Co-Chairs: Steven Romano, MD; Richard Keefe, PhD

Over the past several years, we have seen a movement of R&D investment out of CNS drug development and into disease areas where a better understanding of human biology and genetics can lead to greater confidence in the identification of relevant targets and the advancement of specific pharmacological therapies.  R&D funding, even in some of the largest pharmaceutical companies, is limited and this has led to intense competition for dollars and a shift of portfolios towards other areas of medical need such as diabetes, oncology and inflammation.  How might those of us working on CNS disorders help to reverse this trend?  Many of our attempts to improve the success of our CNS development programs have been directed at the challenges of Phase 3 design and conduct.  But other solutions lie earlier in drug discovery and research, with the acknowledgment that if early phase development can resolve certain key risks, late phase development success will be significantly enhanced.  This meeting will address these developmental challenges, highlighting the fundamentals of early phase development. The session will also address the process of moving from early phase development to full development, and the operational complexities associated with executing global development programs.