Minutes January 25, 2023

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 25, 2023

The National Advisory Council for Biomedical Imaging and Bioengineering (NACBIB) was convened for its 61st meeting on January 25, 2023, 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 12:00 p.m. to 3:36 p.m. for review and discussion of program development, needs, and policy. The meeting was closed to the public from 3:41 p.m. to 3:54 p.m. for the consideration of grant applications.

Council members present:

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

Dr. Gilda Barabino, Olin College, Needham, MA

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

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

Dr. Tejal Desai, 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, University of Arkansas, Fayetteville, AK

Dr. Cynthia McCollough, Mayo Clinic, Rochester, MN

Dr. Kathryn Nightingale, Duke University, Durham, NC

Dr. Daniel Sodickson, New York University, Grossman School of Medicine, New York, NY

Dr. Joyce Wong, Boston University, Boston, MA

Ex officio member attending:

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

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

Dr. Susan Margulies (on behalf of 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. Sohi Rastegar, National Science Foundation, Arlington, VA

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

Call to Order: Dr. David T. George

Dr. David T. George called to order the 61st 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.

1. Staff Updates

   Dr. Tromberg welcomed new NIBIB staff: Jenica Patterson, Ph.D., program director in the Office of Program Evaluation and Strategic Partnerships; Albert Avila, Ph.D., scientific diversity officer in the Office of the Director; Peter Lyster, Ph.D., program manager in the Division of Health Informatics Technologies; Brad Bower, Ph.D. and Mohd Anwar, Ph.D., Data Technology and Advancement (DATA) National Service Scholars; and Mutema Nyankale, chief grants management officer in the Office of Grants Management.

   Dr. Tromberg next thanked departing NIBIB staff: Krishna Juluru, M.D., a Presidential Innovation Fellow; and Rui Sá, Ph.D., a DATA National Service Scholar.

   Dr. Tromberg also thanked the entire NIBIB staff, especially those who helped to plan this council meeting. He specifically thanked the Office of Science Policy and Communications for communicating NIBIB scientific advances and initiatives. He highlighted the NIBIB YouTube channel, which recently surpassed 5M views, along with a 2022 wrap-up of NIBIB scientific and program news.

2. Council Member Updates

   Dr. Tromberg noted that council member Dr. Manu Platt would be ending his term early. This is because Dr. Platt has been selected as the inaugural director of the Biomedical Engineering Technology Acceleration (BETA) Center, a new NIH-wide center for technology-driven interdisciplinary research and clinical translation. The center, housed within NIBIB, will also help to expand diversity, equity, inclusion, and accessibility within the NIH intramural research program. Nicole Morgan, Ph.D., has been selected as the acting² deputy director of the BETA Center. Dr. Tromberg referenced the NIBIB press release that officially announced the creation of the BETA Center.

3. Budget

   Dr. Tromberg next spoke about the FY23 appropriation for NIH, which was enacted in December 2022. Overall, the budget for NIH is $47.5B, reflecting a $2.5B increase (5.6%) compared with FY22. The budget for NIBIB is $440.6M, reflecting a $16.1M increase (3.8%) compared with FY22. Several NIH programs received specific funding lines, including programs in which NIBIB participates. These programs include the NIH Helping to End Addiction Long-term (HEAL) Initiative®, the Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative, and the Implementing a Maternal health and Pregnancy Outcomes Vision for Everyone (IMPROVE) Initiative.

4. Program Announcements, Opportunities, and Updates

   Position openings: Dr. Tromberg highlighted two program director openings, one each in the Division of Applied Science and Technology (DAST) and in the Division of Informatics Technologies (DHIT). The program director opening in DAST is for medical imaging technologies with a focus in nuclear medicine, while the DHIT program director opening is for point-of-care and digital health technologies. These positions are both open to the public and open to status candidates, with a due date of January 27, 2023.

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   ² Correction to the record.

   Trailblazer Award for New and Early-stage Investigators: The R21 Trailblazer Award (PAR-24-022) has been re-issued, with the National Eye Institute and the National Institute on Aging newly participating in this funding opportunity. Dr. Tromberg noted that this award is different from typical R21s or other NIH grants; the award focuses on new and early-stage investigators and preliminary data is not required, expected, or encouraged. Application due dates in 2023 are February 16, June 16, and October 16. Dr. Randy King is leading the NIBIB effort.

