Minutes September 13, 2022

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 13, 2022

The National Advisory Council for Biomedical Imaging and Bioengineering (NACBIB) was convened for its 60th meeting on September 13, 2022, 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 92­463, the meeting was open to the public from 12:00 p.m. to 2:58 p.m. for review and discussion of program development, needs, and policy. The meeting was closed to the public from 3:06 p.m. to 3:14 p.m. for the consideration of grant applications. 

Council Members present: 

Dr. Samuel Achilefu, Washington University School of Medicine, St. Louis, MO 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, University of California, San Francisco, San Francisco, CA Dr. Maryellen Giger, University of Chicago, Chicago, IL Dr. Amy Herr, University of California, Berkeley, Berkeley, CA Dr. Ranu Jung, Florida International University, Miami, FL Dr. Kathryn Nightingale, Duke University, Durham, NC Dr. Bruce Rosen, Massachusetts General Hospital, Charlestown, MA 

Council Members absent: 

Dr. Manu Platt, Georgia Institute of Technology, Atlanta, GA 

Ex Officio Members 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 Members absent: 

Mr. Xavier Becerra, Department of Health and Human Services, Washington, DC Dr. Francis Collins, National Institutes of Health, Bethesda, MD Dr. Vincent Ho, Uniformed Services University of the Health Sciences, Bethesda, MD Dr. Anne Plant, National Institute of Standards and Technology, Gaithersburg, 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 207 observers attended the open session, including NIBIB staff, and members of the general public. 

Call to Order: Dr. David T. George 

Dr. David George called to order the 59th 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. New Council Members and NIBIB Staff 

Dr. Tromberg thanked NIBIB staff for all their work in preparing for Council and welcomed incoming council members: Cynthia McCollough, Ph.D., Mayo Clinic; Daniel Sodickson, M.D., Ph.D., New York University; and Joyce Wong, Ph.D., Boston University. 

Dr. Tromberg next welcomed new NIBIB staff: Alexander Komendantov, Ph.D., Scientific Review Officer, and Lawane Terrell, Extramural Support Assistant in the Office of Scientific Review; Shawn Mulvaney, Ph.D., Program Director in the Division of Applied Science and Technology and Division of Health Informatics Technologies; David Gutekunst, Ph.D., Program Director in the Division of Interdisciplinary Training; and Jermont Chen, Ph.D., Jessica Falcone, Ph.D., and Lee Sims, Program Directors in the Division of Applied Science and Technology. 

B. Budget Update

Dr. Tromberg discussed the new Senate-proposed FY23 appropriations summary. In the proposed budget, NIBIB would receive a 3.1% increase. The final NIBIB FY22 R01 payline was the 19th percentile (24th percentile for New Investigators). 

In the past three years, NIBIB has received a total of $1.7B in additional funding for the purpose of combating COVID-19. Those funds were directed to NIBIB’s pandemic response, specifically imaging and artificial intelligence (AI), in vitro diagnostics, and digital health platforms. 

C. New Funding Opportunities and Updates

Dr. Tromberg brought attention to current funding opportunities and gave updates on previous opportunities:

Notice of special interest (NOSI): Alzheimer’s disease administrative supplements: These supplements, managed by Dr. Randy King, allow a researcher to use the supplement to pivot their current research focus to Alzheimer’s disease. Supplement request may be up to $250K in direct costs. NIBIB awards about 14 of these supplements per year. 

BRAIN RFA for non-invasive imaging technology development: The goal of this research funding announcement (RFA) is to support team-based development and validation of innovative non-invasive imaging technologies that impact the study of brain function/connectivity. The RFA is overseen by Dr. Shumin Wang, uses a phased corporate agreement mechanism and applications are due on October 13th, 2022. 

Program announcement (PAR) for Point-of-Care Technologies Research Network (POCTRN): This is the fourth reissuance of a five-year program that currently includes seven Institutes or Centers: NIBIB, National Heart Lung and Blood Institute (NHLBI), National Institute of Allergies and Infectious Disease (NIAID), National Institute of Drug Abuse (NIDA), Fogarty International Center (FIC), National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI). The purpose is to drive the development and application of point-of-care (POC) technologies, collaborations, and commercialization. Dr. Tiffani Lash is the program leader and applications are due on October 3, 2022. 

