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Policies and Regulatory Pathways to FDA Licensure
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Meeting/ Workshop
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FDA
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NIAID
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The purpose of this meeting was to understand the policies that advance radiation countermeasure agents and biodosimetry devices towards eventual FDA approval. Manuscript preparation is ongoing with input from all agencies, with anticipated submission to Radiation Research
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Polyhalogenated Aromatic Hydrocarbons (PHAH) and Thyroid Cancer
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Research Initiative
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CDC
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NCI
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Polyhalogenated aromatic hydrocarbons are being measured in banked serum/plasma samples from cohort studies to evaluate the association with thyroid cancer incidence. The National Cancer Institute (NCI) investigators are leading nested case-control studies of thyroid cancer in three cohorts to examine associations between pre-diagnostic concentrations of polychlorinated biphenyls (PCB), polybrominated diethyl ethers (PBDE), and organochlorine insecticides and thyroid cancer risk.
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Population Assessment of Tobacco and Health (PATH) Study
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Health Survey
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FDA
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NIDA
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The Population Assessment of Tobacco and Health (PATH) Study is the first large-scale National Institutes of Health (NIH)/ and the US Food and Drug Administration (FDA) collaboration since Congress granted FDA the authority to regulate tobacco products in the Family Smoking Prevention and Tobacco Control Act (FSPTCA) in 2009. The PATH Study is a national longitudinal cohort study that will follow an estimated 59,000 US household residents ages 12 years and older for at least three years. Objectives are to assess initiation and use patterns; to study trends in tobacco-product use cessation and relapse; to monitor behavioral and health impacts, including in risk perceptions and other tobacco-related attitudes; and to assess differences in tobacco-related attitudes, behaviors, and health outcomes among racial/ethnic, gender, and age subgroups. The PATH Study will also collect biospecimens from adults to analyze biomarkers of tobacco use and related health outcomes. By measuring and accurately reporting on the social, behavioral, and health effects associated with tobacco-product use in the United States, the PATH Study will provide an empirical evidence base to help inform FDA’s decisions about changes in tobacco products in meeting the objectives of the 2009 FSPTCA.
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Post Market Safety Study of Opoids
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Research Initiative
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FDA
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OD/DPCPSI/ORWH, NIDA
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Participated in the oversight committee in the FDA Mandated Post-Market Opioid Safety Studies, which is a 100 million-dollar FDA mandated series of research projects related to the safety and risks associated with the long-term use of opioids for pain.
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Post-Traumatic Stress Disorder (PTSD)/Trauma Brain Injury (TBI), Suicide Prevention National Research Action Plan (NRAP) Workgroup
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Committee, Work group, Advisory group, or Task Force
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OS
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NIMH, NIAAA, NIDA, NINDS
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A 2012 White House Executive Order, emphasizing support of Service Members, Veterans, and their families as a top priority, called for an urgent increase in the Departments of Health and Human Services (HHS), Defense (DoD), and Veterans Affairs (VA) research coordination to address the problems of Post-Traumatic Stress Disorders (PTSD), Trauma Brain Injury (TBI), and suicide. Section 5 of this Executive Order requested a National Research Action Plan (NRAP) to develop biomarkers, define the pathophysiology, and develop new treatments for PTSD. HHS charged the National Institute of Mental Health (NIMH) to lead this effort along with a parallel effort for TBI led by National Institute of Neurological Disorders and Stroke (NINDS), with both Institutes working closely with VA and DoD. The NRAP was published in 2013. Prior investments integrating the molecular, genomic, and brain circuitry changes that give rise to PTSD in the context of environmental factors provide the requisite foundation to respond to this White House request for biomarkers for risk prediction, as well as new targets for medications, and other therapies to treat PTSD. This investment has the potential to revolutionize care for individuals at high risk for PTSD and prevent the development of chronic, complex treatment-resistant PTSD. The agencies meet weekly and produce quarterly progress reports.
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Postdoctoral Fellowship in Genomic Science and Health Equity
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Training Initiative
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FDA
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NHGRI
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The FDA, Office of Minority Health and Health Equity and the NHGRI have jointly sponsored a postdoctoral fellowship program to provide training in genetic, genomic and pharmacogenomic approaches to advance minority health and health equity. This program helps fellows learn to bridge research, development and review processes and build awareness of regulatory requirements in the early stages of medical product development.
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PRAMS Interagency Workgroup
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Committee, Work group, Advisory group, or Task Force
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CDC, NIH, CMS, HRSA
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NICHD
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Support team of PRAMS users as they build their internal capacity to link MCH data sets and inform their future programming.
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PRAMS Multi-Jurisdiction Data Linkage Learning Community
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Committee, Work group, Advisory group, or Task Force
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CDC, NIH, CMS, HRSA
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NICHD
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Support teams of PRAMS users Building their internal capacity to link MCH data sets and inform their future programming.
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Preclinical Assessment of Phage Therapy for Pathogen Decolonization
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Research Initiative
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FDA
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NIAID
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This project addresses key regulatory considerations relevant to using bacteriophages for decolonization of the drug-resistant nosocomial pathogens, vancomycin-resistant enterococci (VRE) and methicillin-resistant Staphylococcus aureus (MRSA). These include characterizing pathogen resistance to phage, defining phage mixtures ("cocktails") to circumvent resistance, optimizing mouse models to evaluate pathogen decolonization, and identifying endpoints that support claims for clinical benefit (e.g., reduced risk of disease transmission).
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Predicting Drug Resistance with Machine Learning
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Resource Development
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ASPE
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NLM, NIAID
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This project has its origin in an ASPE-funded PCOR project: Training Data for Machine Learning to Enhance Patient-Centered Outcomes Research Data Infrastructure. The project acquires, curates, and uses high-quality training data sets to predict tuberculosis (TB) drug resistance, in collaboration with NIAID and its TB Portals program. TB drug resistance has been concerning because it is difficult to diagnose in a patient during the early stages and it complicates and prolongs treatment considerably. The idea of the project is to develop new ways of detecting drug-resistance in chest radiographs by using deep learning in combination with large image repositories, clinical data, and genomic information of the bacteria for drug-sensitive and drug-resistant tuberculosis. Researchers use this data to train machine learning models that can detect signs of TB drug resistance.;
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