   Diversity and Health Disparities Funding Opportunity Updates: Based on an NIBIB council recommendation, an additional application due date has been added to the Technology Development to Reduce Health Disparities funding opportunity (NOT-EB-22-016); the additional due date is May 31, 2023. NIBIB has chosen to withdraw from the New Investigators to Promote Workforce Diversity in Genomics, Bioinformatics, or Bioengineering and Biomedical Imaging Research funding opportunity (RFA-HG-21-041) and will instead be participating in an NIH-wide funding opportunity (Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity; PAR-22-181). The goal of this funding opportunity is to support research from new and at-risk investigators from diverse backgrounds, including investigators from underrepresented racial and ethnic groups, to enhance the diversity of R01-funded awardees. Because eight other NIH Institutes and Centers (ICs) participate, Dr. Tromberg noted that joining this funding opportunity aligns NIBIB with the greater NIH effort and will optimize the matching of awards and partnerships of applications with other ICs. Upcoming due dates are May 5, 2023; September 6, 2023; and January 9, 2024. NIBIB contact for this opportunity is Dr. Albert Avila.

   NIH DMS Policy: Dr. Tromberg noted that the NIH Data Management and Sharing (DMS) policy, which was covered extensively in the last Council meeting, goes into effect today. He said that the NIH Scientific Data Sharing website is a ‘one-stop shop’ for DMS-related content, including policies, guidance, and tools. NIH expects investigators to publish their research findings, share scientific data for reproducing published technology, and cite shared data in their publications. He thanked Dr. Qi Duan and his team for leading the NIBIB effort.

   Past and Upcoming Meetings, Workshops, and Events: Dr. Tromberg summarized past events and highlighted upcoming workshops.

   • P41 National Technology Centers Webinar Series: On December 12, 2022, three P41 centers came together to host a workshop about molecular imaging technologies. Over 140 participants from 40 organizations attended the workshop. This was the first P41 workshop that focused on one specific area; additional seminars focusing on data science centers and magnetic resonance imaging (MRI) centers are planned for later this year. Dr. Tromberg noted that recordings of these workshops will be available on the P41 website. Dr. Behrouz Shabestari, Dr. Tatjana Atanasijevic, and Asha Storm organized this effort.
   • 2022 Synthetic Biology Consortium Meeting: On December 14, 2022, over 180 participants attended the Synthetic Biology Consortium Meeting, which focused on control theory approaches for synthetic biology technologies. Breakout sessions focused on toolkits and modeling, engineered biology capabilities and bottlenecks, responses to the pandemic, and scaling-up of biocontrol methods. Meeting recordings are available on the website. Dr. David Rampulla, Dr. Jermont Chen, and Julia Ringel organized this event.
   • NASEM Digital Twins Workshops: The National Academies of Sciences, Engineering, and Medicine (NASEM) are holding three upcoming workshops focused on digital twins. The first workshop, to be held on January 30, 2023, will focus on opportunities and challenges for digital twins in biomedical sciences. The second workshop, which will be held February 1-2, 2023, will focus on digital twins in atmospheric, climate, and sustainability science. The third workshop, which will take place February 7-9, 2023, will focus on opportunities and challenges for digital twins in engineering. Dr. Tromberg hopes that the NIBIB community can take the lead in the digital twin space, as it will likely lead to many research opportunities, such as the development of in silico models that could help reduce the use of animals in the research setting. Dr. Grace Peng is the NIBIB point of contact for these workshops.
   • 2023 NIH Grants Conference: The NIH Grants Conference will take place February 1-2, 2023. This conference will include 25 sessions with live question and answer sessions about the processes and policies behind NIH funding. Dr. Tromberg noted that communicating this information to young and mid-stage investigators who want to get involved in the NIH system is essential. Registration is free and includes access to the entire virtual conference.
   • Joint DOE/NIH Workshop: In conjunction with the U.S. Department of Energy (DOE), NIH is hosting a workshop focused on radiation detection as part of the Advancing Medical Care through Discovery in the Physical Sciences Workshop Series. This workshop is the second in an annual series and will take place March 16-17, 2023, at the Thomas Jefferson Lab in Newport News, Virginia. Technical areas to be discussed at the conference include cameras and detectors for external imaging, diagnostic imaging, and therapeutics; electronics and data acquisition; image reconstruction; and applications of artificial intelligence. Drs. Tatjana Atanasijevic and Behrouz Shabestari are the NIBIB points of contact for these workshops.
   • Maternal Health Webinar and Workshop: A notice of special interest (NOSI), titled Small Business Initiatives for Innovative Diagnostic Technology for Improving Outcomes for Maternal Health (NOT-EB-21-001), was recently announced. To facilitate submissions, NIBIB is hosting a technical assistance webinar on February 10, 2023. As part of the NIH IMPROVE Initiative, there will be a hybrid workshop, titled Innovative Approaches to Improve Maternal Health, held May 8-9, 2023, at the NIH Natcher Center. Dr. Afrouz Anderson is the NIBIB point of contact for these events.

