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

MINUTES OF THE 111th MEETING
June 6th, 2023, 9:00am to 1:00pm

June 6th, 2023 Council Webcast

I.   CALL TO ORDER

The 111th meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC) was held on June 6, 2023, in Room A, 6th Floor, Building 31, National Institutes of Health, Bethesda, Maryland. 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. David Beck, Assistant Professor, New York University Grossman School of Medicine (ad hoc)
Dr. Staja "Star" Booker, Assistant Professor, University of Florida College of Nursing (ad hoc)
Dr. Mary L. Bouxsein, Professor, Department of Orthopedic Surgery, Harvard Medical School; Center for Advanced Orthopedic Studies, Beth Israel Deaconess Medical Center
Ms. Ann Elderkin, Consultant and former Executive Director, American Society for Bone and Mineral Research (ASBMR)
Dr. Andrew Findlay, Assistant Professor, Washington University in St. Louis (ad hoc) (via videoconference)
Dr. Stuart B. Goodman, Robert L. and Mary Ellenburg Professor of Surgery, Department of Orthopaedic Surgery, Stanford Medical Center Outpatient Clinic (via videoconference)
Dr. Ellen M. Gravallese, Chief, Division of Rheumatology, Inflammation, and Immunity,Theodore Bevier Bayles Professor of Medicine, Brigham and Women’s Hospital
Dr. Elizabeth McNally, Elizabeth J. Ward Professor of Genetic Medicine, and Director, Center for Genetic Medicine, Northwestern University Feinberg School of Medicine
Ms. Suzanne Schrandt, Founder, CEO, and Patient Advocate, ExPPect, LLC
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

Staff and Guests

The following NIAMS staff and guests attended:

Staff

Dr. Lindsey Criswell
Dr. Robert Carter
Dr. Gayle Lester
Mr. Rick Phillips
Dr. Susana Serrate-Sztein
Dr. Darren Sledjeski
Dr. Stephanie Burrows
Ms. Justine Buschman
Dr. Emily Carifi
Dr. Faye Chen
Dr. Bernard Dardzinski
Mr. Erik Edgerton
Dr. Mary Garcia-Cazarin
Ms. Stephanie Herndon
Ms. Colleen Labbe
Dr. Marjorie Lindhurst
Ms. Ryan Lombardi
Dr. Marie Mancini
Dr. Aron Marquitz
Ms. Jennifer Morgan Gray
Ms. Sara Myers
Mr. Christopher Nee
Dr. Kristy Nicks
Dr. Heiyoung Park
Ms. Amita Patel
Mr. Arrington Price
Mr. Neil Roberts
Dr. Daphne Robinson
Dr. Kathy Salaita
Mr. Herman Utama
Dr. Xibin Wang
Dr. Yan Wang
Dr. Chuck Washabaugh
Ms. Robin Wolz
Dr. Ted Zheng

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

Guests

Dr. Noni Byrnes, Director, Center for Scientific Review (CSR), NIH

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

Dr. Lindsey Criswell, NIAMS Director, welcomed Council members and staff to the 111th meeting of the NIAMS Advisory Council (the first in-person meeting since the COVID-19 pandemic) and led the Council in a round of introductions. Dr. Criswell also welcomed and introduced NIAMS' new Director of the Division of Extramural Activities (DEA), Dr. Darren Sledjeski, who will also serve as the Council's new Executive Secretary. Dr. Sledjeski has been at NIH for several years and most recently served as the Deputy Director of the Division of Extramural Activities at the National Institute of General Medical Science (NIGMS). Prior to federal service, Dr. Sledjeski was an associate professor at the University of Toledo Medical Center. Dr. Criswell thanked Mr. Erik Edgerton and Dr. Kathy Salaita for serving as Acting DEA Director and interim NAMSAC Executive Secretary, respectively, since April 2022. Dr. Criswell also thanked Ms. Sahar Rais-Danai for serving as Acting Chief Grants Management Officer while Mr. Edgerton was filling the role of Acting DEA Director.

Dr. Sledjeski expressed his excitement at joining NIAMS and thanked Dr. Criswell and NIAMS staff for the warm welcome and support as he came on board. Dr. Sledjeski reviewed the meeting logistics and etiquette for virtual attendees and reminded members of the public that they have fifteen days following the meeting to submit written comments at the email address NIAMScouncilmail@niams.nih.gov. He reminded Council members of their conflict of interest obligations under federal law and noted upcoming conflict of interest reporting deadlines.

