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

MINUTES OF THE 106th MEETING
November 18th, 2021
1:00 P.m. to 2:30 p.m.

November 18th, 2021 Council Webcast

I.   CALL TO ORDER

The 106th meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC) was held on November 18, 2021, via videoconference. The meeting was chaired by Dr. Robert H. Carter, Deputy Director, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

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. Jill P. Buyon, Director, Division of Rheumatology, Department of Medicine, New York University School of Medicine
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
Mr. Vincent Del Gaizo, Patient Advocate and Director, Partnerships and Patient Engagement, Childhood Arthritis and Rheumatology Research Alliance (CARRA)
Dr. Luis A. Garza, Associate Professor of Dermatology, Johns Hopkins School of Medicine
Dr. Anthony Oro, Eugene and Gloria Bauer Professor of Dermatology, Associate Director and Professor, Center for Definitive and Curative Medicine, Department of Dermatology, Stanford University School of Medicine
Dr. Jennifer J. Westendorf, Margaret Amini Professor of Orthopaedic Regenerative Medicine Research, Mayo Clinic

Staff and Guests

Staff and Guests

The following NIAMS staff and guests attended:

Staff

Dr. Nandini Arunkumar 
Ms. Elizabeth Bouras
Mr. Mark Brown
Dr. Robert Carter
Dr. Ricardo Cibotti
Dr. Gayle Lester
Dr. Su-Yau Mao
Ms. Katrina Matthews
Ms. Melinda Nelson
Mr. Neil Roberts
Dr. Susana Serrate-Sztein
Dr. Yan Wang

Guests

Dr. Robert Kimberly, Professor of Medicine, The University of Alabama at Birmingham

II. CONSIDERATION OF MINUTES/FUTURE MEETING DATES/ADMINISTRATIVE REMINDERS

Ms. Melinda Nelson, Executive Secretary, welcomed Council members and staff to the special NAMSAC meeting and reviewed the logistics for virtual meetings. Ms. Nelson reminded Council members that they are obligated to respond to conflict of interest update requests within 30 days of receipt. The next NIAMS Advisory Council meeting is scheduled for February 1, 2022, and it will also be held virtually. Council members can consult the Electronic Council Book for future meeting dates.

Ms. Nelson asked for a motion to approve the minutes of the 105th NAMSAC meeting, which was held on August 31, 2021. The motion was made and the minutes were approved unanimously. 

III. DEPUTY DIRECTOR UPDATE

Dr. Carter noted that Dr. Lindsey Criswell, Director of NIAMS and chair of the NAMSAC, has recused herself from the meeting, which will be a discussion of the Accelerating Medicines Partnership on Autoimmune and Immune-Mediated Diseases (AMP AIM) Working Group report, because of her ties to one of the AMP-AIM’s applicants. 

Dr. Carter reported that Dr. Francis Collins, NIH Director, has announced his intention to retire from his post by the end of the year. Dr. Collins will remain at NIH after he steps down as Director, keeping his role as an investigator at the National Human Genome Research Institute. An interim NIH Director has not yet been named. 

Dr. Carter briefly reviewed the status of the NIH and NIAMS budget. A final FY 2022 budget has not been agreed upon by Congress and NIH is therefore operating under a continuing resolution. This resolution allows for federal agencies to temporarily operate without a permanent budget at approximately the funding levels of the prior fiscal year. Dr. Carter noted that the proposed budgets from the President and both chambers of Congress call for notable increases in funds for NIAMS and NIH as a whole. 

IV.   REPORT OF THE AMP AIM WORKING GROUP OF COUNCIL

Dr. Carter provided a brief review of the Accelerating Medicines Partnership®. AMP AIM is a successor initiative to the recently concluded AMP program in rheumatoid arthritis and lupus (AMP RA/SLE). Building on the tissue collection and sequencing work of AMP RA/SLE, the goals of AMP AIM are to index and map cells and pathways in RA, lupus, and psoriatic spectrum diseases, and Sjögren's syndrome and to use new analytic tools to discover how these pathways and cells interact and identify specific and shared disease mechanisms. AMP AIM has two Requests for Applications (RFAs), one for the disease research teams and a second for groups to operate the program’s Technology and Analytic Cores (TACs) and Research Management Unit (RMU). The AMP AIM Working Group is an Advisory Council subcommittee that was tasked with reviewing the proposed composition of the AMP AIM network, identifying gaps, and providing findings and recommendations back to the Council, which they will do at this meeting. 

