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
    MAY 03, 2018 11:00 AM PDT
    MAY 03, 2018 11:00 AM PDT
    DATE: May 3, 2018TIME: 11:00AM PDT, 2:00PM EDTWhile stress is one of the leading causes of neuropsychiatric disorders, the molecular underpinnings of how stress induces alterations in b...
    MAY 24, 2018 09:30 AM PDT
    C.E. CREDITS
    MAY 24, 2018 09:30 AM PDT
    DATE: May 24, 2018 TIME: 9:30PM PDT The current gold standard in in vitro pre-clinical cancer treatment screening remain cell lines,...
    MAY 22, 2018 08:00 AM PDT
    C.E. CREDITS
    MAY 22, 2018 08:00 AM PDT
    DATE: May 22, 2018TIME: 08:00AM PDT The nuclear receptors pregnane X receptor (PXR) and constitutive androstane receptor (CAR) are closely related transcription factors that...
    APR 27, 2018 10:00 AM PDT
    C.E. CREDITS
    APR 27, 2018 10:00 AM PDT
    DATE: April 27, 2018TIME: 10:00am PST, 1:00pm ESTGlioblastoma (GBM) and Medulloblastoma (MB) are the most common adult and paediatric brain tumours, both of which can have devastating c...
    MAY 02, 2018 08:00 AM PDT
    C.E. CREDITS
    MAY 02, 2018 08:00 AM PDT
    Immunohistochemistry protocols, which utilize antibodies to visualize proteins in tissue sections, have many steps that need optimized to prevent non-specific background effects, artifacts, o...
    AUG 15, 2018 08:00 AM PDT
    C.E. CREDITS
    AUG 15, 2018 08:00 AM PDT
    DATE: August 15, 2018TIME: 08:00AM PDT, 11:00AM EDTThe failure of current chemotherapeutic strategies in the fight against cancer can be largely attributed to the occurrence of drug res...
    Loading Comments...
    Show Resources