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NCI Fecal Microbiota Transplants and Defined Microbiota Cancer Therapeutics Clinical Research Working Group/NCI Convenes Workshop on Reproducibility of Fecal Microbiota Transplants in Cancer Therapeutics
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Committee, Work group, Advisory group, or Task Force
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FDA
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NCI
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To explore the potential role that fecal microbiota transplants (FMT) and pre/probiotics may play in cancer therapeutics and to address reproducibility and safety to inform translational human studies and clinical trials, NCI convened a “Strategic Workshop on Rigor and Reproducibility: Precision Fecal Microbiota Transplant and Microbiome Cancer Therapeutics” on September 5, 2019. This timely meeting brought together scientists and FDA regulatory staff in the fields of FMT, pre/probiotics, nutrition, microbiome, synthetic biology, biomarkers, computation, immunology, gastroenterology, oncology, and infection. Workshop Goals Assess the current state of clinical research and clinical trials involving FMT and microbiome-based cancer therapeutics; Discuss the knowledge gaps and future opportunities in the field; Provide feedback to National Cancer Institute (NCI) and National Institutes of Health (NIH) regarding future priority areas to enhance precision- and mechanism-based rigor and reproducibility of defined microbiome-based therapeutic clinical research for cancer and other diseases Workshop Focus Areas Standardization (material manufacture and quality control), FMT donor selection, microbiome measurement, clinical protocols, procedures, and trial design; Microbiome composition and function as biomarkers associated with cancer therapy, such as reproducibility, safety, and efficacy; Confounding variables — host genetic and disease state, environment, antibiotics, diet and other lifestyle factors; Clinical efficacy and safety of FMT and microbiome-based cancer therapy; Clinically relevant models and human translational studies; Data sharing; FDA regulatory issuesNCI Fecal Microbiota Transplants and Defined Microbiota Cancer Therapeutics Clinical Research Working GroupSince 2019 NCI FMT workshop, the Working Group continues hosting seminar series, yearly to highlight the research discovery and assess the research needs. The most recent webinar is on Nov 6, 2022 in which Drs. Hassane Zarour and Giorgio Trinchieri, the world experts on FMT and cancer immunotherapy, discussed NCI funded study published in Science this year “Fecal microbiota transplant overcomes resistance to anti-PD-1 therapy in melanoma patients”. The next coming FMT talk will be on April 8th, 2022, at 2pmIn addition to the webinar, in FY 2022,Working Groupis working on developing FOA: RFA:Fecal Microbiota Transplants and Defined Microbiota Cancer Therapeutics Clinical Research Network. Plan to present in DCTD meeting in April, May or July. Plan future meeting in 2024.*******************************************************************A2016 NCI workshop on the “State of the Science: Cancer Complementary and Alternative Medicine Therapeutics Research” and the recent upsurge in the field of gut microbiota research suggest that the microbiome plays a role in cancer therapeutic outcomes. This may be especially important for patients receiving anti-PD-1 immunotherapy. To explore the potential role that fecal microbiota transplants (FMT) and pre/probiotics may play in cancer therapeutics and to address reproducibility and safety to inform translational human studies and clinical trials, NCI convened a “Strategic Workshop on Rigor and Reproducibility: Precision Fecal Microbiota Transplant and Microbiome Cancer Therapeutics” on September 5, 2019 (agenda). This timely meeting brought together scientists and FDA regulatory staff in the fields of FMT, pre/probiotics, nutrition, microbiome, synthetic biology, biomarkers, computation, immunology, gastroenterology, oncology, and infection. Workshop Goals Assess the current state of clinical research and clinical trials involving FMT and microbiome-based cancer therapeutics Discuss the knowledge gaps and future opportunities in the field Provide feedback to NCI and NIH regarding future priority areas to enhance precision- and mechanism-based rigor and reproducibility of defined microbiome-based therapeutic clinical research for cancer and other diseases Workshop Focus Areas Standardization (material manufacture and quality control), FMT donor selection, microbiome measurement, clinical protocols, procedures, and trial design Microbiome composition and function as biomarkers associated with cancer therapy, such as reproducibility, safety, and efficacy Confounding variables — host genetic and disease state, environment, antibiotics, diet and other lifestyle factors Clinical efficacy and safety of FMT and microbiome-based cancer therapy Clinically relevant models and human translational studies Data sharing FDA regulatory issues
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NCI Multi-Cancer Detection (MCD) Trial Team
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Research Initiative
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CMS, FDA
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NCI, OD/DPCPSI/ORWH
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Scientific development for the evaluation of Multi-Cancer Detection (MCD) assays for the purpose of cancer screening. This group is also known internally as the Tiger Team
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NCI/CCR-FDA Clinical Investigator Program
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Research Initiative
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FDA
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NCI
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Multilateral Benefit in a Joint Program to Recruit Combined Food and Drug Administration (FDA) and the National Cancer Institute's (NCI) Center for Cancer Research (CCR) Clinical Investigators: the FDA gains an academic oncologist with disease-specific expertise who is actively involved and understands critical nuances of the field; NCI gains a clinical investigator and leader who understands regulatory considerations in drug development; and the oncologic community gains a regulator/academic who will provide a leadership voice to help design trials with regulatory endpoints in mind.
