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MedTech Summit
16 - 20 June 2025
MOA BerlinBerlin, Germany

Lakshman Ramamurthy, PhD
Vice President, Regulatory Affairs at GRAIL
Speaker

Profile

As VP, Regulatory Affairs at GRAIL, my team works closely with our scientists, and clinicians on our mission of early cancer detection. My previous roles include leading Precision Medicine Regulatory at GSK, and Global Regulatory Lead at Foundation Medicine. Prior to that I was at the US FDA CDRH, where as Senior Reviewer and Policy Advisor to Center Director, I led the FDA- CMS Parallel Review pilot project, and as Legislative Analyst on FDASIA and User Fees. Following FDA, I was appointed to CMS Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). I have a PhD in Molecular Biology.

Agenda Sessions

  • A Deeper Dive: Regulating Laboratory Developed Tests (LDTs) in the EU & US

    11:40
  • IVDR Open Forum: Ask the Experts

    16:45