April 10, 2017

Department of Health and Human Services
Public Health Service
National Arthritis and Musculoskeletal and Skin Diseases Advisory Council

Minutes of the 90th Meeting
September 13, 2016
8:30 a.m. to 3:55 p.m.

  1. CALL TO ORDER

    The 90th meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC) was held on September 13, 2016, at the National Institutes of Health (NIH) Campus, Building 31, Conference Room 6. The meeting was chaired by Dr. Stephen I. Katz, Director, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

    Attendance

    Council members present

    Dr. Joan E. Bechtold, Professor, Orthopaedic Surgery, University of Minnesota
    Ms. Magdalena Castro-Lewis, former Vice President for Programs, National Alliance for Hispanic Health
    Dr. Sherine Gabriel, Dean of Rutgers Robert Wood Johnson Medical School
    Dr. V. Michael Holers, Professor, Department of Medicine, University of Colorado, Denver, School of Medicine
    Dr. Sundeep Khosla, Dr. Francis Chucker and Nathan Landow Research Professor; Director, Mayo Clinic CTSA/Center for Clinical and Translational Science; Dean for Clinical and Translational Science, Mayo Clinic College of Medicine
    Dr. Gary A. Koretzky, Dean, Weill Cornell Graduate School; Senior Associate Dean for Research, Weill Cornell Medical College
    Dr. Ethan Lerner, Associate Professor of Dermatology, Massachusetts General Hospital
    Dr. William Mulvihill, The Mulvihill Advisory Group
    Dr. Martha Murray, Associate Professor of Orthopaedic Surgery, Harvard Medical School
    Dr. Amy Paller, Professor, Dermatology, Feinberg School of Medicine
    Dr. Grace Pavlath, Senior Vice President — Scientific Program Director, Muscular Dystrophy Association; Professor, Department of Pharmacology, Emory University School of Medicine
    Dr. Anthony Rankin, Chief of Orthopaedic Surgery, Providence Hospital
    Dr. Christy I. Sandborg, Professor of Pediatrics, Stanford University, Lucile Salter Packard Children’s Hospital
    Mr. Richard F. Seiden, Foley & Lardner LLP
    Dr. Elizabeth Shane, Professor of Medicine and Vice-Chair for Clinical and Epidemiological Research, Columbia University College of Physicians and Surgeons
    Mr. Alexander Silver, Chairman, Jackson Gabriel Silver Foundation
    Dr. Stephen J. Tapscott, Professor, Fred Hutchinson Cancer Research Center
    Dr. Gwendolyn L. Powell Todd, Patient, Health Advocate, and Educator

    Staff and Guests

    The following NIAMS staff and guests attended:

    Staff

    Dr. D. Lee Alekel
    Mr. Steve Austin
    Dr. Carl Baker
    Ms. Pamela Beheler
    Ms. Elizabeth Bouras
    Dr. Amanda Boyce
    Mr. Gahan Breithaupt
    Dr. Stephanie Burrows
    Ms. Justine Buschman
    Dr. Robert Carter
    Dr. Faye Chen
    Ms. Jennifer Chi
    Dr. Thomas Cheever
    Dr. Jonelle Drugan
    Ms. Colleen Dundas
    Ms. Elizabeth Elliott
    Ms. Barbara Footer
    Ms. Sara Hwang
    Ms. Aleisha James
    Dr. Chao Jiang
    Ms. Katie Joffee
    Mr. Andrew Jones
    Dr. Stephen I. Katz
    Ms. Mary Beth Kester
    Ms. Shahnaz Khan
    Ms. Stephanie Kreider
    Dr. Gayle Lester
    Dr. Helen Lin
    Ms. Anita Linde
    Ms. Leslie Littlejohn