Blueprint MedTech: Incubator Hubs for early-stage neurotech products: There will be a solicitation opening on September 27, 2022, with pre-proposals due October 25, 2022, for early-stage neurotechnology products. The Incubator Hubs will support the development of devices that diagnose and/or treat disorders of the nervous system and have a demonstrated proof-of-concept. Applications may propose to adapt an existing device to a new indication. There will be up to 30 new awards per year with up to $500K per year for up to four years. Dr. Michael Wolfson is overseeing this solicitation.

RADx Tech for Maternal Health: The purpose is to leverage the Rapid Acceleration of Diagnostics (RADx®) funnel method to accelerate innovation in point of care and home-based diagnostic and remote-sensing technologies to address severe maternal morbidity and mortality with a milestone-based award competition structure to rapidly validate and de-risk technologies. A total of $8M in prizes are availbale. The submission deadline is November 1, 2022. Dr. Taylor Gilliland oversees this challenge. 

Request for information (RFI) inviting comments and suggestions on pediatric medical devices public-private partnership: This RFI requests input to identify challenges, gaps, clinical needs, and research opportunities related to pediatric medical devices as well as inform research priorities to create a national ecosystem that optimizes collaboration, coordination, investments, and resources in the pediatric medical device space. Dr. Afrouz Anderson is overseeing this RFI. The comment period closes September 21, 2022.

Helping to end addiction long-term (HEAL) - translational development of diagnostic and therapeutic devices: A new funding opportunity for a prototype for diagnostic and therapeutic devices for pain or opioid use disorder was discussed. The application period is open from October 14, 2022 to November 14, 2022. This RFA is being overseen by Drs. Moria Bittmann and Michael Wolfson. 

Kidney X: The Artificial Kidney Prize is a partnership between HHS and the American Society of Nephrology. The prize is divided into two tracks. The purpose of the first track is to clear a path to a prototype of a bioartificial kidney that includes patient input and a timeline to first-in-human trials. Track two is open to applicants who can provide a tool or component that addresses a specific challenge to the development of a functional artificial kidney. There will be up to $10.5M in prizes. Submissions for track one and track two close on October 28, 2022, and on January 28, 2022, respectively. 

RFA: Technology Development to Reduce Health Disparities: Three applications have been funded from the first round of this RFA.  These include projects to develop bias-free pulse oximetry, rapid POC hepatitis C diagnostic technology, and a continuous, real-time, non-invasive CO2 monitor to prevent death in underserved populations from opioid overdose.  The next due date is January 26, 2023. 

Bridge to Artificial Intelligence (Bridge2AI): The goal of the Bridge2AI initiative is to propel biomedical and behavioral research forward by setting the stage for widespread use of AI technologies. It will generate flagship datasets, prepare AI-ready data, emphasize ethical best practices, and promote diverse teams. The announcement of the winners will be made later today, September 13, 2022. 

Design by Biomedical Undergraduate Teams (DEBUT): The 2022 DEBUT Prize Challenge received 73 applications engaging 456 students at 44 universities in 21 states and three foreign countries. There were three NIBIB prize winners with five honorable mentions; four winners from other NIH institutes; and two winners from VentureWell, a not-for-profit partner in the Challenge. NIBIB winners included a bias-free pulse oximeter, a point-of-care test for Group B Streptococcus, and a tool to measure cervical stiffness to determine the risk of preterm birth. 

National Technology Accelerator Challenge (NTAC) for Maternal Health: The goal of this prize challenge was to develop innovative diagnostic technologies to help improve maternal health by diagnosing conditions related to maternal morbidity and mortality.  Winners included a home-based diagnostic tool for surgical site infections and anemia for post-cesarean deliveries, a maternal obstetrics monitoring sock, a near-infrared spectroscopy platform to diagnose maternal hemorrhage and fetal distress during pregnancy, a wearable ultrasound/electrochemical sensor for maternal health surveillance, and a POC diagnostic tool for preeclampsia and anemia in pregnancy. 

