The Joint Project Manager for Medical Countermeasure Systems (JPM-MCS), a program within the U.S. Department of Defense (DoD), is returning to the BIO International Convention this year and looking to collaborate with biopharmaceutical companies through innovative contracting arrangements that support partnerships throughout the drug development life cycle. Two programs, the Advanced Development and Manufacturing Capabilities (ADMC) and the Joint Vaccine Acquisition Program (JVAP) are on site to discuss how other transactional authority (OTA) agreements can be used to connect industry partners to early stage development, advanced development, manufacturing and procurement opportunities.
Advanced Development and Manufacturing Capabilities
New in 2016 is DoD’s ability to support drug development and manufacturing with a dedicated ADM facility. The ADM facility was designed to enable industry to meet DoD’s specific requirements by providing tailored production capabilities and capacity and by sharing related lessons learned.
The state-of-the-art centralized facility located in Alachua, Florida, was built by Nanotherapeutics Inc. It is a contractor-owned, contractor-operated enterprise. Through ADMC, DoD’s JPM-MCS is procuring and installing specialized single-use modular pharmaceutical manufacturing equipment. Through this procurement ADMC will ensure DoD’s priorities in manufacturing of products.
Based on single-use technology and disposable equipment, the facility permits development and manufacturing of MCMs faster and more effectively than most current production processes. It offers a dedicated, cost-effective, reliable, sustainable, and integrated manufacturing infrastructure to support industry needs as well as DoD medical countermeasure pipeline and surge requirements.
The ADM facility is committed to IP protection that will support innovators of all sizes, ensuring that all partners’ products will be safeguarded throughout the manufacturing process and during all other early and advanced development support efforts. Nanotherapeutics Inc. and its partners have established IP Management Policies and Plans detailing comprehensive means for ensuring IP protection. These guiding documents and supporting procedures are based on an extensive track record working with industry and with government agencies, including DoD, the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, and the National Institutes of Health.
DoD is currently seeking partners desiring dedicated infrastructure and with established firms needing an alternative manufacturing space to support DoD.
Joint Vaccine Acquisition Program
JVAP’s participation at BIO this year includes promotion of its new initiative, the Proven Platform Partnerships Initiative (P3I), to facilitate the development of vaccines and implement proven platform technologies in cost-effective ways.
JVAP is responsible for the acquisition and procurement of biodefense vaccine platform systems and vaccines licensed by the U.S. Food and Drug Administration and collaborates closely with the Joint Science & Technology Office (JSTO) in guiding early stage development. Through this collaboration, JVAP and JSTO ensures that all early stage research and development efforts are aligned for a smooth transition into advanced development.
JVAP manages sustainment programs for the DoD that effectively counter anthrax (BioThrax ®) and smallpox (ACAM2000 ®). It also has supported the development and FDA licensure of Vaccinia Immune Globulin Intravenous (VIG-IV). Vaccine candidates in JVAP’s advanced development pipeline include protection against botulinum toxin, pneumonic plague, Ebola and Marburg viruses, ricin toxin, and the Western, Eastern, and Venezuelan equine encephalitis (WEVEE) viruses.
P3I is about leveraging prior knowledge and proven experience to better enable private industry to work with DoD on prototype projects that are directly relevant to enhancing the mission-effectiveness of military personnel by developing and improving chemical, biological, radiological, and nuclear medical countermeasures. P3I seeks to join state-of-the-art and proven platform manufacturing systems with DoD resources to provide multiple vaccine candidates for testing and evaluation. P3I will enable commercial entities to use their technologies, research, and lessons learned in a manner that makes economic sense.
As an added benefit, companies that work with JVAP will have a single point of contact across all military services and may be offered opportunities for follow-on procurement agreements also allowable under the OTA.
Working with DoD
To learn more about these partnership opportunities and how to do business with DoD:
- JVAP and ADMC are located at Fort Detrick, Maryland
- Visit booth #7719 for more information.
Joint Product Manager for the Joint Vaccine Acquisition Program (JVAP)
Joint Product Management Office Medical Countermeasure Systems (JPM-MCS)
Joint Product Director for the Advanced Development and Manufacturing Capabilities (ADMC)
Joint Project Management Office Medical Countermeasure Systems (JPM-MCS)