A Bird Eye View of Pharmaceutical Development: an Industry Perspective on Drug Development in Psychiatry

This talk will review the key components of pharmaceutical development of new treatments in psychiatry. A modest review of the compound discovery and preclinical phases of development will be included, while the focus of the discussion will be on clinical development. We will review first in human, phase 1 single and multiple ascending dose studies in healthy individuals and the subsequent phase 2 and phase 3 patient studies needed for regulatory approval. We will also review the likelihood of success at each phase of development as well as the key requirements to achieve success.

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