D. New Prize Challenges 

NIH Long COVID Computational Challenge (L3C): Lead by Drs. Taylor Gilliland and Qi Duan, this challenge seeks to spur and reward the development of AI/machine learning (ML) models to identify which patients with COVID-19 are more likely to develop Long COVID. Submissions are due by December 15, 2022. 

Virtual 2022 Synthetic Biology Consortium Meeting: This meeting will be held on December 14, 2022, and the theme is “Control theory approaches to create reliable/robust synthetic biology tech, tools, and processes.” There will be pre-meeting breakout sessions and it will showcase NIH-funded research from Synthetic Biology Consortium IC programs as well as provide networking sessions with NIH program staff. 

Interagency Modeling and Analysis Group (IMAG) digital twins: Along with the National Academies of Sciences, Engineering, and Medicine (NASEM), IMAG will launch an 18-month roadmap study that will bring digital twin approaches to biomedical, earth and environmental systems, and aerospace engineering challenges. More information can be found at the NASEM website. 

E. Intramural Research Program (IRP) and Extramural Staffing Updates 

• Kaitlyn Sadtler, Ph.D. received an honorary doctorate from the University of Maryland. 
• Hari Shroff, Ph.D. is taking on a new position at the Howard Hughes Medical Institute’s Janelia Research Campus. He will maintain ties with NIBIB and NIH in his new position. 
• The Instrumentation Development and Engineering Application Solutions (IDEAS) Lab has officially joined NIBIB’s IRP. Composed of eight engineers, the lab has 40 active projects and collaborations with 18 NIH Institutes and Centers. This service provides engineering, computation, and prototyping expertise. 
• Biomedical Engineering and Technology Acceleration (BETA) Center: This will be an NIH-wide center with the purpose of accelerating the development, validation, and dissemination of high-impact biomedical technologies. The Center will partner with the extramural community. 
  • The BETA Center director recruitment is almost complete and should be announced soon. BETA Center director will also be the Associate Director for Science Diversity, Equity, Inclusion, and Accessibility.
• Recruitment for a Scientific Diversity Officer is also in progress. 
• NIBIB is recruiting a Director of the Division of Applied Science and Technology.  Applications will be accepted at USAJOBS -The Federal Government's official employment site) during September 21 – 30, 2022.

F. Pandemic Response: The Medical Imaging and Data Resource Center (MIDRC) and RADx Updates: 

Dr. Tromberg summarized NIBIB’s role in the pandemic response since 2020. NIBIB’s major contributions have been in imaging and AI, in vitro diagnostics, and digital health platforms.  

MIDRC has released a public database of 10 terabytes of data with almost 90,000 studies. MIDRC is comprised of more than 230 users from more than 160 institutions and has produced almost 30 publications. MIDRC has begun to work with NHLBI and National Center for Advancing Translational Sciences (NCATS) to create interoperability with the National COVID Cohort Collaborative (N3C) and Catalyst databases and to expand the influence of its imaging database. 

As of June 2022, RADx Tech had produced 3.9B COVID tests with the dominant tests being at-home tests. There are a total of 45 Emergency Use Authorizations with 11 of them being over-the-counter (OTC) tests. 

NIBIB Deputy Director Dr. Jill Heemskerk discussed the RADx Tech efforts to produce home tests that are accessible for use by people with disabilities. A listening session was conducted in March 2022 with six federal agencies. NIH participants included: NIBIB, National Eye Institute (NEI), National Institute on Aging (NIA), National Institute for Medical Rehabilitation Research (NICMRR), and National Institute of Nursing Research (NINR). Other agencies included: Centers for Disease Control and Prevention (CDC); U.S. Food and Drug Administration (FDA); the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR); the National Council on Disability; and the U.S. Access Board, as well as advocacy groups. The listening session had three focus areas: blind/low-vision, fine motor impairment, and older adults.

