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

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 11, 2021 10:00 AM PDT
C.E. CREDITS
MAY 11, 2021 10:00 AM PDT
Date: May 11, 2021 Time: 10:00zm PDT Your samples are some of the most valuable assets in the laboratory. After spending countless hours on extraction and preparation, your conclusions could...
SEP 14, 2021 7:00 AM PDT
C.E. CREDITS
SEP 14, 2021 7:00 AM PDT
Date: September 14, 2021 Time: 7am PDT, 10am EDT, 4pm CEST A conventional thermal cycler has long been a commodity product in the lab and end-point PCR techniques can be completed almost wit...
JUN 09, 2021 7:00 AM PDT
C.E. CREDITS
JUN 09, 2021 7:00 AM PDT
Date: June 9, 2021 Time: 09 June 2021, 7am PDT, 10am EDT, 4pm CEST cells with dramatic implications on the validity of past cell culture related research. The fact that at least 509 cell lin...
SEP 17, 2021 12:00 PM CST
C.E. CREDITS
SEP 17, 2021 12:00 PM CST
Date: September 16, 2021 Time: 9:00pm (PDT), 12:00am (EDT) 3D cellular models like organoids and spheroids offer an opportunity to better understand complex biology in a physiologically rele...
OCT 14, 2021 9:00 AM PDT
C.E. CREDITS
OCT 14, 2021 9:00 AM PDT
Date: October 14, 2021 Time: 9:00am (PDT), 12:00pm (EDT), 5:00pm GMT Western blot analysis is a method widely used in the lab today because of its versatility in detecting and measuring spe...
OCT 12, 2021 9:00 AM PDT
C.E. CREDITS
OCT 12, 2021 9:00 AM PDT
Date: October 12, 2021 Time: 9:00am (PDT), 12:00pm (EDT) SCIEX’s next-generation Biologics Explorer software is an innovative platform for the comprehensive and deep characterization o...
FEB 22, 2017 7:30 AM PST

KEYNOTE: Where innovation and regulation meet


Specialty

Research And Development

Earth Science

University

Research

Health

Geography

Asia100%

Registration Source

Website Visitors100%

Job Title

Medical Laboratory Technician100%

Organization

Manufacturer - Other100%


Show Resources
Loading Comments...
Show Resources