    Dr. Kan Ma
    Dr. Marie Mancini
    Dr. Kathryn Marron
    Dr. Joan McGowan
    Ms. Leslie McIntire
    Ms. Melinda Nelson
    Dr. Kristy Nicks
    Dr. John O’Shea
    Dr. Carol Parsons
    Ms. Anita Patel
    Ms. Vivian Pham
    Ms. Andree Reuss
    Ms. Trish Reynolds
    Dr. Susana Serrate-Sztein
    Dr. William Sharrock
    Ms. Sheila Simmons
    Ms. Robyn Strachan
    Dr. Dena Sumaida
    Ms. Loan Ta
    Ms. Jamie Thompson
    Ms. Susan Toy
    Dr. Hung Tseng
    Ms. Christine Tsui
    Dr. Bernadette Tyree
    Dr. Fei Wang
    Dr. Xibin Wang
    Dr. Chuck Washabaugh
    Dr. James Witter
    Ms. Robin Wolz
    Dr. Xincheng Zheng

    Guests

    Dr. James Anderson, Director, NIH Division of Program Coordination, Planning, and Strategic Initiatives
    Mr. Mike Bykowski, Consolidated Solutions and Innovations
    Dr. Guy Eakin, Arthritis Foundation
    Ms. Petra Harvey, Osteogeneisis Imperfecta Foundation
    Dr. John Holden, Department of Veterans Affairs
    Ms. Kim James, IQ Solutions
    Dr. Lynne Jones, Orthopaedic Research Society
    Ms. Annie Kennedy, Parent Project Muscular Dystrophy
    Dr. Jon Lorsch, Director, National Institute of General Medical Sciences
    Dr. Bill Riley, NIH Associate Director for Behavioral and Social Sciences and Director, NIH Office of Behavioral and Social Sciences Research
    Mr. Nate Robinson, IQ Solutions
    Mr. Paul Smedberg, American Academy of Physical Medicine and Rehabilitation
    Ms. Sharon Terry, Genetic Alliance
    Ms. Jennifer Tripp, Muscular Dystrophy Association
    Ms. Randi Williams, KAI Research, Inc.
    Ms. Esther Weiss, Office of Human Resources, NIH

  2. CONSIDERATION OF MINUTES

    A motion was made, seconded, and passed to approve the minutes of the 89th NAMSAC meeting, held on June 7, 2016.

  3. FUTURE COUNCIL MEETING DATES

    Future Council meetings are currently planned for the following dates:

    January 25, 2017
    June 21, 2017
    September 6, 2017
    February 7, 2018
    June 12, 2018
    September 5, 2018

  4. DIRECTOR'S REPORT AND DISCUSSION

    Dr. Katz reminded Council members that the public portion of this NAMSAC meeting was being videocast and will be archived on the NIH website. He thanked the following outgoing Council members: Drs. Sherine Gabriel, Martha Murray, Anthony Rankin, and Elizabeth Shane. On behalf of the NIAMS, Dr. Katz expressed gratitude for their many contributions to the Council’s deliberations.

    Budget Update and Funding Patterns

    On October 1, the Federal government will begin its new fiscal year (FY). It is expected that FY 2017 will begin with a continuing resolution, meaning that the NIH can continue to operate at, or slightly below, its FY 2016 budget. Both chambers of Congress have expressed an interest in increasing NIH’s budget for FY 2017. Council members were invited to learn more about NIAMS’ plans for FY 2017 by reading Dr. Katz’s written statement to the Senate Appropriations Committee (available here).

    Congressional Interactions

    In June, NIAMS participated in a series of courtesy visits on Capitol Hill to discuss the impact of skin diseases and how recent breakthroughs in treatments for metastatic melanoma, psoriasis, eczema, and rare diseases have transformed the outlook for patients, especially in the past decade. The visits were arranged by the American Academy of Dermatology Association (AADA).

    On October 5, the NIAMS Coalition will host its biennial tour day for Congressional offices. Staff will visit the NIH Clinical Research Center to learn more about the NIH and the NIAMS, and will tour several labs in the NIAMS Intramural Research Program.

