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

MINUTES OF THE 110th MEETING
January 31, 2023
10:00am to 1:30pm

January 31, 2023 Council Webcast

I.   CALL TO ORDER

The 110th meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC) was held on January 31, 2023, via videoconference. Dr. Lindsey A. Criswell, Director, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), chaired the meeting.

Attendance

Council members present:

Dr. Joan M. Bathon, Professor of Medicine and Chief of the Division of Rheumatology, Columbia University College of Physicians and Surgeons
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
Dr. Elizabeth H. Chen, Professor of Molecular Biology and Professor of Cell Biology, University of Texas Southwestern Medical Center
Ms. Ann L. Elderkin, P.A., 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. Said Ibrahim, Senior Vice President, Medicine Service Line, North Shore/ LIJ Northwell Health System; Chair, Department of Medicine and David J. Greene Professor of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
Ms. Suzanne Schrandt, Founder, CEO, and Patient Advocate, ExPPect, LLC
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. Jennifer J. Westendorf, Margaret Amini Professor of Orthopaedic Regenerative Medicine Research, Mayo Clinic

Staff and Guests

The following NIAMS staff and guests attended:

Staff

Dr. Lindsey Criswell 
Dr. Robert Carter 
Dr. Gayle Lester
Dr. John O'Shea 
Dr. Robert Colbert 
Dr. Rebecca Lenzi 
Ms. Ryan Lombardi 
Dr. Marie Mancini 
Dr. Aron Marquitz
Ms. Melinda Nelson 
Mr. Neil Roberts 
Dr. Kathy Salaita
Dr. Susana Serrate-Sztein 
Dr. Hung Tseng
Dr. Ted Zheng

218 additional NIH staff and members of the public watched via NIH Videocast 

Guests

Dr. Edward Botchwey, Associate Professor, Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology/Emory University
Dr. Walter Koroshetz, Director, National Institute of Neurological Disorders and Stroke (NINDS), NIH
Dr. Helene Langevin, Director, National Center for Complementary and Integrative Health (NCCIH), NIH
Dr. Elizabeth McNally, Professor of Medicine and Biochemistry and Molecular Genetics; Elizabeth J. Ward Professor of Genetic Medicine; Director, Center for Genetic Medicine; Northwestern University Feinberg School of Medicine
Dr. Mark Pitcher, Special Assistant to the Director, NCCIH
Dr. Jinoos Yazdany, Chief, Division of Rheumatology, Zuckerberg San Francisco General Hospital; Alice Betts Endowed Professor of Medicine, University of California, San Francisco (UCSF) School of Medicine

II. CONSIDERATION OF MINUTES/FUTURE DATES/ADMINISTRATIVE REMINDERS

Dr. Lindsey Criswell welcomed Council members and staff to the 110th meeting of the NIAMS Advisory Council. Dr. Kathy Salaita, Acting Executive Secretary of the NAMSAC, reviewed the virtual meeting logistics and noted that members of the public can submit comments to the Council up to fifteen days after the meeting at the email address NIAMScouncilmail@niams.nih.gov. Dr. Salaita reminded Council members of their conflict of interest reporting requirements, which are due at three points during the year, the next being in June. Dr. Salaita then asked for a motion to approve the minutes of the September 14, 2022, 109th NAMSAC meeting. The motion was made and seconded by Dr. Stuart Goodman and Dr.
Joan Bathon, respectively, and passed unanimously. Dr. Salaita announced that the Council's next meeting will be on June 6, 2023. Subsequent meetings are scheduled for August 29, 2023, and January 30, 2024.

III. REVIEW OF COUNCIL OPERATIONS

The Advisory Council is required to review its operating procedures on an annual basis. Dr. Salaita read the statement of understanding between NIAMS and the NAMSAC, which described NAMSAC's role in reviewing grant applications and detailed the types of applications under its purview.

