DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
NATIONAL ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES ADVISORY COUNCIL

MINUTES OF THE 112th MEETING
August 29th, 2023, 9:30am

I. CALL TO ORDER

The 112th meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC) was held on August 29, 2023, in Room A, 6th Floor, Building 31, National Institutes of Health, Bethesda, Maryland, and via videoconference. The meeting was chaired by Dr. Lindsey A. Criswell, Director, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Attendance

Council members present:

Dr. Edward Botchwey, Professor of Medicine, Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology
Dr. Mary L. Bouxsein, Professor, Department of Orthopedic Surgery, Harvard Medical School; Center for Advanced Orthopedic Studies, Beth Israel Deaconess Medical Center
Dr. Leigh F. Callahan, Associate Director, UNC Thurston Arthritis Research Center; Mary Link Briggs Distinguished Professor of Medicine; Professor, Departments of Social Medicine and Orthopedics; Director, Osteoarthritis Action Alliance; University of North Carolina School of Medicine
Ms. Ann Elderkin, Consultant, American Society for Bone and Mineral Research (ASBMR)
Dr. Luis A. Garza, Associate Professor of Dermatology, Johns Hopkins School of Medicine
Dr. Stuart B. Goodman, Robert L. and Mary Ellenburg Professor of Surgery, Department of Orthopaedic Surgery, Stanford Medical Center Outpatient Clinic
Dr. Valentina Greco, Carolyn Walch Slayman Professor of Genetics, Yale University
Dr. Matlock Jeffries, Associate Professor, Arthritis & Clinical Immunology Research Program, Oklahoma Medical Research Foundation; Clinical Assistant Professor of Medicine, University of Oklahoma Health Sciences Center (ad hoc)
Dr. Renuka Nayak, Assistant Professor, University of California, San Francisco (UCSF) School of Medicine (ad hoc)
Dr. Elizabeth McNally, Elizabeth J. Ward Professor of Genetic Medicine, and Director, Center for Genetic Medicine, Northwestern University Feinberg School of Medicine;
Dr. Teodora P. Staeva, Chief Scientific Officer, Lupus Research Alliance
Dr. Maria E. Suarez-Almazor, Barnts Family Distinguished Professor, Department of Health Services Research, Cancer Prevention and Population Sciences, and Section of Rheumatology and Clinical Immunology, Department of General Internal Medicine, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center
Dr. Jinoos Yazdany, Chief, Division of Rheumatology, Zuckerberg San Francisco General Hospital

Staff and Guests

The following NIAMS staff and guests attended:

Staff

Dr. Lindsey Criswell
Dr. Robert Colbert
Dr. Robert Carter
Dr. Gayle Lester
Dr. Darren Sledjeski
Dr. Stephanie Burrows
Ms. Justine Buschman
Dr. Emily Carifi
Dr. Faye Chen
Ms. Elissa Golan
Ms. Stephanie Herndon
Ms. Colleen Labbe
Dr. Aron Marquitz
Ms. Leslie McIntire
Ms. Jennifer Morgan Gray
Dr. Heiyoung Park
Mr. Neil Roberts
Dr. Susana Serrate-Sztein
Dr. Raj Srinath
Dr. Robert Walker, Jr.
Dr. Chuck Washabaugh

Guests:

Dr. Joan Bathon, Director, Division of Rheumatology, New York-Presbyterian Hospital/Columbia University Medical Center and Professor of Medicine, Columbia University College of Physicians and Surgeons
Dr. Lisa Begg, Senior Program Officer, Office of Research on Women's Health (ORWH), NIH
Dr. Judith James, Executive Vice President & Chief Medical Officer, Oklahoma Medical Research Foundation
Dr. Sarah Temkin, Associate Director for Clinical Research, ORWH, NIH
Dr. Xenia Tigno, Associate Director for Careers, ORWH, NIH
Dr. Richard Woychik, Director, National Institute of Environmental Health Sciences (NIEHS)  and the National Toxicology Program (NTP)
Dr. Karen Wylie, Health Science Policy Analyst, ORWH, NIH

244 additional staff and members of the public watched via NIH Videocast. 

II. INTRODUCTIONS/CONSIDERATION OF MINUTES/FUTURE COUNCIL MEETING DATES

Dr. Lindsey Criswell, NIAMS Director, called to order the 112th meeting of the NIAMS Advisory Council and led attendees in a round of introductions. 

