Director, Expanded Access Programs & Policy
Richard Klein, Director, Expanded Access Programs & Policy at GE2P2 Global Foundation, 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. He spent more than 40 years with FDA. Most recently he was the director of the FDA’s Patient Liaison Program in the Office of Health and Constituent Affairs, the primary interface between the FDA and patient and patient advocate communities. Interacting extensively with outside communities and within the agency’s scientific offices, he helped facilitate patient engagement to address issues and concerns of patients (including treatment access to unapproved drugs, product safety, and clinical trial design). The program ensured representation of patient voices in approval and policy decisions, and at FDA advisory committee meetings. Mr. Klein has worked in various capacities and with each of the medical product Centers at FDA, giving him a well-rounded understanding of the regulatory issues that affect patients. He helped develop revised expanded access regulations and guidelines, the streamlined Individual Patient IND application, and the waiver of full board IRB review for single patient expanded access. Earlier, he was actively involved in human subject protection policy development, working closely with other federal agencies and DHHS to ensure consistent and meaningful policy for the protection of human subjects in biomedical research.
Monday, November 18
2:45 PM – 4:00 PM