Draft SOO Feedback Survey: Advanced Research and Development of Medical Countermeasures Through Agile and Distributed End-to-End Drug Manufacturing (26-13-EDM)

The primary objective of this project is to develop and commercialize manufacturing capabilities that allow for end-to-end production of drug substances and drug products under cGMP and subsequent regulatory filing that enables broad commercial adoption and sale of domestically produced drug substances and drug products to meet US demands for medical countermeasures. Performers must include activities that enable the commercialization and sustainment of agile and distributed manufacturing capacities, including those that improve cost competitiveness and establish capacities that can rapidly scale up manufacturing of drug substances and drug products during high-demand periods and national emergencies. Approaches must be built on flexibility, innovation, augmentation and commercial sustainability. Data-driven production that aligns in-process metrology with rich data collection to bolster cGMP production and regulatory review is preferred, while traditional batch manufacturing and reliance on global just-in-time supply chains will not be considered.

Please note: Membership is not required to provide feedback to this survey.