The conference aims at bringing statisticians, subject matter experts and regulators together to exchange on the intersection of statistics and science, and to pave the way to improve the usage of CMC Statistics, data analytics, and modeling for Biologics. The sessions will cover topics including day-to-day applications of CMC Statistics, regulatory framework for statistical applications, and case studies of statistics as a catalyst for better science and engineering.
A call for abstract will take place during the workshop. Applicants are encouraged to target industry hot topics including comparability, application of statistical and data analytics tools to practical scientific challenges in CMC, the impact of upcoming regulatory changes to data analysis applications, data-driven influence in decision making, clinically relevant specifications, and case studies of applications that impact CMC productivity. Preference will be given to topics that showcase partnership/collaboration between scientists and statisticians / data scientists / modelers, particularly those that demonstrate practical impact to CMC business or regulatory challenges.