Proof-of-Concept Pilots: TEAM DEMOS


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Overview: The Blue Team developed a distributed platform to be *owned and operated by industry* (including trade partners and service providers) to demonstrate its ability to meet all track & trace requirements, as well as be a platform for future business process innovation. It covers all movements of the drug up to the point where it is removed from the manufacturer’s packaging/ unique identifier, and its design is based on the initial commissioning, then change-of-ownership, of those identifiers. Pilot demonstrates how the industry can use the blockchain to 1) execute salable returns verification, 2) meet the interoperable 2023 system requirements, and 3) block/eliminate counterfeits.  

* Full overview document
* Presentation slides


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Overview: This pilotdemonstrates how digital ledger technology is complimentary to existing track & trace solutions. It demonstrates a blockchain-based, end-to-end tracking solution (from manufacturer to patient) that can be used to easily transfer data from one party to another, improve operational efficiency, and create a positive impact on patient outcomes. The Team demonstrates a fully viable 2023 interoperable solution that meets the regulatory requirements of DSCSA and beyond.  Pilot will demo interoperability, saleable returns, drug recall, supply chain integrity, and borrow & loan. 

* Full overview document
* Presentation slides


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Overview: Systech and RxTransparent represent both ends of pharma supply chain manufacturers and dispensers, respectively. With their unique industry insights and perspectives, they came together as a team to build a pilot platform that demonstrates blockchain as a viable solution for compliance with upcoming DSCSA interoperability system requirements. The presentation is designed for a broad audience of stakeholders across the entire life sciences and healthcare spectrum including manufacturers, wholesalers, dispensers, regulators and logistics providers.

* Full overview document
* Presentation slides


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Overview: This pilot proposes how a secure open source storage system housing encrypted and non-encrypted data can be used in conjunction with blockchain and other distributed ledger technologies to meet the data exchange requirements of both the DSCSA and the industry at large. This open-source, blockchain-validated solution is focused on interoperability and scalability in heterogeneous trading partner environments. It is designed to allow partners to securely store, validate, and exchange product tracing information and is intended to be complimentary to existing track & trace solutions. Additionally, it optionally leverages the superior security of public blockchains at scale for data integrity validation. 

* Full overview document
* Presentation slides


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Overview: The team has designed an enterprise-wide blockchain solution for asset traceability and data transparency that allows unrelated parties to have end-to-end visibility across the value chain regarding transfer of ownership, business events and transactions. Participants can share pertinent business information via a distributed system, allowing them to share cryptographically assured data across a secure supply chain network. Business logic will be applied and implemented via chain codes (Smart Contracts) and combined with analytics to dashboard the asset information. Utilizing the “product-centric” ReferenceModel #3 developed in “DSCSA & Blockchain Phase 1” Study, the team employs an Oracle BCS-based blockchain infrastructure to augment existing business systems. 

* Full overview document
* Presentation slides


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Overview: This PoC demonstrates how an immutable chain of custody and granularity of ownership can reshape logistics, and shows current advances enabled by FDA led GS1 GTIN and PI labeled unique identification and demonstrate full ‘creation to end use’ traceability through all parties in the supply and use network. Team analyzed current real usage of FDA Regulated GS1 GTIN + PI uniquely labeled traceability and how full traceability is already being used for more than just FDA compliance. Real examples then illustrate why a distributed ledger and blockchain are necessary and suitable as part of a traceability solution for the pharma industry.

* Full overview document
* Presentation slides (to come)