Ensuring Biologics Advanced Development and Manufacturing Capability for the United States Government: A Summary of Key Findings and Conclusions

摘要

Medical countermeasures (MCMs) are urgently needed to protect military and civilian populations against a chemical, biological, radiological, and nuclear (CBRN) attack and naturally occurring outbreaks of emerging infectious diseases. However, the United States Government (USG) does not have the capability to rapidly develop, license, and manufacture MCMs and many USG requirements for MCMs remain unmet. Ensuring the rapid development, licensure, and cost-effective production of MCMs especially biologics-based vaccines and therapeutics, is crucial to building a balanced portfolio of MCMs at the Department of Defense (DoD) and the Department of Health and Human Services (HHS) to protect national security and public health. Consequently, the Defense Advanced Research Projects Agency (DARPA) entered into a cooperative agreement with the University of Pittsburgh Medical Center (UPMC) to study the best means for creating and sustaining this critical capability. At the request of DoD and in coordination with HHS, the UPMC study examined the scientific advantages, technical feasibility, and economic savings related to building a centralized capability for advanced development and manufacture of MCMs to support the approximately 80 biodefense innovators (biotechnology companies, academia, and research & development R&D) labs currently funded by DoD and HHS. To this end, the study first determined current USG demand for biologics manufacturing and identified the collective strengths and weaknesses of the current MCM development and acquisition model as articulated in interviews with multiple interagency and industry experts. The study then examined ways in which to leverage advances in biomanufacturing technology and regulatory guidelines for flexible manufacturing and combine advance development and production of biologics in a multi-product facility focused on satisfying USG needs. Finally, the study identified various operating models for structuring the capability and m.