MediLedger's Blockchain Pilot to Assist Drug Supply Chain Stakeholders in Developing an Interoperable Track & Trace System for the US DSCSA Regulations Has Kicked Off
SAN FRANCISCO, June 18, 2019 /PRNewswire/ -- The MediLedger Project today announced the start of their participation in the U.S. Food and Drug Administration (FDA) Pilot Project Program for assisting drug supply chain stakeholders in developing an electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the United States. The focus of the MediLedger pilot will be on the Drug Supply Chain Security Act (DSCSA) requirements related to the interoperable, electronic tracing of products at the package level, which go into effect in 2023.
The MediLedger pilot's aim will be to explore and evaluate methods to enhance the safety and security of the drug supply chain by utilizing a blockchain-based solution which was built in earlier MediLedger Project work and whose conclusions were published in the MediLedger 2017 Progress Report. The prototype was a joint effort by pharma industry leaders Pfizer, Genentech, a member of the Roche Group, Amgen, Gilead, and the three largest pharmaceutical wholesalers in McKesson, AmerisourceBergen, and Cardinal Health. These companies have been joined in the pilot by FFF Enterprises, Dermira, Eli Lilly, Walgreens, and Walmart.
The total number of companies supporting the MediLedger effort is more than 20 and they represent a diverse set of industry stakeholders including large pharmaceutical manufacturers, virtual manufacturers, contract manufacturers, repackagers, wholesale distributors, third-party logistics companies, and major retail pharmacy chains.
Matt Sample, VP of Manufacturing Operations at AmerisourceBergen, commented, "The MediLedger pilot's strength is that it's a cross industry effort to explore the use of a blockchain network to enable the interoperability required by the Drug Supply Chain Security Act (DSCSA) requirements in 2023. The potential solution is especially viable because it's open to all participants in the Pharma industry. We've been working with Chronicled since 2017 on solving these industry challenges and we believe that there is potential to great improvements to the prescription drug supply chain."
The MediLedger pilot is coordinated by Chronicled, a San Francisco technology company who for more than four years has leveraged blockchain to power smart, secure supply chain solutions. Chronicled is helping the pharmaceutical industry to launch a permissioned blockchain network based on open standards and specifications. Nodes are distributed - operated by industry participants and technology providers who serve the industry. This is possible due to unique cryptographic constructs Chronicled has developed which solve data privacy challenges.
Talvis Love, SVP, CIO Pharmaceutical Segment at Cardinal Health, commented, "Cardinal Health is excited to partner with Chronicled. Blockchain provides an alternative to meet the 2023 interoperability requirements for the DSCSA. Specifically, the FDA pilot has the potential to extend the pharmaceutical blockchain business network to meet the requirements and enhance security of prescription drugs and patient safety."
Pablo Medina, Head of US Product Lifecycle and Protection, and Genentech echoed those comments about patient safety, "Further advancement in patient safety in the supply chain can only be achieved by strong cross-industry collaboration and a robust yet efficient technology solution. As founding members of the MediLedger Project, we believe that blockchain technology truly holds promise to further secure the distribution of pharmaceutical products and it is only through a common vision that we will be able to achieve it."
Scott Mooney, VP of Distribution Operations at McKesson, added, "Years ago, we saw an opportunity to build a more efficient system. And together with industry partners and peers, we are strategizing to develop solutions that build in greater efficiencies, effectiveness and safety into the supply chain – that will ultimately benefit the patient. This is just the beginning of the type of industry-altering impact new technologies like blockchain will have -- and we're proud to be a founding member of this initiative."
The MediLedger pilot will complete by the end of November 2019 and regular updates on the pilot's progress will be shared with industry stakeholders and posted on www.mediledger.com.
About Chronicled
Based in San Francisco, Chronicled is a software technology company leveraging blockchain to bring trust, efficiency, and automation to global supply chains. The company is developing solutions to enable decentralized blockchain networks that support multi-party supply chain ecosystems. The decentralized network architecture extends trust boundaries and enforces cross-organization business rules without revealing private and/or competitively sensitive data. The company is a founding member of Enterprise Ethereum Alliance, Trusted IoT Alliance, and Mobility Open Blockchain Initiative and has an active presence in Pharmaceuticals and Precious Metals and Minerals industries. See: http://www.chronicled.com and http://www.mediledger.com.
Contact: Eric Garvin, [email protected]
SOURCE The MediLedger Project
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