    Personnel Changes at the NIH

    Dr. Katz reported on the following NIH-level personnel changes:

    • Dr. Joshua Gordon has been appointed as the new Director of the National Institute of Mental Health.
    • Dr. Diana Bianchi has been named as Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
    • Dr. Katz and Dr. Tony Fauci (Director, National Institute of Allergy and Infectious Diseases) are leading the search for a Chief Executive Officer for the NIH Clinical Center.
    • Dr. John Gallin will serve in the newly created dual position of NIH Associate Director for Clinical Research and Chief Scientific Officer for the Clinical Center.

    NIH and NIAMS Activities

    • The Advisory Committee to the Director is looking at strategies to ensure that all grant applications are evaluated on the basis of their scientific merit and that scores are independent of a researcher’s race or sex.
    • The NIH is requiring multi-site clinical studies to use a single Institutional Review Board beginning with applications submitted on or after May 25, 2017.
    • The Institute may need to reconsider its approach to accepting applications submitted to Parent FOAs with a primary mechanistic objective and a clinical outcome as an appropriate secondary objective in light of an anticipated change in NIH policy regarding the receipt of such applications under the Parent FOAs. This policy change will affect all NIH Institutes and Centers (ICs) that currently accept these hybrid R01 and R21 proposals under the parent announcements. The NIAMS is working closely with the NIH Office of Extramural Research and other ICs to develop an approach that meets the needs of NIAMS-funded investigators and is consistent with the intent of the trans-NIH Clinical Trial Stewardship Reforms Task Force.
    • Since the last Council meeting, the NIH has funded the Precision Medicine Initiative’s Data and Research Support Center, its Participant Technologies Center, and a network of healthcare provider organizations. With these awards, the NIH expects that investigators will begin enrolling participants as scheduled this year.
    • During the last Council meeting, the public health issue of bisphosphonate use among postmenopausal women who are at risk of osteoporotic fractures was discussed. A group of NIH staff is exploring the possibility of organizing a Pathways to Prevention Workshop with the NIH Office of Disease Prevention.
    • As part of a larger NIH effort to address innovation, flexibility, and stable funding for the most promising research, the NIAMS has launched a series of funding opportunities known as Research Innovations for Scientific Knowledge (RISK). These projects are intended to: (1) pursue unusual observations, (2) test imaginative hypotheses, (3) explore creative concepts, or (4) discover ground-breaking paradigms within the NIAMS mission.
    • NIAMS Grants Management Branch is developing a plan to shorten time-to-award for NIAMS applicants.

    Communication and Outreach Highlights

    • As part of NIH’s overall communications strategy to highlight the impact of federally-funded biomedical research on health, knowledge, and society, the NIH hosts a series of web pages that describe research accomplishments from intramural and extramural scientists. The NIAMS Office of Science Policy, Planning, and Communications has been working closely with NIH Director Dr. Francis Collins’ staff to make sure that NIAMS-supported work is well represented.
    • Dr. Katz noted that the NIAMS continues to leverage social media to share credible health information with people around the world. In celebration of Juvenile Arthritis Awareness Month in July, the institute partnered with the Arthritis Foundation, the American College of Rheumatology, and researchers from the Childhood Arthritis and Rheumatology Research Alliance (CARRA) to answer questions during a Twitter Chat in real-time.

    Highlights of Selected Recent Scientific Advances

    Dr. Katz described several scientific advances of interest to the Council.

