FEB 22, 2017 7:30 AM PST

KEYNOTE: Where innovation and regulation meet

Speaker
  • 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


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