Dr. Robert Kimberly, chair of the AMP AIM Working Group, presented an overview of the report’s findings and recommendations. The Working Group agreed with the program’s plan to consist of the four disease teams focus on RA, SLE, psoriatic spectrum diseases, and Sjögren's syndrome. The Working Group report emphasized the importance of including substantial patient-reported outcomes as part of the disease teams’ phenotyping strategy. The Working Group also believed it to be crucial that the program establish strategies for robust patient engagement in order to help ensure steady patient recruitment and longitudinal follow-up. 

The Working Group supported the inclusion of a Tissue Repository Core in AMP AIM to assist the disease teams in the acquisition, storage, and transfer of tissue samples throughout the network. Dr. Kimberly noted that the Working Group suggested the program consult NIH disaster mitigation guidance and consider operating storage facilities in multiple locations for redundancy purposes. The Working Group strongly recommended AMP AIM include two Systems Biology Cores with complementary focuses in order to increase capacity for data analysis. They recommended one core have expertise in developing and utilizing novel analytical tools and the second core provide experience in data management, data integration, and spatial analysis. Additionally, the Working Group strongly encouraged the program incorporate rigorous and harmonized quality control procedures across the network.

The Working Group also supported the inclusion of paired blood and tissue analytics projects, such as plasma and serum proteomics and transcriptomics. The Working Group suggested that the program add a Tissue Spatial Mapping Core to support the addition of spatial transcriptomics methods such as Visium HD, MERFISH, and other emerging high-resolution technologies. Additionally, the Working Group suggested AMP AIM consider including a Microbiome Core and increased metabolomics capacity. The Working Group believes the study of oral, skin, and gut microbiomes to be relevant to the goals of AMP AIM. It also recommended incorporating epigenomics and methods to profile antigen-specific T and B cells as exploratory projects.

Dr. Carter and Dr. Kimberly discussed revisions to the proposed organizational structure models for AMP AIM as influenced by the Working Group recommendations. The current model incorporates the Tissue Transcriptomics Core and Microbiome Core but leaves blood transcriptomics and metabolomics among the exploratory projects, with the potential to be brought online as full cores depending on how the needs of the program evolve. In addition to the Systems Biology Core, this model includes a Systems Genomics Core responsible for assessing and coordinating spatial technologies. 

Discussion

Dr. Anthony Oro asked how the Working Group determined, from a funding perspective, what are necessary technologies versus those that are more ambitious but are not crucial to achieving the program’s goals. Dr. Kimberly said that the exploratory projects that the Working Group suggested hold the potential to decrease downstream costs once validated. Dr. Oro asked how AMP AIM will maintain and store the data it collects. Dr. Carter said AMP AIM will establish a cloud-based knowledge and data portal for this purpose. Dr. Oro commented funding to maintain and clean data will be crucial to the success of the project. Dr. Jennifer Westendorf highlighted the need to emphasize artificial intelligence and machine learning approaches and to consider the influence of social determinants of health and patient diversity on the data obtained in the program. 

Dr. Luis Garza applauded NIH for expanding the scope of the program and expressed the hope that successor programs expand even further to include disciplines such as muscle and bone biology. He also cautioned NIH from removing or minimizing blood research projects given the high clinical applicability of blood-related research. Dr. Carter reassured Dr. Garza that blood-related topics would remain central to AMP AIM despite the removal of blood transcriptomics from the fully funded cores. He added that NIAMS is waiting for the results of the RA/lupus blood transcriptomics studies before making a determination on its value for AMP AIM or its successors. Dr. Kimberly added that there were concerns about the complexity and novelty of the technology that guided the recommendation against immediate inclusion. Dr. Elizabeth Chen added that there remains a need for characterization of disease phenotypes at the cellular level. Council members also discussed endophenotyping and the importance of obtaining a diverse and inclusive set of social-behavioral phenotypes for developing precise therapies. Mobile technology holds a great deal of promise for real-time collection of granular patient data. 

Ms. Nelson asked for a motion to accept the Working Group’s findings and recommendations. The motion was made by Dr. Garza and seconded by Dr. Westendorf. The motion was approved unanimously.

V. ADJOURNMENT

The 106th National Arthritis and Musculoskeletal and Skin Diseases Advisory Council adjourned at 2:22 p.m.  

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