Notre Dame lab partners with Artifacts to halt substandard generics

By Jenni Spinner contact

- Last updated on GMT

(FTiare/iStock via Getty Images Plus)
(FTiare/iStock via Getty Images Plus)

Related tags: Counterfeit drugs, Counterfeit medicines, Supply chain, Blockchain

The Distributed Pharmaceutical Analysis Lab and the blockchain-based platform provider will work to prevent fake and low-quality drugs from circulating.

Artifacts, creator of a blockchain-based platform for scientific research, has announced a partnership with the University of Notre Dame’s Distributed Pharmaceutical Analysis Lab (DPAL). The collaborators plan to develop a prototype solution for tracking drug chain-of-custody information in real-time, via distributed ledger technology; the entities will record physical handling and research metadata, starting from point-of-purchase prescription drugs.

According to the World Health Organization (WHO), about one in 10 medical products distributed within low- and middle-income nations are either substandard or fake. Estimates place monetary losses at up to $200b USD; more tragic is the loss of lives—about 200,000 deaths occur annually in Africa to counterfeit antimalarial drugs alone.

Most existing efforts to curtain fraud along the pharma supply chain lean heavily on manual effort, lack transparency, and offer no robust chain-of-custody element. The Artifacts-developed prototype, aligned with the DPAL use case, reportedly will provide a more effective transcript of all critical information; underlying data is to be housed in a blockchain-based ledger for stakeholders along the supply chain to turn to.

Current efforts to reduce fraud in the global pharmaceutical supply chain are heavily reliant on time-consuming manual effort and lack transparency, with no robust chain-of-custody. ARTiFACTS is developing a prototype aligned with the DPAL use case that will provide an immutable and trusted transcript of all critical "Who-What-Where" information about each compound. Underlying data will be housed permanently in an immutable, blockchain-based ledger of record for use by researchers, public health and regulatory authorities, and organizations in the manufacturing and distribution supply chain.

According to the collaborators, the partnership will seek to:

  • Make all relevant information available online to researchers and regulators
  • Create a trusted, secure chain-of-custody of drug samples and their metadata
  • Scale-up across the DPAL participant community
  • Deliver findings that contribute to improved health outcomes.

"Artifacts is an ideal partner for our use case because they bring expertise in designing systems for managing workflow and securing the provenance of research materials​, " said Marya Lieberman, University of Notre Dame professor. "The DPAL project has pioneered innovative and low-cost ways of bringing analytical chemistry out of the lab and into the world​."

Lieberman added, “Working with our network of collaborating organizations, DPAL has made significant inroads by conducting post-market surveillance of drugs in local markets where the risks of substandard and falsified products are the greatest. Partnering with ARTiFACTS, we will demonstrate our ability to increase the frequency of product testing with full transparency of the drug sample history, both of which are necessary to conduct this work at scale and impact the quality of drugs.​”

David Kochalko, CEO and co-founder of Artifacts, said the partnership will help increase safety and offer stakeholders greater power.

By providing a secure and immutable chain-of-custody of metadata about participants, tasks, location and analysis results, regulatory authorities will be empowered to effect meaningful improvements in the drug supply chains serving their constituents​,” Kolchalko said. “Success with this prototype will position DPAL and Artifacts to pursue development of a commercial-scale system to expand coverage of drugs, countries, and regions globally​.”

Led by Lieberman in the Department of Chemistry and Biochemistry at the University of Notre Dame, the DPAL project seeks to understand, innovate and impact the quality of public health in low and middle-income countries by increasing analytical resources for detecting poor-quality pharmaceutical products.

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