Accelerating the Development of New Drugs and Diagnostics

Advances in technologies and knowledge are creating new avenues for research and opportunities for the discovery and clinical development of innovative therapies and diagnostics. However, despite these opportunities, only a small fraction of investigational products are successfully developed into cures and therapies that can be accessed by patients. One response to the ever-widening gap between the number and promise of basic scientific discoveries and the translation of those discoveries into therapies is a renewed emphasis on collaborative approaches among federal agencies, academia, and industry, all directed at the advancement of the drug development enterprise. The newly developed Cures Acceleration Network (CAN)-a part of the National Center for Advancing Translational Sciences (NCATS) within the National Institutes of Health (NIH)-has the potential to catalyze widespread changes in NCATS, NIH, and the drug development ecosystem in general. On June 4-5, 2012, the IOM Forum on Drug Discovery, Development, and Translation held, at the request of NCATS, a workshop-bringing together members of federal government agencies, the private sector, academia, and advocacy groups-to explore options and opportunities in the implementation of CAN. Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary summarizes the workshop. Table of Contents Front Matter 1 Introduction 2 Approaches to Accelerating Translational Science 3 Application of Matching Authority 4 Application of Flexible Research Authority 5 Situating CAN Within the Drug Development Ecosystem 6 Final Reflections on Ways to Maximize the Goals of CAN References Appendix A: Workshop Agenda Appendix B: Public Health Service Act, Title IV - National Institutes of Health Appendix C: Participant Biographies