AUG 22, 2013 03:00 PM PDT

Evaluation challenges and regulatory considerations for next-generation sequencing and other high throughput genomic technology based clinical applications

C.E. CREDITS: CE
Speakers
  • Associate Director for Science and Technology, Office of In Vitro Diagnostics and Radiological Health (OIR), CDRH, U.S. Food and Drug Administration
    Biography
      Živana Težak, Ph.D., is an Associate Director for Science and Technology, Personalized Medicine Staff, in the Office of In Vitro Diagnostic Device (IVD) Evaluation and Safety (OIR), at the Center for Devices and Radiological Health, Food and Drug Administration (FDA). Prior to joining the FDA in 2004, as a scientific reviewer in microbiology, genomics and molecular biology, Dr. Težak worked in biotechnology industry, holding research and development scientist positions in a bioinformatics and array developer company. Dr. Težak received a Ph.D. in Biochemistry/Molecular Biology from Florida State University in 1997. From 1998 to 2001 she was a research fellow at the University of Pittsburgh Medical Center and Children's National Medical Center, Research Center for Genetic Medicine, working on neuromuscular disorders, human genetics, gene therapy, and high-throughput screening technologies. Her work resulted in a number of publications in peer-reviewed journals, book chapters and proceedings. In her current position, Dr. Težak has been leading efforts to develop flexible regulatory policies for novel technology based IVDs, such as chromosomal microarrays and next-generation sequencing, in order to enable their smoother translation into the clinic.

    Abstract:
    The use of ultrahigh throughput diagnostic tests that determine genetic sequence variation to guide patient care is rapidly expanding, fueled by the enormous growth in sequencing platform development. With the emergence of novel technologies, the FDA is faced with new regulatory challenges while continuing to apply scientific evidence-based oversight. While there are no broadly accepted standards or methods to analytically validate ultrahigh throughput sequencing tests yet, there are a number of efforts underway, including establishing reference materials to aid in assessing analytical performance. The additional challenge in informed clinical application of sequence information is inadequate knowledge about correlations between genomic variations and their clinical significance. The FDA is proactively working to encourage cross-collaboration in this area. Ultimately, the FDA has to balance public safety concerns with fostering innovation and enabling the translation of emerging technologies that can improve medical care and benefit public health.

    Show Resources
    You May Also Like
    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...
    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
    C.E. CREDITS
    NOV 18, 2019 07:00 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...
    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...
    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 26, 2019 09:00 AM PDT
    C.E. CREDITS
    JUN 26, 2019 09:00 AM PDT
    DATE: June 26, 2019TIME: 9:00am PDT, 12:00pm EDT An excessive number of software solutions are available to help manage your clinical, biobank, or biorepository sample inform...
    Loading Comments...
    Show Resources