Dr. Sledjeski noted that the meeting was the Council's first official hybrid meeting, with some Council members and staff participating via videoconference. He reviewed the logistics for the meeting and reminded members of the public that they have 15 days following the meeting to submit written comments at the email address NIAMScouncilmail@niams.nih.gov. Dr. Sledjeski reminded Council members of their conflict of interest obligations under federal law and noted upcoming conflict of interest reporting dates. 

Dr. Sledjeski asked the Council if there were any comments or corrections on the minutes of the 111th NAMSAC meeting, which took place on June 6, 2023. There were no comments, and Dr. Sledjeski moved to approve the minutes. The motion was approved unanimously. 

Dr. Sledjeski noted the dates of the next three Council meetings. The next meeting is scheduled for January 30, 2024, and will be a virtual meeting. The May 29, 2024, meeting will be an in-person meeting, and the August 27, 2024, meeting is tentatively scheduled to take place in a hybrid format.

III. NIAMS' DIRECTOR’S REPORT AND DISCUSSION

Dr. Criswell announced that several Council members whose terms were about to expire have been granted 180-day administrative extensions, through March of 2024. These Council members are Drs. Mary Bouxsein, Leigh Callahan, Luis Garza, and Ms. Suzanne Schrandt. Dr. Criswell thanked them for agreeing to continue serving on the Council and devoting their valuable time in support of NIAMS. Dr. Criswell then introduced the Council's newest member, Dr. Edward Botchwey from Georgia Tech, joining for the first meeting of his four-year term. The Council also welcomed two ad hoc members, Drs. Renuka Nayak of UCSF and Matlock Jeffries of the Oklahoma Medical Research Foundation, who joined the meeting as representatives of NIAMS' pool of K awardees.

Personnel Changes

NIH leadership recently announced that Dr. Jeanne Marrazzo has been selected as the next Director of the National Institute of Allery and Infectious Diseases (NIAID). Dr. Marrazzo will be joining NIH this fall from the University of Alabama at Birmingham, where she directs the Division of Infectious Diseases. NIH has also announced that Dr. Jane Simoni was recently named the new NIH Associate Director for Behavioral and Social Sciences Research and Director of the NIH Office of Behavioral and Social Sciences Research (OBSSR).

Dr. Criswell noted several recent and impending departures within the NIAMS Division of Extramural Activities (DEA): Dr. Shahnaz Khan, Ms. Nicole Nyack, and Mr. Neil Roberts. The search is underway for Dr. Khan's replacement as chief of the Clinical Research Operations and Management Branch, and NIAMS hopes to have that position filled by October. Dr. Criswell also announced that Dr. Peter Koch has been hired as Director of the Epidermis, Dermis and Skin Senses Program following the retirement of Dr. Hung Tseng. Dr. Koch joined NIAMS from the Brody School of Medicine at East Carolina University. Other new hires include Ms. Shalanda Wellington, Ms. Anamika Singh, and Mr. Jon Davis. Finally, Dr. Criswell updated the Council on NIAMS' nationwide search for Dr. John O'Shea's successor as NIAMS Scientific Director and Director of the Intramural Research Program. The vacancy announcement was published on August 28th. Dr. Criswell encouraged Council members to spread the word among their colleagues. NIAMS hopes to fill the position by next summer. 

Budget

Dr. Criswell updated the Council on the status of negotiations on NIH's fiscal year 2024 budget between the White House and the two chambers of Congress. Despite the prospect of cuts to NIH's overall budget, the NIAMS' budget is expected to remain flat for the next fiscal year. Both chambers of Congress have passed their versions of the budget, which must be combined into a final budget through the conference committee process. Dr. Criswell noted the possibility that the final budget will not be signed before the start of the new fiscal year, in which case the federal government will likely operate under a continuing resolution based on the FY 2023 budget. 

As Dr. Criswell discussed at the last Council meeting, NIAMS' FY 2023 funding plan set the R01 payline for most investigators at the 10th percentile, with a higher 15th percentile payline for early-stage investigators (ESIs). While the 10th percentile figure is lower than in previous years, NIAMS has expanded funding for its "select pay" program, which makes funds available to program directors for applications identified as being of the highest priority that score beyond the published payline. This has enabled NIAMS to fund the same number of R01 grants as in previous years, while also granting program directors the discretion to look critically at proposals that go above the payline. NIAMS hopes to increase the pool of funds available for select pay in FY 2024 and is looking into policy changes that could add further select pay support in future years. These proposals will be brought to the Advisory Council for its consideration. 

