Consultant - Former FDA Patient Program Director
Richard Klein is an expert in issues related to treatment use of investigational medical products (Expanded Access). 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 represntation 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. He also developed the agency’s patient web pages, and disease-specific electronic listservs. Earlier, he managed the agency’s HIV/AIDS Program, and was actively involved in human subject protection policy development for the agency. He worked closely with other federal agencies and DHHS to ensure consistent and meaningful policy for the protection of human subjects in biomedical research.
Friday, November 16
11:15 AM – 12:30 PM
Saturday, November 17
11:30 AM – 12:45 PM