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Autoimmune Diseases Coordinating Committee (ADCC)
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, HRSA
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NIAID, NCCAM, NCI, NEI, NHLBI, NIA, NIAMS, NIBIB, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NINDS, NINR
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The purpose of the ADCC is to provide a forum for the coordination of research efforts in autoimmunity and autoimmune diseases among various stakeholders including the NIH, other federal agencies such as the FDA and the CDC, and private organizations with an interest in autoimmune diseases. The ADCC meets twice yearly to discuss a broad range of basic, preclinical and clinical endeavors.
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Autoimmune Diseases Coordinating Committee (ADCC)
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, HRSA
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NINR, NCCAM, NCI, NEI, NHLBI, NIA, NIAID, NIAMS, NIBIB, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NINDS
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The purpose of the ADCC is to provide a forum for the coordination of research efforts in autoimmunity and autoimmune diseases among various stakeholders including the NIH, other federal agencies such as the FDA and the CDC, and private organizations with an interest in autoimmune diseases. The ADCC meets twice yearly to discuss a broad range of basic, preclinical and clinical endeavors.
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Behavioral Aspects of Prep Counseling HIV Prevention Trials Network (HPTN) Protocol #067: The ADAPT Study (Y01-MH-0315)
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Research Initiative
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CDC
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NIMH, NIAID
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This behavioral research study is evaluating whether non-daily medication regimens for HIV Pre-Exposure Prophylaxis (PrEP) may be more acceptable and foster better adherence to product. PrEP represents a novel biomedical approach to HIV prevention in which individuals at-risk for HIV take antiretroviral medications to help prevent HIV infection. The HPTN 067 study is conducted through the NIAID-led HIV Prevention Trials Network. An Inter-Agency Agreement between NIMH and CDC supports the implementation of this international research study at a clinical research site in Bangkok, Thailand.
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Best Pharmaceuticals for Children Act Activities
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIMH, NHLBI, NICHD
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NIH, FDA, and non-Federal experts in pediatric pharmacology meet several times a year to identify important unmet needs for conducting research on the efficacy and safety of medications in children.
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BHCC subcommittee on marijuana
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, SAMHSA
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NIDA
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Committee that collaborates on issues related to marijuana.
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BHCC subcommittee on primary care and behavioral health integration
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Committee, Work group, Advisory group, or Task Force
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ACL, AHRQ, CMS, HRSA, IHS, SAMHSA
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NIDA, NIAAA, NIMH
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Committee that collaborates on primary care and behavioral integration.
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Big Data to Knowledge
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Research Initiative
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AHRQ, CMS, FDA, OS
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OD/DPCPSI, NHGRI, NHLBI
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The Big Data to Knowledge (BD2K) program aims to facilitate broad use of biomedical big data, develop and disseminate analysis methods and software, enhance training for disciplines relevant for large-scale data analysis, and establish centers of excellence for biomedical big data. In FY 2014, BD2K held discussions with several HHS agencies who have shared interests in Big Data.
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Biomarkers of Nutrition for Development (BOND) Convening: Summary of conclusions of Phase 1 and Future Plans
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Meeting/ Workshop
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CDC, FDA
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NICHD
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BOND Objectives:
To provide information and service to support the entire food/nutrition research and global health enterprise by developing consensus on accurate assessment methodologies that are applicable and relevant to users domestically and internationally in both the public and private sectors, and representing research (lab/clinical/surveillance); clinicians; program creators/implementers/evaluators), and: policy- makers (i.e., data consumers)
Specific Meeting Objectives:
To develop a “road map” for achieving greater utilization of the recommended biomarkers in: 1) assessing population and individual status globally, and 2) evaluating program outcomes, this meeting will:
I. Summarize:
o BOND Phase I Expert Panel conclusions for each of the Phase I nutrients (iron, zinc, iodine, vitamin A, folate and vitamin B12)
o Results of relevant ancillary projects to address inflammation (INSPIRE/BRINDA)
II. Discuss strategies to implement the findings clinically, programmatically and from a global policy perspective. This conversation will engage the members of the BOND Steering Committee, which includes key USG agencies involved in food and nutrition (NIH, USDA, CDC, FDA, USAID), relevant UN agencies (WHO, UNICEF, IAEA, WFP) NGOs (Sight and Life, GAIN, HarvestPlus) and the private sector.
III. Provide an overview of currently available analytical technologies and platforms that can be used to
o Measure the recommended biomarkers, including in field settings in LMICs;
o Discuss potential new analytical technologies and platforms that may be required or desirable, and possible use of unconventional tissue specimens
IV. Discuss future directions to facilitate deployment and implementation
V. Present and discuss the BOND interactive web resource/QBS and future directions for BOND;
o Its utility
o Opportunities for data sharing/linkages.
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Biomedical Innovation: Challenger and Prioritizing Needs in Medical Device Research and Development
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Meeting/ Workshop
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FDA
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NICHD
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Rapidly evolving technology, emerging markets, an increasingly globalized development process, and evolving health policy reforms are presenting device manufacturers with unprecedented opportunities for valuable innovation. However, these trends are also creating significant challenges to current biomedical development frameworks. In response, the U.S. must sustain the industry''s entrepreneurial spirit, and maintain an environment that encourages innovation and access to novel devices. On Wednesday, March 5, 2014, the Engelberg Center for Health Care Reform and the National Institutes of Health (NIH) held an all-day forum to discuss emerging issues in biomedical innovation. The panel sessions explored a number of challenges for developing novel medical devices that benefit patients, and for prioritizing medical device research that accommodates unmet medical need. Over the course of the day, manufacturers, regulators, payers, investors, patient representatives, and other stakeholders engaged in a thoughtful discussion on a number of topics. These topics included developing incentives to support investment in research and development; providing adequate infrastructure to support medical device development; and creating more efficient and transparent regulatory and reimbursement pathways. Attendees also discussed the need to actively engage patients in the decision-making process throughout the development pipeline.
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Bioresource Development, Validation Tools, and Integrating High-Throughput Screening Technology Standards in Complementary and Alternative Medicine (CAM) Product Use in Children
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Research Initiative
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CDC, HRSA, SAMHSA
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NCCAM, NICHD
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Collaborative efforts between the FDA/CBER and the NIH/NCCAM for substantiating health benefit claims for probiotics under Investigational New Drug Applications (INDs) were placed in the framework of U01 Cooperative Agreements that began in 2008. The successful evaluation of the initiative has recently developed into an invitation to develop a Memorandum of Understanding (MoU) to promote resource sharing and exchange of research expertise; development of demonstration project(s); and the initiation of trans-agency research initiatives focused on the integration of advanced molecular technologies that lead to harmonization standards and improved diagnostics for safety and substantiation of the health benefits of probiotic interventions. In 2011, a collaboration with FDA/CFSAN was initiated to expand the validation tool. In 2012, a Materials Transfer Agreement [MTA] was approved and the FDA/CFSAN received the entire data collection to undergo testing employing their novel microarray multi-loci sequence testing system [MLST].
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