Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Biologics Track
Presenter
Karen Jackler
Program Manager – Patient Engagement
Office of the Director
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA)
Karen Jackler is the program manager for the Center for Biologics Evaluation and Research (CBER) Patient Engagement Program. She works with patient organizations and with her FDA colleagues to coordinate patient engagement activities and to facilitate information sharing and collaboration. Ms. Jackler joined the FDA in 2009. Prior to joining CBER in 2018 she served as a strategic communication advisor and project manager for the FDA Center for Drug Evaluation and Research and the FDA Center for Devices and Radiological Health. Her experience also includes communication research and outreach roles with the National Institutes of Health and the Centers for Disease Control and Prevention. She holds a Master of Public Health with a concentration in Health Communication and Education and a Bachelor of Science in Cellular and Molecular Biology; both degrees are from Tulane University.
Abstract
Karen Jackler, the Patient Engagement Program Manager at FDA’s CBER, presents on patient engagement, defining it as activities where patient stakeholders share their experiences, perspectives, needs, and priorities to help inform FDA’s public health mission. Engaging with patients allows learning about the impact of the disease and treatment, the burden of living with the condition, patient perspectives on potential treatments, unmet needs, and the natural history of the disease. Engagement is crucial throughout the medical product development process, from preclinical stages informing endpoints and clinical trials tailoring procedures for patients to marketing applications where patient data is considered and post-market follow-up. FDA considers submitted patient experience data and information from other sources, which is documented in public memos and informs review decisions. Patients are considered experts on living with their disease and can be valuable drug development partners. FDA offers various resources to guide stakeholders, including Voice of the Patient reports, listening session summaries, Genmed ED programs, workshops, and patient-focused drug development guidances.