March 11, 2021
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NIAMS extramural staff continually work to identify critical research opportunities and needs within our mission area. When identified, NIAMS program officers recommend concepts, which describe the basic purpose, scope, and objectives of a potential initiative that NIAMS may wish to pursue. Concept clearance is the planning process that begins approximately two years prior to any potential funding. Through this process, NIAMS receives input from the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC) regarding the merits of proposed research concepts. Concepts presented to the Council are posted here to alert researchers to NIAMS research interests and potential funding opportunities.

On May 18, 2021, the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC) considered the following concept.

NIAMS Disease Profiling Initiative

Description:

The NIAMS is proposing an interdisciplinary disease profiling initiative that will better allow for large, interdisciplinary team approaches to deepen our understanding of individual musculoskeletal, rheumatic, and skin diseases.  Research teams would be brought together to use unique combinations of innovative techniques, technologies, and analytical methods that could ultimately lead to better phenotyping of disease and discoveries that could impact design and targeting of future therapies.

On January 26, 2021, the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC) considered the following concept.

Promoting a Basic Understanding of Chemical Threats to Skin

Description:

Developing countermeasures against chemical attacks to the civilian population is a major goal of the civilian defense program at NIH, of which the Chemical Counter-measures Research Program (CCRP) is a part.  NIAMS has been one of several ICs participating in the CCRP since its inception in 2006. In order to broaden its research base and raise awareness of the research community at large about the urgent need for countermeasures against terrorist attacks using chemical agents, the CCRP is encouraging its participating ICs to issue IC-specific FOAs to reach out to the respective research disciplines that were not engaged previously in the countermeasure research.  This initiative is a response to that request. The goal of the initiative is to encourage the NIAMS skin research community to contribute to the basic understanding of injuries caused by toxic chemicals and to explore the local and systemic mechanisms of chemical wound development, healing, and long-term consequences.  An emphasis is on understanding the commonalities of injuries caused by a variety of chemical toxins and identifying potential shared therapeutic targets, which could be used for developing broad spectrum countermeasures.

On September 1, 2020, the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC) considered the following concept.

Accelerating Medicines Partnership Program in Autoimmune and Immune-Mediated Diseases (AMP AIM)

Description:

Over the last 6 years, the Accelerating Medicines Partnership – rheumatoid arthritis and systemic lupus erythematosus (AMP RA/SLE) program has brought together public and private communities to make unprecedented progress in understanding the molecular and cellular mechanisms that cause these diseases. AMP RA/SLE program has advanced the concept of disease deconstruction by establishing the value and feasibility of using high dimensional, single cell analytics on biopsy samples taken from tissues of patients with RA or lupus to discover novel cell populations and pathways active in the diseased tissues and to identify promising targets for drug development.

The goal of the new phase – AMP Autoimmune and Immune-mediated Diseases (AMP AIM) – will be to extend disease deconstruction and mapping of cells and pathways in RA, lupus, to include Sjogren’s syndrome and psoriasis/psoriatic arthritis. The cornerstone of AMP AIM will be the concept of disease reconstruction based on high dimensional study of cell interactions. AMP AIM will not only refine and extend the single cell analysis of tissues to other autoimmune diseases (disease deconstruction), but will also bring in high dimensional novel analytics to discover how innate and adaptive cells of the immune system and tissue resident cells network with each other to cause inflammation, injury, abnormal function and clinical disease (disease reconstruction). Integration of these multi-modality data will accelerate the discovery of new mechanisms of disease and new targets for therapeutic development.

On June 9, 2020, the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC) considered several concepts.

 