IV. DIRECTOR’S REPORT AND DISCUSSION

Council Member Changes

Dr. Criswell opened her remarks by announcing that Drs. Joan Bathon, Elizabeth Chen, Said Ibrahim, and Jennifer Westendorf would be rotating off the Council after the meeting. All four previously agreed to extend their service past their original four-year terms, and Dr. Criswell thanked them for their efforts on behalf of the Council and NIAMS. Four new Council members have been named: Ms. Ann Elderkin, Dr. Edward Botchwey, Dr. Elizabeth McNally, and Dr.
Jinoos Yazdany. Drs. Botchwey, McNally and Yazdany are serving as ad hoc members for this meeting as they await completion of the formal appointment process. Dr. Criswell introduced the new members and briefly described their professional backgrounds.

Budget

Dr. Criswell updated the Council on NIAMS' enacted budget for FY 2023, which was signed into law by the President in late December as part of Congress' omnibus appropriations bill. NIH's budget was set at nearly $48B, an increase of 5.5% from FY 2022. Dr. Criswell noted that this total included $635M for the Helping End Addiction Long-term (HEAL) Initiative. NIAMS' budget is approximately $685.5M, representing an increase of 4.5% from the previous year. Five million is specifically allocated for pain and opioid research, which aligns with several important NIAMS mission areas. Dr. Criswell intends to update Council on the proposed FY 2024 budget at the next meeting. 

Personnel Changes

Dr. Criswell highlighted several recent personnel changes of note across NIH. Dr. Anthony Fauci, longtime Director of the National Institute of Allergy and Infectious Diseases (NIAID), retired from federal service after an outstanding career as a scientist and public servant. Dr. Hugh Auchincloss is Acting Director of NIAID while NIH conducts its search for Dr. Fauci's successor. Dr. Roger Glass has stepped down as Director of the Fogarty International Center (FIC). Dr. Glass served in that position since 2006, making him the longest-serving FIC Director. Dr. Roger Kilmarx will lead FIC in an acting role as NIH conducts a formal search for a new FIC Director. After 40 years in federal service, Ms. Andrea Norris stepped down as NIH Chief Information Officer (CIO) and the Director of the NIH Center for Information Technology (CIT). As NIH conducts its search for permanent hires, Mr. Ivor D'Souza has been named Acting Director of CIT and Mr. Dennis Papula is Acting CIO. Dr. Criswell then announced two NIH leadership hires that had occurred since the last NAMSAC meeting. Dr. Joni Rutter was formally named Director of the National Center for Advancing Translational Sciences (NCATS) and Dr. Nina Schor had been made NIH Deputy Director for Intramural Research. At NIAMS, Dr. Paul DeMarco was hired as the Rheumatology Fellowship Training Program Director in the Intramural Research Program. Dr. Criswell also noted transitions in the Division of Extramural Research. Drs. Tony Kirilusha and Amanda Boyce left NIAMS for other opportunities at NIH. Dr. Criswell welcomed Dr. Marjorie Lindhurst to NIAMS, where she serves as Program Director of the Muscle Development and Physiology Program.

NIH and NIAMS Activities

Dr. Criswell shifted gears to discuss noteworthy NIH-wide activities, including the new Advanced Research Projects Agency for Health (ARPA-H) which is seeking applicants for program managers. Applicants can be at any career stage but need to demonstrate an interdisciplinary track record. Specifically, ARPA-H is seeking fearless risk-takers with clear ideas and technical integrity. Unlike program director positions in Institutes and Centers, these positions are designed to last for a term of three to six years.

Based on the evidence that diverse teams outperform homogeneous teams, the NIH BRAIN Initiative now requires applicants to submit a Plan for Enhancing Diverse Perspectives (PEDP). In addition to the benefits of diversifying the research team itself, recruitment of diverse research participants and inclusion of diverse community feedback ensure that the benefits of research are widely applicable. PEDPs are a scored criterion in the BRAIN Initiative's application review process. Inspired by this addition, NIAMS is working to develop similar language to insert into its application requirements.

