The rise of targeted- and immune-therapies has shifted the focus in early-phase dose-finding studies away from finding the Maximum Tolerated Dose (MTD) and toward identifying the Optimal Biological Dose (OBD). 

The PKBOIN-12 method, developed by Dr. Hao Sun, Biostatistician at Bristol Myers Squibb, and colleagues, enhances the established BOIN12 algorithm by incorporating Pharmacokinetic (PK) information into the OBD determination process. 

This webinar will cover the motivations for developing this new method, its implementation in advanced statistical software, as well as its statistical underpinnings. The conversation will be framed within the context of the shifting regulatory assessments of biologics in Phase II clinical trials, encapsulated in the FDA’s Project Optimus. Please join us for a fascinating conversation. 

Key Topics

• Dose-finding studies for biologic treatments
• PKBOIN-12 motivation and statistical background
• FDA’s Project Optimus and a new regulatory framework

Speakers

• Kevin Trimm, Chief Product Officer, Cytel Inc.
• Dr. Hao Sun, Senior Manager, Biostatistics, Bristol Myers Squibb