Initiative: Leads Description
New Activity
Exploring New Mammalian Models for Studying Tissue Regeneration Alexey Belkin This initiative aims to promote research exploring new mammalian models with naturally high regenerative capacity such as the African spiny mice or naked mole rat. It is expected to facilitate basic studies focused on the discovery of previously unidentified developmental paradigms and delineation of key cellular and molecular mechanisms that should help provide therapeutic targets for the development of future regenerative therapies. 
Role of Inflammation Resolution in Chronic Inflammatory Diseases within NIAMS Mission Heiyoung Park This initiative promotes research on resolution of inflammation, which is a complex and distinctively coordinated response from the onset of inflammation. Uncontrolled and dysfunctional resolution of inflammation would directly link to chronic inflammation, a common pathogenic element among diseases within the NIAMS core mission. Therefore, unraveling basic, translational, and pre-clinical mechanisms of inflammation resolution would contribute significantly to the understanding of pathogenesis and the development of innovative therapies for chronic inflammatory diseases within the NIAMS mission.
Accelerating Host Gene-Microbiome Interactions Research in NIAMS Core Mission Diseases Ricardo Cibotti Host genetics, (i.e. the description of polymorphism at the level of non-coding risk loci or disease causal genes), and the diversity of the gut and/or the skin microbiome, have both been considered to be important contributing factors to a variety of pathologies. However, they are usually considered as independent contributors, and their synergism is poorly understood. Defining the synergism between the host genetics and the diversity and composition of the microbiome may be key to progress in the understanding of the pathogenesis of many diseases and conditions supported by the NIAMS. This initiative proposes to accelerate research focused on describing how host gene-microbiome interactions may impact diseases and conditions within NIAMS mission.
Evidence, Challenges and Lessons Learned in Clinical Trials of Cell-based Therapies for Knee Osteoarthritis Ted Zheng This initiative proposes a scientific conference to engage a diverse group of stakeholders, including thought leaders in the orthopaedic research and clinical communities, clinical investigators who have conducted or are currently conducting cell-based OA clinical trials, and the FDA to discuss and share knowledge gained through these trials.
Addressing Health Equity in OA Kristy Nicks There is evidence of differential OA treatment outcomes and access to care in diverse populations, which lead to poor health. This concept is a placeholder for development and implementation of recommendations from a “state of the science” workshop of OA that would be similar to but smaller scale than the NIH P2P workshops. The underlying premise of the P2P workshop, which seeks to move a public health issue forward after a detailed, unbiased, evidence-based assessment of the current scientific research, will be followed. The proposed workshop would provide a snapshot of the current issues, particularly surrounding disparities and access to health care. The goal is to identify research gaps/needs that could be addressed in future NIAMS activities. NIAMS intends to implement these activities in collaboration with other NIH Institutes, Centers, and Offices and federal agencies.
Re-Issued Funding Opportunity Announcements
Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers Emily Carifi The purpose of this initiative is to solicit applications for Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers. These Centers promote collaborative basic, translational, and clinical research, and provide important resources that can be used by the national muscular dystrophy research community. The Centers also provide outstanding environments for the training of new scientists electing to pursue careers conducting research in high priority areas of muscular dystrophy. Furthermore, Center investigators participate in community outreach efforts to increase awareness and convey the importance and implications of their research activities to the patient and advocacy communities.
Core Centers for Clinical Research (CCCR) Aron Marquitz The CCCRs provide avenues to advance the methodological sciences that support clinical research within and across the NIAMS' portfolio of diseases. The overall goals of the CCCR are to advance prevention, diagnosis and treatment of musculoskeletal, rheumatic, and skin diseases by developing and fostering the implementation of novel methods, metrics, and outcome measures that address critical existing and emerging clinical research needs.
NIAMS Clinical Studies Operations Management and Support Contract Shahnaz Khan This initiative will provide essential clinical research operations management, resources and services using a highly skilled contract research organization (CRO) for NIAMS funded clinical research studies. This mechanism allows the Institute to meet its responsibility for providing oversight functions to ensure the safety of participants and quality of data generated from clinical studies it supports.


On June 5, 2019, the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC) considered several concepts.

 

Initiative: Leads Description
New Funding Opportunity Announcement
Translation of Biomedical and Behavioral Research Results from Academic/Non-profit Lab to Marketplace (R43/R44)
 