   NIH HEAL Initiative: Dr. Tromberg shared the list of awards funded out of an initiative entitled, Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management, which is supported by the NIH HEAL Initiative. Seven R61/R33 applications have been awarded, totaling more than $5M. Technologies supported include MRI, ultrasound, optical imaging, photoacoustic imaging, bioimpedance spectroscopy, surface electromyography, electrical impedance myography, and positron emission tomography (PET)/computed tomography (CT). Dr. Tatjana Atanasijevic and Dr. Guoying Liu are leading the NIBIB effort.

   MIDRC: Since its inception, The Medical Imaging and Data Resource Center (MIDRC) has released roughly 105,000 imaging studies and more than 24 algorithms, with 70,000 imaging studies released in the last six months. Dr. Tromberg noted that there is growing momentum for MIDRC, exemplified by the growth in users (350 users total from over 250 institutions). The dataset sequestered by the U.S. Food and Drug Administration (FDA) for product validation has also grown, totaling approximately 20,000 imaging studies.

   Dr. Tromberg highlighted that one way to leverage the MIDRC community’s expertise is through challenges. The first MIDRC grand challenge was recently completed, and the winners were announced at the Radiological Society of North America meeting in December 2022. The challenge was focused on COVID-19 positivity based on frontal-view portable chest radiographs; the winning code is posted on the public MIDRC GitHub website. Drs. Brad Bower and Rui de Sá are leading the NIBIB effort.

   DEBUT Challenge: The Design by Biomedical Undergraduate Teams (DEBUT) Challenge has a total prize purse of $145,000 this year, with a submission deadline of May 31, 2023. The most recent prize addition is a special award for technologies to empower nurses in community settings. Dr. Tromberg noted that the challenge typically garners approximately 500 participants around the country from roughly 75 institutions. NIBIB hopes to expand participation; Dr. Tromberg urged the council members to encourage students and teams to apply. He underscored that the prize money goes directly to the students. Dr. Dave Gutekunst is leading the NIBIB effort.

5. RADx® Updates

   Expansion to other partnerships: Dr. Tromberg talked about how the Rapid Acceleration of Diagnostics (RADx®) program has generated additional partnerships with other ICs. He noted that there are four current “innovation funnels” in progress. These funding opportunities include the development of next-generation and accessible COVID-19 diagnostic tests (“Tech 3”); the development of devices to diagnose and treat nervous system disorders (Blueprint MedTech); the development of devices to monitor post-partum health at the point of care (RADx Tech for Maternal Health Challenge); and the development of point-of-care viral load tests to monitor treatment and infectiousness of HIV/AIDS (Advanced Platforms for HIV Viral Load Testing at the Point-of-Care).

   Dr. Tromberg also spoke of three initiatives through the Independent Test Assessment Program (ITAP): One for mpox (formerly monkeypox), one for multiplex respiratory tests, and a new viral point-of-care test pending announcement. Dr. Tromberg noted that all these funding opportunities illustrate how the processes that were developed and expanded to produce COVID-19 diagnostics can be applied to other disease areas.

   Impact: Dr. Tromberg noted that RADx-supported companies have contributed 6.7B COVID-19 tests as of December 2022. He also spoke of transformational programmatic advances, such as the development of the Home Test to Treat program. Further, on the national COVID.gov website, where free COVID-19 diagnostic tests can be ordered, a prominent button directs users to report their at-home test results on the Make My Test Count website, an effort supported by NIBIB.

   Accessible Home Test Program: Deputy Director Dr. Jill Heemskerk gave an overview of steps taken to make at-home COVID-19 tests more accessible. She explained that this effort was stimulated by advocacy and outreach groups who noted that the at-home tests distributed by the government could not be used independently by users with disabilities.

   As a first step, NIBIB convened a listening session with other government agencies and advocacy groups. The advocacy groups represented people with no/low vision, motor impairments, and older adults. From this listening session, a variety of challenges with current at-home tests were discussed, such as the test packaging and instructions, the test procedure, and interpreting test results. Dr. Heemskerk noted that while these issues were brought up from advocacy groups, these challenges are universally faced by all who use tests currently on the market.

