FDA/AD Allies Meeting on Combination Therapy Development

To address critical issues in the development of new Alzheimer’s disease treatments, the Accelerate Cure/Treatments for Alzheimer’s Disease (ACT-AD) coalition and the Critical Path Institute will co-host the fifth-annual FDA/AD Allies Meeting. This annual meeting sponsored by ACT-AD brings together leaders in Alzheimer’s drug development from the patient advocacy community, federal health and regulatory agencies, academic research, and the private sector for focused discussions on key issues surrounding the development and regulation of Alzheimer’s drugs and therapies.

Combination therapy development has been successful in other life-threatening diseases in part because collaborative approaches were established to identify necessary pathways and tools that enabled more efficient trials. Our primary goal is to explore how similar partnerships could foster more robust collaboration in Alzheimer’s disease (AD) in order to encourage the development of combination therapies.

FDA has published draft guidance on the co-development of multiple treatments for use in combination. This meeting will allow stakeholders to gain greater clarity of FDA’s requirements for the development of multiple therapies in combination for the treatment of Alzheimer’s disease and explore the feasibility of practically designing clinical trials for more than one AD therapy.