Drs. Xibin Wang, Ricardo Cibotti, Fei Wang This initiative will solicit Small Business Innovation Research grant applications from small business concerns that propose research and development studies to facilitate translation of lab discoveries from academic or non-profit institutions to marketplace to advance the diagnosis, treatment, and prevention of musculoskeletal, rheumatic or skin diseases.
New Activities
Accelerating Discovery in NIAMS Studies with Computational Models, Tools, and Workflows Drs. Anthony Kirilusha, Ted Zheng, and Ricardo Cibotti This initiative will explore opportunities to accelerate research in rheumatic, musculoskeletal, and skin diseases through the development, validation, and adoption of computational models, tools, and workflows.  A variety of mechanisms will be used to seek community input, integrate responses with feedback from the strategic plan listening sessions, and to inform next steps.
Roundtable on Neurogenic Inflammation Research: Gaps and Opportunities
Drs. Ricardo Cibotti, Faye Chen, Ted Zheng, Heiyoung Park, Marie Mancini
Experimental evidence indicates that the functions of the immune and peripheral nervous systems are connected, yet the cellular and molecular mechanisms by which these systems communicate, are not fully elucidated. It is critical to fully understand the mechanisms by which sensory and autonomic signals regulate different types of immune cells at baseline and during inflammation and autoimmunity. As a result, NIAMS proposes to conduct a roundtable to identify important scientific opportunities, barriers, knowledge gaps and research needs in neurogenic inflammation research as related to NIAMS mission relevant research.
Advancing Research on Drug Therapies for Fracture Prevention Drs. Faye Chen and Kristy Nicks This initiative is a placeholder for implementing recommendations from the NIH Pathways to Prevention workshop on Appropriate Use of Drug Therapies for Osteoporotic Fracture Prevention. NIAMS intends to implement these activities in collaboration with other NIH ICOs and federal agencies.
NIAMS Clinical Trial Roundtable: Who to Treat When with What Drs. Robert Carter, Tom Cheever, Chuck Washabaugh, and James Witter The goal of this proposed roundtable is to gather information from the NIAMS research communities to inform the NIAMS on the best trial designs to conduct research that informs clinical care. The discussions from this meeting will focus on understanding the fit between different trial designs, the intervention, and outcomes and how the evidence generated from trials influence various stakeholders in their decision-making.
Re-Issued Funding Opportunity Announcements
Resource-based Centers for Rheumatic Diseases Research and Resource-based Centers for Musculoskeletal Biology and Medicine Drs. Marie Mancini and Faye Chen Centers supported under these funding opportunity announcements will focus on developing and providing access to research resources.
Centers of Research Translation (CORT)  Drs. Yan Wang and Chuck Washabaugh The goal of this continuation of the CORT Program is to foster translational research, directed at elucidating the relevance of basic research to human disease in an area within the NIAMS mission. A CORT must have a minimum of three highly meritorious research components consisting of one or more translational Research Projects and one or more Research Cores. Using an investigative team science approach, the projects and cores will enable the generation of new knowledge that will improve our understanding of human pathophysiology, and lead to identification of new targets, other tangible products or deliverables and development of more effective treatment, diagnostic or prevention strategies for human disease.
NIAMS Clinical Trial Implementation Cooperative Agreement Dr. Tom Cheever
Awards funded under this initiative would support implementation of investigator-initiated clinical trials where applicants would be required to have completed necessary planning activities. NIAMS expects supported trials will address highly significant clinical questions with the potential for impact, and be hypothesis driven, milestone-defined, and within the research mission of the NIAMS.
Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases Dr. Ricardo Cibotti The purpose of the Exploratory Clinical Trials Grants Program is to foster clinical trials that can be completed within a limited timeframe and budget, and that will lead to clinically meaningful improvements in prevention, diagnosis, or treatment of NIAMS core mission diseases. Awards funded under this initiative support and facilitate clinical trials that can be completed within a limited timeframe and budget.
Clinical Observational Studies (COS) in Musculoskeletal, Rheumatic, and Skin Diseases Drs. Ricardo Cibotti, Heiyoung Park, and Ted Zheng Awards funded under this initiative would support clinical observational studies to obtain information that is necessary for designing clinical trials for musculoskeletal, rheumatic, or skin diseases or conditions. Applicants will be required to justify the need for the observational study in preparing for a future trial or trials. Applications may include characterization of cohorts similar to potential future trial participants and collection of data to justify the use of a biomarker or a patient outcome measure in a future trial. Applications for early stage development of new biomarkers or outcome measures, studies of disease mechanisms or pathophysiology, and therapeutic target identification will not be responsive to this initiative unless the resulting data is necessary for designing a clinical trial in the near term. This initiative will only support observational studies and will not support intervention studies.

 


On February 5, 2019, the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC) considered several concepts.

 

Initiative: Leads Description
Re-Issued Funding Opportunity Announcements

Small Business Innovation Research on Rare Musculoskeletal, Rheumatic and Skin Diseases

Drs. Ricardo Cibotti and Xibin Wang

This initiative would encourage Small Business Innovation Research grant applications from small business concerns that propose translational studies to advance the development of products for diagnosis, treatment, and prevention of rare musculoskeletal, rheumatic or skin diseases.

