ARMI | BioFabUSA Roadmap Reports

The Essential Medicines Supply Chain and Manufacturing Resilience Assessment, BioFabUSA Technical Roadmap, Roadmap for BioFabUSA Education and Workforce Development and National Technology Roadmap for Pandemic Response and Recovery are available below.

Essential Medicines Supply Chain and Manufacturing Resilience Assessment

Led by the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response and ARMI’s Next Foundry for American Biotechnology (NextFAB), the Essential Medicines Supply Chain and Manufacturing Resilience Assessment report outlines the supply chain vulnerabilities – specifically those affecting critical medicines on the FDA’s Essential Medicines List.

Technical Roadmap

The ARMI | BioFabUSA 2020 Technical Roadmap report outlines and describes a consensus-based list of technology development tasks aimed at achieving the vision for scalable, consistent, and cost-effective manufacturing of cells, tissues and organs. 

Roadmap for BioFabUSA Education and Workforce Development

The Education Workforce and Development roadmap identifies highly needed skills for the biofabrication field. The workforce needs skills that reflect the integrated nature of the industry, where technology bridges cell biology, engineering, automation, regulatory and data analytics.

National Technology Roadmap for Pandemic Response and Recovery

The manufacturing sector is at the center of a stronger, faster and more coordinated U.S. response to COVID-19 and future pandemics. The National Technology Roadmap for Pandemic Response and Recovery—the first pandemic roadmap driven by the manufacturing sector—outlines a technology-based action plan for strengthening and accelerating U.S. pandemic response and preparedness. 

This roadmap informs industry, non-profit and government organizations on:

  • How the United States can ensure longevity through intentional regulatory and deployment frameworks
  • Optimized predictive capabilities
  • Stronger data infrastructure for manufacturing and supply chain networks, which drives down response time on everything from personal protective equipment and medical workforce to vaccine development and delivery.
 

Funding for this project was provided by the Department of Commerce’s National Institute of Standards and Technology (NIST) through a CARES Act grant. ARMI | BioFabUSA partnered with Nexight Group on this project. The technical roadmap resulting from this initiative has been developed to guide a wide variety of stakeholders on the technologies, platforms, and infrastructure needed to accelerate their response and recovery to COVID-19 and future pandemics.

Using lessons learned from COVID-19 as we begin the recovery, the roadmap outlines how such an improved response can be achieved through investment in technologies, platforms and infrastructure improvements in six key technical focus areas:

Supply Chains — to ensure access to all raw materials and components needed for manufacturing

Manufacturing — to rapidly and flexibly meet demands for PPE, medical devices, therapeutics and vaccines 

Deployment and Access — to ensure products and support are available when and where they are needed most

Data Infrastructure — to help inform public health response decisions

Predictive Capabilities — to enhance early detection and tracing, prediction of new outbreaks, prediction of prognosis, drug development and vaccine design

Regulatory Processes — to facilitate the accelerated approval of safe and effective medical products critical to pandemic response

For each area, the roadmap recommends specific technology development and commercialization efforts that can be implemented immediately to respond to COVID-19, as well as longer-term research and development priorities needed to improve readiness for future pandemics. 

To develop this national initiative, ARMI | BioFabUSA drew upon input from more than 75 multidisciplinary experts and senior leaders from the frontlines of pandemic response, representing academia, government, manufacturers, healthcare, supply chain, data infrastructure, biosecurity, professional societies  and consortia.