On a related note, the NIH's Center for Scientific Review (CSR) is leading an NIH-wide effort to re-examine the Research Project Grant (RPG) review criteria to make peer review fairer and more effective and to achieve the goal of identifying the strongest, most impactful scientific research. As a result of this effort, CSR is proposing changes that are intended to refocus the peer review process on scientific merit, reduce administrative burden, and mitigate reputational bias. The existing five scored criteria would be reorganized into three factors: importance of the research, rigor and feasibility, and expertise and resources. The first two factors would be scored, while aspects of the third factor would be gauged as “appropriate” or “additional resources needed.” Reviewers would then consider all three factors, along with additional review criteria, in determining an overall impact score. Comments on the proposed changes can be submitted to CSR through March 10.

Dr. Criswell noted that NIAMS and NIH are always seeking volunteers to serve as grant application reviewers. There are a number of advantages to serving as a reviewer, and Dr. Criswell encouraged attendees to spread the word to their colleagues. CSR also has an Early Career Reviewer Program for early-stage researchers who are interested in gaining experience in the peer review process. Dr. Criswell announced that NIAMS will invite three Mentored Career Development Awardees to serve as ad hoc NAMSAC members starting with the June meeting. The goals of this initiative are to provide Council-related experience to early-career investigators and to provide the Council and NIAMS with diverse perspectives about NIH and NIAMS activities.

Dr. Criswell updated the Council on NIH's new Data Management and Sharing Policy, which requires investigators to submit plans describing how their scientific data will be managed and shared. As an example of NIAMS' commitment to data sharing, Dr. Criswell described the new NIAMS Arthritis and Autoimmune and Related Diseases Knowledge (ARK) Portal that provides online access to data and tools produced by the Accelerating Medicines Partnership in Rheumatoid Arthritis and Systemic Lupus Erythematosus (AMP RA/SLE) and the AMP Autoimmune and Immune-Mediated Diseases (AIM) programs. She encouraged Council members to spread the word about this new resource. Dr. Criswell also updated the Council on the Team Science Leadership Scholars Program in Women's Health, Autoimmune and Immune- Mediated Disease, which was announced at the last Council meeting. The FOA has been published with a due date of February 20.

The Institute recently launched a new, searchable collection of almost 200 scientific images that are free for the research community or any other interested party to download. The growing collection is called the NIAMS Multimedia Library and is available through the NIAMS website.

Dr. Criswell touched on NIAMS' development of its next strategic plan, which will cover fiscal years 2025 through 2029. NIAMS issued a Request for Information to solicit input from the stakeholder community and received over 40 responses. NIAMS will hold listening sessions for the scientific community and the NIAMS Coalition and will seek Council input at future meetings.

Finally, to highlight the impact of NIAMS research, Dr. Criswell informed the Council of a recent article in The New Yorker, titled "Nobody Has My Condition but Me," which was written by a patient being treated by Dr. Michael Ombrello, Chief of the NIAMS IRP's Translational Genetics and Genomics Section.

Discussion

Dr. Luis Garza remarked on the strides the Institute has taken in recent months. He passed along comments he had received from researchers encouraging the Institute to maintain the strongest
 
R01 payline possible. Dr. Criswell acknowledged that R01 grants are a priority, emphasizing the importance of investing NIAMS funds as effectively as possible within the constraints of its budget. Seeking supplemental funds from other sources, such as by participating in the HEAL Initiative and AMP, helps NIAMS stretch its dollars. NIAMS always needs to balance the R01 research budget with its desire to take on new programs.

On the subject of proposed changes to CSR's framework for peer review, Ms. Suzanne Schrandt asked if adding patients or patient advocates to peer review panels had been considered. Dr.
Criswell said that generally there was increased awareness at NIH on the importance of patient and family input at all phases of research. She noted that NIAMS' AMSC study section review committee includes a patient community representative as a full member. Dr. Salaita added that, while such requirement was not explicitly part of the proposed CSR framework, inclusion of patient representatives could be written into FOAs as appropriate.