 

Mechanistic Ancillary Studies to Ongoing Clinical Projects Dr. Heiyoung Park This initiative would encourage applications that propose time-sensitive mechanistic ancillary studies related to the NIAMS mission in conjunction with ongoing clinical projects. The ongoing “parent” project would have to be a clinical study that can provide a sufficient cohort of well-characterized patients, infrastructure, data, and biological samples. Applications submitted in response to this initiative would undergo an accelerated review and award process.
Limited Competition: Small Grant Program for NIAMS K08 and K23 Recipients Dr. Su Yau-Mao
 

This initiative would continue the NIAMS small grant program for investigators to develop preliminary data for their first R01 application. The program would provide NIAMS-supported K08 and K23 recipients the opportunity to apply for  support in the second to fourth year of their K awards.
NIAMS Clinical Trial Planning Grant Dr. Tom Cheever This initiative would provide the necessary administrative and planning support for investigator-initiated clinical intervention clinical trials. Completion of the required milestones of a planning grant are a prerequisite for acceptance of a U01 clinical trial application, which supports the implementation and conduct of the study. Consultation with NIAMS staff would continue to be strongly encouraged prior to the submission of the planning grant application.

 


On September 5, 2018, the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC) considered the following BACPAC proposal. NIAMS is moving forward with the initiative for Fiscal Year 2019.

NIH Back Pain Consortium (BACPAC) Research Program

Description:
The NIH Back Pain Research Consortium (BACPAC) is a potential initiative to address opioid addiction. BACPAC is a patient-centric translational research program that will address the need for effective and personalized therapies for chronic low back pain by probing the biomedical mechanisms in a biopsychosocial context using interdisciplinary methods and innovative technologies.

Expected Benefit to the Public Health:
Back pain is a major contributor to the use of opioids in the U.S., however, at present no effective treatment exists that provides long term, sustained relief of back pain and disability for all patients. Further, there is no way to predict what treatments are most likely to be effective in individual patients. This initiative will foster development of integrated models of back pain to improve understanding of the condition and generate new tools for better targeting of existing and new therapies.


On September 6, 2017, the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC) considered several initiative proposals. NIAMS is moving forward with the following initiatives for Fiscal Year 2019, pending the availability of funds.

Clinical Observational Studies (COS) in Musculoskeletal, Rheumatic, and Skin Diseases Re-Issue

Description:
This initiative will support clinical observational studies to obtain information that is necessary for designing clinical trials for musculoskeletal, rheumatic, or skin diseases or conditions. Data obtained through the studies may also have a direct impact on clinical care. Applications can include characterization of cohorts similar to potential future trial participants and collection of data to justify the use of a biomarker or a patient outcome measure in a future trial. Researchers must explain how the data they propose to collect could contribute to the design of a clinical trial or trials in the near term. This initiative will emphasize the collection of data that addresses significant obstacles to the design of a clinical trial or trials. Applicants will be required to justify the need for the observational study in preparing for a future trial or trials.

Expected Benefit to the Public Health:
This initiative will improve understanding of diseases and conditions within the NIAMS mission. Research data from observational cohort studies can enhance clinical trial design by providing essential information about disease symptoms, stages and timing of disease progression, comorbid conditions, availability of potential clinical trial participants, and outcomes that are important to patients. Clinical observational studies also can facilitate efforts to validate and eventually qualify objective biomarkers or subjective outcome measures for use in future trials or in the clinical care setting.

Core Centers for Clinical Research (CCCR) Re-Issue

Description:
The CCCRs provide avenues to advance the methodological sciences that support clinical research within and across the NIAMS' portfolio of diseases. The overall goals of the CCCR are to advance prevention, diagnosis and treatment of musculoskeletal, rheumatic, and skin diseases by developing and fostering the implementation of novel methods, metrics, and outcome measures that address critical existing and emerging clinical research needs.

Expected Benefit to the Public Health:
This initiative builds on emerging thinking and innovative ideas, such as the surge in 'omics' data, enabling these new approaches to ultimately improve health-related outcomes for patients with musculoskeletal, rheumatic, or skin diseases or conditions.

Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases Re-Issue

Description:
This initiative would address the need to support and facilitate clinical trials that can be completed within a limited timeframe and budget. A broad range of types of exploratory studies are suitable for this initiative. The trials must address research questions related to the mission and goals of the NIAMS and may evaluate interventions with drugs, biologics, devices, or surgical, dietary, behavioral or rehabilitation therapies.

