PSI Webinar: Master protocols - theory, application and regulatory considerations
For this webinar, PSI brings together experts on master protocols from the pharmaceutical industry, academia, and regulatory agencies.
If you have an interest in being involved in this SIG, or have an interesting case study or experience to share please contact Fabian Tibaldi (email: email@example.com)
Vaccines have been playing a critical role in public health through prevention of infectious diseases. An effective vaccine could prevent serious diseases, reduce disease burden on families and communities, or even eradicate diseases (e.g. smallpox). Vaccine research and development have been and will be important in this everchanging world. In developing new vaccines and managing life cycles of existing vaccines, new challenges keep emerging, and innovations are following.
As an integral part of the vaccine development, statisticians also come up with innovations in study designs and analysis methodologies. Speakers from academia, industry and government will share their experiences with some of the following innovations in solving challenges in vaccine development: biomarker assessment (correlates of risk and correlates of protection) especially for first-in-class vaccines; bridging of vaccine efficacy to new settings; multiplicity challenges in multivalent vaccines (multiple serotypes of a pathogen) or due to co-administration with routine vaccines that results in testing of many hypotheses to show non-inferiority of the routine vaccines with vs. without investigational vaccine; evaluation of effects for new serotypes added on top of an existing vaccine; real world data/evidence implementation (e.g. hybrid trial design); application of estimands in vaccine trials to address intercurrent events; and safety assessment/monitoring.
Chair: Josh Chen
Organizers: Frank, Lihan Yan (FDA CBER) and Wenquan Wang (Sanofi)
Potential speakers for the session include, to be confirmed
Dr. Peter Gilbert, Fred Hutch
Dr. Lihan Yan, CBER, FDA
Dr. Judy Pan, Sanofi Pasteur
Dr. Jianing Li, Merck & Co., Inc.
More meetings, conferences and presentations in our Newsletter from May 2020.