FEB 22, 2018 07:30 AM PST

Keynote Presentation: Predictive Biomarkers to Diagnostic Tests - Scientific and Regulatory Consideration in Development of Companion Diagnostic Tests

C.E. CREDITS: P.A.C.E. CE | Florida CE
Speakers
  • Biologist, CDRH/OIR/DMGP, U.S. Food and Drug Administration
    Biography
      Janaki Veeraraghavan graduated from University of Texas Health Science Center at San Antonio with Ph.D. in Biochemistry. Her thesis investigated the role of Growth factors in tumor growth and the impact of Mismatch repair protein mutations on cell cycle progression. Her post-doctoral fellowship at University of Rochester focused on sequence expansion from DNA replication errors, following which she joined a biotechnology startup. Her experience includes development/validation, from target discovery to Phase II clinical trial, of antibody therapeutics for autoimmune disorders and cancer immunotherapy as well as identification and development of response predictive biomarkers and associated test systems. In the last 3 years, as an FDA review staff in office of in vitro diagnostic and Radiological health at CDRH, she has been involved in the review of companion and complementary diagnostic devices for oncology indications with focus on devices to support immunotherapy and checkpoint inhibitors and update of policy guidelines for review of immunohistochemistry devices.

    Abstract:

    The path form biomarker discovery to conversion to a clinically useful companion diagnostic test presents many challenges. The talk will outline the regulatory requirements to developing a successful companion diagnostic test and the challenges that are encountered during the process. 


    Show Resources
    You May Also Like
    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...
    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...
    JUN 26, 2018 06:00 AM PDT
    C.E. CREDITS
    JUN 26, 2018 06:00 AM PDT
    Date: June 26, 2018Time: 6:00 a.m. PDT, 9:00 a.m. EDT, 1500 CEST Today’s hematology analyzers employ various methods for enumerating platelets. These methods include: e...
    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...
    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...
    Loading Comments...