VIEWPOINT CHEM BIO PROTECTION
Chem-Bio Defense Program Eases Path for Industry
Photo: Defense Dept.
In a 2016 congressional hearing, former Director of National Intelligence James Clapper stated that chemical, biological, radiological, and nuclear weapons and emerging infectious diseases constitute a major threat to the security of the United States.
The Department of Defense is facing the challenges of this evolving threat environment head-on.
The joint program executive office for chemical and biological defense and the joint project manager for medical countermeasure systems are transforming ways of doing business with industry partners in order to rapidly develop and field medical countermeasures to support U.S. service-members around the world.
Medical countermeasures, such as vaccines, diagnostics, and therapeutics, are a critical component of a multi-
layered defense strategy to protect troops from CBRN threats and emerging infectious diseases. The medical solutions developed add an initial layer of protection and enhance the diagnostic capabilities and post-exposure treatments that save lives and enable U.S. servicemembers to complete their mission.
Medical countermeasure systems is a joint project management office located at Fort Detrick in Frederick, Maryland, and facilitates the advanced development and fielding of these medical countermeasures.
In order to streamline the acquisition process that provides critical medical countermeasure products to the warfighter, the two offices are employing a new “agile medical paradigm,” or AMP. Its mission is to decrease risk, address a broader threat environment, and enable a rapid response capability to future threats.
“We are undergoing a transformation in how we do our business and the technologies we are pursuing,” said Jason Roos, deputy program executive officer for chemical and biological defense. “From a medical countermeasure perspective, we need innovative solutions to stay ahead of the enemy, and a robust pipeline of capability to draw upon in a crisis.”
Part of this transformation includes incentivizing industry members to work with the two offices. Currently there are few economic incentives for industry to participate, coupled with the lengthy requirements of Federal Acquisition Regulation contracting, and reliance on the U.S. government as the only customer for medical countermeasures against many CBRN threats.
The medical countermeasures system office is overcoming these hurdles by utilizing “other transaction agreements” — also known as OTA — as set forth in U.S. law in 10 USC 2371b. Other transactions are legally binding instruments that are used to engage industry and academia on a broad range of research and prototype projects. The mechanism provides an opportunity for nontraditional defense contractors to partner and address important capability requirements across the federal government.
Employing OTAs allows for speed, adaptability and accessibility in providing prototypes and medical countermeasures, without having to meet the many statutory requirements governed by the FAR. In short, this authority is designed to stimulate innovation.
As a part of this effort, the office has partnered with Advanced Technology International to create the Medical CBRN Defense Consortium. Now with over 130 members — including prominent industry, academic and nonprofit partners — the consortium facilitates a flexible arrangement with the Defense Department to accelerate medical countermeasure development.
The office identifies requirements through Army Contracting Command-New Jersey and solicits proposals for prototype projects from consortium members. By working with industry and academic leaders, the office streamlines the process for providing new medical products to the warfighter.
Members receive benefits such as networking opportunities with other consortium members and government stakeholders; providing visibility into government needs and priorities; and expanding their market by creating a channel for small companies and nontraditional technology providers to engage in the federal acquisition process.
The consortium is another tool in the medical countermeasures systems toolbox that improves acquisition and incentive strategies.
Recently, the chemical defense pharmaceuticals product management office under medical countermeasures utilized the existing other transaction authority and the consortium to facilitate the development of autoinjectors containing drugs that combat the effects of nerve agent exposure.
Through a competitive source-selection process, the office awarded Emergent BioSolutions a five-year agreement through the consortium to develop the novel multi-drug autoinjector for nerve agent antidote delivery. The office is leveraging partnerships with other consortium members such as SHL Pharma Inc., Battelle and Ology Bioservices Inc. in order to develop autoinjectors to deliver nerve agent treatments.
By examining past experience and lessons learned from medical countermeasure development, the joint program office is looking toward the future by utilizing the other transaction authority to improve and enhance the ability to treat and protect servicemembers from the effects of CBRN agents and emerging infectious diseases.
Included in the initiative is the Advanced Development and Manufacturing facility in Alachua, Florida, which provides the Defense Department with a dedicated manufacturing capability, particularly for niche military pharmaceutical products.
"We are undergoing a transformation in how we do our business and the technologies we are pursuing."
