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

NATIONAL ADVISORY COUNCIL FOR BIOMEDICAL IMAGING AND BIOENGINEERING
Summary of Meeting¹ January 23, 2024

The National Advisory Council for Biomedical Imaging and Bioengineering (NACBIB) was convened for its 64th meeting on January 23, 2024, online by 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 11:00 a.m. to 2:44 p.m. for review and discussion of program development, needs, and policy. The meeting was closed to the public from 3:03 p.m. to 3:40 p.m. for the consideration of grant applications.

Council members present:
Dr. Samuel Achilefu, University of Texas Southwestern, Dallas, TX
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. Amy Herr, University of California, Berkeley, Berkeley, CA
Dr. Ranu Jung, University of Arkansas, Fayetteville, AR
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 not attending:
Dr. Gilda Barabino, Olin College, Needham, MA

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 

Ex officio members absent:
Mr. Xavier Becerra, Department of Health and Human Services, Washington, DC
Dr. Anne Plant, National Institute of Standards and Technology, Gaithersburg, MD
Dr. Lawrence Tabak, National Institutes of Health, Bethesda, MD
Dr. Jeffrey Shuren, U.S. Food and Drug Administration, Silver Spring, MD

Chairperson:
Dr. Bruce J. Tromberg

Executive Secretary:
Dr. David T. George

Also Present: 

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

Call to Order: Dr. David George

Dr. David George called to order the 64th 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.

A. Introducing the New NIH Director

Dr. Tromberg began his presentation by highlighting the confirmation of Monica Bertagnolli, M.D., as the 17th director of NIH. Dr. Tromberg noted that Dr. Bertagnolli is the first surgeon and second woman to hold the position. He encouraged members of Council to watch her confirmation hearing on C-SPAN.

Dr. Tromberg took a few moments to summarize Dr. Bertagnolli’s priorities for NIH. Her main guiding principles include the following:

• Our work is not finished when we deliver scientific discoveries, our work is finished when all people are living long and healthy lives.
  • NIH research encompasses the laboratory, the clinic, and the community. Patients are partners in discovery.
    • To tackle the most persistent and complex problems, NIH aims to bring more members of the public into the research enterprise as our partners in discovery.
    • Income, age, race, ethnicity, geographic location, and disability status should not be barriers to participating in research or to benefitting from research advances.
• Progress is accelerated when advanced scientific methods, such as new data analytics, are applied to data that includes everyone, and when new discoveries are rapidly and equitably adopted in clinical care.
  • NIH is committed to harnessing the power of artificial intelligence (AI)/machine learning (ML) to advance research across diverse fields, diseases, and scientific communities.
    • Advanced scientific methods, new data analytics, and technologies are unlocking possibilities to harness data in ways that achieve faster and more definitive results.
    • NIH has launched and will continue to launch innovative and ambitious initiatives to propel fusion of biomedicine and AI/ML.
• We remain hopeful that we will not be subject to drastic cuts, however, even a “flat budget” will have a significant impact.
  • Great ideas and the potential for new discoveries will be lost.
  • There is real concern that we will lose a generation of early career investigators.
  • The Intramural Research Program (IRP) is particularly sensitive to budget cuts as most of the expense is fixed personnel costs and IRP investigators have a very restricted ability to seek additional funding to compensate.

B. Budget Updates

Dr. Tromberg then segued into an update about the budget. He noted that the NIH is currently operating under a continuing resolution at the FY23 appropriation level, which expires on March 8. He also noted that a top-line spending agreement for FY24 was reached on January 8, and that the non-defense discretionary portion of the budget may remain at FY23 levels ($773B). Individual appropriation bills are still under development. In terms of the budget’s impact at NIBIB, the interim payline for parent R01 announcements is 14% (19% for new investigators) and most awards are being paid at reduced levels pending a final FY24 appropriation.

C. NIBIB Communications and Staff Updates

Dr. Tromberg highlighted the NIBIB communications team and their second annual year-in-review post. He noted that a major theme of 2023 coverage focused on ultrasound technologies. He also pointed out NIBIB program highlights, including the Rapid Acceleration of Diagnostics (RADx®) Tech maternal health challenge, the Make My Test Count website for self-reporting COVID-19 test results, and the Home Test to Treat program.

