NEW CONFERENCE

Co-sponsored with the FDA

Complex Innovative Trial Designs (CID) have the potential to increase the efficiency and lower the cost of drug development which will accelerate patient access to life-altering therapies. The 21st Century Cures Act (Cures Act) and the sixth iteration of the Prescription Drug User Fee Act (PDUFA VI) recognize the need for CID and include provisions to advance their use to enhance medical product development. One such provision within PDUFA VI is the launch and implementation of the FDA CID Pilot Meeting Program which aims to foster discussions and education of the use and value of CID within drug development programs.

In an effort to promote CID, the unique conference will provide a platform for extensive scientific exchange among the FDA, other global health authorities including EMA, PMDA, and CFDA, patient advocates, and drug development innovators on CID topics such as master protocols, complex adaptive design, and Bayesian techniques, highlighting also the potential of alternative data sources.

Each session will begin with an introductory presentation by an FDA representative to set the stage followed by presentations and perspectives from a diverse group of expert speakers and panelists. The suitability of each CID topic and the proposed innovations from a US and global regulatory perspective, their usefulness from a patient perspective, and how challenges in the designs can be overcome, will be explored.

This conference is designed for key drug development decision-makers including clinicians, regulatory scientists and reviewers, and other key stakeholders, in addition to statistical specialists. Join us in this unique forum that will catalyze progress in advancing innovation in drug development.

The program is developed in collaboration with BIO, PhRMA and FDA.

The program has been released! Preview all session descriptions, speakers, and more all in one place!
View Program.