JUN 20, 2018 01:30 PM PDT

Regulation of Precision Medicine

C.E. CREDITS: P.A.C.E. CE | Florida CE
Speakers
  • Counsel, Potomac Law Group
    Biography
      Neil A. Belson is Of Counsel at Potomac Law Group, in Washington, D.C., where he handles transactional and regulatory compliance matters. He focuses on Precision Medicine, Life Sciences and Information Technology. Mr. Belson has also been an entrepreneur, and has founded, run and sold an industrial biotechnology business.
      Mr. Belson received his J.D. cum laude from Harvard Law School, and received B.S. and M.S. degrees from the University of Maryland. Mr. Belson also served as a Peace Corps Volunteer in the Dominican Republic.

    Abstract:

    Regulation of precision medicine is rapidly evolving.  The pre-existing regulatory framework did not contemplate many of the products and technologies which are becoming available with precision medicine.   FDA and other federal agencies have responded by attempting to develop a “flexible and adaptive” approach to regulation which simultaneously encourages innovation while still assuring that new precision medicine drugs and medical devices are safe and effective.
     
    FDA has issued a series of non-binding “Guidance Documents” addressing different topics in precision medicine.   While non-binding, these guidance documents explain the Agency’s current thinking on specific issues and should be viewed as recommendations.

    FDA in 2017 issued a Guidance Document relating to the use of “Real World Evidence” (RWE) to support regulatory decisions involving medical devices.   RWE represents a potentially faster, less expensive and more useful alternative to traditional randomized clinical trials (RCT’s) for generating data to support regulatory approvals of drugs and devices.  RWE consists of clinical evidence of a product's usage, benefits and risks obtained from an analysis of real-world data sources, such as patient EHR’s, insurance claims data and disease or device registries.  In 2017, FDA approved a new indication for a medical device based entirely on RWE.   

    FDA has recently issued Guidance Documents and draft guidances covering many other aspects of precision medicine, including NGS–based tests, genetics variant databases and companion diagnostics.  Additionally, FDA and CMS have developed a parallel review process for devices aimed at allowing developers to concurrently obtain both marketing approval and eligibility for Medicare coverage. 

    Many of FDA regulatory guidances have issued within the last 12 months.  It is likely that regulation of precision medicine will continue its evolution for the foreseeable future.


    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...
    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...
    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...
    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...
    JUN 19, 2019 10:00 AM PDT
    JUN 19, 2019 10:00 AM PDT
    DATE: June 19, 2019TIME: 10:00am PDT, 1:00pm EDT As we develop new methods to create more biologically relevant models for research in understanding disease etiology and in...
    OCT 02, 2019 11:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    OCT 02, 2019 11:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    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...
    Loading Comments...
    Show Resources
    Attendees