Dr. Tromberg then welcomed new NIBIB staff: Dr. Robert Barry, a program director in the Division of Applied Science and Technology (DAST); Dr. Rui Pereira de Sá, a program director in the Division of Health Informatics Technologies (DHIT); Dr. Yi Huang, a Data and Technology Advancement (DATA) National Service Scholar who will be working within DHIT; and Adrianna Aliquo, a scientific innovation program specialist. Dr. Tromberg also thanked departing staff: Dr. Peter Kirchner, a science advisor for the extramural science program, and Ruthann McAndrew, a grants management specialist.

Dr. Tromberg next congratulated Dr. Behrouz Shabestari who recently received a professional achievement award from IEEE (Institute of Electrical and Electronics Engineers) EMBS (Engineering in Medicine & Biology Society).

Dr. Tromberg concluded his staff updates on a sad note by notifying Council of the death of NIBIB staff scientist Dr. Ying Ma (1964-2023). Dr. Ma joined NIBIB in 2004 at the launch of the intramural research program. He was a highly respected expert in mass spectrometry and separation technologies, with more than 100 publications and two U.S. patents. Dr. Ma was known for his profound sincerity, cheerfulness, and eagerness to help others. Dr. Tromberg sends condolences to Dr. Ma’s family and colleagues.

D. Funding Opportunities

BEITA at HBCUs: Dr. Tromberg highlighted the release of a funding opportunity announcement for enhancing biomedical engineering, imaging, and technology acceleration (BEITA) at historically black colleges and universities (HBCUs). This funding opportunity (RFA-EB-23-006) is a two-phase award (UG3/UH3 mechanism) with the goal to enhance bioengineering and imaging research capacity. Application due dates are January 29, 2024; September 30, 2024; and September 30, 2025. Dr. Albert Avila is the NIBIB point of contact for this effort.

NIH HEAL Initiative funding opportunity: Dr. Tromberg noted NIBIB’s participation in a request for applications (RFA-NS-24-023). This RFA is part of the Helping to End Addiction Long-term (HEAL) Initiative® and is focused on the development and validation of remote or patient wearable device-derived objective biosignatures or functional assessments to monitor pain for use as endpoints in clinical trials. This is a two-phase (UG3/UH3) award with application due dates on January 30, 2024, and October 4, 2024. Drs. Tiffani Lash and Moria Bittmann are the NIBIB points of contact for this effort.

Quantum sensing technologies in biomedical applications: Dr. Tromberg next mentioned a notice of special interest (NOT-EB-23-022) that focuses on quantum sensing technologies in biomedical applications. This notice has been jointly issued by NIBIB, the National Eye Institute (NEI), the National Heart, Lung, and Blood Institute (NHLBI), the National Institute of General Medical Sciences (NIGMS), the National Center for Advancing Translational Sciences (NCATS), and the National Cancer Institute (NCI). The are multiple funding mechanisms, and the first available application date is January 16, 2024. Dr. Afrouz Anderson is the point of contact for the NIBIB effort.

RCF & NIH partnership program: Dr. Tromberg highlighted another notice of special interest (NOT-OD-24-040) that focuses on the Research Council of Finland (RCF) – NIH Partnership Program. This effort aims to disseminate knowledge and information regarding a program fostering the expansion of U.S.-Finland biomedical and behavioral research collaboration. Dr. Tromberg noted specific research areas of interest, such as photonics, AI, bioeconomy and materials research, and digital precision cancer medicine. Funding mechanisms include parent R01 PA-20-183 and PA-20-185, with a first available application date of February 5, 2024. Dr. Anderson is the point of contact for the NIBIB effort.

CRCNS: Finally, Dr. Tromberg noted a new issuance of the collaborative research in computational neuroscience (CRCNS) program, which is supported by both NIH (NOT-MH-24-140) and the National Science Foundation (NSF 24-510). This international collaboration program, founded in 2002, is led by NSF and includes potential partnerships with Spain, Japan, Israel, France, Germany, and the U.S. Department of Energy. The next application date is March 7, 2024. Dr. Qi Duan is the NIBIB point of contact for this effort.

