Mitigation of US Pharma Supply Chain Risk is Goal of New NIPTE Strategy

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The National Institute for Pharmaceutical Technology and Education (NIPTE), a nonprofit organization that partners with 17 universities in the United States along with other institutions in and outside of academia, has released a strategy to reduce risks to the US pharmaceutical supply chain, in a white paper and press release issued June 18, 2024 (1–3).

The white paper, “Overcoming Global Risk to the Pharmaceutical Supply Chain for the United States: Achieving Pharmaceutical Independence by Reshoring Manufacturing Capacity and Capability,” was co-authored by Vadim J. Gurvich, NIPTE executive director and a professor at the University of Minnesota, and professors Fernando J. Muzzio of Rutgers University and B. Frank Gupton and James K. Ferri of Virginia Commonwealth University (2).

"We are issuing a call to action to refine the identified priorities and begin to work towards implementation," Gurvich said in the press release. "The time to act is now."

In summary, the authors say that because the United States relies on imports from overseas, primarily China, for the majority of APIs for the manufacture of drug products of crucial importance to US patients, there is a need to find new “synthetic pathways” for APIs as well as excipients, using “chemical building blocks” manufactured in the US or countries which are close allies (1).

"If a major disruption of international commerce prevented the US from importing APIs and finished pharmaceutical products, the impact could be catastrophic," Gurvich said. "We currently lack much of the industrial capacity needed to replace API imports. We need to find consensus and begin to implement a plan."

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).