Richard Klein

Advisory Board Member

Richard Klein began his career working in patient engagement, helping to develop policies and regulations for the protection of human research subjects, both at FDA and HHS, including the original Common Rule, and provided guidance for institutional review boards (IRBs). He worked at the FDA for more than 40 years, and while there he helped develop the revised expanded access regulations and guidelines, led the creation of the FDA expanded access website, and helped develop the streamlined application for individual patient access and the Reagan Udall Foundation Expanded Access Navigator. As director of the FDA's Patient Liaison Program, he interacted extensively with outside communities and the agency's scientific and policy offices to advocate for patient interests and facilitate patient engagement in regulatory activities. He worked closely with patient communities in a variety of areas, including treatment access to unapproved drugs, product safety, and clinical trial design. Before taking on that role, he created the FDA's HIV/AIDS program, working with AIDS activists and advocates to coordinate their input and participation in regulatory policy and decision-making related to HIV/AIDS. Richard is an internationally recognized expert in expanded access to unapproved therapeutic agents.

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