E. Program Updates

NIBIB program director position hiring & recruitment: Dr. Tromberg alerted Council that NIBIB is currently hiring two program directors, one focused on image-guided interventions and another focused on point-of- care technologies and digital health. Interested applicants should contact Dr. Guoying Liu and Dr. Behrouz Shabestari, respectively, for more information. Both positions are accepting applications from January 17-26, 2024, via USAJobs.gov [GS-0601-12/13/14 (Program Officer)].

Home Test-to-Treat program: Dr. Tromberg reviewed the Home Test-to-Treat program, which began as a pilot in Berks County, PA, in January 2023 and expanded to Atlanta and Houston in August 2023. Both initial phases provided tests and treatments for COVID-19. In December 2023, the program was rolled out nationwide and provided a combined test and treatments for both COVID-19 and the flu. The nationwide rollout of the program received media coverage from ABC News, Time, Boston Globe, and JAMA.

Dr. Tromberg elaborated on the nationwide rollout of the program. The multiplex home test used in the program is the Lucira PCR test; Dr. Tromberg noted that NIBIB’s RADx Independent Test Assessment Program (ITAP) played a critical role in getting this test validated. Home reporting of test results was made possible by RADx Mobile At-home Reporting through Standards (MARS) and the MakeMyTestCount.org website. To date, the program has enrolled 47,500 participants, resulting in 5,300 telehealth visits and 4,400 antiviral prescriptions. Research questions that stem from this effort include program reach, use, efficacy, impact, and sustainability in populations with limited access to health care. Dr. Andrew Weitz is the point of contact for the Home Test-to-Treat program.

NASEM digital twin report: Dr. Tromberg highlighted the recent publication of the NASEM (National Academies of Sciences, Engineering, and Medicine) Digital Twins Consensus Study Report, which NIBIB co-sponsored. He noted that an important component of this report is the development of an accessible and standardized definition of a digital twin. This definition reads, “A digital twin is a set of virtual information constructs that mimics the structure, context, and behavior of a natural, engineered, or social system (or system-of-systems), is dynamically updated with data from its physical twin, has predictive capability, and informs decisions that realize value. The bidirectional interaction between the virtual and the physical is central to the digital twin.”

Dr. Tromberg then gave an example of digital twin elements in the context of a patient with cancer. Elements include a virtual representation (mechanistic and empirical models representing tumor growth, patient response, etc.) and a physical counterpart (patient data collected from imaging studies, blood tests, and other clinical assessments). These components interact bidirectionally, updating the virtual representation to reflect characteristics of the individual patient and informing clinical decisions (treatments and clinical assessments), with new clinical assessments informing and updating the digital twin.

Dr. Tromberg noted that NCI has released a notice (NOT-CA-24-015) for administrative supplements to support the development of digital twins in radiation oncology. He also noted that NIBIB is leading the Interagency Modeling and Analysis Group (IMAG) in road mapping next steps. Dr. Grace Peng, who leads IMAG, is the NIBIB point of contact for the digital twin effort.

Contributing to national AI infrastructure: In January 2023, the Office of Science and Technology Policy (OSTP) released a statement to build a national research infrastructure to broaden access to resources essential to AI research and development. The National AI Research Resource (NAIRR), led by NSF, is a $2.6B/six-year investment in national infrastructure for AI, and NIH is participating in the NAIRR pilot program in 2024 to deploy resources to early NAIRR users. The Medical Imaging and Data Resource Center (MIDRC) was selected as a pilot program resource for NAIRR. Dr. Tromberg noted that NIBIB will have a unique opportunity to take a leadership role, allowing the biomedical community to contribute to this initiative. He noted that NIBIB’s Drs. Rui de Sá, Brad Bower, and Kris Kandarpa have championed this engagement and pilot program.

Dr. Tromberg noted that MIDRC is also being funded by the Advanced Research Projects Agency for Health (ARPA-H) to contribute to the ARPA-H Biomedical Data Fabric (BDF) Toolbox, a national infrastructure for data ingestion, curation, discovery, and visualization for trustworthy AI in health care. This funding will extend MIDRC’s activities from COVID-19 into cancer. Dr. Tromberg noted that MIDRC activities span BDF technical areas, and that MIDRC’s AI/ML bias tool is a key resource.

