Phase 2B Strategies and Optimization of Drug Development Programs

• Activity Number: 377
• Type: Topic Contributed
• Date/Time: Tuesday, August 5, 2014 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Zoran Antonijevic*+
• Companies: Cytel
• Keywords: optimization ; drug development ; dose selection ; adaptive design

Abstract

Selecting the right dose is critical for the success of any drug development program, and for maximizing the value of a product. The high attrition rate in Phase 3 is likely due, in part, to faulty dose selection. In the new environment where payers are not reimbursing every product that is granted a marketing authorization, dose selection becomes even more important. A well selected dose will have a better chance for a desirable risk/benefit profile and thus increase the chance for the product to be reimbursable. It will also result in improved patient care, and greater benefit to society.

This talk will present findings of four papers published as the output of DIA Adaptive Design Scientific Working Group activities. The main topics covered are the impact of study design and dose selection criteria on the expected value of a product, measured by the expected net present value. The session will also demonstrate why it is essential to always compare multiple development scenarios, and to have a closer collaboration of R&D and commercial teams.