Dr. Mary Bouxsein asked Dr. Criswell to comment on how NIAMS identified and developed proposals for new partnership opportunities, i.e. the NIH Common Fund. Dr. Criswell said it was a mixture of strategy and opportunism. The Institute is always looking for opportunities that align with particular components of its mission while staying vigilant about the need to maintain a broad perspective. Recently, the Common Fund asked each IC to propose two concepts and invited Institute Directors to provide input on which ones to forward to the Office of the NIH Director. Dr. Bouxsein asked whether the Council can play a role in helping identify concepts that could be used in this effort. Dr. Criswell said the Council could put forward concepts, although this year the deadline was not conducive to formally consulting the Council. NIAMS is working to refine its concept development process and continues to consider how best to include the Advisory Council's input on its activities.

Dr. Valentina Greco commented on the potential unintentional consequences of CSR's changes to scoring criteria that were designed to reduce the effects of reputational bias. Dr. Criswell said NIAMS piloted a program that anonymized applications in the early stages of review in order to eliminate institutional bias. NIAMS also is trying to add consideration of investigators’ community service to its review process for certain Center applications. In the context of the BRAIN Initiative's PEDP, Dr. Greco worried about a lack of enforcement mechanisms for this effort to increase diversity. Dr. Criswell acknowledged that having metrics to hold programs accountable was important to diversity programs, and she praised the BRAIN Initiative for being on the forefront of this effort.

The Council discussed the effects of inflation on NIAMS' grant portfolio. Following NIH-wide trends, NIAMS is seeing a significant increase in non-modular R01 applications. It is becoming increasingly apparent that researchers do not believe $250,000 could cover their study costs, which is something that would likely have to be addressed at the NIH level in the coming years. Dr. Criswell said that the cost of doing research was increasing faster than the budget, which posed a challenge to the NIH community.

V. HELPING TO END ADDICTION LONG-TERM (HEAL) INITIATIVE

Dr. Criswell introduced the next panel of speakers who presented on NIAMS and NIH activities related to the HEAL Initiative. The HEAL Initiative was launched in 2018 as a component of the government's response to the opioid epidemic. It is taking a two-pronged approach: understanding, managing, and treating pain; and improving prevention and treatment of opioid misuse and addiction.

HEAL consists of six scientific teams, two of which focus on the first prong and four aimed at the second prong. Thus far, HEAL has funded over 1,000 programs nationwide, totaling over $2.5B. Dr. Criswell noted that 1 in 5 Americans experienced chronic pain and the lack of safe, non-addictive treatment options is a major contributor to the opioid crisis. Many conditions in the NIAMS purview include pain as a prominent symptom, which made NIAMS well-positioned to contribute to the pain management aspects of HEAL. NIAMS has participated in HEAL since its inception and continues to play an increasingly larger role. The Back Pain Consortium (BACPAC) and Restoring Joint Health and Function to Reduce Pain (RE-JOIN) Consortium are two HEAL programs in which NIAMS plays a major role.

Dr. Robert Carter, NIAMS Deputy Director, discussed how HEAL is influencing joint pain research, a major NIAMS interest. He provided a brief introduction to the BACPAC and RE- JOIN programs, as well as two other programs. BACPAC focuses on spinal pain and includes a clinical trial looking at treatment outcomes and biomarkers. RE-JOIN focuses on sensory neuron innervation of the joint tissues that mediate the sensation of pain, particularly in the context of the knee joint and the temporomandibular joint (TMJ), in the hopes of informing future interventions. NCCIH is the lead IC of an RFA titled Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management, which aims to identify imaging biomarkers to monitor responses or predict outcomes of pain management regimens. NINDS manages a fourth program of note called the Program to Reveal and Evaluate Cells-to-gene Information that Specify Intricacies, Origins, and the Nature of Human Pain (PRECISION Human Pain). This program focuses on the spinal cord, basal ganglia, and peripheral tissues and hopes to characterize functional genetic, epigenetic, and molecular pathways that contribute to the sensation of pain. Dr. Carter noted that the common thread of all four programs is the need to better understand the fundamental mechanisms of pain. It is crucial to assess how these programs inform one another over time, through the lens of systems biology.