Blueprint MedTech: Dr. Tromberg next focused on how RADx Tech has impacted NIBIB programs, and how RADx principles have been extended to neurotechnologies. He then introduced Dr. Michael Wolfson, an NIBIB program director who helped to launch the Blueprint MedTech program. Dr. Wolfson then proceeded to give a short presentation about the evolution and purpose of Blueprint MedTech.

Dr. Wolfson began by giving a brief overview of the program, which begins after the successful conclusion of an R01 project that has the potential to diagnose or treat a disease without a clear path to market. The Blueprint MedTech program takes these projects in through solicitation. These projects are taken in either at the “seedling” (very early) or “development” stage. Once projects are ready for in-human feasibility studies, they transition into the “translator” stage. Throughout all stages of the program, investigators receive key resources to be successful, such as capital, business development tips, consultants and industry experts, clinical expertise, and more.

Dr. Wolfson next elaborated about the two initial stages—the seedling and development stages—which use hubs to solicit applications. The seedling projects need support in one or more areas, such as project details, team expertise, or scope of work. These projects are coordinated through NeuroTech Harbor based out of Howard University, which gives the projects up to $50K in direct funds plus at least $50K of in-kind support, including mentoring, regulatory consulting, and entrepreneurial training. The development projects are coordinated through one of two hubs: CIMIT, which is based out of Mass General Hospital, or NeuroTech Harbor, based out of Johns Hopkins University. Full projects receive up to $500K in direct funds plus in-kind resources for preclinical studies and regulatory support.

Dr. Wolfson next highlighted funded Blueprint MedTech projects. In 2022-2023, 36 projects were funded, resulting in more than $14M plus in-kind resources awarded to innovators. He pointed to a science highlight on the NIBIB website that details some of these awards. Dr. Wolfson then shared a “success story” about a project led by Julie Pilitsis from Florida Atlantic University that focuses on non-addictive treatment for neuropathic pain using low-intensity focused ultrasound modulation of the dorsal root ganglia. Over the last few years in the program, Pilitsis has made significant advancements in technological, regulatory, and marketing aspects of her project. Dr. Wolfson concluded his remarks by noting that the program has a solicitation that will be released in February. This solicitation is open to a wide range of applications, including addiction and abuse, Alzheimer's and related dementias, trauma or other injury, psychiatric disorders, and more.

F. Training and Dissemination

BESIP: Dr. Tromberg highlighted the biomedical engineering summer internship program (BESIP), pioneered by Robert Lutz (lutzr@mail.nih.gov). With the arrival of Dr. Manu Platt, the BESIP program has recently come under the aegis of the BETA Center (Center for Biomedical Engineering Technology Acceleration). The program now contains two tracks: BESIP-BME and BESIP-STEM. The BESIP-BME track is for applicants that are working towards a bachelor's degree in engineering, physical science, or computer science who have had previous hands-on experience with biomedical engineering research. The BESIP-STEM track is for applicants that are not majoring in the aforementioned subjects but are interested in pursuing biomedical engineering in graduate school or as a career, or for applicants who have not had prior in-person biomedical engineering research experience. Dr. Tromberg noted that these two tracks will effectively double the size of the program. Online applications must be submitted by February 9, 2024, and reference letters must be submitted by February 16, 2024.

DEBUT: Dr. Tromberg spotlighted the Design by Biomedical Undergraduate Teams (DEBUT) Challenge, which has a total prize purse of $160K in 2024 for 16 winning teams. New this year is a kidney technology development prize from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Detailed guidelines and submission forms can be found on the VenutreWell website. Dr. Tromberg also noted that the 2023 DEBUT winners received their awards at the NIBIB plenary session at the Biomedical Engineering Society (BMES) meeting in October 2023. These awardees are eligible for phase one of the Concept to Clinic: Commercializing Innovation program. Dr. Tromberg noted that NIBIB is not only giving monetary awards as part of the DEBUT Challenge, but also resources to promote innovation and entrepreneurship.