NIH and NIAMS Activities of Interest

Dr. Criswell announced an exciting new initiative by the NIAMS Culture Committee to update the Institute's core values. The goal of the project was to help ensure a civil workplace environment where staff works together toward a common goal with respect, accountability, and diversity of experiences and perspectives. The core values, called TOGETHER We Make NIAMS Great, were developed with broad input from NIAMS staff and were rolled out earlier in August.

Dr. Criswell updated the Council on the Institute's strategic planning, which includes an upcoming idea generation meeting, broad stakeholder outreach, and solicitation of input via RFIs.

The NIAMS Coalition 2023 Outreach and Education Meeting will be held on the NIH campus on Tuesday, September 19, with presentations streamed via webcast. This will be the first in-person NIAMS Coalition meeting since 2019. Dr. Criswell highlighted the value of this meeting for bringing together Coalition members with NIAMS staff. 

Another upcoming milestone is the release of early research results from the Molecular Transducers of Physical Activity Consortium (MoTrPAC). MoTrPAC is an NIH Common Fund program co-led by NIAMS to study molecular changes that occur during and after exercise and to advance the understanding of how physical activity improves health. The preprint of the first publication is available now, and Dr. Criswell has co-authored a commentary that will be released when the paper is formally published. Dr. Criswell plans to invite a MoTrPAC investigator to present their findings at a future Council meeting. 

Dr. Criswell provided some updates and highlights from ongoing NIAMS programs. These include Notices of Special Interest (NOSIs) on pain research in rheumatic, skin and musculoskeletal diseases that were enabled by the previous fiscal year's budget increase. Pain research will remain a priority area for NIAMS going forward, particularly in partnership with the NIH Helping to End Addiction Long-term (HEAL) Initiative, which strives to address the ongoing opioid-related public health crisis. Within HEAL, NIAMS leads the Back Pain Consortium (BACPAC) and the Restoring Joint Health and Function to Reduce Pain Consortium (RE-JOIN), and participates in several other programs in the HEAL research ecosystem. Dr. Criswell also updated the Council on the HEAL KIDS (Knowledge, Innovation, and Discovery Studies) program. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) recently issued two Notices of Funding Opportunity (NOFOs) for a pain resources and data center and to support an acute pain clinical trials program. NIAMS has signed on to both NOFOs. 

Dr. Criswell also highlighted the collaboration between NIAMS and the Office of Research on Women's Health (ORWH) to establish a women's health research leadership and mentorship pilot program. The program is called Team Science Leadership Scholars Program, and the initial round of awardees will be announced in the coming weeks. Due to the robust response to the first Funding Opportunity Announcement (FOA), Dr. Criswell was excited to report that a second FOA will be issued later this fall. 

NIAMS and ORWH are also participating in the EXposome in Autoimmune Disease Collaborating Teams PLANning Awards (EXACT-PLAN), which solicits applications for exploratory, early, and conceptual stage research planning projects aimed at developing a future team science research network. 

Dr. Criswell also briefed the Council on NIAMS' participation in the NIH All of Us Research Program and highlighted the program's efforts, in collaboration with the National Institute of Environmental Health Sciences (NIEHS), to incorporate location and environmental exposure data in order to help achieve precision medicine goals. 

Finally, Dr. Criswell drew the Council's attention to a recently-issued NIH RFI to solicit feedback on a revision to the NIH mission statement based on recommendations from the Advisory Committee to the NIH Director's Working Group on Diversity. Dr. Criswell encouraged Council members to review the proposal, share it with their communities, and to consider providing input. 

Discussion

Regarding the expansion of select pay, Dr. Luis Garza said NIAMS should expect researchers to want to know the specific criteria for that decision process. He also asked if the NIAMS programmatic goals were published anywhere for researchers to consult. Dr. Criswell acknowledged that how NIAMS makes funding decisions is one of the most important things the Institute does. The scientific review of grants by the Center for Scientific Review (CSR) study sections is a vital part of the grant review process, but NIH leadership has reemphasized in recent years that it is not the only part of the review process. In other words, those review scores do not account for the priorities and perspectives of the Institutes, such as emerging areas of research, the biomedical workforce, and challenges of ESIs. Dr. Criswell said NIAMS prioritizes communication and transparency for this process. Select pay considerations include ESI status and at-risk investigators, both of which are NIH priorities, as well as NIAMS' strategic priorities. Incorporating portfolio analysis and aligning funding decisions with the next strategic plan will also be focus areas in the coming months. NIAMS is committed to communicating to the community its priorities for select pay going forward. 

