In October 2023, Marta Wosińska and Rena Conti concluded a one-year pilot demonstration of how analytics can inform national technology strategy in biopharmaceuticals. Their demonstration was part of a large, cross-industry pilot titled the National Network for Critical Technology Assessment. Funded by the National Science Foundation’s Technology Innovation and Partnerships (TIP) Directorate under the CHIPS Act, this pilot set out to identify and evaluate societal, national, and geostrategic challenges facing the United States and investments in key technologies that could help address those challenges.
Within this framework, Wosińska and Conti set out to identify how the federal government can leverage advanced manufacturing technologies (AMTs) to support greater generic drug supply chain resilience. AMT is often cited by FDA and outside experts as a potential solution to shortages by offering better and more consistent quality, more flexible supply that can scale up, and reduced lead times between identified need and production at scale. Yet generics manufacturers, where supply chain vulnerabilities are the greatest, are also least likely to explore adoption of AMT because of lack of economic incentives to do so.
As part of their work on federal government policies to improve drug supply chain resilience, Wosińska and Conti set out to identify which drug supply chains should be prioritized and, among those, which are amenable to AMT-based improvements in manufacturing. Their empirical work, coupled with expert interviews, suggests prioritizing focus on prescription drugs that are high volume, with sustained demand, and include generic drugs with complex manufacturing requirements, such as sterile injectables, antibacterials, antivirals, and drugs with a narrow therapeutic index (NTI) which require greater precision in formulation.
The full report, spanning demonstrations in global competitiveness, artificial intelligence, semiconductors, energy and critical minerals, and biopharmaceuticals can be found here.
The framework for prioritizing drug supply chains that was developed as part of the one-year pilot was separately published in Health Affairs Forefront.
Acknowledgements and disclosures
This research was supported by grants from the National Science Foundation and the Sloan Foundation. Conti has also received grant funding from the National Cancer Institute, the Leukemia and Lymphoma Society, Arnold Ventures, the U.S. Veterans Affairs Department, and the National Institute of Drug Abuse, as well as consulting fees from Greylock McKinnon Associates and Keystone Consulting. Other than the aforementioned, the authors did not receive financial support from any firm or person for this article or from any firm or person with a financial or political interest in this article. The authors are not currently an officer, director, or board member of any organization with a financial or political interest in this article.
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