Bio

As Head of Precision Medicine & Digital Health Global Regulatory at GSK, I provide creative and tactical solutions to accelerate patient access to life-saving medicines. Most recently I was Global Regulatory Lead at Foundation Medicine. My 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, I was appointed to CMS Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). I have consulted for device/Dx clients on regulatory and payor strategy, value and evidence both at Avalere Health and through my own company DxDevice Strategies LLC. I have over two decades in genomics/bioinformatics, diagnostics and regulatory and have worked in academia, biotech, government, consulting and pharmaceutical industry. I have a PhD in Molecular Biology from UNC-Chapel Hill, post-doctoral training at St. Jude Children's Research Hospital. I am an avid runner and have run several full and half-marathons #marine_corps_marathon #wineglass_marathon