Dr. Edward Botchwey asked if researchers are permitted to interact with program officers about the select pay process. Dr. Criswell said select pay recommendations come from program directors and self-nominations are not part of the process. However, researchers are encouraged to reach out to program officers with any questions about their grant or the application process. Dr. Renuka Nayak asked if applicants will have the opportunity to write written rebuttals to review summaries or in the consideration of select pay. Dr. Criswell said program officers may reach out to applicants with questions during the review process. Dr. Gayle Lester said rebuttals are allowed as part of scientific review, but are not part of the select pay process. Dr. Bob Carter added that, in general, investigators are allowed to respond to program officers regarding specific critiques of their application. Dr. Matlock Jeffries said he thinks the expansion of select pay is a great idea and he hopes NIAMS will use it to enhance diversity initiatives. Dr. Criswell confirmed that is one of the target areas. NIAMS staff attempted to dispel myths about negative consequences related to contacting program officers. 

IV. LOOKING TO THE FUTURE OF ENVIRONMENTAL HEALTH SCIENCES

Dr. Criswell introduced Dr. Richard Woychik, Director of NIEHS and the National Toxicology Program (NTP), to share his insights on the future of the environmental health sciences. 

Dr. Woychik opened his remarks by underscoring his Institute's interest in establishing research collaboration with NIAMS and other ICs, with the overall aim of enabling a more systematic approach to integrating environmental exposures into studying the etiology of human disease. Dr. Woychik provided a brief over of NIEHS. Its mission is "to discover how the environment affects people in order to promote healthier lives," and the Institute's vision is "to provide global leadership for innovative research that improves public health by preventing disease and disability." Unlike other NIH ICs, NIEHS focuses exclusively on preventing disease, rather than seeking cures. NIEHS defines the environment broadly, and many environmental factors can impact health, from manmade products and lifestyle behaviors to biological and organic factors. 

In the context of NIAMS' mission areas, researchers have discovered several environmental risk factors for arthritis and rheumatic disease, such as childhood exposure to pesticides and male farmers' exposure to the chemicals atrazine and toxaphene. In the area of muscle and bone diseases, reduced bone density has been associated with childhood PFAS exposure, altered adolescent bone health due to developmental exposure to organophosphate esters, and association of reduced bone density in postmenopausal women with elevated air pollution exposure. In skin diseases, air pollution has been shown to increase the risk of psoriasis and eczema, and ultraviolet radiation-induced DNA damage can occur even in sun-shielded skin. All these findings highlight the need to incorporate environmental exposures in order to better understand the etiology of diseases within NIAMS' mission areas. 

NIEHS believes the environmental science research field must move beyond the traditional approach of studying exposures one by one and embrace what is called the exposome framework. The exposome is the totality of exposures across the lifespan, including both external and internal exposures, incorporating lifestyle, ecosystem-level, social and physical/chemical exposures. The exposome has achieved acceptance among the environmental science research community, but the next step will be how to conduct exposomics research and collect exposomics data that account for the complex myriad of factors within the exposome framework. Dr. Woychik discussed the work of Dr. Gary Miller from Columbia University, who highlighted the need for an operational definition of the exposome at a recent NIEHS Council meeting. New technologies will likely need to be developed, but the field can begin by considering what can be studied using existing tools, what Dr. Miller called the "pragmatic" exposome, using, for example, high resolution mass spectrometry. Dr. Miller pointed to the development of the field of genomics since its inception several decades ago as a model. 

To support the development of exposomics, NIEHS held a series of five virtual workshops in 2022 on how to operationalize the field. One dominant theme was the need to develop a plan to operationalize exposomics in a concerted manner across the global biomedical research community. In response, NIEHS will be issuing a NOFO in the coming days called Global Exposome Research Coordination to Accelerate Precision Environmental Health, which NIAMS has signed onto as a partner IC. The goals of the program are to establish a center that develops a common framework for exposomics, to promote best practices in data collection and data sharing, and to build a diverse and inclusive global research community in order to foster national and international partnerships. NIEHS is simultaneously working to promote the integration of exposomics data into environmental health research. The Human Health Exposure Analysis Resource (HHEAR) is a tool available to NIH-funded researchers to help add or expand exposure analysis in biological and environmental samples and to provide a public access data repository. Dr. Woychik also expanded on the EXACT-PLAN program that Dr. Criswell mentioned in her Director's Report. The program will utilize emerging approaches in exposome science to study the etiology of autoimmune disease in combination with the necessary data infrastructure support. This program will also be important to help set the groundwork for future exposomics collaborations. 