Dr. Marie Mancini, Program Director for, NIAMS Systemic Autoimmune Disease Biology Program and RE-JOIN team lead, provided a more detailed introduction to the RE-JOIN program. The goal of RE-JOIN is to study the innervation of the different articular and periarticular tissues that collectively form the joint by sensory neurons which mediate the sensation of pain. RE-JOIN consists of interdisciplinary teams that study sensory innervation of knee or TMJ tissues in animal models and human tissues and can explore how joint innervation changes with age, sex, physical activity, or joint degeneration. The ultimate goal is to identify key pain-related receptors and mediators that could then provide novel targets for pain reduction. Dr. Mancini described other specific examples of deliverables expected to emerge from RE- JOIN such as mapping of pain-related neurites, neuronal phenotyping, and the production of large shared data sets. RE-JOIN is managed by NIAMS and five other participating ICs. Five grants were awarded in response to funding announcements issued in September 2022. Dr. Mancini described the governance structure of RE-JOIN and briefly explained the study teams and their areas of focus and study designs. She noted that all five teams are multi-PI and multi- institutional. Two teams are focused on knees, two are focused on the TMJ, and the fifth will study both. All will be supported by a data coordinating group and two data management cores under the umbrella of the NIH Common Fund's Stimulating Peripheral Activity to Relieve Conditions (SPARC) program. Dr. Mancini underscored RE-JOIN's goal of promoting an integrated and whole-person approach to understanding pain and its treatment or prevention. Going forward, RE-JOIN investigators plan to include interactions with other HEAL projects and additional joints beyond the knee and TMJ.

Dr. Helene Langevin, Director, NCCIH, opened her remarks by expressing her excitement about her Institute's increasing collaboration with NIAMS and other ICs interested in musculoskeletal pain. Dr. Langevin's presentation was on the concept of whole joint health. One of the most common reasons people seek complementary and integrative treatments is due to musculoskeletal pain, and much of NCCIH's budget is devoted to research in this area. Dr.
Langevin described a schema by which health could be seen as a spectrum, with healthy on one end and disease on the other. Biomedical research tends to focus on the stage when the diseased state had already arrived, which could lead to a compartmentalized perspective. A whole person approach seeks to address a person's health before the emergence of fixed or irreversible pathologies. NCCIH is interested in research on multicomponent interventions that address psychological, nutritional, social, and biological components of self-care and traditional healthcare delivery. A similar approach could be used at the joint level, which has numerous components, but joint pain research has historically focused on the articular tissues. More recent research efforts have taken an expanded view of joint pain to include peri-articular tissues, which can be seen in projects like the RE-JOIN Consortium, the HEAL Initiative Workshop on Myofascial Pain, and HEAL's RFA on Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management. How joint health and whole person health are interrelated and influence each other is another important area of research. As part of this effort, NCCIH, in collaboration with NIAMS and other ICs, will hold a workshop in July entitled Understanding and Restoring Whole Joint Health in Pain Management. The two- day workshop will cover the topics of articular and peri-articular components, joint-specific differences and challenges, interventions, and emerging technologies and research models.

Dr. Walter Koroshetz, Director, NINDS, opened his remarks by emphasizing the centrality of pain to the field of medicine writ large. No IC at NIH focuses solely on pain research, but every IC studies diseases that have pain components. There have been trans-NIH pain-related efforts over the years, such as the NIH Pain Consortium, and NINDS houses the Office of Pain Policy and Planning (OPPP). These efforts led to a paper describing a proposed national pain strategy, which led to a National Academies of Science report on Relieving Pain in America. These efforts took greater prominence in light of the ongoing opioid epidemic and Congressional efforts to address the epidemic, a primary result of which is the HEAL Initiative. As noted above in Dr. Criswell’s Director’s Report, the HEAL budget is now $635M; $280M of this is devoted to NINDS. Dr. Koroshetz discussed how NINDS used prior year’s funds to issue over 400 research grants. In broad strokes, the two major goals of this research effort are to develop non-addictive therapies for pain and to study ways to use current therapies in a manner that limits the risk of addiction while also successfully treating pain symptoms. Dr. Koroshetz noted that much of the pharmacological industry had exited pain research in the aftermath of the opioid epidemic, making NIH's research on new interventions even more vital. He described studies focused on musculoskeletal pain that might be of interest to the NIAMS community. Non-pharmacologic interventions, some of which are led by NCCIH, are also important aspects of NINDS's funded HEAL-related grant portfolio. Dr. Koroshetz raised one challenge that the research community was facing: a dearth of investigators interested in pain research, which NINDS is attempting to address through training programs and centers of excellence.