Dr. Sledjeski asked the Council if there were any comments or corrections on the minutes of the 110th NAMSAC meeting, held on January 31, 2023. There being no comments, Dr. Sledjeski moved to approve the minutes, which were approved unanimously. Dr. Sledjeski announced that the Council's next meeting is scheduled for August 29, 2023. Subsequent meeting dates are January 30 and May 29, 2024.

III. NIAMS DIRECTOR’S REPORT AND DISCUSSION

Dr. Criswell began her remarks by reminding the Council of NIAMS' commitment to appoint NIAMS mentored career development award recipients as ad hoc members for Council open sessions. The goal is to provide these individuals with experience with the Council and to allow the Council to receive input from early-career researchers. Dr. Criswell introduced Drs. David Beck, Staja “Star” Booker, and Andrew Findlay, the first three awardees selected to serve as ad hoc Council members.

Budget

Dr. Criswell updated the Council on NIAMS' funding plan for FY 2023, which sets the R01 payline for most investigators at the 10th percentile. This payline is slightly lower than previous years, but Dr. Criswell emphasized that this does not mean NIAMS will be funding fewer R01 grants. Rather, it empowers NIAMS program directors to look more critically at applications above the payline and determine which ones should be recommended for funding. NIAMS will be maintaining its more generous 15th percentile payline for early-stage investigators (ESIs).

In March, President Biden released his FY 2024 budget request, which calls for a 3.9% increase in funding for NIH and a flat budget for NIAMS. Dr. Criswell cautioned that these numbers are likely to change as both chambers of Congress work to develop and reconcile their own budget proposals for FY 2024. Dr. Criswell presented a slide depicting how NIH and NIAMS spent their budgets in FY 2022, which highlighted the fact that a large proportion (79% and 83%, respectively) went to supporting extramural research.

Personnel Changes

At the NIH level, President Biden recently named Dr. Monica Bertagnolli, Director of the National Cancer Institute (NCI), as his nominee to be the 17th Director of the NIH. Dr. Bertagnolli is the first female NCI Director, and prior to joining NIH she held appointments at Harvard Medical School, Mass General Brigham Hospital, and Dana Farber Cancer Institute.

At NIAMS, Dr. Criswell announced that Dr. Mary Garcia-Cazarin joined as NIAMS' new Deputy Director of the Division of Extramural Research. Dr. Garcia-Cazarin came to NIAMS from the Office of Disease Prevention in the Office of the NIH Director. Dr. Criswell also announced the recent departure of several NIAMS staff members. Dr. Hung Tseng, the longtime director of the Epidermis, Dermis and Skin Senses Program, retired on March 31. Dr. Shahnaz Khan, chief of the Clinical Research Operations and Management Branch, will be departing NIAMS to join the NHLBI Center for Translational Research and Implementation Science. Dr. Criswell in particular noted Dr. Khan's work in support of the Council's Clinical Trials Working Group. Dr. Sledjeski will be taking over Dr. Khan's responsibilities in the Extramural Program as NIAMS seeks her permanent successor.

On the Intramural side, Dr. Criswell shared that Dr. John O'Shea, NIAMS Scientific Director, was recently elected to the National Academy of Sciences, one of the most prestigious accomplishments for scientific researchers. In addition, Dr. O’Shea had previously announced his intent to step down from his role as Scientific Director. He has been at NIH for over 40 years and served as NIAMS Scientific Director for 18 years. Dr. Criswell congratulated Dr. O'Shea for his myriad achievements over the course of his career and thanked him for agreeing to stay on as Scientific Director as NIAMS searches for his replacement. Lastly, Dr. Criswell announced that Dr. Robert Walker, Jr. had been named NIAMS Chief Diversity Officer. Dr. Walker previously served as director of the Intramural Research Program's Office for Scientific Operations. In his new role, Dr. Walker will lead the development and implementation of research, research capacity-building, training, and career development programs to enhance scientific diversity of NIAMS efforts, among other responsibilities.

NIH and NIAMS Activities

On March 23, the NIH hosted Dr. Ashish Jha, the White House COVID-19 Response Coordinator. During Dr. Jha's visit, he heard a presentation from NIAMS' Dr. Mariana Kaplan on the impact of COVID-19 on individuals with systemic autoimmune diseases and also toured Dr. Kaplan's laboratory.

Dr. Criswell was recently invited to participate in two congressional briefings. The first briefing was as part of the Coalition of Skin Diseases Hill Day activities in which Dr. Criswell delivered prerecorded remarks highlighting NIAMS' investments in skin biology and disease research. On May 22, Dr. Criswell participated in an in-person panel briefing on the Hill organized by Research!America where she discussed NIAMS' work on lupus research and other high-cost, high-burden diseases. These briefings are important opportunities to highlight the outstanding work supported by NIAMS and to educate members of Congress and their staff about the Institute.

