Strategic Goal 3

The public health supply chain is a multifaceted, dynamic, and interdependent system that produces and delivers critical public health supplies, including PPE, diagnostics, and other medical devices; as well as pharmaceuticals – therapeutics, biologics, and vaccines. To identify vulnerabilities, anticipate challenges, and prevent or mitigate disruptions, the U.S. Government should strengthen its industry partnerships to gain more insight and visibility into this complex system.

Robust, streamlined, and real-time information and data sharing between the U.S. Government and industry enables increased visibility into the public health supply chain. This can lead to better coordination between the public and private sectors when challenges occur. Greater visibility can also inform where additional capacity and capability investments may be needed, stockpiling requirements – including distribution needs during public health emergencies and disasters – and effective strategies to build resilience. The U.S. Government can leverage existing stakeholder engagement mechanisms across the interagency to strengthen its industry partnerships. There is also opportunity to expand the programs and tools developed during the COVID-19 pandemic to increase communication with industry and transparency into all components of the public health supply chain.

Newly emerging threats without existing diagnostics and treatments will require rapid MCM research and development pipelines. MCM development for unknown threats is a challenge in the United States and globally. MCM preparedness involves rapid development of standards and clinical research response to ensure that the candidate vaccines, therapeutics, and diagnostics are both safe and effective for all populations, including at-risk individuals. This requires standing global and domestic clinical research capacities in the form of integrated networks capable of rapidly pivoting to regulatory-level clinical trials. Sustained public and private funding for basic, translational, and clinical research to develop innovative technology is crucial to building MCM pipelines that are commercially viable and can be easily adapted to combat and mitigate an emerging infectious disease or unknown threat.

Stronger partnerships between research institutions, government, academia, private industry, and community-based philanthropies, along with innovative, adaptable, and scalable MCM development technologies, can facilitate rapid development of new MCMs to combat emerging threats. Promoting the development of innovative technologies and streamlining manufacturing processes can create more agile MCM pipelines that can scale up production quickly. Investing in MCMs that have other commercial applications can enable manufacturers to quickly repurpose existing products and pivot research and development to combat a new or emerging threat. In addition, producing safe and effective MCMs while improving regulatory capacity will further advance and modernize the MCM development process.

AMR is one of the major threats to the health care, veterinary, and agriculture sectors, and remains a concern as antibiotics are overprescribed and misused globally, fueling the evolution of resistant pathogens. Fewer new antibiotics are getting to market due to a lack of financial incentives, new economic models to incentivize antibiotic development and product approval are required. Many infectious diseases are becoming more difficult and expensive to treat as antibiotics become less effective.

Adopting strong antibiotic stewardship strategies and increasing the development of new treatment courses can combat the threat of drug-resistant organisms. Health care, public health, and private industry delivering collaborative communication and education on responsible antibiotic use can improve infection prevention and control. Increased research and development of new antibiotics, novel combination therapies, and new rapid diagnostics to detect AMR bacteria in clinical settings are vital to addressing the AMR threat. These strategies will require collaboration with the private industry to ensure a sustainable antibiotic market and sufficient quality of and access to treatments for everyone in need.