Another emerging area of the environmental health sciences is precision environmental health (PEH), which aims to address individual variability associated with responses to environmental exposures and ultimately to better understand individual risk to prevent disease. The PEH program complements NIH's Precision Medicine Initiative and goes a step further by incorporating epigenetics and omics data in addition to genetics. Assessing the genetic contributions that factor into differential responses to environmental exposures will require analyzing complex traits, which in turn will require cohorts of subjects in the tens of millions. The International Common Disease Alliance (ICDA) aims to develop standardized procedures to facilitate the integration of data from programs around the world. As a next step, the environmental health sciences community should encourage the ICDA to include exposomics as part of its efforts. Along similar lines, NIEHS has engaged the NIH All of Us Research Program to incorporate geospatial environmental exposure data collection in order to ultimately conduct a study on the combined genomic, environmental, and social determinants of health. Dr. Woychik described how this geospatial data could potentially be used in combination with air quality models, regional daily climate factors, and CDC's Social Vulnerability Index. A case-short study [SR([1] is planned to test this approach with the All of Us repository in the context of type 2 diabetes. 

Dr. Woychik also described NIEHS's efforts to address health challenges related to climate change. The effects of climate change on human health have been a priority for the Biden Administration, and NIH's FY 2023 budget included $40M to NIEHS for climate change and health (CCH) research. Dr. Woychik believes that CCH research requires taking a trans-NIH approach, and he engaged the directors of six other ICs to form an Executive Committee on Climate Change and Health, under which is the NIH Climate Change and Health Working Group. Among other activities, the Working Group has drafted an NIH-wide Strategic Framework on Climate Change and Health to guide the NIH Climate Change and Health Initiative. Dr. Woychik argued that climate change is best studied using the exposome framework given the complexity of direct and indirect effects of climate change on human health. He emphasized that any plan to confront climate change must acknowledge that climate change affects human unequally, with certain populations more impacted than others. The NIH strategic framework is based on four core elements: health effects research, intervention science, health equity, and training and capacity building. More information about the NIH Climate Change and Health Initiative can be found at www.nih.gov/climateandhealth. Dr. Woychik also described NIEHS' concurrent efforts to establish CCH centers of excellence via the U24, P20, and U54 mechanisms, and the Alliance for Community Engagement - Climate and Health (ACE-CH), which aims to coordinate and develop opportunities to support climate change-focused community-engaged research and outreach and to promote the inclusion of underserved communities most vulnerable to the effects of climate change. 

Dr. Woychik concluded his presentation by emphasizing NIEHS and NIAMS' strong partnership and shared interests, and noted possible areas of future collaboration, including the development of comprehensive exposomics tools, a collaborative data repository framework, and additional partnerships on climate change and health.

Discussion

Dr. Garza commented that, based on his experience in the clinic, many conditions that may be influenced by environmental exposures seem to be increasing in incidence rate, including autoimmune conditions. He asked Dr. Woychik if he was aware of any comprehensive effort to identify and track such conditions, perhaps by analyzing medical coding. Dr. Woychik said that is not something NIEHS has done, but it is a great suggestion, and perhaps an area where NIEHS and NIAMS can work together. He was aware of specific conditions that are increasing in incidence, such as early-stage colon cancer, which NIEHS is conducting research on. Council members were in agreement that more data and more research are needed to discern true increases in incidence from increased diagnosis rates. 

Dr. Botchwey noted that while the life expectancy gap between Black and White Americans has been narrowing nationally in recent years, it has been expanding in certain geographic locations, including in Washington, D.C. Research has shown that racism is a negative healthcare exposure, including in conditions within NIAMS' purview. Research in mice has shown the negative health effects of stress in an attempt to model the impact of psychosocial stress in humans. Dr. Woychik said that many elements related to racism are incorporated into the exposome framework. One of NIEHS' goals is to develop objective biomarkers to assess the impact of psychosocial stress and other environmental exposures. Additionally, NIEHS has several environmental justice-related programs that gather data to help confront the disparate impact of many environmental exposures. 