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NCI/FDA Memorandum of Understanding for Proteomics
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Research Initiative
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FDA
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NCI
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This Memorandum of Understanding (MOU), signed in 2007, renewed in 2012, 2017, and 2022 establishes an official relationship in clinical proteomic regulatory science between NCI's Office of Cancer Clinical Proteomics Research and the FDA. Active areas of research collaboration include sample collection, preparation, storage and processing; bioinformatics and data analysis; discovery and validation of biomarkers; and surrogate biomarkers of cancer development and drug response, including standardization among technology platforms and assay standards development.
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NEHEP Partnership Summit
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Meeting/ Workshop
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OASH
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NEI
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The National Eye Institute's National Eye Health Education Program (NEHEP) will be joined by the Office of Disease Prevention and Health Promotion in a partnership summit in 2023 to connect NEI and NEHEPs work to the Healthy People 2030 vision objectives.
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NEI-FDA-ONC Joint Workshop on Promoting Adoption of Ocular Imaging Standards
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Meeting/ Workshop
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ONC, FDA
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NEI
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This virtual NEI, FDA, and ONC hosted workshop will focus on delineating the state of the science and improving interoperability among ocular imaging modalities and devices to improve biomedical research and patient care. This meeting will consist of a day of discussion that will identify the gaps in knowledge, barriers to progress, and potential strategies for overcoming them in the context of addressing the goal of Promoting the Adoption of Ocular Imaging Standards. This will be an open workshop to the general public, and it is anticipated that researchers from academia, industry, non-profits, other government agencies, patients and care partners will attend. The discussion will be disseminated to the vision community in the form of a published white paper.
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Networking and Information Technology Research and Development (NITRD) Program
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Committee, Work group, Advisory group, or Task Force
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AHRQ, ONC, CDC
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OD/DPCPSI/ODSS, NLM, NHGRI, NIBIB, NCI, NCATS, NIGMS
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NITRD coordinates Federal RD to identify, develop, and transition into use the secure, advanced IT, high-performance computing, networking, and software capabilities needed by the Nation, and to foster public-private partnerships that provide world-leading IT capabilities. As a NSTC subcommittee, the President’s Council of Advisors for Science and Technology (PCAST) provides regular reviews of the NITRD programs.
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Newborn Screening Coding and Terminology Guide
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Resource Development
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CDC, FDA, HRSA, IOS, AHRQ
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NLM, NHGRI, NHLBI, NICHD
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This ongoing collaboration develops, supplements, and publicizes a free online resource with guidance to help promote the efficient electronic exchange of standardized newborn screening data. Related efforts include studying the screening process for diseases including severe combined immunodeficiency (SCID), lysosomal storage disorders (LSDs), and critical congenital heart disease (CCHD), and developing standard codes for ordering and reporting the results of newborn screening for SCID, CCHD, and other conditions added to the Uniform Recommended Screening Panel by the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children.
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Newborn Screening Federal Partners Committee
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Committee, Work group, Advisory group, or Task Force
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AHRQ, CDC, FDA, HRSA
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NICHD, NHGRI, NLM
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The federal members of the Advisory Committee on Heritable Disorders in Newborns and Children meet monthly to share information about newborn screening activities.
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Next Generation Microfluidics Workshop
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Meeting/ Workshop
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FDA
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NHLBI
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This workshop focused on discussion of the state of the microfluidics (MF) field in biomedical applications, limitations in the field of MF, and how to move the field forward to extract the maximum utility to help patients. This meeting was a call to educate colleagues at the National Institutes of Health (NIH) about what can be done collectively to enable better research and move closer to translational applications, and bring more products to researchers in the MF space and to clinicians and patients.
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