FEB 22, 2017 7:30 AM PST

KEYNOTE: Where innovation and regulation meet

Speakers
  • Personalized Medicine Staff at the Food and Drug Administration in the Center for Devices and Radiological Health
    Biography
      Laura M. Koontz, PhD, is a member of the Personalized Medicine Staff at the Food and Drug Administration in the Center for Devices and Radiological Health. Prior to joining the FDA, she was the Director of Policy for the Ovarian Cancer National Alliance, where she oversaw Congressional and regulatory policy, including issues pertaining to use and regulation of genetic technologies. Prior to that, she was an ASHG-NHGRI Genetics and Public Policy Fellow from 2012-2013 and worked in the House of Representatives on issues related to genetic testing and genetic nondiscrimination. Dr. Koontz holds a PhD in Biochemistry, Cellular and Molecular Biology from the Johns Hopkins University School of Medicine.

    Abstract:

    Launched in early 2015, the Precision Medicine Initiative (PMI) takes advantage of the progress made in genomic testing – progress largely driven by rapid advances in DNA sequencing technology - to accelerate the development of new treatments that are designed specifically to meet patients’ individual characteristics, including their genetic makeup. In support of the PMI, FDA has been adapting its regulatory authorities for genomic tests in ways that both encourage innovation and ensure that these tests provide accurate and useful results. While current regulatory approaches are appropriate for conventional diagnostics that measure a limited number of substances associated with a disease or condition, such as blood glucose or cholesterol levels, new next generation sequencing (NGS)-based tests can rapidly characterize an entire human genome and identify millions of genetic variations at a time. Thus these tests require an oversight that is adapted to their unique nature.  We will discuss the dynamic, flexible approach that FDA has proposed for oversight of NGS-based tests, which seeks to protect public health, while driving innovation.

    Learning objective 1: Understand FDA’s proposed community developed standards-based approach to demonstrating a tests analytical validity.

    Learning objective 2: Learn about FDA’s proposed approach to recognizing genetic databases.

    Learning objective 3: Understand how FDA is supporting the development of bioinformatics approaches for NGS by the community


    Show Resources
    You May Also Like
    SEP 05, 2019 4:00 PM CEST
    C.E. CREDITS
    SEP 05, 2019 4:00 PM CEST
    DATE: September 5, 2019TIME: 7:00am PT, 10:00am ET, 4:00pm CEST PCR (Polymerase Chain Reaction) has gone through a massive evolution since its development in 1983. Besides it...
    JAN 23, 2020 9:00 AM PST
    C.E. CREDITS
    JAN 23, 2020 9:00 AM PST
    DATE: January 23, 2020 TIME: 9:00am PST, 12:00pm EST...
    AUG 27, 2019 9:00 AM PDT
    C.E. CREDITS
    AUG 27, 2019 9:00 AM PDT
    DATE: August 27, 2019 TIME: 9:00am PDT, 12:00pm EDT Immunotherapies targeting PD-1 or PD-L1 have proven remarkably effective for treating cancer in some patients, with considerabl...
    OCT 02, 2019 11:00 AM PDT
    OCT 02, 2019 11:00 AM PDT
    DATE: October 2, 2019TIME: 11:00am PDT, 2:00pm EDT Ditch the Excel spreadsheets and manage your molecular workflows entirely in your LIMS Achieve configuration of molecular workf...
    NOV 18, 2019 7:00 AM PST
    C.E. CREDITS
    NOV 18, 2019 7:00 AM PST
    DATE: November 18, 2019TIME: 7:00am PST, 11:00am EST, 4:00pm CEWT How often do you pipette in your cell culture lab every day? Usually, we do it so often that we tend stop th...
    FEB 26, 2020 9:00 AM PST
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    C.E. CREDITS
    FEB 26, 2020 9:00 AM PST
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    DATE: February 26, 2020 TIME: 9:00am PST 3D cell culture and analysis and the study of organoids and spheroids are becoming more prevalent as a research method in publications as traditional...
    Loading Comments...
    Show Resources