With increasing attention toward patient-centric drug development, patients play an integral and growing role in the development of therapeutic products. Patient organizations are engaging in basic disease research, working with medical product developers and providing meaningful input to regulators. Through its Office of Health and Constituent Affairs, the FDA has been working since the early 1990s to engage patients and enrich their role in medical product development through FDA’s patient liaison program. This presentation will provide insight into the various ways that patients, and patient advocacy organizations can voice their thoughts and opinion to the FDA.
Salina Prasad joined FDA’s Office of Health and Constituent Affairs, located within the agency’s Office of the Commissioner, as a Health Programs Coordinator in March 2013. Serving on OHCA’s Patient Liaison Team, Ms. Prasad is the Office’s team lead for neurology-related issues and medical products. A large part of her work also focuses on helping to manage FDA’s Patient Representative Program, a critical program within the agency that ensures that patient perspectives are included in the medical product review process. Prior to joining the FDA, Ms. Prasad was with FDA’s sister agency, the Agency for Healthcare Research and Quality, for nearly 18 years. There she served as the Agency’s liaison for the Department’s Partnership for Patients initiative, which focused on reducing hospital acquired conditions and hospital readmissions, and also served as a communications lead for issues related to patient safety and medical errors. Ms. Prasad received a B.S. in chemistry and biology from Columbia Union College and a Master of Science and a Master of Business Administration in Biotechnology from Johns Hopkins University.
CDR Steve L. Morin. has been in the Office of Health and Constituent Affairs since December 2011, and as a Health Programs Coordinator works closely with numerous patients and patient advocate organizations to help them understand the regulatory process, medical product approval process, expanded access, and other topics important to patients. He also assists with the Patient Representative Program, handling telephone and email communications from patients and the public. CDR Morin currently manages the Patient Network and is responsible for the creation of content, updating and daily management of the Patient Network website. Prior to joining OHCA, CDR Morin was part of the FDA’s Office of Surveillance and Epidemiology for 2 years, and performed Medication Guide and Patient Package Insert reviews for the Patient Labeling & Education Team. In addition to his work at the FDA, CDR Morin has a strong background as a health care professional. After receiving a B.S. in Nursing from the University of Southern Maine, he worked as an Oncology nurse at Maine Medical Center and the National Institutes of Health. CDR Morin was commissioned in the United States Public Health Service as a Nurse Officer with the rank of Lieutenant and continued his work at the NIH as a research nurse for the National Cancer Institute. He spent over 4 years at the Department of Homeland Security as the Infection Control Officer and coordinated continuation of care for newly diagnosed tuberculosis patients before earning his flight wings in the United States Air Force, where he assisted with the coordination of care for critically ill detainees.