Sonali P. Gunawardhana Esq.
Wiley Rein LLP
Sonali P. Gunawardhana Esq., Of Counsel, Wiley Rein LLP, draws on early 10 years’ experience as an FDA lawyer to offer clients practical, forward-looking guidance on avoiding and resolving FDA regulatory challenges. At the FDA she worked closely with district-office investigators inspecting devicemakers, IRBs, clinical investigators and CROs. Her civilian practice expertise includes current Good Manufacturing Practices (cGMP); clinical trial compliance strategies; and programs that FDA field investigators use during inspections.
Vini Doraiswamy, PhD
Senior Vice President of Clinical, Regulatory, and Scientific Affairs
Vini Doraiswamy, Ph.D. joined AtriCure in March of 2017. Prior to joining AtriCure, he served as Vice President of Global Clinical Operations at St. Jude Medical overseeing clinical operations for over 100 clinical trials worldwide and managed a team of over 300 people. He spent a large portion of his career in the Afib market and served in various leadership capacities, including program management, clinical affairs, strategic planning, and portfolio management. Before St. Jude Medical, Dr. Doraiswamy’s held several positions of increasing responsibility in marketing, field clinical engineering, IDE and post market clinical studies at Boston Scientific, Guidant Corporation, and Promega Corporation. Dr. Doraiswamy received his Ph.D. from North Dakota State University.