Lakshman Ramamurthy knows regulatory strategy.
Read his latest regulatory review guide for diagnostics and biomarkers of TBI here:
https://www.sciencedirect.com/science/article/pii/B9780128163467000038As Head of Precision Medicine & Digital Health Global Regulatory at GSK, he provides creative and tactical solutions to accelerate patient access to life-saving medicines. Most recently he was Global Regulatory Lead at Foundation Medicine. Ramamurthy's experience includes a tenure ('07-13) at the US FDA Center for Devices and Radiological Health (CDRH), as Senior Reviewer leading the FDA- CMS Parallel Review pilot project, Acting Associate Director, Policy Advisor to the Office of Center Director CDRH and finally as Legislative Analyst in the Office of Commissioner on issues pertaining to Device Law, FDASIA and User Fees. Following FDA, he was a healthcare consultant at Avalere Health, coinciding with an appointment to CMS' Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). Ramamurthy has consulted for device/Dx clients on regulatory and payor strategy, value and evidence both at Avalere Health and through his own company DxDevice Strategies LLC. He has over two decades in genomics/bioinformatics, diagnostics and regulatory and has worked in academia, biotech, government, consulting and pharmaceutical industry. Ramamurthy has a PhD in Molecular Biology from UNC-Chapel Hill and post-doctoral training at St. Jude Children's Research Hospital. He is an avid runner and has run several full and half-marathons #marine_corps_marathon #wineglass_marathon