The Program Committee has selected interesting and timely speakers for the ACT Annual Meeting Plenary Lectures.
Monday, November 16, 10:45 AM–11:45 AM (EST)
Jayanthi Wolf, PhD
Executive Director, Global Regulatory Affairs, Merck
Dr. Jayanthi Wolf has more than 19 years of experience in the development of vaccines and biotherapeutics. She is currently an executive director in the department of Global Regulatory Affairs and Clinical Safety at Merck in Pennsylvania, where she provides regulatory leadership for project teams by developing and implementing global regulatory strategies for Infectious Disease/Vaccine programs. She also manages a team of global regulatory liaisons. Her expertise is in the development of vaccines for emerging infectious diseases, including Merck’s Ebola vaccine (ERVEBO), which has been approved by the European Medicines Agency, the US Food and Drug Administration, and several African countries and has been prequalified by the World Health Organization.
Before working in regulatory affairs, Dr. Wolf held various scientific and managerial positions in Safety Assessment and Bioprocess Development at Merck. She has contributed to the discovery, development, and licensure of several vaccines and biological products. Dr. Wolf earned her PhD in molecular biology and immunology from Princeton University before joining Merck in 2001. She is a member of the Regulatory Affairs Professional Society, the Society of Toxicology, the Biotechnology Innovation Organization (BIO) Vaccines Regulatory Affairs Committee, and BIO-Safe’s Special Biologics Expert Working Group.
Lessons Learned in the Development of the ERVEBO Vaccine
Development of vaccines is important to achieve long-term prevention and control of pandemic diseases. Experience gained in the development of Ebola vaccines provides important lessons in the clinical, manufacturing, and regulatory process that can be applied to SARS-CoV-2 and other epidemic pathogens. This report outlines key lessons learned by Merck during the development of an Ebola Zaire vaccine (ERVEBO). The five-year period from the start of phase 1 trials in October 2014 to ERVEBO approval in November 2019 was much faster than the typical 10- to 15-year timeline for vaccine development and approval. A number of valuable insights have emerged that are applicable to vaccine development efforts for SARS-CoV-2 and other epidemic pathogens, particularly those related to use of vaccine platforms and regulatory harmonization.
Wednesday, November 18, 10:45 AM–11:45 AM (EST)
Janet Woodcock, MD
Director of the Center for Drug Evaluation and Research, US Food and Drug Administration
Dr. Janet Woodcock is director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (US FDA). In 2015, Dr. Woodcock also assumed the role of acting director of the newly formed CDER Office of Pharmaceutical Quality (OPQ). Dr. Woodcock first joined CDER in 1994. For three years, from 2005 until 2008, she served the US FDA commissioner, holding several positions, including as deputy commissioner and chief medical officer, deputy commissioner for operations, and chief operating officer. Her responsibilities involved oversight of various aspects of scientific and medical regulatory operations. Before joining CDER, Dr. Woodcock served as director, Office of Therapeutics Research and Review, and acting deputy director in the US FDA Center for Biologics Evaluation and Research. Dr. Woodcock received her MD from Northwestern Medical School and completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco. She joined US FDA in 1986.
Predicting Effects of Candidate Drugs: The Future
Preclinical evaluation of candidate drugs has long relied on empirical toxicologic evaluations in animals as final screens for potential human toxicities. However, societal concern about the use of animal testing has been growing. Proponents of new in vitro technologies, including those that are mechanism based and others that attempt to reproduce physiologic systems, assert that these can be viable alternatives. How realistic are these claims? What gaps exist between our understanding of the predictive value of animal testing versus that of in vitro systems? How can such gaps be bridged? What efforts are ongoing, and what additional steps would advance the field? The presentation will discuss a practical roadmap to better understanding of these issues. In the near future, new technologies will likely supplement, not supplant, current toxicologic paradigms. The CDER Office of New Drugs has recently undergone a major reorganization. The Pharmacology/Toxicology discipline has new visibility and cohesion in the new structure, reflecting the growing amount of data available from in vitro, animal model, and classic toxicologic studies, and the need for a unified regulatory response.