RFA-FD-24-041 Project Summary/Abstract The Kidney Health Initiative (KHI) is a public-private partnership among the American Society of Nephrology (ASN), US Food and Drug Administration (FDA), and all major constituents in the kidney community (patients, healthcare professionals, members of industry and government). KHI is the largest consortium in the kidney community and is focused on addressing barriers to the development of new drugs, devices and biologics for people with kidney diseases. KHI’s community, governance, and infrastructure makes it uniquely positioned to convene and identify issues facing the kidney community, translate them into a pre-competitive collaborative activity, and produce a consensus deliverable. These resources provide recommendations and direction for any individual, company, or organization to use for the development of innovative kidney drugs, devices, and biologics. The current proposal builds on KHI’s accomplishments and leverages the expertise within KHI’s Board of Directors, the member community, and ASN to execute projects that include but are not limited to development and evaluation of clinical trial endpoints, creation of roadmaps to advance product development, and tools to integrate the patient perspective in clinical research and product development; convene the community to define and communicate solutions addressing shared challenges; and collaborate within and outside of the kidney community to strengthen the impact of KHI resources. Over the next five years under the direction of KHI’s Board of Directors and guidance of KHI’s Patient and Family Partnership Council, KHI will continue to advance its project portfolio and annual meeting. KHI remains a neutral and patient-centered platform that convenes the kidney community to exchange information and explore pre- competitive collaborations. To further the community’s evolution, KHI projects and annual meeting will be supplemented with increased in-depth topical activities including workshops, virtual convenings, and consistent communications with the member community. KHI will also pursue outreach opportunities to further adopt or strengthen KHI resources, support activities and projects led by strategically aligned organizations, and pursue partnerships with complementary organizations. KHI has spent a decade building an innovation community, now is the time to increase the depth of solutions that fill critical gaps impacting progress of kidney innovations.