Expanded Access Summit - Cambridge MA, Sept 15, 2017

Early Access Care participated in the 2017 Expanded Access Summit in Boston MA on September 15, 2017.   Over 30 years have passed since the first IND Regulations were revised to provide access for a broad patient population under a Treatment IND/Protocol.  The State of Expanded Access was chaired by Anne Cropp (EAC).  Kay Holcombe (Sr VP for Science Policy, BIO), Richard Moscicki MD (Deputy Center Director for Science Operations, FDA) and Kathi Kinnett MSN (Sr VP, Parent Project Muscular Dystrophy)  joined Anne in presenting "Lessons Learned from the first 30 years".  The meeting, hosted by WideTrial,  was the convergence of  disease organizations, clinical researchers, policy institutes and biopharmaceutical manufacturers  to discuss existing and emerging best practices for integrating well-designed Expanded Access programs into the clinical development process.  The full session will be published in the near future.  Stay tuned for the link.