FAIL FORWARD AND PIVOT
can advance vaccine development at the speed of relevance through partnerships with government agencies and perform- ers with a record of proven performance.
THE NEED ARISES As the COVID-19 pandemic unfolded, a program management team at JPM CBRN Medical, a component of the Joint Program Executive Office for Chem- ical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), focused on the development and acquisition of medical solutions to combat CBRN threats, took note of the criticality of rapidly manufac- tured vaccines in battling the pandemic, and the distinctive value emergency use authorizations provide in an emergency situation. Te program management team forecasted that this invigorated require- ment for rapid advancement of vaccines in times of acute need was applicable to DOD in rapidly pivoting biological defenses for the warfighter and the nation in response to emerging and novel threats.
A team of program managers, scientists, lawyers and contracting officers set in motion a flexible contracting strategy that could accept funding and move quickly to support development of new vaccines. Additionally, the team utilized its estab- lished partnership with the Office of the Deputy Assistant Secretary of Defense for Chemical and Biological Defense to begin messaging essential investment and identification of enhanced biodefense and pandemic preparedness funds.
When JPM CBRN medical leaders returned to their DOD roles after details to positions with Operation Warp Speed and other critical COVID-19 responses, they brought with them the lessons learned from their front row seats to the twists and turns of the pandemic and our nation’s public health response. Such
lessons came on the heels of shepherd- ing several medical countermeasures into pivotal Phase III clinical trials and ulti- mately, emergency use authorizations at a never-before-seen pace.
Te question was, could DOD build off this experience to similarly address prior- ity threats to the warfighter? Supporting vaccine development toward FDA licen- sure can be a long process, but the response to COVID-19 rebuked this narrative. Te pandemic revealed that full FDA licensure is not necessary to get shots in arms when circumstances permit. If success hinged on emergency use authorizations rather than full licensure, how rapidly could DOD move?
To accelerate advanced research to the necessary pace, the development of part- nerships with other government agencies was indispensable, as demonstrated by the relationships built during Operation Warp Speed and previous interagency coordination. JPEO-CBRND contin- ues to strengthen its relationship with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), and with other DOD agencies, such as the Defense Innovation Unit.
As an interagency partner, BARDA contributes both funding and technical expertise to the VAMP program. Collabo- rating with BARDA allows the program to tap into a vast array of experts in vaccine design, manufacturing, testing and regu- latory navigation, all of which are essential to maintaining an efficient program. A new partnership with the Defense Innovation Unit, which will leverage its accelerated contracting process, will allow VAMP to rapidly seek out and contract innovative biotechnology companies to provide cutting-edge medical capabilities.
VAMP FOUNDATIONS Moving at an accelerated pace and main- taining the latitude to address emerging biological threats requires an acquisi- tion approach that values nontraditional defense contractors with significant exper- tise in vaccine manufacturing. It also requires the development of system-of- systems technologies that move beyond the “one-bug-one-drug” dogma, the incor- poration of a mechanism to consistently review progress, and be ready and will- ing to end efforts that underperform and easily pivot to the next candidate in line.
Tese pillars underpin the VAMP program and its use of the other transaction author- ity for prototype projects to enter into agreements with nontraditional defense contractors for rapid vaccine development.
Other transaction authority has provided a consistent capability to provide basic, applied and advanced research for decades. Although originally required to be directly relevant to weapons or weapon systems, other transaction authority agreements for prototype development can now be created for any effort directly relevant to enhanc- ing the mission effectiveness of military personnel and the support or improve- ment of platforms, systems, components or materials. Vaccines are a prime exam- ple of meeting this need by developing vaccines toward lethal pathogens that lack medical countermeasures and are largely unmitigated risks to warfighter readi- ness and effectiveness. Tese vaccines are intended to provide an additional layer of protective defense, regardless of natural or intentional threat exposure, augmenting the warfighter’s biological armor against such threats.
PLATFORM DEVELOPMENT Lessons learned from Operation Warp Speed continued to influence the VAMP
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Army AL&T Magazine
Fall 2023
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