Dr. Criswell then discussed the first project from the Advanced Research Projects Agency for Health (ARPA-H), Novel Innovations for Tissue Regeneration in Osteoarthritis (NITRO), which aims to solve osteoarthritis treatment challenges by exploring technologies in three research areas: injectable bone regeneration, injectable cartilage regeneration, and replacement joints built from human cells. ARPA-H will be holding a Proposers' Day on June 15 for interested research teams.

Last month, the Foundation for the NIH (FNIH) announced that the Bespoke Gene Therapy Consortium (BGTC) selected eight rare diseases for its clinical trial portfolio: congenital hereditary endothelial dystrophy (CHED), NPHP5 retinal degeneration, retinitis pigmentosa 45, multiple sulfatase deficiency, Charcot-Marie-Tooth disease type 4J, spastic paraplegia 50, propionic academia (PCCB), and Morquio A syndrome (mucopolysaccharidosis IVA). Dr. Criswell noted that these diseases were chosen based on BGTC's established criteria for selection. At least two of these diseases are of great interest to the NIAMS community.

As Dr. Criswell first announced at the last Council meeting, Congress has directed funds to establish the Office of Autoimmune Disease Research within the Office of Research on Women’s Health (ORWH), with $10M in initial funding, in response to the National Academies of Science, Engineering, and Medicine’s (NASEM) consensus report titled “Enhancing NIH Research on Autoimmune Disease.” The goals of the new office, which were pulled from the NASEM report, are to develop a trans-NIH strategic research plan, identify areas of innovation, evaluate the NIH’s autoimmune research portfolio, and foster and coordinate collaborative research, among other activities. As a leading funder of autoimmune research, NIAMS has been working in close collaboration with the new office as it begins its work. One of the first initiatives to emerge from this effort is the Notice of Special Interest (NOSI) on Exposome in Autoimmune Diseases Collaborating Teams Planning Awards (EXACT-PLAN), which is a collaborative effort among ORWH, NIAMS, and several other NIH Institutes. The goal is to invite applications for exploratory, early, and conceptual stage research planning projects aimed at building a future team science research network to discover the environmental exposures that influence disease susceptibility, onset, and outcomes, and to develop a systems-level approach to understanding the mechanisms underlying how exposures perturb cellular, organ, and tissue function across autoimmune diseases.

The Understanding Chronic Conditions Understudied Among Women R01 and R21 Notices of Funding Opportunities (NOFO) are other examples of collaboration between ORWH and NIAMS. Dr. Criswell also updated the Council on another OWRH initiative, the Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) program, which has been supported by NIAMS and other ICs over the years. BIRCWH is a mentored career development program designed to connect junior faculty to senior faculty with shared interest in women’s health and sex difference research. There have been more than 700 participants in BIRCWH since its inception in 2000, including Dr. Criswell herself, and there are currently 19 active programs. Dr. Criswell announced that NIAMS will begin administering a BIRCWH program this year.

NIAMS has been involved in the planning and development of another trans-NIH program, the HEAL KIDS (Knowledge, Innovation, and Discovery Studies) Pain Initiative, led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). NICHD recently released two Notices of Intent to Publish for HEAL KIDS, one for a pain resource and data center and the other for supporting an acute pain clinical trials program. NIAMS will provide further updates to the Council as this program advances.

Under the umbrella NIH UNITE initiative, NIH recently announced the Research With Activities Related to Diversity (ReWARD) program, which will provide support to scientists who are making a significant contribution to diversity, equity, inclusion, and accessibility (DEIA) in the research enterprise and who have no current NIH research project grant (RPG) funding. Successful applicants will receive funding through the R01 mechanism for both their scientific research and DEIA activities. Applications will be accepted through May 2026.

Dr. Criswell briefed the Council on an effort by the Center for Scientific Review (CSR) to seek public comment on how National Research Service Award (NRSA) fellowships are reviewed. This was spurred by an NIH working group's conclusion that the current process is excluding promising scientists because it too heavily favors elite institutions and prestigious sponsors, and too narrowly emphasizes early markers of future academic success. NIH has released a Request for Information (RFI) on revised review criteria and corresponding changes to the review process. Responses are due by June 23.

