Lakshman Ramamurthy, PhD

As VP of Regulatory Affairs at GRAIL, Lakshman leads a team that works closely with colleagues across the business in R&D, Operations, Medical Affairs, and Commercial. He helps bring to market the inventions, ingenuity, and innovations of GRAIL’s scientists, clinicians, and engineers to detect cancer early.

Lakshman’s previous roles include leading Precision Medicine Regulatory at GSK and serving as Global Regulatory Lead at Foundation Medicine. From 2007 to 2013, at the US FDA CDRH, he led the FDA-CMS Parallel Review pilot project, served as Policy Advisor to the Office of Center Director at CDRH, and as Legislative Analyst in the Office of Commissioner on issues pertaining to Device Law, FDASIA, and User Fees. Following his tenure at FDA, he was appointed to the CMS Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). Lakshman has consulted for device and diagnostic clients on regulatory and payor strategy, value, and evidence at Avalere Health and through his own company, DxDevice Strategies LLC.

With over two decades of experience in genomics/bioinformatics, diagnostics, and regulatory affairs, Lakshman has worked in academia, biotech, government, consulting, and big pharma. He holds a PhD in Molecular Biology from UNC-Chapel Hill, with post-doctoral training at St. Jude Children’s Research Hospital.