The impact of statistics and data science in Chemistry, Manufacturing & Controls (CMC) is constantly expanding, with the introduction of advanced statistical methods and the ability to mine “big data” in the development and
lifecycle management of biological products.
Multiple aspects within the ever-evolving CMC landscape include: improving and developing innovative statistical methodologies to address key development decisions; addressing questions arising from yet unexplored modalities or technologies; advancing the regulatory framework through revised guidance;
and implementation of harmonized statistical
This workshop will provide a forum for statisticians, data scientists, development engineers, and regulators to explore approaches that serve future generations of technical and regulatory innovation in biologicals development and lifecycle management.