At its last meeting, the Council heard from Dr. Faye Chen on NIAMS' decision to withdraw from the NIH-wide parent R21 program. After receiving feedback from the Council, NIAMS issued a NOSI to notify the research community that NIAMS will now only accept exploratory/developmental R21 grant applications focused on NIAMS' core mission areas through the NOSI and not through the NIH-wide parent R21 notice of funding opportunity. This decision was made bearing in mind the Institute's strategic goals for efficient and effective stewardship of its extramural funding. These goals are to support highly meritorious science, support a diverse portfolio of research across the spectrum of NIAMS' research areas, support projects that align with NIAMS priorities, and to allow for flexibility to address emerging areas or unique scientific challenges.
As part of the Institute's strategic planning process, NIAMS recently convened a two-day Extramural Scientific Planning Retreat to discuss strategies for future investments.

Approximately 50 NIAMS staff members participated in the retreat. A summary of the conversations held at the retreat will be published to the NIAMS website in the coming weeks. Dr. Criswell invited the Council to provide feedback related to topics discussed at the retreat, such as how to leverage strategic partnerships to expand Institute resources for supporting research, how to optimize funding decisions, and how to better communicate the Institute's goals. These questions are of particular importance during a climate of rising research costs and concerns about future appropriations.

Discussion

In response to a question about NIAMS' partnership with the nascent Office of Autoimmune Disease Research at ORWH, Dr. Criswell discussed how ORWH, as an NIH Office, cannot administer grants or awards, and therefore relies on forming partnerships with NIH Institutes and Centers, such as NIAMS. Dr. Criswell is impressed with the planning work performed by ORWH on such a short timeline. NIAMS intends to have a representative from ORWH present at the next Council meeting to discuss the new office’s efforts.

Dr. Maria Suarez-Almazor asked if NIAMS will have a dedicated R21 mechanism and/or study section after separation from the trans-NIH mechanism. Dr. Gayle Lester said the applications will go through the normal CSR review process and then will be assessed against NIAMS' payline and funding decision process. Dr. Criswell said that this change was largely driven by concerns about "mission creep" in which NIAMS was seeing an increase of applications that did not fully align with the Institute's mission. This was, in part, caused by other ICs deciding not to accept any R21 applications, which necessitated applications that would more naturally go to those ICs to be sent somewhere else. Dr. Faye Chen encouraged investigators to communicate with NIAMS program officers before submitting R21 applications to make sure the project is within the core mission areas of NIAMS.

Ms. Suzanne Schrandt said she hoped NIAMS and NIH can find a way to recognize and incentivize patient and community engagement expertise among researchers during the grant review process. Engagement is important because it leads to better science. Dr. Criswell agreed with Ms. Schrandt's comment and suggested this might be a topic to discuss more deeply at a future Council meeting. The importance of patient engagement is a growing sentiment at NIH and some programs are already requiring patient engagement components. Many search and review committees now include patients as members to include the patient voice in the process. Dr. Carter suggested that this would be a good topic for the Clinical Trials Working Group to consider. Council members noted the overlap of patient engagement with DEIA-based community engagement efforts.

In reference to Dr. Criswell's request for feedback on questions raised at the scientific planning retreat, Dr. Beck asked how NIAMS decided between setting payline-based fixed limits and allowing for discretionary decisions by program officers. Dr. Criswell said there is variation across NIH ICs on how they approach this topic. For example, some ICs adhere more closely to CSR scores than others, and some ICs publish their paylines publicly while others do not. This issue has risen to the forefront at NIAMS because of the tight budget climate. Dr. Criswell believes NIAMS program directors have invaluable scientific expertise and perspectives that should be consulted during the funding decision process. Dr. Beck suggested conducting an outcomes pilot study to assess the performance of discretionary decisions. Dr. Criswell said that the funding decision process is highly dynamic and complex and that NIAMS strives to be as data-driven as possible. Dr. Lester stressed that discretionary decisions are not made by any single program director and are results of group deliberations and assessments. NIAMS will conduct assessments of these decisions, and Dr. Lester reminded the Council that it is a fluid situation given the state of the budget. Dr. Criswell added that NIAMS will strive to make these decisions throughout the fiscal year rather than waiting until the end of the fiscal year, which will require NIAMS to continue to better systematize the process for these select pay decisions. Over the past year, approximately 10% of the extramural budget was used to nominate highly meritorious applications that had not made the payline. NIAMS will continue to assess whether that is the right balance. Dr. Suarez-Almazor advised NIAMS to be wary that increasing the select pay tranche may unintentionally make the payline worse. Dr. Criswell indicated that NIAMS believes the success rate is a more important metric, which will remain unchanged. Seeking out partnerships and collaborative projects can help fill the payline gap. Ms. Ann Elderkin said that engaging with professional societies and focusing on open communication with the community will be crucial because any change that affects the payline is likely to be controversial.

