About
National needs, gaps and current landscape.
The United States faces significant challenges ensuring supply chain resiliency and redundancy for medicines, pharmaceuticals, and healthcare delivery. Drug shortages have been a significant national issue in the US since the 2010s, with hundreds of medications facing supply constraints annually. The COVID-19 pandemic further highlighted the vulnerability of the medical products supply chain. Difficult-to-manufacture drug products such as sterile injectables, including life-supporting oncology and antibiotic treatments, have been prevalent on drug shortage lists.
The United States heavily relies on China for most pharmaceutical Active Pharmaceutical Ingredients (APIs) and many generic finished drug products. This dependence poses significant risks to national security, public health, and economic stability. These concerns highlight the urgent need to enhance domestic production capabilities. The 2020 White House Executive Order 13944 provided strategic steps to enhance America’s capacity to make and supply critical medical products domestically. Among them is building resilient medical product supply chains that can “match supply and demand in both normal and emergency conditions” which requires agile manufacturing processes and flexible capacity with fast lot release.
In recognition of the potential of AI to advance pharmaceutical manufacturing technology and improve its reliability and robustness, the FDA issued a call in 2023 for public input on the issue of AI in drug manufacturing as a part of its Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative. The work by the Center for Drug Evaluation Research (CDER) identified current gaps and challenges for the use of AI in drug manufacturing, including a) the lack of high-quality, comprehensive and unbiased datasets that are crucial for training AI models; b) uncertainty about requirements on regulatory requirements and oversight for use of AI in current Good Manufacturing Practices (cGMP) manufacturing, including change control processes for continuously evolving models; and c) the need for highly specialized technical expertise to develop, implement, and maintain AI-based systems in drug manufacturing.
Critical infrastructure protection, workforce development, and the establishment of more equitable regional distribution networks are additional areas needing attention. The generic drug market's stability and the overall system's ability to maintain consistent supplies of essential, low-margin drugs remain ongoing challenges. While efforts are underway at various levels to address these issues, significant work that goes beyond the capacity of any single entity or industry remains to achieve a truly resilient and redundant pharmaceutical and healthcare supply chain in the United States.
Overview
The Advancing Medicines, Materials, and Pharmaceutical Supply Chain Resilience with AI (RAMP UP) Institute, led by Purdue University, brings together industry, academia, government, standards development organizations, and workforce partners to develop secure, trustworthy Artificial Intelligence (AI) solutions that enhance the resilience of essential medicine, vaccine, and diagnostic supply chains in the United States. Addressing critical national needs and gaps, RAMP UP unites pharmaceutical manufacturers with their Original Equipment Manufacturers (OEMs), material suppliers, tech industry leaders, and academic experts — for the first time together— to harness AI's potential.
The Institute aims to produce medicines at lower costs while comprehensively addressing energy, water, and waste management challenges. The RAMP UP Institute will enable creating and sharing data on medical product supply chains, manufacturing processes, and quality control, including for critical medicines and starting materials such as generic antibiotics from the FDA's List of Essential Medicines.
Mission and Core Partners
AMMPS.ai’s mission is to enable trustworthy AI in cGMP manufacturing, fortifying the resilience of US medical product manufacturing and supply chains. RAMP UP aims to bring transformational change that will fortify the resilience of the domestic medical product manufacturing and supply chains – a grand challenge that cannot be solved by one entity or industry. To connect the people, ideas, and technology that are needed to address this urgent national need, AMMPS.ai’s ecosystem network of core partners includes well-established industry, university, government, economic development, workforce partner organizations with significant capacity and experience delivering large-scale collaborative initiatives in the pharmaceutical, life sciences, and AI sectors. The core group includes the National Institute for Pharmaceutical Technology and Education (NIPTE), which is a non-profit organization that brings together 15 leading US universities in pharmaceutical research and education. NIPTE, founded in 2005, works with the FDA, industry, and other stakeholders to improve the design, development, and manufacturing of pharmaceutical products to meet the needs of patients in the 21st century. NIPTE has led major initiatives in the last two years to define strategy and prioritize actions toward securing the supply chain and onshoring critical medicines. NIPTE member universities span states with heavy concentrations of manufacturing jobs in the American Midwest, including the lead institution, Purdue University in the State of Indiana, which has the nation’s largest concentration of manufacturing employment. From this group, Purdue, Rutgers University, the University of Minnesota, and the Virginia Commonwealth University will host AMMPS.ai manufacturing testbeds. With a significant national footprint, AMMPS.ai also includes a distinguished cluster of leading universities and regional stakeholders focused on medical product manufacturing and the tech industry in the Pacific Northwest. Notably, Oregon has the largest concentration of manufacturing jobs in the US West Coast. Moreover, our core team includes Morgan State University, and US Pharmacopeia. AMMPS.ai will also build on the decade-long history of enabling advanced manufacturing innovations by LyoHUB, a university-industry consortium with 34 active members across the value chain of pharmaceuticals. The enclosed letters present broad interest from diverse stakeholders of the proposed ecosystem. AMMPS.ai will catalyze unique collaborations across a set of communities that will offer crucial solutions in AI-based medicine supply.
Impact
Accelerating drug development and streamlining regulatory approvals will bring new medicines, including generics, to market faster and reduce healthcare costs. AI-powered optimization of production processes will reduce machine downtime and minimize waste resulting in significantly lower prescription drug costs. AI can bolster regulatory review and compliance, ensuring pharmaceutical products meet the highest standards of safety and efficacy. RAMP UP’s collaborative ecosystem network and open-access AI driven approach will secure a stable supply of critical medicines, preparing the nation for future health crises and enhancing economic resilience. Collectively, these advancements contribute to improved public health outcomes and foster greater confidence in our healthcare systems. By harnessing AI's potential, we can create a more efficient, responsive, and trustworthy healthcare ecosystem that benefits all Americans, making vital treatments more accessible and affordable. Moreover, the combined benefits of job creation, increased self-sufficiency, improved productivity, and potential for innovation make this an important avenue for strengthening U.S. economic competitiveness in the 21st century, in alignment with the mission and vision of NIST’s Manufacturing USA Institute on Artificial Intelligence for Resilient Manufacturing and its cohort of institutes.