Dr. Leigh Callahan noted similarities between the exposome framework and the social-ecological model that the CDC uses, and asked if there are collaborations between NIEHS and that agency. Dr. Woychik confirmed that there are, noting that the NTP is a collaboration between the NIH, CDC and FDA. The Agency for Toxic Substances and Disease Registry (ATSDR) is another relevant interagency partnership.

Dr. Jinoos Yazdany asked Dr. Woychik to expand on his Institute's communication strategy regarding climate change and health, particularly in the context of the politicization of climate change. Dr. Woychik says NIEHS adheres to Dr. Anthony Fauci's mantra of sticking to the science. NIEHS also regularly briefs Congress on its activities to keep appropriators abreast of NIEHS' activities. Dr. Yazdany expressed the opinion that having a science communication strategy will become increasingly important in the years to come. Dr. Woychik agreed, and noted that the COVID-19 pandemic offers many lessons learned for the biomedical research community as a whole when it comes to communication of science.

Dr. Criswell asked Dr. Woychik to talk about intramural-extramural collaborations and leveraging resources to enhance efficiency. Dr. Woychik said NIEHS recently launched a program in partnership with the NIH Office of Intramural Research called Intramural Targeted Climate Change & Health (ITCCH) that is dedicated to studying the health effects of climate change. One goal of this program is to establish an NIH-wide center on climate change and health research. 

V. ADVANCING THE HEALTH OF WOMEN: UPDATE ON ORHW-NIAMS COLLABORATIONS

Dr. Criswell introduced Dr. Janine Austin Clayton, NIH Associate Director for Research on Women's Health and Director of ORWH. Dr. Clayton was unable to attend the Council meeting but delivered a pre-recorded presentation.  ORWH staff members Drs. Lisa Begg, Sarah Temkin, Xenia Tigno, and Karen Wylie were present to answer questions from the Council following Dr. Clayton's remarks.

For many years, ORWH and NIAMS have partnered on a range of scientific diseases, biomedical workforce initiatives, and topics important to the health of women. Examples include the Osteoarthritis Initiative back in 2001 and, more recently, the Accelerating Medicines Partnership on Autoimmune and Immune-Mediated Diseases (AMP AIM). NIAMS is also providing critical support as ORWH establishes it's Office of Autoimmune Disease Research (OADR). Dr. Clayton described ORWH's multidimensional framework for thinking about the health of women across the lifespan. The framework includes both external factors of women in the societal context and internal factors of biology and genetics, and the interaction between internal and external factors. 

One of ORWH's major focus areas is chronic diseases in women, which have historically been understudied. This focus gained urgency in 2021 when Congress asked NIH to examine its efforts related to maternal morbidity and mortality, plateauing cervical cancer survival rates, and increasing rates of chronic debilitating conditions in women. ORWH subsequently held a conference that year to discuss these topics called Advancing NIH Research on the Health of Women, which led to the publication this year of Chronic Conditions in Women: The Development of a National Institutes of Health Framework and an ongoing ORWH-supported National Academies study on chronic debilitating conditions in women. The 2021 conference also ultimately led to the issuance of two RFAs (R21 and R01) on Understanding Chronic Conditions Understudied Among Women, of which NIAMS is a partner ICO. These RFAs respond to Goal 1 of the NIH Strategic Plan for Women's Health Research to advance rigorous research relevant to the health of women.

Dr. Clayton spoke in greater detail about the purpose and role of the new Office of Autoimmune Disease Research. This year, Congress directed NIH to establish the office within ORWH, in alignment with the recommendations of the 2022 National Academies' Enhancing NIH Research on Autoimmune Disease report. The directive from Congress tasks OADR with coordinating the development of a multi-IC strategic research plan, identifying emerging areas of innovation and research opportunity, and annually evaluating NIH's autoimmune disease research portfolio, among other responsibilities. In FY 2023, 11 ICs submitted applications in support of OADR research, which will include extramural and intramural research and intramural training awards.