Discussion

Ms. Schrandt said that encouraging patient referrals to occupational and physical therapists at the early stage of treatment is a major gap or area for improvement that could pay major dividends. Dr. Westendorf raised the issue of the lack of pain diagnostics and asked whether this was an area of focus for HEAL. Dr. Koroshetz talked about how the lack of pain biomarkers was one reason pharmaceutical companies had cut pain research. HEAL is funding studies to develop pain biomarkers, but it remains a challenging research area. Dr. Langevin added that developing tissue-level biomarkers is one of the goals of the myofascial pain program. Dr. Goodman emphasized the importance of patient-reported outcome measures and clinical biomarkers as a complement to traditional biomarkers. Dr. Koroshetz agreed, adding that HEAL funding had enabled wide-scale patient engagement that was not previously possible.

VI. NIAMS INTRAMURAL RESEARCH PROGRAM (IRP) ANNUAL REPORT AND CLINICAL PROGRAM UPDATE

Dr. Criswell invited Dr. John O'Shea, NIAMS Scientific Director, to deliver the annual report on NIAMS IRP activities. The NIAMS IRP consists of 270 staff members and represents approximately 10% of NIAMS' total budget. It employs 38 faculty level researchers, 23 of whom conduct clinical research and 15 who focus on basic research. Dr. O'Shea noted that the NIAMS IRP is relatively new compared with similar programs in other NIH ICs, which requires it to be more coordinated and focused in its work. The IRP has two clinical programs--one in rheumatology (including a community health clinic) and one in dermatology, as well as six research cores, a Career Development and Training Branch, and an Administrative Management Branch. Dr. O'Shea briefly listed the IRP's faculty researchers and their areas of research. He then discussed some research highlights that emerged from the 137 publications produced by the IRP over the last year, touching on the work of Drs. Andy Mammen, Peter Grayson, Robert Colbert, Mariana Kaplan, Vittorio Sartorelli, Maria Morasso, and his own research. Dr. O'Shea also detailed the numerous awards and career milestones achieved by IRP staff and alumni in recent months.

The IRP, and NIH as a whole, continues to acclimate to the changing work environment brought on by the COVID-19 pandemic. The Clinical Center still requires masks, but other ICs and labs on campus do not. At NIAMS, individual labs have their own telework policies, leading to a great deal of variance.

Dr. O'Shea also briefed the Advisory Committee on the IRP's efforts to strengthen diversity, equity, inclusion, and accessibility (DEIA) by contributing to the NIAMS Racial and Ethnic Equity Plans, conducting DEIA training, and improving training opportunities. Dr. Stephen Brooks serves as the acting IRP Scientific Data Officer and is tasked with helping to improve the management of IRP data and implementing the new NIH Data Management and Sharing Policy.

Dr. Criswell then invited Dr. Robert Colbert, NIAMS Clinical Director, to provide an update on the NIAMS Clinical Program. Dr. Colbert opened his presentation by updating the Council on changes at the leadership level to the Adult Rheumatology Fellowship Program (RFP). In recent years, the RFP has faced challenges attracting fellows due to limitations in the types of training that it provided at NIAMS and the NIH Clinical Center, which led to difficulties in staffing the Rheumatology Consult Service and the NIAMS Community Health Clinic (CHC). The previous RFP Director, Dr. James Katz, retired in late 2021, and Dr. Peter Grayson volunteered to serve as Acting Director while NIAMS recruited a permanent director. As Dr. Criswell announced in her Director's Report, the permanent RFP director, Dr. Paul J. DeMarco, recently started at NIAMS. NIAMS is particularly excited about his expertise in rheumatologic ultrasonography. In 2022, NIAMS had three Rheumatology Fellows, Drs. Ecem Sevim, S. Amara Ogbonnaya-Whittlesey, and Dale Kobin, and has two Fellows in 2023, Drs. Christopher Tidwell and Benjamin Turturice. Dr. Colbert briefly described their research interests and professional backgrounds. Dr. Colbert also announced Dr. Will Ambler as NIAMS' 2022 Henry Metzger Scholar.