2023 synthetic biology workshops: Dr. Tromberg next discussed two recent synthetic biology workshops that were held last year. The first meeting, Synthetic Biology for Aging Research Workshop, was held September 6-7. The goals of the workshop included promoting awareness of synthetic biology in the aging research field and stimulating interest in collaborative efforts between the two disciplines. Dr. Tuba Fehr is the point of contact for this effort, and updates and additional materials related to the workshop will be posted on the NIBIB synthetic biology consortium website. The second meeting, the NIH Synthetic Biology Consortium 2023 Annual Meeting: Synthetic Biology and Biomanufacturing, was held November 2-3. This meeting focused on current issues in synthetic biology and biomanufacturing in research, regulation, and clinical applications, and connected universities, companies, and government agencies. Dr. Tromberg encouraged Council to watch the videocasts of the conference. He thanked Drs. Fehr, Jermont Chen, and Nichole Daringer for organizing this event.

POCTRN conference and tech showcase: Dr. Tromberg then focused on the recent Point-of-Care Technologies Research Network (POCTRN) conference and technology showcase, which was held November 28-29, 2023, on the NIH campus. This meeting focused on accelerating point-of-care/over-the- counter technology innovation, validation, and commercialization, with NIH Director Dr. Bertagnolli giving a talk. Dr. Tiffani Lash and Feben Zenebe are the points of contact for this effort.

BEAMS: Dr. Tromberg concluded his presentation by announcing the winners of the Biomedical Engineering Adapted for Middle Schoolers (BEAMS) Challenge. This Challenge was an effort lead by Jessica Meade in the NIBIB communications office to generate curriculum targeted to middle school students to provide exposure to biomedical engineering and technology. The winners of the inaugural BEAMS Challenge are:

• Nanoparticles for drug delivery, designed by Benjamin Treutler
  • Introduces the concept of nanoparticle drug delivery and includes example presentations, case studies, and lab activities that are designed to be affordable and simple
• Genetic telephone: A story-driven journey through the world DNA & gene editing, designed by Prathic Sundararajan, Suraj Rajendran, Anika Moorjani, and Harshini Manikanda Ilango
  • Provides a comprehensive understanding of genetic variations and cutting-edge techniques such as CRISPR that allows us to modify them
• Engineering design process and surgical robots, designed by Kiara Quinn
  • Introduces the concept of biomedical engineering and surgical robots and engages students in a hands-on activity where they work in teams to design, create, and test their own surgical robot prototypes
• Biomaterials, designed by Katy Lydon
  • Introduces students to biomaterials and their potential applications within the medical field to inspire new ideas for how to improve biomaterials and subsequently health care

Dr. Tromberg noted that these lessons plans will be disseminated through many different channels, and if Council is interested in collaborating in this process, they should contact Ms. Meade.

G. Discussion

Council expressed enthusiasm about the BEAMS Challenge and inquired about ways to get involved and share the resources. Dr. Tromberg noted that Council should feel free to reach out with ideas to integrate the curriculum and that the lesson plans are currently being finalized for final broad dissemination. Council also asked about the status of the NIBIB Strategic Plan and Dr. Tromberg’s vision for the next five years. He responded that the final strategic plan product is in process. In response to vision, Dr. Tromberg focused on the need to expand the cutting-edge of AI and other tools/concepts to benefit human health. Council also applauded MIDRC’s progress and expansion into the cancer data space but noted that many other players already exist in this domain. Dr. Tromberg said that other resources lack a unique feature that MIDRC brings which is a “physics to medicine” perspective and expertise paying close attention to data sources. He also noted that MIDRC will hopefully have the opportunity to expand into other areas besides cancer. The discussion concluded with a question about pediatric health. Dr. Tromberg said several efforts are underway including the RADx Tech Fetal Monitoring Challenge which is in the process of selecting semi-finalists.

Dr. Woychik began by describing the mission and vision of the National Institute of Environmental Health Sciences (NIEHS) located in central North Carolina. The mission is to discover how the environment affects people to promote healthier lives. The vision is to provide global leadership for innovative research that improves public health by preventing disease and disability.

A wide variety of NIEHS programs support the mission, including intramural labs, extramural funding, clinical research, and the National Toxicology Program. One intramural lab supports the toxicology program and collaborates with other federal agencies, including the U.S. Food and Drug Administration (FDA), on bringing new technologies and approaches to study toxicology and take on some of the big challenges on a national scale in toxicology science.

Dr. Woychik then mentioned the institute’s six emerging scientific priority areas: the exposome, precision environmental health, mechanistic and translational biology/toxicology, climate change and health, environmental justice and health disparities, and computational biology and data science.