Dr. Mary Bouxsein asked Dr. Criswell to expand on the ARPA-H NITRO program. Dr. Criswell noted the high-risk, high-reward nature of ARPA-H projects. NIAMS is very excited about NITRO given its relevance to NIAMS mission areas, and the Institute plans to collaborate and communicate with the ARPA-H team as much as possible. However, ARPA-H was designed to be separate from the NIH ICs and will make its own decisions on its timelines.

IV. CSR'S INITIATIVES TO STRENGTHEN PEER REVIEW

Dr. Criswell welcomed Dr. Noni Byrnes, Director of the NIH Center for Scientific Review. CSR's mission is "to ensure that NIH grant applications receive fair, independent, expert, and timely scientific reviews, free from inappropriate influences, so NIH can fund the most promising research." In FY 2023, CSR reviewed approximately 60,000 applications, representing 76% of all applications received by NIH during that period, and the Center reviewed 94% of all R01 applications. CSR employed approximately 275 Scientific Review Officers (SROs) in FY 2023 and engaged approximately 19,000 reviewers. In addition to standard applications, CSR reviewed 161 special initiatives in FY 2023, including trans-NIH programs such as the HEAL Initiative.

CSR issued a new strategic plan in 2022, which was built on the Center's existing strategic framework that has been in place since 2019. The primary goal of the framework is to optimize the output of peer review across three domains: study sections, reviewers, and process. CSR aims to be transparent, make decisions based on data, maintain engagement with stakeholders, and to prioritize staff training and development.

Dr. Byrnes described how CSR implemented a process it calls ENQUIRE (Evaluating Panel Quality in Review) in 2019 to restructure and evaluate its study sections. Approximately 20% of CSR's study sections are assessed each year via a two-stage assessment process comprised of a scientific evaluation and process evaluation. The scientific evaluation is conducted by an external panel and the process is assessed by an internal panel, after which the study section is reviewed by the CSR Advisory Council. Further assessment steps take place after Council approval of restructured or new study sections, and the entire process takes around 12-18 months to complete. To date, 152 study sections have completed or begun the ENQUIRE process. ENQUIRE has led to substantive changes to many of the study sections that have gone through the process, including the elimination or merging of smaller, "boutique" panels and development of new sections on emerging scientific areas.

Dr. Byrnes next discussed CSR's efforts over the last several years to simplify the review of RPG applications. This project has two main goals: to refocus peer review on providing advice on the scientific and technical merits of grant applications and to mitigate reputational bias in the peer review process. The proposed changes are designed to reduce the overall burden on reviewers by, for example, relieving reviewers of the responsibility of assessing policy compliance and to ultimately facilitate the identification of the strongest research with the highest potential impact. Dr. Byrnes described the CSR's process and activity timeline related to this effort and then described the proposed new peer review framework that emerged as a result. She noted that CSR has regulatory guardrails that it must adhere to; in particular, the five criteria used in peer review are mandated by federal statute and cannot be changed without Congressional action. However, NIH does have latitude in how those criteria are assessed and scored. The primary recommendation is to combine the five criteria into three factors: Factor 1, importance of the research; Factor 2, rigor and feasibility; and Factor 3, expertise and resources. Additionally, only Factors 1 and 2 will be scored, while Factor 3 will be determined to be either "appropriate" or "gaps identified." CSR determined that the Factor 3 criteria related to research environment were an area where bias was more likely to occur, which is why the decision was made to have it be unscored. Dr. Byrnes noted that Factor 3 will still influence the overall score. Most "Additional Review Criteria" will remain unchanged by the proposal, but most "Additional Review Considerations" will be eliminated from first-level peer review. CSR has received generally supportive feedback from the public and other stakeholders, with many encouraging CSR to develop and promulgate robust training resources for SROs and reviewers. The next step is for a trans-NIH implementation committee to consider input from stakeholders and develop a rollout strategy, with a tentative target of the new process beginning for applications received in October 2024.

Dr. Byrnes described CSR's parallel efforts to improve the review of NRSA fellowships. A working group of the CSR Advisory Council was convened to gather data and community feedback to assess a widespread concern that NIH is excluding promising scientists because the review process too heavily favors elite institutions and individuals with prominent sponsors. The working group's analysis of over 6,000 applications found evidence to support this concern, such as applications being highly concentrated in a small number of institutions and worse outcomes for applications from institutions that submit low numbers of applications. Analysis also showed that outcomes improve as the academic rank of the sponsor rises. The working group proposed two recommendations: to revise the NRSA application to better contextualize the applicant's accomplishments, and to revise the review criteria to focus more on the applicant's potential and the strength of their proposal, without bias towards sponsor and institutional reputation. Dr. Byrnes briefly described how the application and review criteria will be changed under this proposal. The recommendations have been reviewed by NIH leadership but Dr. Byrnes stressed that CSR was still soliciting feedback from the community.