   RADx Tech partnered with 17 designers and reviewers from blind, aging, and motor impairment populations to begin to develop solutions to this problem. The program is currently working with companies, design firms, and subject matter experts to come to agreement on which solutions should be incorporated into prototype tests, with eventual validation.

   To preserve important knowledge learned through this process, a best practices document for the design of accessible tests was recently published on the U.S. Access Board website. (The U.S. Access Board is the U.S. agency responsible for implementing accessibility guidelines under the Americans with Disabilities Act.) This 92-page document is a generalizable roadmap for industry to build more accessible home medical devices and includes potential issues related to accessibility paired with design recommendations. The target audiences are commercial manufacturers, designers, and engineers.

   In parallel, the ‘Tech 3’ innovation funnel, of which one branch focuses on accessible tests, has received 51 applications that are currently undergoing review. This funding opportunity will allow manufacturers to design a test with accessibility as a foremost concern from the outset, rather than modifying existing test design. Further, the second branch of the ‘Tech 3’ innovation funnel has received 167 applications; this funding opportunity focuses on high-performance tests, and accessibility of the design is included in the requirement. She concluded her discussion by expressing hope that the push from the RADx program to bring more accessible tests to the market will take hold across the industry, and that we will see a transformation of the field where accessibility becomes an unprompted priority that test developers incorporate moving forward.

Drs. Krishna Juluru and Andrew Weitz discussed another RADx Tech program called Home Test to Treat. This pilot was launched in January 2023 in Berks County, PA.

Home Test to Treat is made possible as a result of the RADx Mobile At-home Reporting through Standards (MARS) program. The program navigates app developers through the reporting landscape, sets a health care industry standard for test results data, provides NIH funding to cover costs of reporting, and promotes data hubs to lessen the burden of complex channels. It also created parallel data streams to state and federal systems so that the federal health system did not need to rely on the states to send the information. The program also developed a high-end schema to help developers design the workflow for users.

RADx MARS built on existing health care standards. NIBIB and the Office of the National Coordinator for Health Information Technology (ONC) collaborated to develop Health Level 7 version 2 (HL7v2) and Fast Healthcare Interoperability Resources (FHIR) specifications for capturing and transmitting over-the-counter test results from mobile and web applications that:

• Conformed to federal and state guidelines for required data elements
• Had out-of-the box compatibility with state health systems
• Are currently undergoing the FHIR balloting process
• Lend itself to downstream de-duplication

There are multiple companies already using and reporting results through RADx MARS and there are a number of other companies in discussions or onboarding to the platform. Altogether, the companies involved in RADx MARS represent the majority of market share of test makers in the U.S.

RADx MARS has accomplished many of its primary goals, such as establishing a standard for capturing home test result data, establishing standardized mechanisms to transmit that data to downstream health systems, and driving adoption of the standard by the majority of test manufacturers.

The Home Test to Treat program enables individuals to be tested for COVID-19, see a health care provider, receive a prescription for an oral antiviral treatment (if warranted), and have the prescription filled—all from their home or nearby pharmacy.

For the pilot Home Test to Treat program in Pennsylvania, the expected population size was up to 121,000. It is expected that there will be 86,000 test kit shipments, 8,170 telehealth visits, and 6,183 antiviral shipments. The Home Test to Treat program is in active discussions to include additional pathogens such as the flu in multiplex testing and hopes to empower individuals to manage their health care data.

Council members asked if RADx MARS was connected to the SHIELD program, a local testing program operated by the University of Illinois. Dr. Juluru responded that RADx MARS has been closely tied with the community at large and that there is a need for standardization in communicating results. Council members also appreciated how RADx MARS could help address future point-of-care testing and treatment for other pathogens as well. Council also asked how RADx MARS would be able to incentivize those who were not able or willing to test or report results. Dr. Weitz acknowledged that there would never be a 100% reporting rate, but the goal of RADx MARS is to enable pathways for those who are willing to report their results to be able to do so. Instead of focusing on compliance, NIBIB and RADx MARS will instead look at trends in data as opposed to absolute infection rates. This tactic is similar to how the FDA has tracked flu data for many years. Council asked whether the initiative has thought about double counting—for instance when someone reports a home test and is also tested at a doctor’s office or point-of-care testing site. Dr. Weitz acknowledged that the data could have some reporting duplicates but reiterated the importance of looking at data trends rather than absolutes. Council also discussed the importance of continuous monitoring and streamlining the transfer of data from wearables. Council members brought up the issue of accessibility for those who speak other languages. Dr. Juluru responded that NIBIB is trying to make tests and reporting accessible to people who speak other languages, have disabilities, and other underserved communities.