ORWH also partners with NIAMS on several critical career development and support programs, including the Building Interdisciplinary Research Careers in Women's Health (BIRCWH) initiative, the Team Science Leadership Scholar Program (LSP) in Women's Health, Autoimmune and Immune-Mediated Diseases, continuity and retention supplements, and re-entry and re-integration supplements. BIRCWH was one of ORWH's first programs and over 750 scholars have completed the program since 1999, 88% of whom remain in the research field. Dr. Clayton noted that NIAMS administers 18 of the 19 active BIRCWH awards. The LSP initiative is a pilot program to support and train women's health scholars by helping them acquire and hone team science leadership and mentoring skills. The first class of LSP scholars will be announced in the coming weeks. The program will be managed by the Oklahoma Medical Research Foundation (OMRF) on behalf of AMP AIM. Dr. Criswell invited Dr. Judith James, Executive Vice President & Chief Medical Officer of ORMF, to offer comments on this program. Dr. James said AMP AIM is excited about the potential for the LSP program to develop team science leaders in diseases important to women's health and thanked ORWH and NIAMS staff for their support.  

Discussion

Dr. Nayak asked Dr. James if eligibility for the LSP program would be expanded beyond the associate professor level in future iterations to include assistant professors and, perhaps, full professors. Dr. James said the program will expand so that assistant professors and other early-stage professors will be eligible. Dr. Susana Serrate-Sztein added that the Foundation for the NIH's AMP AIM Steering Committee is also very supportive of the LSP program. Dr. Mary Bouxsein said NIAMS and ORHW might want to consider expanding the LSP model beyond autoimmune disorders and into other mission areas in its purview, such as orthopedics. Dr. Xenia Tigno agreed and said ORWH will look to expand on the successes and lessons learned from the LSP pilot. Dr. Yazdany emphasized the importance of outcome measures in these programs.          

VI. CLINICAL TRIAL WORKING GROUP UPDATE

Drs. Stuart Goodman and Joan Bathon, co-chairs of the Working Group, presented an update and interim recommendations of the Clinical Trial Working Group (CTWG) of Council. The Working Group is charged with exploring how NIAMS can more optimally support applications for high-impact clinical trials in the NIAMS mission areas and to provide findings and recommendations to the Council. The CTWG has engaged in high-level consultations with NCCIH, NIDCR, and NHLBI to gather information on how those ICs handle relevant clinical trial programs.

The CTWG's interim recommendations contemplate how NIAMS can structure its programs to foster more impactful clinical trials. The CTWG's first recommendation is that NIAMS should consider options for smaller, exploratory/preliminary feasibility clinical trial mechanisms with larger budgets and extended timeframes. Dr. Goodman briefly described the rationale behind the recommendation. The current primary mechanism for small clinical trials at NIAMS is the R21, with has three-year and $400,000 direct cost limits, which the Working Group found to be too restrictive. These caps mean only very small pilot studies can be supported, and they do not allow for the potential of submissions towards an FDA IND-type trial. The CTWG acknowledges, however, that this recommendation could lead to fewer trials being supported. 

Secondly, for large clinical trials, the CTWG recommends that NIAMS consider establishing a two-phase, milestone-based awards process via the UG3 and UH3 mechanisms. This would allow for increased flexibility in the timing of each phase and establish clear milestones to monitor progress. The CTWG found this model to be successfully used at other ICs, and believes it will accelerate the overall trial timeline while maintaining momentum between planning and implementation phases.

The CTWG's next steps will be to focus on what studies have the greatest impact, whether NIAMS should invite the extramural community to suggest research priorities, and what NIAMS role is in the larger clinical trials landscape. The Working Group will also explore how NIAMS can better support applicant and budget impacts of alternate trial sizes and budgets. The CTWG hopes to submit its final report to the Council in January of next year.

Discussion

Dr. Garza asked if the CTWG discussed the role of industry in drafting its recommendations. Dr. Bathon said the group was primarily focused on improving NIAMS-based trials, but she believes the large trial recommendation opens up space for investigators to take advantage of other translational mechanisms. 

The Council discussed lessons learned from the other ICs and budget implications of the CTWG's recommendations. Dr. Carter said the topic of clinical trial budgets is a perennial issue; relative to other ICs, NIAMS has historically spent less on clinical trials, but has had high success rates. There is a consensus, however, that shifting to align with the CTWG's recommendation will lead to better outcomes despite leading to fewer trials being supported. 

The Council and NIAMS staff discussed with the CTWG members the importance of attempting to measure the impact of clinical trials and the value and feasibility of translational research components. 

Dr. Teo Staeva suggested that the CTWG consider basket trials during its analysis. She also suggested the Working Group explore soliciting input from the patient community on what kinds of studies are most impactful and relevant to them. While she agreed with comments regarding the importance of creating a pathway to industry, Dr. Staeva also emphasized NIAMS' role in supporting research that industry is not interested in, such as repurposing of drugs or alternative medicine. 

