This conference will provide a venue to discuss important statistical issues associated with the development and review of therapeutic drugs and biologics. A primary focus for this meeting will be to establish an ongoing, annual dialogue in an open, public forum, regarding FDA’s “Critical Path” initiative — emphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials data.

This conference will be an opportunity for statisticians, clinicians and other interested professionals from industry, academia, CROs, and government agencies to learn about and discuss the current and emerging statistical methodologies and quantitative approaches used to develop evidence of the efficacy and safety of new drug and biologic therapeutic products.