Tracy Rockney is a respected regulatory leader with more than 20 years of experience in the pharmaceutical industry. She is the Co-founder and Managing Partner at OneSource Regulatory, a consulting firm specializing in Regulatory Advertising & Promotion, Medical Review, Labeling Development and Healthcare Compliance. Tracy received her JD from Washburn University School of Law, and her BA from the University at Albany, SUNY, Rockefeller College of Public Affairs & Policy. Tracy is a board advisor and Regulatory Officer in Residence for Doctor Evidence, a specialty software platform and services company that transforms clinical studies, drug labeling and epidemiological databases into reusable dynamic relational databases.

Joy Liu advises drug, biotech, and device companies on a broad range of FDA regulatory matters. Joy has significant experience working on advertising and promotion compliance matters, Hatch-Waxman patent and exclusivity issues, and regulatory risk management. She has also worked on numerous government investigations and gained experience as in-house product attorney while on secondment to two pharmaceutical companies. Joy serves on the Board of Directors of the Food and Drug Law Institute.

Dr. Kulkarni is Principal Attorney for the Kulkarni Law Firm which focuses on providing legal and regulatory solutions to pharmaceutical companies and their providers. He is a pharmacist & lawyer and advises clients on bringing their product to market, focusing on post IND thru commercialization and genericization.