The facility was developed through a partnership with Ology Bioservices, which is also a member of the OTA consortium. The facility is designed as a contractor-owned, contractor-operated enterprise that provides the government with the capacity to support routine product manufacturing, as well as surge privileges in times of increased national security and defense needs.
A world-class facility, it utilizes state-of-the-art single use technology, and contains two current “good manufacturing practices” compliant manufacturing suites. The facility is biological safety level 3 capable, which allows staff to work with microbes that can cause serious and potentially lethal disease via inhalation. It facilitates development and manufacturing of medical countermeasures that will protect and treat servicemembers who may be exposed to biological or chemical weapons, toxins or infectious diseases, as well as radiological or nuclear events.
With guidance from the White House, the medical countermeasures system office “determined that a successful facility would leverage the development expertise of large biopharmaceutical corporations while retaining the innovative spark possessed by many smaller biotech companies,” said Tim Belski, joint product director for advanced development and manufacturing capabilities at the Pentagon.
“This meant that any business arrangement had to be attractive to private industry partners seeking a return on their investments, be able to support DoD surges in the event of an emergency, and support DoD’s manufacturing of medical countermeasures at smaller volumes than typical commercial levels,” Belski added.
The facility enables small innovator companies the opportunity to utilize their capabilities to support medical countermeasure development from research to licensure. Ultimately, the facility lowers the hurdles for industry to work with the department while also stabilizing production for military relevant products.
Establishment of platform technologies also supports the agile medical paradigm framework by streamlining medical countermeasure development.
Chartered in October, the platforms for rapid integrated solutions for medical countermeasures (PRISM) joint product lead aims to accelerate medical countermeasure delivery to the warfighter through the development and implementation of platform systems. PRISM is a part of a translational team with the Defense Threat Reduction Agency’s joint science and technology office.
PRISM will establish a toolbox of platform systems that can be used to counter a variety of threat agents using standardized discovery, design, manufacturing and testing processes to streamline generation of a portfolio of medical countermeasure candidates. PRISM will also adapt some of these platform systems to support a rapid response capability needed to respond to emerging and novel threats.
“The platform approach leverages standardized processes and efficiencies that enable us to deliver capabilities to the warfighter sooner,” said Nicole Kilgore, joint product lead for PRISM. “The goal is to rapidly identify new and emerging threats and quickly deliver a medical countermeasure product that protects U.S. troops.”
“Advanced development and manufacturing of antibody technologies” is the first platform being implemented under PRISM. It is a monoclonal antibody platform that provides a capability to respond to recognized, emerging and engineered threats; provides interim fielding candidates early in development; and cost effectively brings antibody countermeasures from discovery to licensure and fielding.
The platform is currently being used to develop a botulinum toxin therapeutic and prophylactic medical countermeasure at the Advanced Development and Manufacturing facility.
AMP also emphasizes the importance of cooperation with other federal agencies and intra-agency partners. Partnerships are crucial to developing medical countermeasures. This integration not only ensures synchronization between government agencies through the product development, acquisition and procurement cycles, but also enables industry members to participate in this process across agencies.
In particular, the Departments of Defense and Health and Human Services — to include the Centers for Disease Control and Protection, the Biomedical Advance Research and Development Authority, and the Food and Drug Administration — synergize at many levels across the CBRN spectrum. This partnership facilitates medical countermeasure development across a wider range of threats than either agency could do alone. Collaboration and information sharing is facilitated through HHS’ public health emergency medical countermeasures enterprise, which coordinates federal efforts to enhance civilian medical countermeasure preparedness. It also leverages relationships with defense agencies to address the needs of military populations, especially where product development efforts are parallel.
Army Col. David P. Hammer, joint project manager for medical countermeasure systems said, “At MCS, we are leveraging a whole-of-government approach to combating CBRN threats that not only affect the warfighter, but also civilian populations. Our cooperation with other government agencies is paramount in developing effective medical countermeasures that protect our nation and save lives.”
In all, Hammer said, “We are redefining what it means to do business with the Department of Defense. The innovative tools at our disposal make it easier for industry members to partner with us and get medical countermeasures into the warfighter’s hand faster.” ND
Tim Belski is the joint product director for advanced development and manufacturing capabilities within JPO medical countermeasure systems at Fort Detrick, Maryland. Lt. Col. Matthew G. Clark is the joint product manager for JPO chemical defense pharmaceuticals. Hannah Feldman is a public affairs specialist. Nicole Kilgore, joint product lead for PRISM, also contributed to this article.