Another priority for CSR has been to promote integrity and fairness in the peer review process. CSR holds orientation sessions for the approximately 90 incoming study section chairs per year and emphasizes the role of the chair in promoting fairness. Since 2021, CSR has held bias awareness training for reviewers to help address the most common types of bias in the peer review process. In 2021, CSR also updated its review integrity training module, and over 12,000 reviewers have completed the updated module since late 2022. CSR has also established a direct reporting mechanism for instances of potential bias, which, if confirmed, can lead to applications being re-reviewed.
Finally, Dr. Byrnes discussed CSR's work to diversify its peer review panels. In addition to improving the review itself, a diverse panel can also help mitigate bias. She described a tool that CSR has developed to help SROs better identify qualified reviewer candidates. CSR is also working to train SROs on best practices in recruitment, raising awareness on the importance of broadly diverse panels including on Special Emphasis Panels. CSR has successfully improved the diversity of its reviewer pool over the last few years, both in terms of gender and underrepresented minority status.

Discussion

Dr. Criswell applauded Dr. Byrnes and CSR for these improvements, particularly noting her experience watching study sections evolve through the ENQUIRE process. Dr. Susana Serrate-Sztein, NIAMS Associate Director for Strategic Initiatives, asked Dr. Byrnes to elaborate on how Factors 1 and 2 will be incorporated into the overall score under the new schema and how CSR sees that improving the quality of the review, in addition to lightening the burden and mitigating bias. Dr. Byrnes said that those factors will operate similarly to how scored criteria were considered in the past; the major difference is the removal of scoring for Factor 3 criteria. All three factors will be considered for the overall score, which is the score that gets percentiled for payline purposes, and reviewers will be required to explain how they reached the final score. Better focusing reviewers on what drives the overall score will help ensure that the strongest science is identified. Dr. Byrnes also discussed the new review process in the context of resubmissions, which now requires full assessment of the resubmitted application on its merit.

Dr. Beck asked if the changes proposed for NRSA reviews will also apply to Research Career Development Awards (K) applications. Dr. Byrnes said that CSR is not usually involved in reviewing K applications, which are normally handled at the IC level, which is why it focused on the NRSA process. However, she did not rule out K applications being assessed in a similar fashion in the future.

V. UPDATE ON NIAMS STRATEGIC PLAN

Dr. Criswell invited Dr. Stephanie Burrows, Chief of the NIAMS Scientific Planning, Policy, and Analysis Branch (SPPAB), to update the Council on the Institute's strategic planning
process. Dr. Burrows began by reminding the Council of the purpose behind the strategic plan, which is for it to be a public statement of the NIAMS' interests, to serve as a guidepost for researchers, and to act as an internal reference for the Institute staff. Because the upcoming plan will be the first strategic plan issued under Dr. Criswell's leadership, it is expected to be of particular interest to the community.

One of the more immediately noticeable differences will be a significant reduction in length. The current FY 2020-2024 Strategic Plan is 144 pages; in contrast, the plan for FY 2025-2029 is expected to be 40-50 pages long. Some sections will remain the same, either because of statutory requirement or because they cover central components of NIAMS' mission. The bulk of the scientific portion of the plan will consist of at least three cross-cutting thematic research opportunities, shortened descriptions of NIAMS' five disease- and tissue-specific scientific areas, and a description of the NIAMS IRP. A Request for Information (RFI) was issued last fall to solicit feedback on potential cross-cutting research opportunities and ideas for bold aspirations for the Institute over the next five years. On September 11, 12, and 14, NIAMS will hold a virtual idea generation meeting to gather more input on cross-cutting themes. Dr. Burrows encouraged Council members to participate in this meeting. She noted that this meeting will replace the disease- and tissue-specific listening sessions that were held as part of previous planning cycles. Following the meeting, a second RFI will be issued, after which the Strategic Plan drafting process will take place. NIAMS and the Council anticipate reviewing and revising the draft plan in the May-June 2023 timeframe, followed by a third RFI for public comment on the draft, with final Council review and approval occurring at the August 27, 2024, Council meeting. Dr. Burrows noted that NIAMS will also be preparing an internal implementation plan and hopes to provide updates and related information on NIAMS' website.