    • Council member Dr. Elizabeth Shane and Dr. Edward Guo at Columbia University used individual trabecula segmentation and other analytical tools to assess the trabecular plates and rods of the tibias and radiuses of 45 women with and without a history of vertebral fractures. The differences they found suggest a pattern of abnormalities that may contribute to an increased vertebral fracture risk (Bone. 2016 Jul;88:39-46. doi: 10.1016/j.bone.2016.04.003. Epub 2016 Apr 12. PMID: 27083398).
    • Researchers led by Dr. Lou Soslowsky at the University of Pennsylvania showed that the Achilles tendons from female rats were stronger and more elastic than those from males. Females also had smaller muscle fibers. Because muscle fiber size is one of the factors that determines muscle strength, the female tendon may be protected from rupture by virtue of being attached to weaker muscles (Ann Biomed Eng. 2016 May 5. [Epub ahead of print] PMID: 27150673).
    • New work from Drs. Michelle Rozo, Liangji Li, and Chen-Ming Fan at the Johns Hopkins University demonstrates that a protein called beta1-integrin is crucial for muscle regeneration. The investigators were authors on two papers that describe how muscle stem cells and their interactions with their microenvironment are altered in aging and disease (Nat Med. 2016 Aug; 22(8):889-96. Epub 2016 Jul 4. PMID: 27376575) (Nat Med. 2016 Aug;22(8):897-905. Epub 2016 Jul 4. PMID: 27376579).
    • Dr. Gerard Karsenty at the Columbia University Medical Center recently published a paper demonstrating that bone improves muscle performance during exercise via the hormone osteocalcin. When investigators examined mice, monkeys, and humans, they observed that osteocalcin levels decrease with age. Osteocalcin injections reversed the age-related exercise capacity decline in mice, restoring performance of aged mice to that seen in younger adult animals (Cell Metab. 2016 Jun 14;23(6):1078-92. doi: 10.1016/j.cmet.2016.05.004. PMID: 27304508).
    • Dr. Tim Bhattacharyya and colleagues in the NIAMS Intramural Clinical and Investigative Orthopaedic Surgery Unit found that hospitals that perform more than 400 total knee and hip replacement surgeries had lower complication rates and better patient outcomes. Although more than 80 percent of the U.S. population lives within 50 miles of a high volume hospital, approximately 6 percent of people still elect to have these surgeries at lower volume hospitals (J Bone Joint Surg Am. 2016 May 4;98(9):707-12. doi: 10.2106/JBJS.15.00399. PMID: 27147682).
    • Research led by Drs. Gary Firestein and Wei Wang at the University of California, San Diego, suggests that rheumatoid arthritis (RA) mechanisms may vary by joint. When they compared the epigenetic and gene expression signatures of cells from rheumatoid and osteoarthritis patients who underwent total joint replacement surgeries, they found differences between the two diseases as well as between tissues collected from knees and hips of RA patients. These findings may help to explain why some joints improve, while others do not, in response to the same RA drug treatment (Nat Commun. 2016 Jun 10; 7:11849. PMID: 27282753).
    • Dr. Boris Reizis’ group at the New York University School of Medicine identified the enzyme DNASE1L3 as an essential molecular gatekeeper of immune tolerance—this may explain why mutations in this enzyme have been associated with several cases of early-onset familial lupus. This research paves the way for new therapeutic strategies to treat or prevent lupus by restoring DNase1L3 function (Cell. 2016 Jun 30; 166(1):88-101. doi: 10.1016/j.cell.2016.05.034. Epub 2016 Jun 9. PMID: 27293190).
    • NIAMS intramural researchers are evaluating the use of existing drugs to treat lupus symptoms. A team led by Dr. Max Gadina found that tofacitinib could both prevent and reverse several lupus symptoms including skin inflammation, kidney disease, and impaired blood vessel relaxation (Arthritis Rheumatol. 2016 Jul 18. doi: 10.1002/art.39818. [Epub ahead of print] PMID: 27429362).
    • Drs. Aimee Payne and Michael Milone at the University of Pennsylvania used chimeric antigen receptor technology to stop pemphigus vulgaris by selectively removing the disease-causing B cells in a mouse model. They created chimeric autoantibody receptor (CAAR) T cells engineered to express chimeric receptors consisting of the disease-causing autoantigen desmoglein 3 fused to signaling domains that activate T cells and showed that these CAAR T cells target and destroy cells expressing surface antibody to the keratinocyte adhesion protein Dsg3 (Science. 2016 Jul 8; 353 (6295):179-84. Epub 2016 Jun 30. PMID: 27365313).

    Discussion

    Council members commented on the science advances, noting that some are a good example of collaboration between clinical and basic scientists.

