ACT-AD Presents at Brookings Institution Workshop on Expedited Drug Development for Promising Therapies
The Engelberg Center for Health Care Reform at the Brookings Institution hosted an expert workshop on Expedited Drug Development for Promising Therapies. This workshop brought together a diverse set of stakeholders to discuss existing tools for facilitating expedited market access, opportunities for improving and expanding upon these tools, therapeutic areas most in need of an expedited development pathway and how promising therapies can be defined. The second half of the workshop explored methodological approaches to enable a compressed drug development timeline and potential evidence gaps that may result in the post-market environment for products approved through an expedited pathway.
ACT-AD Chairman Daniel Perry spoke about the coalition’s experience working with regulators on issues related to the development and review of Alzheimer’s disease therapies. Mr. Perry also highlighted that the review of neurological products could be improved by additional clarity and transparency around the application of existing pathways like Fast Track and Accelerated Approval to new Alzheimer’s treatments.