FEB 22, 2017 07:30 AM PST

KEYNOTE: Where innovation and regulation meet

C.E. CREDITS: P.A.C.E. CE | Florida CE
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 04:00 PM CEST
    C.E. CREDITS
    SEP 05, 2019 04:00 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...
    JUN 05, 2019 05:00 PM CEST
    C.E. CREDITS
    JUN 05, 2019 05:00 PM CEST
    DATE: June 5, 2019TIME: 8:00am PDT, 11:00am EDT, 5:00pm CEST Eukaryotic cell cultures respond to the most subtle influence. Apart from the risk of contamination, minimal chan...
    AUG 27, 2019 09:00 AM PDT
    C.E. CREDITS
    AUG 27, 2019 09:00 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...
    MAY 16, 2019 04:00 PM CEST
    C.E. CREDITS
    MAY 16, 2019 04:00 PM CEST
    DATE: May 16, 2019TIME: 7:00am PDT, 10:00am EDT, 4:00pm CEST The emergence of NGS is revolutionizing the microbiological sciences and transforming medicine. Deep sequencing has...
    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 07:00 AM PST
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    C.E. CREDITS
    NOV 18, 2019 07:00 AM PST
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    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...
    Loading Comments...
    Show Resources