Dr. Colbert then provided an update on the NIAMS Community Health Clinic, the primary goal of which is to reduce barriers to participation in clinical studies among underrepresented populations. The clinic also provides unique training opportunities, increased access to specialized care in the community, and opportunities to conduct research on health disparities. Created in 2001, the CHC has been located at several sites in the D.C. area, but most recently was sited in the Clinical Center on the NIH Campus. In 2023, the CHC will relocate to a new site in Ward 5 in Washington, D.C. The new CHC, scheduled to open in March, will partner with NHLBI and will be renamed the Hope Center.

Dr. Colbert highlighted several recent scientific advances from the Clinical Program, including Dr. Grayson and Dr. Marcel Ferrada's work on VEXAS syndrome; NIAMS researcher's participation in the American College of Rheumatology's 2022 Basic and Clinical Research Conference on "Understanding and Detecting Somatic Mutations in Health & Disease;" and research from Dr. Ombrello's lab on DRESS-like hypersensitivity reactions in patients with Still's disease. Dr. Colbert also touched on work from Dr. Kaplan and Dr. Sarafaz Hasni on the potential of pioglitazone, a peroxisome proliferator-activated receptor γ (PPARγ) agonist, as a treatment for systemic lupus erythematosus.

Discussion

Dr. Maria Suarez-Almazor asked Dr. Colbert to expand on the reason for the decrease in the number of Rheumatology Fellows over the years and whether it was related to funding levels. In addition to the reasons mentioned above, Dr. Colbert said NIAMS intentionally decided to go from three to two fellows per year because the pool of applicants did not support three fellows. During the pandemic, it became difficult to even fill two fellowships. NIAMS has been working to improve recruitment to sustain at least two fellows per year. Dr. Colbert said funding was not a factor. Dr. Bathon said that many institutions, including her own, were struggling to find academically minded fellows for their programs. Dr. Goodman expressed his belief that including orthopaedic and rheumatologic practitioners and clinician-scientists would be a major benefit for NIAMS' programs.

On the topic of improving DEIA, Dr. Greco suggested including DEIA considerations in promotion evaluations. She asked Dr. O'Shea whether the IRP had seen its DEIA initiatives bear fruit in the form of increased representation. Dr. O'Shea said NIAMS had three Independent Research Scholars, which was a large number for an IC of its size. Dr. Greco stressed the importance of representation at the higher levels in creating cultural change throughout an organization. Dr. O'Shea concurred and said that NIAMS and the IRP were working on a top- down approach. Dr. Criswell stated that a new element had been added to the federal employee assessment that evaluated individuals' contributions to developing a more diverse workforce. The Racial and Ethnic Equity Plans were another aspect of NIH's efforts to add metrics and accountability to DEIA initiatives.

VII. CONCEPT CLEARANCE

Dr. Salaita described the process by which NIAMS extramural staff identify critical research opportunities and needs within the IC's mission area. Concept clearance is the process by which NIAMS receives public advice and input on the merits of proposed concepts from the Advisory Council. Concepts are also published on the NIAMS website to make the research community aware of NIAMS interests and potential funding opportunities.