He first discussed the exposome and the need for an operational definition. Dr. Woychik emphasized that to truly understand the impact of environmental exposures on the etiology of disease, the focus must go beyond studying single exposures. The proposed exposome research network would assess multiple toxins that people are exposed to internally and externally and integrate that data with determinants of health.

The overall goal for the exposome priority area is to develop a common framework for exposomics, promote best practices in data collection and sharing, and build a global exposome research community to foster collaborations. NIEHS, NCI, the National Institute on Aging, the National Institute of Neurological Disorders and Stroke, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the NIH Office of Research on Women’s Health will provide $1.55M in funding for a new Center for Exposome Research Coordination later this year.

The Center would also accelerate the second scientific priority area—precision environmental health. The idea is to build on precision medicine while bringing genetic and environmental effects into the equation. To study complex traits, NIEHS is building on the existing work of the International Common Disease Alliance that uses large genetic cohorts. Dr. Woychik encouraged the environmental health science community to collect and integrate exposomic and epigenetic data into the alliance’s databases. He also discussed a new initiative to advance precision medicine that would integrate geospatial data into the NIH All of Us Research Program. The proposed initiative would have three phases: 1) integrate geographic information system (GIS) coordinates for where participants live/work into the datasets, 2) develop bioinformatics and computational tools to correlate GIS coordinates with different environmental exposures, and 3) conduct a clinical trial with a small cohort from the All of Us Research Program to study type 2 diabetes.

A third scientific priority area for NIEHS is mechanistic translational biology/toxicology. The institute’s Division of Translational Toxicology is collaborating with the Centers for Disease Control and Prevention (CDC) to use AI/ML to understand how genetic expression is impacted by environmental exposures. Dr. Woychik also mentioned that NIEHS is involved in the NIH-wide Complement Animal Research and Experimentation (AIRE) program that will develop, standardize, validate, and use human-based new approach methodologies to transform the current way of doing basic, translational, and clinical research.

Dr. Woychik then summarized two current collaborations with NIBIB and other institutes:

• The Machine Vision-Enabled Behavioral Tracking for Cross-Species Extrapolation would build a broadly applicable cross-species modeling capability that could be used beyond toxicity screens.
• The Multi-tissue Platform for Modeling Systemic Pathologies was developed by Columbia University researchers. The tissue-chip system is linked by recirculating vascular flow for interdependent organ function.

Dr. Woychik concluded his remarks by suggesting possible areas for NIBIB collaboration with NIEHS. He reiterated the need for innovative thinking on the exposome and precision environmental health to integrate data to better understand how complex genetic traits work together to trigger disease phenotypes. He noted that another area ripe for NIBIB collaboration is predictive toxicology involving developing new approach methodologies.

Council members asked what type of technologies within NIBIB’s portfolio are most needed to assess environmental health. Dr. Woychik said the ability to do longitudinal testing is important and that there’s a lot of interest in high-resolution mass spectrometry and epigenetic changes. Council asked what the priorities were for the exposome to focus their short-term efforts. Dr. Woychik reiterated his prior comments and added that operationalizing the exposome is critical that includes defining what data should be collected and monitored and deciding which data management tools to use.

Council also asked whether Dr. Woychik had considered theranostic aspects of the initiatives he described. Dr. Woychik responded that developing a therapeutic requires a fundamental understanding of the etiology of human disease. He added that technologies could be developed to mitigate environmental problems such as air pollution or contaminated water supplies. Council also asked where the new microbiomics or other aspects of the gut microbiome fit into the NIEHS priorities. Dr. Woychik responded that the microbiome is an integral part of their efforts and that they’re discovering that chemical agents may be potentially impacting human health by changing the composition of microbiome.

A. Imaging Phantom Development and Sharing, Dr. Afrouz Anderson

Dr. Anderson started by describing the need for phantom development and dissemination to fill current gaps in the medical imaging device community.

She identified four major gaps that this effort would address:

• Provide repeatability, reproducibility, and quantification.
• Bring quality control and standardization to the fast-growing medical imaging device market.
• Reduce measurement variability and costs for device developers.
• Accelerate innovation, production, regulatory approvals, and translation of medical devices toward clinical use.