VII. CONCEPT CLEARANCE

Dr. Sledjeski described the process by which NIAMS extramural staff identifies critical research opportunities within NIAMS' mission areas. Concept clearance is the planning process by which NIAMS receives feedback on the merits of a proposed concept from the Advisory Council and approval from the Council. Dr. Sledjeski noted that concepts often represent broad, early-stage proposals and do not always ultimately result in formal funding opportunities. Approval covers a five-year period under which more specific proposals can be crafted based on the budget climate, research priorities, and other factors.

Dr. Gayle Lester, Director, Division of Extramural Research (DER), presented one concept to the Council: Integrated Research on Mechanisms of Musculoskeletal Pain. This concept would leverage HEAL Initiative funding and proposes to address musculoskeletal and peripheral pain as integrated processes with certain shared functions. Several currently existing initiatives would be managed under this program, and new programs would be devised via programmatic input to address knowledge gaps and identify new research directions. The current initiatives in question are BACPAC, RE-JOIN, the PRECISION Human Pain Network (NINDS), and the myofascial tissue biomarkers (NCCIH) and pain signatures and biomarkers (NINDS) programs. The process of integrating these programs under one umbrella would occur over a span of several years. 

The Advisory Council unanimously approved the concept. 

Due to the Council being ahead of schedule on its agenda, Dr. Criswell opened the floor for discussion on topics for future meetings, questions from the Council, or other matters. Dr. Jeffries encouraged the Institute to continue efforts to enhance inclusion of individuals from underprivileged and underrepresented minorities in the biomedical research workforce. Dr. Criswell pointed to the CSR's revised review criteria as one effort at the NIH-wide level in this direction. Dr. Jeffries added that collecting more data on specific minority groups is also needed. Dr. Robert Walker, Jr., NIAMS' Chief Diversity Officer, said that NIAMS is trying to capture that data. Drs. Criswell and Walker affirmed that this larger topic remains a priority for the broader NIAMS and NIH communities. The Council and NIAMS staff discussed related efforts including the NIH Common Fund’s Faculty Institutional Recruitment for Sustainable Transformation (FIRST) program, which included anonymous review and pooled applications by institutional resources, as well as the NIAMS' Research Innovation for Scientific Knowledge (RISK) for Musculoskeletal Diseases program.

Dr. Nayak raised the issue of the pandemic and its effects on younger researchers. More mentoring programs and programs that offer protected time are needed for this younger cohort, particularly in light of the pandemic. Dr. Criswell thanked Dr. Nayak for her participation on the Council and said NIAMS needs to think about how it can better support investigators at all career stages. Dr. Botchwey said graduate student support is another, related topic that NIAMS should explore as part of its efforts to attract and retain talented future scientists. Dr. McNally agreed, and warned that as costs continue to increase the result will be fewer graduate students, which will have negative consequences for the entire research community. 

XIII. CLOSED SESSION

This portion of the meeting was closed to the public in accordance with the determination that it concerned matters exempt from mandatory disclosure under Section 552b(c)(4), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended. Members exited the meeting during the discussion and voting process on applications from their own institutions or other applications that presented a potential conflict of interest, real or apparent. Members signed a statement to this effect. 

REVIEW OF APPLICATIONS 

The 112th National Arthritis and Musculoskeletal and Skin Diseases Advisory Council met in person on August 29, 2023.  Three Council members and two Ad-Hoc Council members attended in person and eight attended virtually. En bloc concurrence was unanimously approved for 695 primary and 311 secondary applications. The total cost requested in year -01 for all applications was $ 504,038,914. 

IX. ADJOURNMENT

The 112th National Arthritis and Musculoskeletal and Skin Diseases Advisory Council adjourned at 4 p.m.  Proceedings of the public portion of this meeting are recorded in this summary.

I hereby certify that, to the best of my knowledge, the foregoing summary and attachments are accurate and complete.

Darren Sledjeski, Ph.D.
Executive Secretary, National Arthritis
and Musculoskeletal and Skin Diseases
Advisory Council
Director, Division of Extramural Activities
National Institute of Arthritis and
Musculoskeletal and Skin Diseases
 
Lindsey A. Criswell, M.D., M.P.H., D.Sc.
Chairperson, National Arthritis
and Musculoskeletal and Skin Diseases
Advisory Council
Director, National Institute of Arthritis and
Musculoskeletal and Skin Diseases