Dr. Gayle Lester, Director, Division of Extramural Research (DER), presented two concepts to the Council. The first concept was a new program, entitled Accelerating Research in Non-White Skin Types. The concept’s goal is to promote research on the causes of inferior diagnoses, increased prevalence, elevated clinical severity, and altered treatment responses to skin diseases in African American, Asian American/Pacific Islander, American Indian, and non-White Hispanic populations. Ms. Schrandt recommended that NIAMS reach out to other groups working on this topic, such as the Society to Improve Diagnosis in Medicine. As part of the discussion, Dr. Garza asked NIAMS to reconsider its decision not to participate in the clinical trial aspects of the NIH Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) program.

The second concept presented was reissuance of the Supplements to Advance Research (STAR) from Projects to Programs initiative. This program was designed to promote innovation and exploration of high-risk ideas by providing supplemental funding to early-career investigators, which NIAMS defined as researchers who had successfully renewed a first NIAMS-supported R01 award under Early Stage Investigator (ESI) status and did not hold more than two R01- equivalent grants. NIAMS believes this program is meeting its goals. Dr. Bathon asked whether NIAMS had conducted an outcomes assessment on the STAR Program. Dr. Lester said NIAMS did maintain analytics, which could be made available to the Council. In response to a question from Dr. Bouxsein, Dr. Heiyoung Park, the concept lead, conveyed that the STAR Program had issued 24 awards since its creation in 2015. Awards are for two years and provide up to $300,000 per award.

VIII. NIAMS RESEARCH INNOVATIONS FOR SCIENTIFIC KNOWLEDGE (RISK) PROGRAM

Dr. Lester introduced Dr. Hung Tseng, Program Director, Epidermis, Dermis and Skin Senses Program, NIAMS, to deliver a presentation on the RISK Program. Dr. Tseng began with a brief overview of the origins of the program, dating back to 2014. The goal was to promote innovation in the NIAMS mission areas in the model of the NIH Common Fund High-Risk, High-Reward Research Program. The FOA design team decided to only consider translational research concepts and developed a unique "innovation filter" application review process to reach the most innovative, high-impact ideas. Novel features of the review included a focus on innovation and significance, applicant anonymity, and scoring innovation and significance separately, with no overall score. Dr. Tseng noted that the RISK program was the first NIH FOA to his knowledge to review applicants anonymously; this practice has now been adopted elsewhere at NIH. Another unique aspect of RISK is its two-phase funding mechanism (R61/R33) by which only the most promising studies receive the second stage of funding. The RISK FOA was active from 2017-2022 and issued three funding rounds over two FOA issuances. The program received 391 X02 applications, solicited 162 R61 applications, and ultimately issued 32 awards. An analysis of the program found that publications emerging from RISK studies achieved a higher citation rate and Field Citation Ratio when compared to the parent R21 over the same period. Dr. Tseng concluded by discussing the potential for a reissuance of the RISK Program and areas where the program could be improved.

Discussion

Dr. Lester encouraged Council members to provide their comments on this program in anticipation of a potential concept reissuance in the future. Dr. Westendorf asked if RISK tracked which of its studies resulted in patent applications. Dr. Tseng said the impact of the RISK research was ongoing and NIAMS would continue to monitor progress, such as resulting patents. Many studies involved very nascent research, and it could take some time to see clinical applications.

IX. BRIEFING - IRP SCIENTIFIC DIRECTOR REVIEW

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)(6), Title 5, U.S.
Code and Section 10(d) of the Federal Advisory Committee Act, as amended.

X. SPECIAL ACTIONS AND CONSIDERATION OF APPLICATIONS - INITIAL MERIT NOMINATION AND MERIT EXTENSION

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.

The 110th National Arthritis and Musculoskeletal and Skin Diseases Advisory Council met
virtually via Zoom on January 31, 2023. Thirteen council members attended. En bloc
concurrence was unanimously approved for 628 primary and 283 secondary applications. The
total cost requested in year -01 for all applications was $438,341,584.

XII. ADJOURNMENT

The 110th National Arthritis and Musculoskeletal and Skin Diseases Advisory Council adjourned at 4:00 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.

Kathy Salaita, Sc.D.
Acting Executive Secretary, National Arthritis and
Musculoskeletal and Skin Diseases Advisory Council
Chief, Scientific Review Branch
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