NIBIB is proposing a multiprong approach with the goal of expanding the existing NIBIB/National Institute of Standards and Technology (NIST) phantom library begun in 2021. This would involve three new approaches: create a new library within the NIBIB BETA Center, leverage phantoms in the community, and create an industry-university partnership.

Dr. Anderson then discussed the current NIBIB/NIST phantom library that provides a unique government resource to the biomedical research community. She mentioned four services the library provides:

• Access to common standards for round-robin testing and validation
• Phantoms are calibrated and traceable to fundamental standards
• Phantoms are curated with stability monitored (including during shipping)
• Open analysis software and image database

Dr. Anderson summarized the history and growth of the library, noting that it began with three magnetic resonance imaging (MRI) phantoms and has grown to 12 phantoms that include functional MRI (fMRI) and Magnetic Resonance Spectroscopy. Since 2021, there have been 28 phantom loans and more than 30 published articles. This year, the goal is to expand the library to include other imaging types, including optical imaging, acoustic imaging, and computed tomography (CT)/positron emission tomography (PET).

To highlight the library’s value beyond a lending site, Dr. Anderson shared a success story about an isotropic diffusion MRI phantom. She emphasized the roles of multiple partners. An NIH basic research partnership between the Eunice Kennedy Shriver National Institute of Child Health and Human Development and NCI kicked off the phantom development, then the Quantitative Imaging Biomarkers Alliance and the Radiology Society of North America designed the phantom profile, then NIST conducted calibrations and traceability, and finally CALIBER MRI supported its commercialization.

She emphasized that the library not only supported the development of neural and tissue-mimic diffusion phantoms, but it also helped advance new modalities, especially MRI-guided radiation therapy and low-field MRI.

Dr. Anderson elaborated on how the three approaches to expand the library would work.

• The first approach is to establish a second library site within the NIBIB BETA Center to support federal agencies and the imaging community to share and disseminate phantoms and related resources. The deliverables would be:
  • Transferring phantoms from FDA to the BETA Center to share with the community.
  • NIST would characterize and curate phantoms as they come through the new library. They would also develop best practices, standard operating procedures (SOPs), and comprehensive documentation to have reproducible phantoms that can be shared with the public.
• The second approach is to leverage phantoms in the community to support the optimization, characterization, and dissemination of existing phantoms within the community. The deliverables would be:
  • Leveraging existing mechanisms to support phantom development and sharing
  • Developing reproducible and calibrated phantoms [all imaging modalities: optical imaging, MRI, CT, PET, single-photon emission computed tomography (SPECT), acoustic imaging, etc.]
  • Creating best practices and relevant documentations and software
  • Incorporating the phantoms within NIBIB BETA Center phantom library
• The third approach to advance phantom development would be to establish an industry-academic partnership. This would involve:
  • Creating a collaborative multi-sector effort to develop novel tissue-mimicking, dynamic, and standardized optical phantoms.
  • Facilitating regulatory approvals and accelerating the translation of optical imaging devices.
  • Creating an inter-agency collaboration based on the Industry-University Collaborative Research Center (IUCRC) model.
  • The deliverables would be:
    • Calibrated, novel, dynamic, and tissue mimicking optical imaging phantoms
    • SOPs and recommendations related to optical imaging standards
    • Incorporation of the phantoms within the NIBIB BETA Center phantom library

Dr. Anderson concluded her presentation by thanking her colleagues at NIBIB and collaborators at FDA, NIST, NSF, the U.S. Department of Veterans Affairs (VA), the Trans-Agency (Medical) Imaging Phantom (TAIP) working group, the NIBIB/NHLBI Tech Transfer Office, and the NIBIB Office of Science Policy and Communications.

Council was enthusiastic about the concept. Council asked about whether some aspects of phantom development could be disseminated publicly through digital open sources. Dr. Anderson responded that one use for digital open sources would be to obtain feedback from phantom users who are trying to reproduce the phantoms, making it interactive. She added that FDA has posted instructions for its tools on its website. An ex officio council member representing FDA said that these regulatory science catalogues include instructions on how to build phantoms but that 80% of medical device companies don’t have anyone to build phantoms. A phantom library could augment the resources of these companies.

Another council member asked whether the library is interested in tissue imaging phantoms. Dr. Anderson responded that they want to have a wide variety of imaging phantoms, including tissue phantoms. She noted that FDA also has tissue-based phantoms.

