jueves, 14 de febrero de 2019

Ebola research update | 2019 funding deadline reminder

U.S. Food and Drug Administration - Medical Countermeasures Initiative Update

Researchers in the Sabeti Lab prepare a genomics experiment. (Credit: Oliver Douliery, Broad Institute)

A new approach for understanding Ebola virus pathogenesis
MCMi regulatory science update
In late 2018,  FDA awarded a contract to the Broad Institute to conduct the largest Ebola virus and host gene expression study to date. Researchers will use the latest sequencing technologies to assess how Ebola virus evolves and spreads within the body. 

This work will help fill significant gaps in the scientific community’s understanding of how Ebola virus disease progresses at the molecular level, which will help identify biological pathways and mechanisms that could be useful biomarkers to assess the efficacy of Ebola medical countermeasures, or advance development of potential therapeutics.

Read more, in the new project profile
 Related links:
    Funding deadline reminder
    Submit BAA white papers for FY19 by March 29, 2019
    Extramural MCM regulatory science is primarily funded through a Broad Agency Announcement(BAA) for research and development to support regulatory science and innovation, under area 7: Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security.

    The current BAA announcement will remain open until further notice, but proposers are encouraged to submit white papers by March 29, 2019 for current fiscal year (FY19) awards.
    Electronic data standards for Animal Rule studies
    Notice of upcoming comment periodand webinar
    FDA has been working with the Critical Path Institute and the Clinical Data Interchange Standards Consortium (CDISC) to develop electronic data standards for the natural history and efficacy studies conducted in animals that support Animal Rule applications. 

    CDISC SENDIG-AR comment period
    The draft Standard for Exchange Nonclinical Data (SEND) Implementation Guide for Animal Rule studies (SENDIG-AR) will be available for public review and comment on the CDISC website by February 25, 2019, with the comment period closing on April 12, 2019.   

    CDISC SENDIG-AR public webinar
    A free webinar providing an overview of the SENDIG-AR is scheduled for March 5, 2019, 11:00 a.m. – 12:30 p.m. (ET).  Register by March 5, 2019.
    Controlled terminology comment period
    Critical to the development of data standards is the development of appropriate controlled terminology.  A major portion of the controlled terminology associated with the new SENDIG-AR has already completed its public comment period. It is anticipated that the remaining portion of the controlled terminology will be posted for public review and comment from March 22 – April 19, 2019, at CT-P38-Link.  (The preceding link will be activated on March 22, 2019, and will not work until that date.)

    • New! February 28 - March 1, 2019: Disaster Research Response (DR2) Tucson Workshop(Tucson, AZ), hosted by partners including the National Institute of Environmental Health Sciences (NIH), and the University of Arizona College of Medicine - Tucson. FDA representatives plan to attend. Registration will close February 15, 2019, or when capacity is reached. 
    • New! March 6-7, 2019: Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting (Silver Spring, MD and webcast) - Topics include discussion and recommendations on the selection of strains to be included in the influenza virus vaccines for the 2019 to 2020 influenza season.
    • New! March 14, 2019: Webinar - The Least Burdensome Provisions: Concept and Principles Final Guidance, 1:00 - 2:30 p.m. ET. This final guidance describes the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles to the activities pertaining to the regulation of medical devices.
    • New! March 26-29, 2019: Preparedness Summit (St. Louis, MO) - Hosted by NACCHO; FDA is a sponsor. This year’s theme is “Preparedness Summit 2019: The Evolving Threat Environment." (fee)
    Information for industry

    Drugs and biologics

    Combination products
    More: MCM-Related Guidance by Date
    In case you missed it
    • FDA issued the Sentinel System Five-Year Strategy: 2019-2023 (PDF, 1.7 MB).  This plan lays out the major goals associated with the future of the Sentinel System and FDA Catalyst. It is intended to serve as a roadmap to guide the development of Sentinel over the next five years. (January 9, 2019)
    • The National Association of County and City Health Officials (NACCHO) and the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) are accepting applications for the fourth annual National Health Security Award. This award recognizes local health departments that have demonstrated significant accomplishments in implementing health security-related initiatives within their jurisdictions. Apply by April 26, 2019.
    • From HHS - ASPR has released an updated quadrennial strategy to safeguard the nation’s health in times of crisis. The 2019-2022 National Health Security Strategy (NHSS) provides a vision to strengthen the nation’s ability to prevent, detect, assess, prepare for, mitigate, respond to, and recover from disasters and emergencies.  It includes strategies to improve readiness and adapt operational capabilities to address evolving threats such as the use of chemical, biological, radiological, and nuclear (CBRN) weapons; cyber warfare; emerging infectious diseases that could lead to a pandemic; and catastrophic natural disasters and human-caused incidents. Also see: National Health Security Strategy Overview (January 15, 2019)
    • From NIH - Investigational monoclonal antibody to treat Ebola is safe in adults - The investigational Ebola treatment mAb114 is safe, well-tolerated, and easy to administer, according to findings from an early-stage clinical trial published in The Lancet. (January 24, 2019) 
    • You want to make a difference. FDA wants to hire you. Follow @FDAJobs on Twitter, or visitwww.fda.gov/jobs.

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