    Dr. Katz led a discussion on how the Institute can better prepare or inform Council members so that they are more able to address some of the issues that are raised at NAMSAC meetings. Suggestions included:

    • Convening a retreat or other forum for Council members to discuss their perspectives on issues affecting academic medicine, health care funding, and training.
    • Forming Council subcommittees tasked with establishing metrics for, and evaluating the success of, NIAMS’ new and existing programs. Various other Council subgroups have been effective in providing advice/guidance to the Institute on specific questions/issues in the past.
    • Providing Council members with advance notice of upcoming NAMSAC agenda items has been extremely helpful in preparing Council members to provide feedback at the meetings.
  5. STRATEGIC PLAN OF THE OFFICE OF BEHAVIORAL AND SOCIAL SCIENCES RESEARCH (OBSSR)

    Dr. William Riley, NIH Associate Director for Behavioral and Social Sciences and Director, OBSSR, provided Council members with an update on the OBSSR Strategic Plan. The OBSSR was authorized by Congress in 1993 and established in 1995 to: (1) coordinate behavioral and social sciences research conducted or supported by the agencies of the NIH, and (2) identify projects of behavioral and social sciences research (BSSR) that should be conducted or supported by the national research institutes, and develop such projects in cooperation with the institutes. After providing examples of overlapping work between the NIAMS and OBSSR, Dr. Riley described the guiding principles that informed the development of OBSSR’s Strategic Plan.

    Dr. Riley also described how the OBSSR communicates BSSR findings, coordinates BSSR programs across the NIH and integrates BSSR within the larger NIH biomedical research enterprise. OBSSR also trains the next generation of BSSR researchers, evaluates the impact of BSSR and addresses scientific policies. He highlighted the following scientific priorities tied to OBSSR’s Strategic Plan while providing examples relevant to the NIAMS:

    • Improve the synergy of basic and applied BSSR
    • Enhance the methods, measures, and data infrastructures to encourage a more cumulative BSSR
    • Facilitate the adoption of BSSR research findings in health research and practice

    Discussion

    Council discussion focused on difficulties in translating knowledge into behavior change; and it was noted that this remains a significant challenge. Dr. Riley noted that context is one of the major challenges facing BSSR—the patient’s culture, environment, family, social interactions, etc.—all of which are outside of what can be controlled in an intervention. He agreed that behavioral interventions need to more effectively translate and advance science from efficiency to effectiveness to dissemination and adoption.

    It was noted that the NIAMS and many other ICs have supported a significant amount of cognitive behavioral therapy (CBT) research and Dr. Riley was asked about efforts at the NIH level to advance this work and acknowledge its effectiveness. He explained that while CBT is seen as effective at the general population level, in many areas more work is needed at the subpopulation level and in different contexts (e.g., for tobacco use, CBT is only 20 percent effective). New approaches and innovations are needed and some of these advances may come from basic research.

  6. CONCEPT CLEARANCE FOR SCIENTIFIC INITIATIVES

    Dr. McGowan explained that the Institute relies on the Council, scientific meetings, trans-NIH groups, professional and scientific societies, its annual scientific retreat, and its annual roundtables to learn about emerging opportunities and inform its internal initiative development process. On an annual basis, Council members are asked to review possible NIAMS initiatives—this year, Council members were asked to review the following concepts:

    • The Neuroendocrine Influence on Cutaneous Biology
    • Research Grants Using Resources from the Osteoarthritis Initiative (OAI)
    • NIAMS Rheumatic Diseases Research Resource-based Centers
    • Small Business Innovation Research (SBIR) on Rare Musculoskeletal, Rheumatic and Skin Diseases
    • Mechanistic Ancillary Studies to Ongoing Clinical Trials
    • Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers

    Discussion

    It was noted that a future NAMSAC meeting will include a summary of NIAMS Centers programs. With regard to the SBIR on Rare Musculoskeletal, Rheumatic and Skin Diseases concept, there was a suggestion that particular attention be given to the criteria used for identifying which diseases are considered rare, particularly among those diseases for which prevalence data are lacking.