Council also asked Dr. Anderson to clarify which community would build the phantoms and whether they would be distributed intramurally or extramurally. She responded that the goal is to replicate the NIBIB/NIST library model through the NIBIB BETA Center. The Center will be a resource to share these phantoms with the outside community but will not be developing new phantoms. A council member asked whether the library would provide guidance about calibrating phantoms, which is often lacking. Dr. Anderson responded that she hopes that their NIST and FDA partners will help with the calibration of phantoms.

B. Biomedical Research Initiative for Next-Gen BioTechnologies (BRING BioTech), Dr. Tuba Fehr

Dr. Fehr began her presentation by noting that the purpose of this initiative is to turn innovative discoveries into human health through improved interagency collaboration by adapting existing NIH funding mechanisms. She explained that a major limitation of existing collaborations stems from the fact that NIH is primarily a biomedical research agency while other government partners support foundational research that are not necessarily well-positioned to transition to NIH funding. Turning foundational discoveries into biomedical technologies requires additional grant applications, resulting in delays to transition the projects to biomedical applications. Because of this, the transition from a partner agency award to an NIH award happens over a long timeframe, if at all, and foundational knowledge can remain siloed.

BRING BioTech is a proposed solution to overcome these limitations. The goal of this initiative is to accelerate the transition of novel fundamental discoveries at partner agencies to early-stage biomedical technologies at NIH. Dr. Fehr proposed adapting the existing NIH R21/R33 bi-phasic awarding process for interagency collaboration. This existing process divides the project into two distinct phases, where the first phase focuses on exploratory and feasibility studies and the second phase focuses on expanded development. Transition between the two phases is not guaranteed, as there is a milestone-driven, go/no-go decision point at this stage. Dr. Fehr emphasized that this funding mechanism is not new to NIH but is instead repurposed to expand existing collaboration with partner agencies.

Dr. Fehr further explained that this bi-phasic approach will entail a single application that allows the seamless transition of fundamental discoveries within the partner agency domain (phase one) into biomedical technologies relevant to the NIH mission (phase two). To ensure success, programmatic oversight will include quantitative milestones in the first phase, and only projects that demonstrate that their discoveries can be developed into biomedical technologies will be allowed to transition into the second phase at NIH. Further, there will be a mid-point programmatic review to assess the readiness of the project to transition into the second phase.

Dr. Fehr notes that many fields could benefit from this initiative. She spotlighted a few key areas:

• Synthetic biology: foundational concepts, such as the design and characterization of new synthetic biological tools and parts, could lead to tools/technologies to modify cell/tissue function
• Quantum technologies: quantum sensing could lead to biomedical technologies to affect health outcomes
• Biomaterials/living materials: chemical/physical properties of new biomaterials could lead to scaffolds to modify/enhance tissue function
• Novel materials for imaging: materials with new physical/chemical properties could lead to improved biomedical imaging

Council expressed enthusiasm about this concept clearance and asked how the proposals would be reviewed by both partner agencies. Dr. Fehr explained that the investigators would prepare a single package that would be reviewed jointly by both partner agencies. Council also asked which federal agencies would be partners in this effort. Dr. Fehr envisions that any federal agency that focuses on basic science and foundational research would be a good partner. Council also asked if there would be a way to match a foundational discovery with a biomedical research application. Dr. Fehr noted that the onus is ultimately on the investigator, as they will need to develop a package for both phases of funding. However, she anticipates that resources, such as webinars, will be provided to potential applicants to help traverse this gap. Council suggested that NIBIB could potentially gather a list of investigators with translational expertise to aid potential applicants with their proposals.

The open session of the NACBIB meeting was adjourned at 2:44 p.m.

Review of Council Procedures and Regulations: Dr. David 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). The closed session was adjourned at 3:40 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.

The National Advisory Council for Biomedical Imaging and Bioengineering considered 1906 research and training applications requesting $2,822,663,510 in total costs. The Council recommended 1906 applications with a total cost of $2,822,663,510.

Adjournment

The closed session was adjourned at 3:40 p.m.

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

²These minutes will be approved formally by the Council at the next meeting on May 15, 2024, and corrections or notations will be stated in the minutes of that meeting.