new models of public/private partnerships
    • Adding makerspaces to campus to accelerate the technology design-build-test process
    • Connecting investigators and resources at NIH with engineering and imaging interests and expertise
    • Driving innovation and entrepreneurship at NIH
    • Leading the U.S. government in response to urgent and national biomedical problems

    More than 70 investigators from 16 institutes have already expressed interest in being a part of the BETA Center. The investigators have various specialties in areas ranging from imaging microscopy to clinical trials and NIBIB wants to help connect researchers who can benefit from collaboration.

    The BETA Center is also interested in playing a major role in workforce development and helping to train the next generation of biomedical engineers. Dr. Platt discussed how this year he and Dr. Nicole Morgan piloted a BETA internship program for students to experience working in a biomedical engineering lab for the first time. In addition, NIBIB agreed to fund four postbaccalaureate fellows in partnership with the Office of Intramural Training and Education. NIBIB also partnered with the NSF’s INTERN program for graduate students on the NIH campus.

    The BETA Center is also recruiting at diverse scientific venues including the BMES annual meeting, the Annual Biomedical Research Conference for Minority Students, the American Indian Science and Engineering Society National Conference, and the Society for Advancement of Chicanos and Native American Scientists National Diversity in STEM conference. They will be soliciting job opportunities from BETA Center researchers and advertising them on the BETA Center website and at the conferences.

    Dr. Platt discussed plans to bring BMES to NIH in 2024 as the meeting will take place in Baltimore. The plans include a pre-event with invited speakers on the NIH campus before the BMES conference begins, campus tours, recruiting other ICs to exhibit at the BMES conference, and recruiting postdocs, summer researchers, and postbaccalaureate students for intramural positions.

    Dr. Platt concluded by talking about the plans to begin the makerspace in February 2024. It will include 3D printers, computer and design equipment, and a demo space. Additionally, BETA will have a machine shop fabrication space including a 3D metal printer that was requested by NIH researchers during the listening sessions.

    Council members asked how BETA will be funded across other ICs. Dr. Platt responded that while NIBIB has frontloaded much of the funding, there are plans for cost-sharing among ICs that use the makerspace and other center resources. Council asked about how the BETA Center plans to track the impact of the programs to increase diversity among underrepresented communities. Dr. Platt talked about a plan to track students from the beginning to measure the return on investment. Council asked how BETA plans to ensure that the interns have good experiences in their first time in a lab. Dr. Platt outlined their efforts to ensure that PIs of lab have an accurate understanding of the levels and capabilities of the interns who are embarking on their first-ever research experience. Dr. Leapman expounded that NIH has expanded their DEIA efforts in the last few years and that this interest is not just at NIBIB but NIH-wide. Regarding the practicalities of choosing collaborations, Dr. Platt reiterated that he would rely on Dr. Morgan and the other resource directors who have experience with those types of conversations and collaborations.

III. Adjournment

The open session of the NACBIB meeting was adjourned at 12:30 p.m.

IV. Closed Session

Review of Council Procedures and Regulations: Dr. Kathy Salaita

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). The closed session was adjourned at 2:42 p.m.

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.

VI. Review of Applications

The National Advisory Council for Biomedical Imaging and Bioengineering considered 2162 research and training applications requesting $3,686,135,924 in total costs. The Council recommended 2162 applications with a total cost of $3,686,135,924.

Adjournment

The closed session was adjourned at 2:42 p.m.

 

Certification:

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

_______________________________________

Kathy Salaita, Sc.D.

Executive Secretary (Acting)

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



2 These minutes will be approved formally by the Council at the next meeting on January 23, 2024, and corrections or notations will be stated in the minutes of that meeting.