  7. CAN WE ENHANCE THE EFFICIENCY AND IMPACT OF RESEARCH CORE FACILITIES?

    Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) Director Dr. James Anderson explained that core facilities are centralized, shared research resources that provide access to instruments, technologies, expert consultation and other services to laboratory and clinical investigators. He noted that cores are challenging to characterize, largely because:

    • The NIH does not maintain databases to track the necessary information for understanding a core’s function and capabilities.
    • Redundancy exists within institutions and within and between funding ICs, but the level of redundancy is unclear.
    • Many institutions are motivated to manage and share cores, but management practices vary.

    Dr. Anderson presented FY 2013 data showing the funding for mechanisms supporting cores by IC as well as by institution. He acknowledged the perspective of Research Deans, who generally feel that cores are fundamental to supporting research, but are potential institutional liabilities because they take up space from researchers, can have duplicative personnel costs, and have potential cost overruns.

    At the NIH level, a series of workshops were held starting in 2009 to examine how cores can be more efficiently managed and utilized. One of the major conclusions was that the NIH ICs establish similar cores at a single institution to ensure that the researchers associated with that IC have access to instruments, and that this can lead to duplication and underutilization of the separate cores. Efficiencies resulted from consolidated billing, purchasing, and scheduling and tracking services; centralization of data processing, licenses, and software; advanced methodologies and technologies not available in the smaller cores; cross-training of staff; enhanced consultation and analyses of complex data; standard operating procedures; and institutional centralized oversight and planning.

    The NIH also partnered with the Association for Biomolecular Research Facilities to hold a 2015 workshop to identify lessons learned and best practices for enhancing the efficiency of research core facilities. Dr. Anderson concluded his remarks by suggesting some potential next steps, such as: (1) enhancing the visibility and knowledge of cores through a central database and/or registering cores with a unique digital identifier, (2) encouraging centralized and enhanced institutional oversight, and (3) changing the culture—perhaps by including sharing as a review criterion.

    Discussion

    Council members agreed that there are significant opportunities and challenges related to trying to consolidate research cores and expressed support for these activities. Opportunities noted by Council members included more rigorous and reproducible science conducted in a centralized and standardized way, regional and national sharing of large and expensive instrumentation, and cost savings. Some of the challenges identified by Council members include geographical considerations, the difficulties associated with introducing standardization with constantly changing techniques, and funding concerns/considerations.

    Others noted that the intramural programs within NIH ICs have cores and that there is overlap across the NIH in their activities. It was suggested that the NIH itself could be used as a test case in consolidating research cores while reducing overlapping efforts. This could help provide the extramural community with guidance and best practices in how to coordinate and integrate cores within and across institutions.

  8. ENHANCING THE EFFICIENCY, PRODUCTIVITY, AND SUSTAINABILITY OF FUNDAMENTAL BIOMEDICAL RESEARCH: THE NIGMS MAXIMIZING INVESTIGATORS’ RESEARCH AWARD (MIRA) PILOT PROGRAM

    National Institute of General Medical Sciences (NIGMS) Director Dr. Jon Lorsch described the Maximizing Investigators’ Research Award (MIRA) program, through which the NIGMS plans to fund research programs rather than individual projects. MIRA awards provide one NIGMS research grant per PI through the R35 mechanism which is larger (a direct cost range of up to $750,000) and longer than current R01 averages. MIRA awards are not tied to specific aims; the review is instead based on the investigator’s track record and overall research ideas (with consideration given to service and contributions to workforce development). MIRA applications are evaluated by separate panels, with modified review considerations for early stage investigators.

    Dr. Lorsch described NIGMS’ initial implementation plan for the MIRA program, still in its pilot phase. If the pilot phase is successful, the program will be expanded to include all PIs with an NIGMS R01. To date, the NIGMS has conducted two competitions, one for established investigators and one for early stage investigators. The NIGMS is developing an FOA to allow any investigator with an NIGMS R01 to apply for a MIRA instead of waiting until their R01 is up for renewal.