Since NIBIB was established, there has been a rapid growth of undergraduate programs in biomedical engineering (BME). More than 175 accredited undergraduate BME-related programs currently exist at over 150 U.S. institutions, but only three of the 107 HBCUs have BME programs. NIBIB wants to meet the nation’s growing need to accelerate the development and translation of high-impact biomedical innovation and technologies by:

• Increasing the capacity and research infrastructure of HBCUs
• Enhancing BME scientific workforce diversity
• Enriching the diversity of perspectives in BME

The intent of the initiative is to:

• Expand the pool of students exposed to BME research and career opportunities
• Enhance HBCU competitiveness for NIH funding
• Incentivize institutional commitment and program sustainability beyond the lifetime of the funding period and support institutional BME champion(s)
• Build partnerships with the BME/technology community, trans-NIH Intramural BETA center, and other private and public sectors
• Develop BME innovative technologies

Potential future directions include:

• Establish or enhance BME departments, academic centers, certificate program minors for undergrad and/or graduate students
• Research opportunities, maker spaces, core technology facility support
• Faculty development/research support, training and mentoring opportunities
• Student research/educational opportunities
• Curriculum and course development
• Entrepreneurship programs

The next steps include:

• Partnering with other ICs across NIH
• Collaboration with the trans-NIH BETA center
• Support provided via grant and/or cooperative agreement mechanisms

Council was highly supportive of this concept clearance and their comments focused on the challenges of implementing the initiative. One idea was bringing mentors and mentees together to learn as a team at the BETA center. They also discussed that the diversity of perspective from underrepresented communities is important and that even encouraging some more specialized bioengineering programs would be useful, even if it is not a full BME program. Council discussed sustainability as well as partnership with the National Science Foundation (NSF). Council brought forward many ideas, including teacher training, community college partnerships, and how to educate the community that will be writing these grants. Dr. Tromberg invited Council to continue to send suggestions for this initiative.

There is a growing prevalence of robotic and bionic devices in health care. NIBIB has prioritized the development of these technologies and has invested about $20 million between 2017-2022 in robotics and prosthetics. Ethical concerns related to bionic and robotics have also increased in the past few years. Those questions include the level of autonomy, long-term implications, equitable access, and risks of using a device versus other traditional clinical practices. NIBIB is partnering with the Office of Science Policy (OSP) to further the goals of this initiative, which includes:

• Supporting research that analyzes and/or addresses bioethical issues related to bionic and robotic devices
• Cultivating an interdisciplinary community of bioethicists, engineers, scientists and clinicians
• Developing a robust bioethics research evidentiary base to inform policy and program decision-making with regards to the device lifespan, such as:
  • Best practices
  • Design principles
  • Reimbursement justification

Potential topics of interest include:

• Ethical issues pertaining to the research and development of bionic and robotic devices
  • Participant representation in study design and participant selection
  • Informed consent practices
  • Long-term obligations to research participant populations
• Ethical implications related to the use of bionic and robotic devices
  • Autonomy
  • Activation/monitoring
  • Data security
  • Equitable availability
• Risk/benefit analysis of device interventions compared to other available treatments

In order to create a successful bioethics funding opportunity, NIBIB is proposing to use the R21 funding mechanism. This R21 would have $275K direct costs over two years and there would be a receipt date in each of FY23 and FY24. The applications would be reviewed by a special emphasis panel. Unlike many other NIBIB-supported funding opportunities that focus on technology development, this funding opportunity would focus specifically on bioethics research.

NIBIB has a plan to inform potential grantees of this new opportunity by

• Reaching out to its interdisciplinary community of grantees
• Using webinars, OSP and NIBIB newsletters
• Engaging with federal agency partners

Council members expressed support and excitement for the initiative and described many areas in which this research is necessary, such as making sure that patients are cared for long term, developing patient trust for the use of robotic technologies, and ensuring equitable access to robotic technologies. Council asked about current patient data regulations and emphasized the importance of having diverse members of the interdisciplinary community. Council members also suggested an NIH-NSF partnership.

The open session of the NACBIB meeting was adjourned at 3:36 p.m.

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

The grant application review portion of the meeting was closed to the public in accordance with provisions set forth in Section 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2). The closed session was adjourned at 3:54 p.m.

Certification:

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