ABC-FDA TAP Program Partnership

The Foundation is supporting a collaboration between the American Brain Coalition (ABC) and the US Food and Drug Administration (FDA) to test a new multidirectional “liaison/convener” engagement model to embed patient and family perspectives in regulatory processes and decision-making (i.e., in developing new therapies), via the FDA Total Product Life Cycle Advisory Pilot Program (FDA-TAP). ABC will leverage these relationships to help gain buy-in, facilitate engagement between neural device sponsors and brain health community stakeholders, and educate participants about FDA-TAP. They will also strengthen relationships among the stakeholders and with the FDA by hosting gatherings to build trust and bridge the gap in understanding between neural device sponsors and the brain health community. After each meeting, ABC will follow up with all parties to address questions and work with the device sponsors to use brain health community feedback to improve device development, clinical trial design, communication strategies, and risk/benefit analyses. This grant represents an opportunity for ABC to ensure that and family needs are meaningfully considered early in technology development, while serving an overarching goal of cultivating trust and meaningful interactions among brain health community stakeholders, FDA, and industry groups within the FDA-TAP.