    Discussion

    In response to questions about evaluation metrics for the MIRA program, Dr. Lorsch explained that the NIGMS has been working to develop a robust evaluation scheme. Some effects from the program will take years to discern. In the shorter term, the NIGMS is determining if investigators want to participate in the program, if the NIGMS can support an increased number of researchers through MIRA, and if the NIGMS can fund MIRA awardees at increased budget, on average, compared to R01s.

  9. PCORnet: PEOPLE-POWERED OUTCOMES RESEARCH

    Sharon Terry, President and CEO of Genetic Alliance and Co-Principal Investigator of the PCORnet Coordinating Center, explained that the national clinical research system is not generating the evidence needed to support the healthcare decisions that patients and their doctors need to make every day. PCORnet, a product of the Patient Centered Outcomes Research Institute (PCORI), is a large, highly representative, national patient-centered clinical research network. PCORnet’s vision is to support a learning U.S. healthcare system and enable large-scale clinical research conducted with quality and efficiency. PCORnet’s mission is to enable faster, more trustworthy clinical research that helps people make informed health decisions.

    PCORnet has led to the creation of a nationwide functional research network that: (1) engages people, clinicians, and health system leaders throughout; (2) creates infrastructure, tools, and policies to support rapid, efficient clinical research; and (3) utilizes multiple data sources including electronic health records, insurance claims data, data reported directly by people, and other data sources. It embodies a community of research by uniting people, clinicians, and systems. PCORnet is made up of two kinds of individual partner networks—Clinical Data Research Networks (CDRNs, operated and governed by patient groups and their partners) and Patient-Powered Research Networks (PPRNs, networks that originate in healthcare systems). At present, PCORnet includes 13 CDRNs and 20 PPRNs. PCORnet can be leveraged to obtain faster answers to pre-research queries, valuable expertise through network collaboration, and enhanced credibility via PCORnet study designation. Through PCORnet’s Front Door, PCORnet researchers and others will be invited to collaborate on important people-centered clinical research studies.

    Discussion

    Dr. Katz explained that PCORI is funded through 2018; beyond that, funding is uncertain. Ms. Terry described plans to convert PCORnet to a 501(c)(3) entity in 2017 and examining what services it can provide to the nation’s research community while charging reasonable fees. Non-traditional revenue streams are being considered and pursued.

    Council members discussed targeting early to mid-career clinicians who are pursuing scholarly research careers and ensuring that Hispanic and other minority research groups are included in PCORnet efforts.

  10. BOARD OF SCIENTIFIC COUNSELORS REPORT

    This portion of the meeting occurred during closed session.

  11. A PIVOTAL YEAR AND PATH FORWARD FOR MUSCULAR DYSTROPHY CLINICAL RESEARCH

    This portion of the meeting occurred during closed session.

  12. SPECIAL ACTIONS

    This portion of the meeting occurred during closed session.

  13. CONSIDERATION OF APPLICATIONS

    In closed session, the Council reviewed a total of 956 applications requesting $3,827,054,778 in total costs and recommended 956 for $3,827,054,778 in total costs. 64 applications were considered by early concurrence. For the record, it is noted that secondary applications were also considered en bloc.

  14. ADJOURNMENT

    The 90th National Arthritis and Musculoskeletal and Skin Diseases Advisory Council Meeting was adjourned at 3:55 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.

Laura K. Moen, Ph.D.
Executive Secretary, National Arthritis
and Musculoskeletal and Skin Diseases
Advisory Council

Director, Division Extramural Research
Activities, National Institute of Arthritis and
Musculoskeletal and Skin Diseases

Stephen I. Katz, M.D., Ph.D.
Chairman, National Arthritis
and Musculoskeletal and Skin
Diseases Advisory Council

Director, National Institute of
Arthritis and Musculoskeletal and
Skin Diseases

Last Reviewed: 04/10/2017