Biological incidents possess an alarming ability to wreak havoc on a massive scale, capable of rapidly escalating beyond the scale seen during COVID-19. The need lies in developing solutions that surpass the speed of these threats. Our warfighters need to swiftly defend themselves against a biological threat, or better yet, prevent it entirely, to ensure they remain operationally ready to carry out their mission. The COVID-19 pandemic is the perfect example of how a biological incident can start off small and swiftly snowball into unprecedented crisis levels.
The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), on behalf of the Defense Department (DOD), partnered with the Department of Health and Human Services (HHS) to support the national response to the COVID-19 public health emergency. Though its role in the pandemic response will fully transition to HHS this fall, JPEO-CBRND implemented lessons learned to update its approach to tackling emerging threats. This dynamic strategy underscores the principles of rapid response, integrated layered defense and partnerships to protect military personnel from CBRN threats.
In the 2022 National Biodefense Strategy, the White House outlined the importance of staying ready for any biological incident through investing in capabilities such as manufacturing, developing prototypes, analyzing existing data that could be useful in developing future countermeasures and standardizing clinical trials. Collectively, these goals will enable future response efforts to move faster at lower cost.
The future of biodefense depends on the ability to rapidly respond to an event by quickly developing and distributing medical countermeasures (MCMs), such as vaccines and therapeutics. This includes optimizing manufacturing techniques and establishing robust partnerships to ensure these MCMs can be quickly and effectively deployed in the event of a threat.
JPEO-CBRND’s Joint Project Lead for CBRN Defense Enabling Biotechnologies (JPL CBRND EB) has led a significant investment in platform technologies and programs to improve preparedness for future threats. Platform technology refers to the use of standardized processes and tools to rapidly develop and manufacture MCMs in response to a threat. This approach is like setting up an assembly line that can be turned on when needed, rather than building the line from scratch each time a product is required. The goal is to have the ability to quickly develop and manufacture MCMs in response to a threat.
In addition to the use of platform technologies, another practice to ensure rapid development of MCMs is to quickly pivot from a prototype to a product that can be distributed in compliance with U.S. Food and Drug Administration (FDA) regulations for emergency use. This puts safe and effective medicines and drugs into the hands of warfighters faster, leveraging processes such as emergency use authorization (EUA) on the path to full FDA licensure, since the licensure process can take nearly decades for countermeasures to be available.
“This dynamic approach allowed us to get vaccines out the door quickly, because we have already completed a lot of the upfront work,” said Bruce Goodwin, Joint Project Lead for JPL CBRND EB. “We are deliberatively looking for stepping stones along the FDA licensure path, positioning safe and effective products so they are safe enough for our warfighters and the medical community to respond quickly to a demand signal.”
Partnerships are another key to a strong biodefense approach. Collaborating across disciplines and with industry was critical to the COVID-19 response and will continue to be important to push other biological threat solutions forward. In addition to HHS, JPEO-CBRND worked with organizations such as the Defense Contract Management Agency, Army Contracting Command, U.S. Agency for International Development and Army Corps of Engineers, and supported Operation Warp Speed during the COVID-19 response. These diverse partnerships helped the organization understand the options available to move solutions forward, brought different minds to the table and helped the program find a way to say, “yes,” quickly.
“One of our leaders during the response would tell us repeatedly that ‘every day counts.’ At the time, we thought he was trying to inspire. In retrospect, he was absolutely and literally correct. Not only every day, but every hour counts in a response. Issues like ‘wrong type of funding’ and ‘delayed contract modifications’ are antithetical to rapid response,” said Dr. Chris Earnhart, Chief Technology Officer for JPL CBRND EB.
Platforms and strong partnerships are two key enablers to a rapid response. JPEO-CBRND has several programs underway to support speed and agility in medical countermeasure development. These programs take a proactive approach through constantly examining possible solutions for potential incidents, rather than simply waiting for something to happen first. Moreover, these programs leverage readily available data and materials, maximizing their efficiency and effectiveness.
“Our medical strategy is a direct output of our COVID-19 response,” said Nicole Kilgore, Deputy Joint Program Executive Officer for CBRND. “One of our biggest lessons learned is we can’t wait for perfect to act. We need to approach these efforts by working activities in parallel and accepting risk as we work our way through testing potential courses of action. This is why our Medical Strategy relies on flexible contracting, innovative approaches, and proven platforms to get our Joint Force safe solutions quickly.”
“Programs that allow us to actively modernize biodefense such as Rapid Acquisition and Investigation of Drugs for Repurposing (RAIDR) is already underway within our Joint Project Manager for CBRN Medical. RAIDR finds additional uses for approved and safe drugs that are currently not being used. So, we take a second look at those proven-safe medical countermeasures and see whether they can help us respond quickly to the ever-changing threat landscape,” said Kilgore.
Another program managed by the Joint Project Manager for CBRN Medical is the Vaccine Acceleration by Modular Progression (VAMP) Enhanced Biodefense program, which brings together interagency, industry and academia to design and construct vaccine prototypes and evaluate them in clinical and non-clinical studies.
Within JPL CBRND EB’s program portfolio are two additional biodefense efforts. The Generative Unconstrained Intelligent Drug Engineering (GUIDE) program is a robust suite of computational tools that enable rapid countermeasure development using information gleaned from subject matter expert knowledge, databases, artificial intelligence/machine learning tools, and infrastructure for efficient development of potential MCMs. Rapid Access to Products in Development (RAPID) is another new program, which provides a broad library of MCMs ready for emergency fielding in a potential CBRN incident.
“As we face an uncertain future, the lessons learned from COVID-19 will undoubtedly shape our approach to biodefense. With a strong and coordinated response, we can be prepared for any biological threat that may come our way. The importance of speed cannot be overstated, and we must continue to work together to protect the men and women of the Joint Force and the public,” said Kilgore.
The DOD is currently underway with a review of the Nation’s current and future bio-preparedness posture and working to create tools and capabilities to mitigate emerging threats. The work the JPEO-CBRND has done to respond to and mitigate COVID-19 has ensured a more stable supply chain and a ready industrial base, laying the foundation for future readiness.