Thursday, April 27, 2023 1:30 PM - 4:30 PM EDT
Wayne L. Pines President, Healthcare APCO Worldwide
Wayne L. Pines is a member of APCO Worldwide’s International Advisory Council and president of healthcare at APCO Worldwide. He has served as a trusted advisor to FDA leadership for several decades. Pines served for 10 years in senior positions at the FDA, including as chief media spokesman and associate commissioner for public affairs. He has authored or edited a dozen books about the FDA and was a co-founder and long-term president of the Alliance for a Stronger FDA.
Steven A. Grossman President HPS Group
Steven A. Grossman is the president of HPS Group, a policy and regulatory consulting firm. He is also the executive director of the Alliance for a Stronger FDA, a 150-member stakeholder coalition that advocates for increased resources for the FDA. Prior to becoming a consultant and association executive, Grossman was the health staff director of the Senate Labor and Human Resources Committee (now HELP), where he helped negotiate the Orphan Drug Act and the Drug Price Competition and Patent Term Restoration Act (known as Hatch-Waxman). After leaving the Senate, Grossman was a deputy assistant secretary for health at HHS.
Lowell M. Zeta Partner, Life Sciences and Global Regulatory Practice Hogan Lovells US LLP
Lowell M. Zeta, is a partner in the Life Sciences and Global Regulatory practices at Hogan Lovells US in Washington, DC. Zeta previously served senior counselor to the FDA commissioner, where he provided leadership on the agency’s cross-cutting and high-priority initiatives promoting innovation and addressing public health issues. He was responsible for leading the FDA's COVID-19 PREPP initiative to help guide the agency's response and strategic planning.
Cathy Burgess Partner Alston & Bird LLP
Cathy Burgess leads the firm’s FDA compliance and enforcement team and co-leads the firm’s FDA practice. Burgess advises clients on a range of matters affecting prescription and OTC drugs, biologics, medical devices, foods and cosmetics. She has extensive experience regarding current good manufacturing practice regulation and supply chain management. Burgess conducts liability risk assessments and works with clients to identify and analyze potential legal risks associated with their products. She advises clients on quality systems, adequacy of SOPs, investigation reports, inspection management, recalls, and responses to Form FDA 483s and warning letters.
Nancy Bradish Myers, JD President Catalyst Healthcare Consulting, Inc.
Nancy Bradish Myers, JD, president of Catalyst Healthcare Consulting, Inc., is a Washington-based attorney with deep expertise in healthcare law and regulation, policy development and government relations. She has been closely involved in cutting edge drug, biotechnology and medtech regulatory issues from a range of vantage points over the past two decades. Ms. Myers advises clients from the Board room, to executive leadership teams, to regulatory affairs groups on regulatory and health policy matters, ranging from crisis management to long-term strategy development.