SCOTT M. LASSMAN is a Partner in the Washington, DC office of WilmerHale, LLP. Before joining WilmerHale, Mr. Lassman served as the Assistant General Counsel for The Pharmaceutical Research and Manufacturers of America (PhRMA), where he is responsible for Food and Drug Administration (FDA) regulatory and compliance issues. Mr. Lassman played a leading role in negotiating the $400 million Prescription Drug User Fee Act (PDUFA) agreement with FDA, which is currently under consideration by Congress. Mr. Lassman also coordinated the development of industry policies, comments and testimony to FDA and Congress on drug safety, direct-to-consumer (DTC) advertising, the PhRMA Marketing Code, clinical trial disclosure, anti-counterfeiting strategies, Citizen Petitions, and implementation of the Hatch-Waxman provisions of the Medicare Modernization Act. He also provided counseling for PhRMA’s Scientific & Regulatory Affairs Department. Prior to joining PhRMA in March 2003, Mr. Lassman was a Partner with the law firm of Kleinfeld, Kaplan and Becker in Washington, D.C. specializing in food and drug law, particularly the Hatch-Waxman Act and drug promotional issues. Mr. Lassman received his J.D. from the University of Virginia and his B.A. from Yale University and also has a masters degree in philosophy from the University of Texas at Austin.

ANNETTA C. BEAUREGARD, MS, MBA is a Director of Regulatory Affairs in Global Regulatory Intelligence and Policy at Amgen, Inc. based in the Washington DC office.   Prior to joining Amgen, she spent seven years at Eli Lilly in global product development and regulatory affairs.  Ms. Beauregard was a member of the Cialis product development team from Phase I through launch.  She then founded and developed Lilly’s Office of Scientific and Regulatory Policy (OSRP), a group dedicated to healthcare policy development and reform.  In this role, Ms. Beauregard developed the domestic and international policies on clinical trial disclosure for the industry.  She also had a primary role in the development of the Prescription Drug User Fee Act (PDUFA) IV recommendations to Congress and the subsequent policy development for the FDA Amendments Act (FDAAA).  She continues to be an active member of the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Association (BIO).  Prior to Eli Lilly, Ms. Beauregard practiced in outpatient sports medicine and was a faculty member at the University of Indianapolis Krannert School of Physical Therapy.

D. BRUCE BURLINGTON, MD is an Independent Consultant on regulatory affairs and drug development with special interests in helping companies prepare for key meetings with the Food and Drug Administration (FDA), conduct product due diligence evaluations, and set up processes, organizations and staffing plans to achieve their regulatory obligations.  He has long been active in Pharmaceutical Research and Manufacturers of America (PhRMA) and public policy developments, such as the Food and Drug Administration Amendments Act of 2007 and biosimilars legislation. When he was at Wyeth, Dr. Burlington was responsible for global  regulatory, compliance, auditing, quality and pharmacovigilance. Dr. Burlington moved to Wyeth in 1999 from FDA, where he had been Director of the Center for Devices and Radiological Health (CDRH). Dr. Burlington previously held a variety of positions while at FDA in the Drugs and  Biologics Centers. Dr. Burlington received his MD from Louisiana State University School of Medicine at New Orleans and received clinical training at the University of Colorado. Dr. Burlington is board certified in Internal Medicine and Infectious Diseases.