The PDA Metro Chapter proudly present an in-person event on GCP Compliance.
Abstract
PDA talk
Title: Clinical Development – a view of the valley
Tung M. Fong, PhD
Abstract: An overview of the clinical development process of new drugs will be provided, with brief discussion on the goals of Phase 1, Phase 2 and Phase 3 studies. Particular emphasis will be on the challenges of Phase 2 studies which are associated with the lowest success rate, and hence the nickname “Valley of Death”. Published case studies will illustrate the lessons learned, success stories of drug development, and various approaches to increase the probability of success of new drug development.