Issue link: https://www.e-digitaleditions.com/i/1244583
Tablets & Capsules May 2020 9 scenario without interrupting the system's operational performance when a seller sells a molecule to a buyer. Multi-party business process automation. A foun- dational use of the network is as a shared source of truth between transacting parties in a business process for the purpose of automation, operational intelligence, and model innovation. A decentralized business process for sending and responding to drug verification requests means that hundreds of companies can participate in a mostly closed- loop process that upgrades trust and security in the supply chain in an automated and efficient format. Business rule enforcement. With zk-SNARKs plus smart contracts, we can use the blockchain as a neutral regulator, inspector, or enforcer of industry-wide reg- ulatory and business rules. For example, we can create a rule such as, "only manufacturer A is allowed to com- mission or send SGTINs containing manufacturer A's company prefix" or "an SGTIN can only move forward in the supply chain if it originated from a licensed manu- facturer and if all prior transfers between trading partners on the network followed the rules and were valid." Used in this way, blockchain plays the role of an army of clip- board-carrying inspectors, checking and approving every transaction to ensure that the letter of the regulation is followed. Even more exciting is that zk-SNARK applies 128-bit encryption to the payload of every transaction, which proves to be a very strong data privacy solution. You can access the full MediLedger DSCSA Pilot Project report by visiting www.mediledger.com/ fda-pilot-project. T&C References 1. www.federalregister.gov/documents/2019/02/08/ 2019-01561/pilot-project-program-under-the-drug-supply- chain-security-act-program-announcement 2. MediLedger Pilot Project participants include: AmerisourceBergen, Amgen, Cardinal Health, Center for Supply Chain Studies, Dermira, Eli Lilly, Endo, FedEx, FFF Enterprises, Chronicled, Genentech, Gilead, GS1, Glaxo Smith-Kline, Hikma, Inmar, Maxor, McKesson, Novartis (Sandoz), Novo Nordisk, Pfizer, Sanofi, Vax- serve, Walgreens, and Walmart. Muffie Fulton is the senior director of Pharma Solutions at Chronicled (muffie@chronicled.com, www.chronicled.com). Based out of San Francisco, CA, Chronicled is a technology company that is developing solutions to bring trust, efficiency, and automation to the pharmaceutical and life sciences indus- try. Chronicled is the custodian of MediLedger, an open and decentralized blockchain-based network that connects trading partners and enforces cross-organization business rules without revealing private or competitively sensitive data. MediLedger currently facilitates solutions in the supply chain and revenue management functions within the pharmaceutical industry. out appropriate standards, it is unlikely that dispa- rate systems can be made successfully interoperable. • In the absence of a central point of data sharing as other countries have chosen to implement, the US supply chain will suffer as companies struggle with keeping data accurately and completely shared across a wide variety of partners, systems and tech- nical formats. This means that in the event of a significant public-health crisis, stakeholders and agents will struggle to locate and quarantine sus- pect products in a timely manner, continuing to put patients' lives at stake. • We believe we have demonstrated that a well-de- signed, industry-leading, neutral platform (or well-managed interconnected platforms) using the advancements of technology like blockchain can avoid these significant risks. Next steps The project group identified a number of factors that would increase the chances of success in implementing the 2023 DSCSA requirements. First, at least four sets of standards still need to be developed: messaging (EPCIS updates), system interoperability, APIs, and authorized trading partner identification. The group is also very clear that implementation and usage throughout the industry will be simplest if the industry uses a single neu- tral track-and-trace platform that ensures confidentiality and trust throughout each step of the supply chain. In general, a number of industry problems result from inefficiencies between trading partners, failures in cross-company communication, and the current reli- ance on antiquated technology to exchange information. Protocols that use blockchain can be established from which groups of companies will benefit by participating together, enabling enforcement of cross-industry busi- ness rules. The vision is that these protocols are not, in principle, controversial agreements; on the contrary, they simply put in place the pipes that allow for improved capability and reduced friction, so companies can do business with their trading partners in any way they best see fit. Compliance with DSCSA is just one use case. The following are recurring patterns where the MediLedger network with blockchain components can add value in the context of a multi-enterprise business network. Data synchronization. A blockchain can be used as an industry utility for accuracy and completeness of data files. The Synaptic Health Alliance's provider directory data-sharing initiative is an example of this design pat- tern. Proof of Authority (PoA) consensus creates strong guarantees around master data synchronization. Asset exchanges. The network can be used as a two- sided market for the exchange of digital assets that have value for buyers and sellers/curators. Product identifiers serve both as digital intellectual property and as an end- point in an operational messaging so that they can actu- ally be transferred under the mergers and acquisitions