The COVID-19 pandemic demonstrated the need to alter how the DoD conducts research, development and acquisition of medical countermeasure and test products. COVID-19 was not on any threat list, yet it impacted Homeland defense, the Joint Force, and the DOD’s ability to project and generate power. The Chemical and Biological Defense Program (CBDP) cannot simply rely on a discrete list of known biological and chemical agents to better prepare the Joint Force against future and unknown threats. Instead, it must focus on removing or reducing the impact of agents’ effects on the Joint Force by developing MCM products and establishing capabilities for use against any potential threat. This paradigm shift requires CBDP investments in activities across the medical threat preparedness and responses spectrum.
The Department of Defense is modernizing its approach for developing medical countermeasures to protect warfighters from novel biological agents.
This is made clear in a new document, “Approach for Research, Development and Acquisition of Medical Countermeasures and Test Products,” which was recently published by the Office of the Deputy Assistant Secretary of Defense for Chemical and Biological Defense. This office oversees the Department of Defense’s Chemical and Biological Defense Program. The CBDP’s mission is to anticipate future threats and deliver capabilities that enable the Joint Force to fight and win in CB-contested environments.
The CBDP has always prioritized medical countermeasures, which consist of vaccines, medical tests and drugs. “No matter how good our boots, suits, gloves and masks perform, there’s always going to be the risk that our warfighters don’t necessarily have their equipment on when they need it. So having medical countermeasures as an added layer for protection makes sense,” Dr. Kevin Wingerd, CBDP’s medical director, said.
What has changed is the nature of the threat.
“The convergence of different sciences and technologies is transforming the biological threat landscape,” Wingerd said. “In particular, it has created a nearly limitless number of potential threats we must defend against.”
This contrasts to the past, when DOD developed medical countermeasures against a defined list of specific threats, typically ones adversaries had already weaponized. But this “one bug, one drug” approach isn’t viable in the face of the exponentially larger number of potential threats, including novel ones.
Nor is the Department solely focused on deliberate biological threats. In his Biodefense Vision Memo published in November 2021, Secretary of Defense Lloyd J. Austin III directed the Department to be postured against agents that are naturally occurring as well as those that may have been released accidentally, alongside traditional deliberate ones. The new medical countermeasures approach provides a roadmap to address this more challenging problem set.
Nonspecific medical countermeasures are broad-spectrum acting and are designed to target a set of similar agents, diseases or symptoms. Nonspecific medical countermeasures are particularly vital for novel agents that have no medical countermeasures. Administrating nonspecific medical countermeasures could alleviate symptoms, slow down disease progression and reduce transmission of the agent, allowing troops to remain in the battle with little impairment. While the agent may be suppressed for a given period, a medical countermeasure that targets and eliminates the novel agent is still required.
As Wingerd puts it, “Using nonspecific medical countermeasures allows the agent’s effects to be mitigated and the warfighter to remain operational and combat ready, while simultaneously allowing for rapid development of specific medical countermeasures that can be used to completely get rid of the agent and protect incoming warfighters.”
To rapidly develop narrow-spectrum medical countermeasures, the CBDP will leverage cutting edge technology including artificial intelligence and machine learning and establish partnerships with known pharmaceutical manufacturers. The CBDP considers manufacturing capacity a strategic challenge, which the new approach addresses as a goal.
“In a response preparedness posture, we need to invest in unique medical infrastructure designed to rapidly produce new vaccines and drugs, and leverage existing medical infrastructure by adapting them to target new agents quickly,” Wingerd explained.
“What COVID has certainly taught us is that if that industrial base isn’t present, it doesn’t matter how good your ideas are, they’re just not going to go anywhere,” he added, mentioning that partnerships with the interagency, academia and U.S. allies and partners are also critical.
