FEB 22, 2018 07:30 AM PST

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

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  • Biologist, CDRH/OIR/DMGP, U.S. Food and Drug Administration
      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.


    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. 

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