GE2P2 Global Names Richard Klein as Director, Expanded Access Programs & Policy

5 August 2019, Philadelphia – GE2P2 Global said it appointed Richard Klein as Director, Expanded Access Programs & Policy, effective immediately. In this role, Mr. Klein will help advance GE2P2 Global’s work with a special focus on global, country and developer expanded access/compassionate use policies, governance and program access/effectiveness/outcomes Mr. Klein is an internationally recognized expert in preapproval access to therapeutic agents. He was named a Fellow of the GE2P2 Global Foundation in 2017 and has since served as a member of the Foundation’s Independent Bioethics Advisory Committee [IBAC], which provide advisory support to expanded access and compassionate programs globally. Mr. Klein worked at the FDA for more than 40 years before leaving the agency in 2017. He served as director of the FDA’s Patient Liaison Program in the agency’s Office of Health and Constituent Affairs, the primary agency interface with patients and patient advocate communities. He participated in the development of revised expanded access regulations and guidelines, and led the creation of the FDA expanded access website, played an active role in the development of the streamlined application for individual patient access, the exemption from full board IRB review for Individual Patient IND expanded access, and the Expanded Access Navigator. In these roles, he interacted extensively with outside communities and within the agency’s scientific and policy offices to advocate for patient interests, and facilitate patient engagement. He actively addressed issues and concerns of patients in a variety of areas, including treatment access to unapproved drugs, product safety, and clinical trial design. GE2P2 Global Foundation President David R. Curry commented “We are very pleased to have Richard Klein take on this important role as we expand our work addressing policy, regulatory and ethical challenges associated with expanded access and pre-licensure access programs at global, country and developer-level. Richard brings deep insight to this work from his FDA experience, complemented by his extraordinary analytical skills and his deep empathy for patients in need.” More on the GE2P2 Global Foundation here: ge2p2.org. For additional information or interview, please contact: David R Curry, President & CEO, GE2P2 Global - mobile: [US] 267.251.2305 - skype: davidrcurry1 - email: david.r.curry@ge2p2center.net