VI. DATA SCIENCE WORKING GROUP UPDATE

Dr. Serrate-Sztein presented the update on recent activities of the Council's Data Science Working Group. The working group's scope is to provide guidance to the Institute on data science-related opportunities to further research in NIAMS' mission areas. The working group is currently assessing and prioritizing recommendations in a number of areas, including data interoperability and data sharing, training, scientific opportunities, and resources to help researchers meet data science-related policy requirements. The working group's activities are based on the charge set to it by Dr. Criswell and follow parameters laid out by the NIH Strategic Plan for Data Science. The working group has focused its initial activities on the plan's themes related to data infrastructure, a modernized data ecosystem, and workforce development.

The working group has explored emerging themes and active projects in data science, both internal and external to the NIH, including knowledge portals and data repositories. On the topic of data infrastructure, the working group has identified several overarching themes: leveraging generalist knowledge bases/repositories, data interoperability/harmonization, and data sharing. Dr. Serrate-Sztein pointed to NIAMS' Data Science webpage and the Arthritis and Autoimmune and Related Diseases Knowledge (ARK) Portal as examples of NIAMS' early efforts in the realm of data infrastructure. NIAMS has also joined a number of trans-NIH data science NOFOs, NOSIs, and RFAs, including two using the U24 mechanism for resource-related research projects: Biomedical Knowledgebase (PAR-20-097) and Biomedical Data Repository (PAR-23-079).

NIAMS is using data science in some of the programs it sponsors, such as the proposed Accelerating Medicines Partnership® (AMP®) Systems Biology of Inflammation (SBI) program. This program combines biology and data science approaches to identify druggable shared targets and mechanisms of disease across the AMP network. This will enable a precision medicine approach to target and biomarker discovery and lay the foundation for a new molecular taxonomy of disease. Due to the large data sets that are expected to be produced as a result of this initiative, NIAMS is working to develop an infrastructure support tool called Accelerating Interoperable Data Ecosystems (AIDE) that leverages artificial intelligence to generate hypotheses and identify data products, predicted mechanisms, and relevant data for validation. Ultimately, this project is attempting to shift the paradigm from a clinical-based approach to a molecular taxonomy of disease.

Discussion

Dr. Ellen Gravallese asked Dr. Serrate-Sztein to elaborate on the sources of the AMP SBI data sets, how they will be integrated, and when the larger data set will be available to the research community. Dr. Serrate-Sztein said the AMP data sets already exist from previous AMP initiatives, but are maintained in different platforms. The National Institute on Aging is currently sponsoring a pilot program based on the proposed AMP SBI model in which data originally gathered for disparate diseases are used for other conditions. The pilot will be completed next year, after which AMP SBI will hopefully launch. Dr. Carter said the hope for the AIDE tool is for it to enable the utilization of data sets within AMP that, unfortunately, are not currently interoperable. In response to a question from Dr. Suarez-Almazor, Dr. Serrate-Sztein said NIH's goal is to eventually make all AMP data sets publicly available.

Dr. Beck asked whether the smaller AMP genomic data sets will also use other external data sets. Dr. Serrate-Sztein said that is something AMP is exploring. Dr. Carter added that some AMP data sets are larger than others because they were designed for different purposes. The AMP Common Metabolic Disorders program, for example, was designed to serve as a genetics repository, while, in contrast, AMP AIM was more focused on single-cell transcriptomics. The Common Metabolic Disorders database has actually grown over the years to include autoimmune disease data sets.

Dr. Bouxsein observed a focus on autoimmune disease when it comes to data science and asked if NIAMS has any projects related to the other NIAMS mission areas. Dr. Serrate-Sztein said the development of knowledge bases for musculoskeletal diseases is a need NIAMS plans to address in the near future. In general, NIAMS strives to provide a gateway for the research community to find the repositories, resources, and tools they need. Dr. Criswell added that NIAMS determined that leveraging AMP infrastructure seemed like a logical place to start due to the extant databases and resources, but she stressed that the Data Science Working Group is taking a holistic view and not focusing solely on autoimmune disease. 

VII. CONCEPT CLEARANCE

Dr. Sledjeski briefly 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 and approval from the Advisory Council. Concepts are also published on the NIAMS website to make the research community aware of Institute interests and potential funding opportunities.

Dr. Gayle Lester, Director of the Division of Extramural Research (DER), presented three concepts to the Council. There were two new concepts and one reissuance. The first new concept was the Accelerating Interoperable Data Ecosystem (AIDE) initiative discussed by Dr. Serrate-Sztein during her Data Science Working Group update. The second new concept before the Council was the Exposome in Autoimmune Diseases Collaborating Team (EXACT), the planning activities for which were briefly described by Dr. Criswell in the Director's Report. The reissued concept was the Research Innovations for Scientific Knowledge (RISK) awards. This program was the topic of a presentation by Dr. Hung Tseng at the last Council meeting.