Expected Benefit to the Public Health:
This initiative will improve understanding of diseases and conditions within the NIAMS mission by fostering clinical trials that will lead to clinically meaningful improvements in prevention, diagnosis, or treatment of these diseases.

Mechanistic Ancillary Studies to Ongoing Clinical Projects Re-Issue

Description:
This initiative would leverage the existing resources offered by already-funded clinical studies, and maximize the return on the public investment. Successful ancillary studies would enhance the scientific content and value of the parent studies, improve our understanding of the underlying mechanisms of diseases in the NIAMS portfolio, and thus identify novel targets for the diagnosis, treatment, and prevention of disease.

Expected Benefit to the Public Health:
Clinical studies, ranging from epidemiological observational studies to clinical trials, play a valuable role in carrying out the mission of the NIAMS. Large clinical projects offer unique opportunities to conduct additional investigations that go beyond the core activities of the original study and generate new information related to the original study.

Research Innovations for Scientific Knowledge (RISK) Initiative Re-Issue

Description:
The NIAMS RISK initiative is an effort to encourage and facilitate innovative research in NIAMS-supported communities. It is designed to capture and test novel and audacious ideas in their early stages of development, which may be less likely than more conventional proposals to be funded using traditional NIH funding mechanisms.

Expected Benefit to the Public Health:
The initiative provides a way for the Institute to encourage highly innovative research and to accelerate testing of high-risk and high-impact ideas. The research funded through RISK has the potential to produce breakthroughs or paradigm shifts that improve public health or launch new fields of scientific inquiry.

Resource-based Centers Re-Issue - Musculoskeletal Biology and Medicine

Description:
The overall goal of the NIAMS Resource-based Centers program is to promote a cooperative interaction among basic science and/or clinical investigators in a manner that will enrich the effectiveness of ongoing research and promote new research. For these Musculoskeletal Biology and Medicine Resource-based Centers, the emphasis will be on improving access to resources. This includes the potential for either resources or investigators to be distributed at different institutions, particularly for technical resources that do not need to be duplicated at every institution. Shared resource cores could be typical core facilities, or may provide access to unique expertise or services, such as epidemiology, outcomes, genetics, or informatics, which may be necessary to address a common problem.

Expected Benefit to the Public Health:
Musculoskeletal Biology and Medicine Resource-based Centers enable research that should advance understanding of human disease and promote the discovery of the causes, treatment and prevention of musculoskeletal diseases.

Resource-based Centers Re-Issue - Skin Biology and Diseases

Description:
The overall goal of the NIAMS Resource-based Centers program is to promote a cooperative interaction among basic science and/or clinical investigators in a manner that will enrich the effectiveness of ongoing research and promote new research. For these Skin Biology and Diseases Research Resource-based Centers, the emphasis will be on improving access to resources. This includes the potential for either resources or investigators to be distributed at different institutions, particularly for technical resources that do not need to be duplicated at every institution. Shared resource cores could be typical core facilities, or may provide access to unique expertise or services, such as epidemiology, outcomes, genetics, or informatics, which may be necessary to address a common problem.

Expected Benefit to the Public Health:
Skin Biology and Disease Research Resource-based Centers enable research that should advance understanding of human disease and promote the discovery of the causes, treatment and prevention of skin diseases.

Supplements to Advance Research (STAR) from Projects to Programs Re-Issue

Description:
The objective of the NIAMS STAR Program is to promote innovation and exploration of high-risk ideas by providing supplemental funding to early established investigators (EEIs). The STAR Program supports activities that effectively allow EEIs to expand and explore new opportunities within the broader scope of a currently funded, peer-reviewed research project to facilitate the transition from a single, structured research project to a research program.

Expected Benefit to Public Health:
This initiative will contribute to NIAMS efforts to support promising investigators as they develop robust research programs.

Translational Research in Hidradenitis Suppurativa

Description:
Encouraging pre-clinical research on hidradenitis suppurativa (HS) through this initiative has the potential to lead to a better understanding of the pathogenesis and genetics of the disease, as well as define several potential novel targets for repurposing of available drugs or development of new treatments. HS is a complex chronic inflammatory skin disease characterized by recurrent painful nodules and suppuration in different areas of the body such as the axilla and groin.

Expected Benefit to the Public Health:
There is no biological or pathological test to diagnose HS, which is defined only by its clinical features. HS is known to affect three-times more women than men, and is more prevalent among minorities (e.g., African Americans). Disease pathogenesis is poorly understood and available treatments are limited.