Some of the takeaway lessons from the session centered on test packaging and instructions, test procedure, and interpreting results. Regarding packaging, identified problems included: no scannable identifiers on the boxes to indicate the test manufacturer, small print with complex instructions, few language options and no braille, and a need for simple, step-by-step demonstrations. Regarding test procedures, problems included: too many steps, counting drops, small hole for liquids, multiple small parts, and “Do not touch” instructions that make it difficult for people with low vision who need to touch to identify the various parts of the test. When it came to interpreting results, issues included: no clear readout and the fact that smartphones are not accessible to everyone. 

The RADx Fast Track Accessibility Initiative was one arm of NIBIB’s response to this problem. The idea was to get accessible tests available as soon as possible by modifying tests that are already on the market. The plan is for test production to begin in the fall or winter of 2022. Another aspect of the fast-track plan is to develop a new instruction template that can be given to any test manufacturer to create more accessible instructions. The final step in the plan is the creation of best practices recommendations for industry that can be broadly applicable to home tests. 

Dr. Tromberg outlined the new RADx Tech III initiative which will award up to $300M to develop OTC COVID-19 technology designed for independent use by people with disabilities, including blindness, low vision, and fine motor skills; proposed tests will improve accessibility and ease of use. The initiative will also award next-generation OTC/POC COVID-19 technology developments with innovations that significantly improve clinical performance. The application funnel will open on September 20, 2022.

A new opportunity to leverage the RADx Tech infrastructure that has been used during the COVID-19 pandemic is to address the monkeypox virus. Currently there are no authorized POC tests for monkeypox in the U.S. RADx Tech Independent Test Assessment Program (ITAP), NIH’s partnership with the FDA, is working to accelerate regulatory authorizations for monkeypox diagnostic POC nucleic acid tests, POC rapid antigen tests, and at-home self-sampling kits.  

G. Council Discussion: 

Council expressed appreciation for the work coming out of NIBIB and the versatility of the RADx Tech process as it is being applied to other areas. They also expressed interest in the research area of digital twins and hoped to see NIBIB expand research in that area. They also were pleased to see NIBIB’s focus on health disparities and minority research. Concern was expressed over current “medical standards” and databases that have intrinsic bias. Dr. Tromberg responded that NIH is interested in creating fair databases without intrinsic bias. He mentioned that this was a goal of MIDRC. Council was also excited to hear about NIBIB’s focus on accessible testing and requested that the accessibility guidelines be made available to students as well.

Dr. Qi Duan presented an overview of the NIH Data Management and Sharing Policy, which will go into effect in January 2023. In 2015, NIH commenced a process to update the policy, which was originally enacted in 2003. The goal of the policy is to advance rigorous and reproducible research and promote public trust in biomedical research.

The updated policy will apply to all research studies generating scientific data, and a data sharing plan will be required as a part of the grant submission. The focus of the updated plan is to manage and share data, but it is not a requirement to share all data. The updated policy is the NIH-wide minimum requirement for data sharing, but special funding opportunities may have additional requirements. NIH is hosting two webinars to provide grantees with more information about the new policy. The webinars will be recorded and posted to the NIH Scientific Data Sharing  webpage.

Earlier this year, NIBIB formed a working group to develop and strategize implementation of an Institute-specific data sharing policy while maintaining compatibility with the NIH policy. NIBIB has a unique position at NIH that focuses on technology development for biomedical research.

NIBIB’s mission presents a unique relationship between research findings and data. Traditionally, NIH-supported research is hypothesis-driven, where a researcher will design a study to acquire data that supports this hypothesis, which leads to research findings. In contrast, technology-driven research usually starts with engineering principles, which leads to research and development. Technology-driven projects require significant preliminary effort and analysis, rounds of trial-and-error, and redesign of prototypes before the technology can be shared. Data acquired during the research and development process is often significantly smaller than hypothesis-driven research.

An effective way to share outcomes of technology-driven research is publication. Publications include many forms, like peer-reviewed journals, conference papers, and preprints. Dr. Duan shared a few examples of publications that successfully provide data and supplemental information to allow for reliable research or technology reproduction.

He closed by adding that program staff are always able to help grantees throughout the process.

