The strategy would identify the 50 most crucial medicines for life-saving treatment in the US, building on other, existing critical medicine lists. Furthermore, NIPTE intends to use artificial intelligence (AI) tools to optimize manufacturing routes for these drugs.
“AI-assisted retrosynthetic analysis and reaction databases can be used to create potential routes to each regulatory starting material (RSM),” Gurvich said. “Other tools will be expanded to predict impurities and identify separation procedures. In developing updated, advanced manufacturing processes, we can also build in efficiency and environmental and economic sustainability.”
Making manufacturing more efficient in this way, NIPTE said, could lower processing costs for generic drugs, which would play a central role in alleviating drug shortages (1).
With regard to a timeframe for implementing this strategy, the white paper said that development, scaling up, and transfer of each new formulation of each API and excipient of interest would take approximately six months, but that bioequivalence studies and stability testing would require additional time (2). The creation of a nonprofit corporation has been proposed to be the main program management entity that reports to the government, and a board created by the government and participating organizations.
References
1. NIPTE. NIPTE Announces Call to Achieve US Pharmaceutical Independence by Building On-Shore Capacity and Capabilities. Press Release. June 18, 2024.
2. Muzzio, F.J.; Gupton, B.F.; Ferri, J.K.; and Gurvich, V.J., “Overcoming Global Risk to the Pharmaceutical Supply Chain for the United States: Achieving Pharmaceutical Independence by Reshoring Manufacturing Capacity and Capability,” Whitepaper, June 18, 2024.
3. NIPTE. About—The National Institute for Pharmaceutical Technology and Education. NIPTE.org/about (accessed July 1, 2024).