Besides the U.S. Food and Drug Administration, which is the regulating agency for medical countermeasures, Wingerd mentioned the Biomedical Advanced Research and Development Authority (BARDA) and the White House Office of Science and Technology Policy as key CBDP interagency partners. Pointing to the recently updated National Biodefense Strategy, Wingerd said, “This effort is really a whole of government approach, and the CBDP’s new approach aligns with and supports the NBS.”
He added that he expects new advances in medical countermeasures to bear fruit beginning as early as next year, with more to follow.
Approach for Research, Development, and Acquisition of Medical Countermeasure and Test Products. Chemical and Biological Defense Program, 2022.
Medical Countermeasure Research, Development and Acquisition (RDA) Goals
Goal 1: Characterize Threat Agents to Support Broad and Narrow Spectrum Products and Capabilities
- Invest in studies that generate data and information that can support and increase the speed of MCM product development
- Expand medical-focused threat-agent, disease, and host characterization studies
- Develop appropriate animal models or novel alternatives to support New Drug Application (NDA) and Biologics License Application (BLA) submissions, including label expansion
- Expand agent mechanism of action studies
- Establish an adaptable process that allows for testing of existing MCMs against threats as well as drive the development of novel MCMs
Goal 2: Deliver Broad-Spectrum Prophylactic, Therapeutic, and Testing Medical Products
- Invest in non-specific MCM prophylactics and therapeutics
- Initiate programs focused on strengthening the host immune system through enhancement or stimulation
- Develop broad-spectrum MCM products designed to target several threats
- Develop MCM products that limit or contain agents’ effects such as disease progression, transmission, or symptoms
- Invest in non-specific tests that can be used at the point-of-need
- Develop tests targeting host biomarkers
- Develop tests that inform of agents’ effects such as identifying, discriminating, predicting, or informing on onset of disease or disease severity, asymptomatic vs symptomatic, and contagiousness
Goal 3: Deliver Narrow-Spectrum Prophylactic, Therapeutic, and Testing Medical Products
- Invest in activities that generate data and information or that establish processes to support and increase the speed of specific MCM and test product development
- Establish capabilities that inform the selection and repurposing of MCM and test products for use at lower roles of care
- Establish teaming agreements that allow for transfer of MCM and test prototypes, data, or information to commercial companies for further development and manufacturing
- Establish a sustainable process that allows pre-positioning of MCM and test prototypes for further development or use under informed consent
- Invest in specific MCM and test products that target the causative agent
- Establish capabilities that allow for development of MCM and test product prototypes on existing commercial company platforms, or in a form factor readily available for transfer to commercial entities for further development and manufacturing
- Establish capabilities that allow for the storage of MCM and test product prototypes for an indefinite period and will be readily accessible for further development to a usable MCM or test product by a commercial entity in an operationally relevant timeframe
Goal 4: Establish Sustainable, Scalable, and Resilient Public-Private Partnerships for the Access and Acquisition of Medical Countermeasure and Test Products
- Leverage industrial policy to promote the US biotechnology and biopharmaceutical industrial base as preferred performers for CBDP
- Develop contractual relationships with experienced key commercial partners for the development of new and existing products at a rate that ensures continued operation of the desired capability (e.g., 10-30% of annual capacity)
- Leverage interagency partners to mutually support United States Government objectives
- Establish key public-private partnerships with sustainable commercial performers whose manufacturing structure is solvent, have a record of successfully delivering MCM and test products, and can manufacture biodefense products
- Use contractual language to establish rapid surge capabilities beyond current demand for existing and new MCM and test products
- Consider and prioritize supply chain and on-shore production of CBDP MCMs and expand the industrial base for key starting materials (including raw materials, intermediates, reagents, active pharmaceutical ingredients, primary packaging materials for MCM substance, etc.) and finished products to the maximum extent possible
- Design scalability into development plans, when feasible, to rapidly respond to increased demand (horizontal scale-up when possible to keep steady-state production for CBDP products in production throughout the year)
- Leverage contracting authorities to establish priority of access for the production of CBDP products
Article adapted from original by David Vergun, DoD News
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