Duke Margolis Center's Role in Drug Development Policy

This technical report discusses the transition of Mark McClellan and Gregory Daniel's health policy team from Brookings to the Duke Margolis Center for Health Policy. The document outlines their ongoing collaboration with the FDA to address complex drug development issues and enhance regulatory science. It details the team's involvement in initiatives such as the Sentinel Initiative and the development of the electronic postmarketing surveillance system. The report highlights the challenges faced in drug development, including the incorporation of patient-reported outcomes and the development of antibacterial drugs. It emphasizes the importance of stakeholder engagement and the need for effective communication in the regulatory process. The document also describes the resources and infrastructure available at Duke that support their work, including expert workshops, public meetings, and the development of white papers aimed at informing FDA policy. Overall, the report presents a comprehensive view of the team's efforts to improve drug development and regulatory practices.