Council members expressed that they thought it was a good idea to encourage results to be more reproducible. They also expressed concern that many labs still use lab notebooks and asked if NIH is focusing on encouraging electronic lab notebooks. Dr. Duan responded that NIH is requiring investigators to consider data management before beginning research and established a proper framework for data management. Questions were raised regarding sharing human imaging data and facial recognition and what NIH guidance would be. Dr. Duan pointed out that there are efforts to develop tools for proper anonymization. The NIH website outlines considerations for handling sensitive data, including patient data.

Dr. Morris introduced the goal of a proposed new Biomaterials Network, which will be to address challenges to technology translation, specifically in biomaterials. Going from an innovative idea to a clinical application has many challenges, including reproducibility, clinical relevance, support, regulatory considerations, risk, collaborations, follow-through, and time. This network will focus on traversing this biotechnology “valley of death” and enable participants’ technologies to be adopted and disseminated to the broader community. 

Biomaterials are supported across NIH by various ICs. While stimulating interest is not needed, there is a need to reduce project issues in the early stages of new biomaterials technology development by addressing bottlenecks, such as understanding the science, challenges to manufacturing, faulty clinical trial designs, and difficulties in securing funds. The Biomaterials Network is designed to address these bottlenecks and provide the right resources at the right time at every step from the bench to the bedside.

The network is intended to accelerate the translation of biomaterials-based technologies through early access to coordinated expertise that is designed to provide support along the development pipeline. The network is also building on and leveraging some of the success of previous networks, including POCTRN, the Innovative Molecular Analysis Technologies (at NCI), and the Genome Technology Program (at NHGRI).

The three goals of the Biomaterials Network include: 

1. Facilitating the development of a pipeline of a broad array of biomaterials-based technologies with clinical and commercialization potential. 
2. Providing expertise and resources to lay the groundwork to overcome future barriers to implementation and commercialization. 
3. Enabling targeted collaborations within the Network and across NIH at early and advanced stages of technology development. 

Dr. Luisa Russell then discussed the two Network Centers: the Technology Coordination and Integration Center and the Technology Resource Center, which will work together to support the design and translational needs of the technology development projects. The Technology Coordination and Integration Center will focus on coordination of technology development efforts supported by the Network, while the Technology Resource Center will aid in the technology development process by providing expertise and resources to address barriers to technology dissemination and translation. Centers would include funding via the cooperative agreement mechanism and/or contracts.

Two research project types will be supported by the Network. Exploratory research projects are designed to support proof-of-principle through early-stage engineering projects. Prototyping research projects are designed to support biomedical proof-of-concept projects through early-stage validation. Both types of projects are designed to be milestone-driven and will work with Center resources. Prototyping projects would be supported via cooperative agreements or grants. The Network plans to leverage R21 and R01 mechanisms, but these mechanisms will differ due to the focus on the interaction between the Network Centers and the technology development projects.

The Network Centers will be responsible for providing consultancy, modeling, education, and design resources. They will identify and build partnerships and assess projects for need and utilization of resources. They will administer opportunity funds for standards, validation, and studies. The technology development projects will take advantage of technical, clinical, and commercialization consultants as needed as well as modeling and simulation resources. They will also undergo a needs assessment by the Centers and will have the ability to apply for opportunity funds to support partnerships.

The Network will attempt to bring novel biomaterial types to NIH ICs that focus on traditional medical concerns and facilitate partnerships with other ICs, leveraging Network resources to promote biomaterials solutions for IC-specific needs. The structure of this network could potentially be applied to other NIBIB-supported engineering fields such as synthetic biology and biodevices.

Council members were supportive of the concept and raised questions regarding whether other Federal institutions will get involved and how the Network would continue to sustain interest. Council also brought up the importance of bringing in payors (e.g., insurance companies) and other stakeholders and resources available from agencies such as National Institute of Standards and Technology (NIST) and National Science Foundation (NSF), among others early in the process. Dr. Tromberg highlighted how NIBIB leadership meets regularly with Center for Medicare and Medicaid Services (CMS), the FDA, and the CDC to help integrate NIBIB's new technology development into mainstream use.

Dr. Tromberg thanked NIBIB staff and Council for their participation and the open session of the NACBIB meeting was adjourned at 2:58 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 lO(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2). 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

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