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Proof of concept provides pathway to address problem of substandard and falsified drugs

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Updated May 22, 2024
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    Over the last 10  months we’ve been busy working with our partners in the Lieberman Lab at the University of Notre Dame (UND) and their Distributed Pharmaceutical Analytical Laboratory group (DPAL) to develop a platform for conducting verification and reporting of drug APIs (active pharmaceutical ingredients) and safety.  Our goal has been to develop a proof of concept and confirm that it can be deployed at scale. During this project, we published a paper with our friends and colleagues at DPAL about this innovation. And we were also invited by the National Science Foundation to submit a proposal to America’s Seed Fund based on our results. Let’s take a deeper look into what all of this means.

    The current landscape

    When we began working with the Lieberman Lab and its DPAL network of international collaborators, we knew that they were tackling a big, global problem. This has only been made more clear as we delve further into it. An estimated 10% to 30% of essential medicines are substandard in developing regions, and this problem has been exacerbated as the effects of COVID and the war in Ukraine continue to be felt.

    Currently, a lot of time, effort, and resources are being directed at the physical tracking of products as they move through the supply chain . While this is useful – and important – monitoring of a pill’s journey from A to C via B, it doesn’t check the drug’s contents – specifically the active pharmaceutical ingredients (API). This is the critical gap we are addressing, through the combination of science and technology, by building a system that can be integrated at any and all points across the pharmaceutical supply chain. 

    We are supporting the scientific research our partners at UND and DPAL conduct by providing a platform for the extension of their work across many more medicines and nations. Through this work, we have confirmed unmet needs in the market for a service that uniquely combines science with technology to report trusted data on medicine quality and safety.

    Achievements so far and next steps

    In a short time, we’ve made huge leaps forward with our partners to improve drug verification and reporting. These include:

    • Applying rapid, iterative design-development-testing-feedback methodology to achieve impressive results enabling us to stand up a platform for live use within our ambitious timeframe.
    • Connecting participants engaged in collaborative and rigorous scientific workflow processes that span multiple laboratories, continents, and institutions including field labs, universities, and national public health regulatory authorities.   
    • Demonstrating success securing provenance and chain of custody of drug APIs necessary for proving the validity of scientific findings for use by regulatory authorities, and supply chain participants, and healthcare providers in rooting out substandard or falsified products from the marketplace. 

    Having demonstrated a successful proof of concept, our system is now being licensed and introduced for active use by the DPAL community. DPAL will expand its use further to report on a broader range of essential medicines, which include generics and biologics.

    Introducing ARTiFACTS Verify

    This pilot has not only proved our ability to move at scale and speed, but also confirmed a market need for a novel service which fills a significant gap in the supply chain infrastructure. We are delighted to announce our newest product, ARTiFACTS Verify – the drug verification SaaS platform. 

    Verify combines innovative application of scientific processes with technology to provide an information platform that delivers trusted and actionable data for identifying and reducing the prevalence of substandard or falsified drugs in the market. Verify will sit alongside our current offering for researchers, now known as ARTiFACTS File.

    Verify is relevant for those in your organization engaged in assuring supplies meet quality and therapeutic requirements. Verify can strengthen your safety programs wherever your teams are producing, distributing, or purchasing and administering prescription pharmaceuticals. To learn more about Verify and explore its value for you and your teams, please get in touch.

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