Every drug development program must begin with an understanding of how the relevant key stakeholders factor into the development process. It’s not just a matter of courtesy; a comprehensive examination of the roles played by all participants has the potential to produce faster and more concrete results, leading to improved patient outcomes.
Topics in this presentation include:
- Developing a framework for handling multiple endpoints for the drug’s go-to-market label
- Determining the potential of adaptive design for optimizing the trial and evaluating the applicability of various adaptive design approaches
- Key interactions and questions to ask when seeking regulatory input of pivotal study designs
Featured Speakers:
Abie Ekangaki, Ph.D. Vice President, Statistical Consulting, Premier Research
Rupa Doshi Ph.D., Vice President Oncology Strategy
Naomi Kautz, Vice President, Regulatory Affairs, RPI, A Division of Premier Research