Thursday, September 15, 2022 1:30 PM - 4:30 PM EDT
Wayne L. Pines
Member of International Advisory Council and President of Healthcare
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. He provides strategic counsel to clients facing crises or media, legislative, regulatory or marketing challenges. He 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.
Hyman, Phelps & McNamara, P.C.
Deborah Livornese is a Director at Hyman, Phelps & McNamara, P.C. Ms. Livornese more than 18 years of experience in a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory issues, including promotional activities. Ms. Livornese also assists clients by conducting FDA regulatory due diligence on behalf of regulated companies and potential investors or purchasers.
Lowell M. Zeta
Partner in the Life Sciences and Global Regulatory
Hogan Lovells US LLP
Lowell M. Zeta, is a partner in the Life Sciences and Global Regulatory practices at Hogan Lovells US LLP, in Washington, DC. He provides legal counsel to emerging and established life science companies and their investors on critical regulatory and compliance matters, while navigating an ever complex and evolving regulatory landscape. Mr. 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 FDA's COVID-19 PREPP initiative to help guide the agency's response and strategic planning.
King & Spalding FDA and Life Sciences
A partner in the King & Spalding FDA and Life Sciences practice, Eva provides strategic counsel to clients on a wide variety of FDA-regulated products, ranging from biosimilars to cell and gene therapies and complex combination products. Eva advises pharmaceutical and biotechnology companies at every stage of product development and life-cycle, from data generation (including clinical investigations and real-world evidence) to application submissions, exclusivity matters, and dispute resolution.
Before joining King & Spalding, Eva acted as Director for Policy at the FDA’s Office of Therapeutic Biologics and Biosimilars, where she oversaw regulatory policy related to biosimilars and other therapeutic biologics. Additionally, as Associate Chief Counsel at the FDA’s Office of Chief Counsel, Eva provided strategic counseling to FDA’s biomedical product centers on a wide range of drug, biologic, and combination product issues.