Dr. Bouxsein asked what the funding mechanism would be for the new concepts. Dr. Sledjeski said that was to be determined and would be tailored to the concept. Dr. Lester added that the concepts could also result in workshops or roundtables or just be an area of focus for the Institute. The Council discussed budgetary impacts of approving the new concepts. Dr. Lester said approval does affect the payline. If concepts are approved and programs are subsequently developed, NIAMS would seek out collaborative opportunities with other organizations, such as the Foundation for NIH (FNIH). Dr. Lester stressed that approving a concept does not mean that concept will immediately result in a full-fledged grant-issuing program.

Dr. Stuart Goodman asked why the EXACT concept is limited to autoimmune diseases and not immune diseases more broadly. Dr. Criswell said that this concept is leveraging the new Office of Autoimmune Disease Research that she mentioned in her Director's Report. She noted that ORWH and the new office are still deliberating on what exactly is the full scope of the new office, and immune-mediated disorders may ultimately end up within its remit. Dr. Goodman suggested that NIAMS consider changing "autoimmune" to "immune-related" in the concept title. Dr. Carter said he would prefer if the title remained unchanged since the program is tied to specific activities underway in partnership with ORWH and NIEHS that, as of right now, are focused on autoimmune disorders. Dr. Criswell added that NIAMS hopes that lessons learned through EXACT will be readily extrapolated to a broader set of conditions.

The Council discussed with NIAMS staff the changes that were made to RISK as part of the reissue as well as NIAMS' efforts to assess the impact of RISK-supported research. Program staff said that analysis has shown that RISK-supported research has a higher Relative Citation Ratio (RCR) than a sample of non-RISK R21s. Dr. Criswell directed Council members to Dr. Tseng's presentation at the last Council meeting for more details, which was included in this meeting's Council book. Council members encouraged staff to continue to assess RISK's performance as it develops a larger sample size.

The Advisory Council unanimously approved the three concepts.

VIII. OPEN DISCUSSION

Dr. Criswell opened the floor to the Council for general discussion on topics of interest not mentioned during the meeting or ideas for future Council meeting agenda items. Dr. Staja Booker raised the topic of how NIAMS can integrate more community-engaged research and/or partnerships with community-based scientists into its portfolio. Dr. Criswell said this would be a great topic for a future Council meeting.

Ms. Elderkin asked what the previous NIAMS Strategic Plan's bold aspirations were and whether they were achieved. Dr. Burrows said they were to develop a gene therapy for muscular dystrophy or epidermolysis bullosa, identify therapeutic biomarkers for rheumatoid arthritis (RA), develop nonsurgical treatments for osteoarthritis, develop preventative therapies for RA and lupus, discover non-addictive therapies for chronic low back pain, reduce disparities in access to existing osteoarthritis interventions, and use precision medicine to reduce the number of osteoporosis-related fractures. Dr. Criswell stated that NIAMS has made progress on all these topics since the plan was released. For example, NIAMS is the lead Institute on the Regenerative Medicine Innovation Project (RMIP) and the HEAL Initiative's Back Pain Consortium (BACPAC). A NIAMS investigator has also published promising results related to biomarkers for RA. Dr. Criswell noted that the next Strategic Plan will incorporate more formal stewardship activities to help NIAMS better track its commitments. Dr. Goodman suggested advancing research on aging and musculoskeletal tissues as another bold aspiration to consider. Dr. Criswell concurred and suggested that might be a potential concept topic for a roundtable or other activities. Along the lines of bold aspirations, Dr. Bouxsein encouraged NIAMS to emphasize the centrality of musculoskeletal health and mobility to overall wellbeing, and that NIAMS' mission areas are at the core of human health and not at the periphery.

IX. 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.

X. REVIEW OF APPLICATIONS

The 111th National Arthritis and Musculoskeletal and Skin Diseases Advisory Council met in person on June 6, 2023. Seven Council members and two Ad-Hoc Council members attended in person and one Council member and one Ad-Hoc Council member attended virtually. En bloc concurrence was unanimously approved for 653 primary and 242 secondary applications. The total cost requested in year 01 for all applications was $439,786,928.

XI. ADJOURNMENT

The 111th National Arthritis and Musculoskeletal and Skin Diseases Advisory Council adjourned at 3:33 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