The MediLedger Project is a collaboration between Chronicled and The LinkLab, bringing together expertise in both Pharmaceutical Supply Chain and Blockchain technologies. Our intention is to advance the dialogue of a blockchain utility to enhance Pharma companies’ ability to manage their supply chains.
2. Advantages
• Compliance with track and trace regulations
• Patient safety and drug supply security
• Easier reconciliation of exceptions
• Extensible platform for business transformations
• Open Specification
• Based on the blockchain
3. For Trading Partners
• Meeting the spirit of the law with a platform that allows the
verification of each EPCIS message like it was a financial
transaction does not simply deliver a new level of safety for
patients but establishes a new platform for trading partners to
transform their businesses.
• The transactional aspect allows to further optimize the supply
chain with exception handling and reimagined business
processes.
4. For Solution Providers
• The open specifications allows solution providers to
plug-in their products into this GS1-complaint
ecosystem.
• The exchange of EPCIS messages becomes a simple
task over the network.
• The extensibility of the platform will also allow
solutions providers to create new business solutions
that leverage the established network.
5. For Regulators
• While respecting the sensitive nature of the data of
the trading partners, regulators access to critical
information for investigating events is streamlined via
automation with the additional benefit that data
provided by trading partners is fully verifiable against
the cryptographically secure ledger based on the
blockchain.
6. About MediLedger Project
• The MediLedger Project is a collaboration between
Chronicled and The LinkLab, bringing together
expertise in both Pharmaceutical Supply Chain and
Blockchain technologies.
• The intention is to advance the dialogue of a
blockchain utility to enhance Pharma companies’
ability to manage their supply chains.
7. It believes in Pharma industry blockchain utility and ecosystem
can:
• Improve compliance of track and trace regulations
• Improve patient safety and drug supply security
• Enable easier reconciliation of exceptions
• Provide a platform for further business transformation for
processes associated with the transfer of ownership of
prescription medicines
8. Why MediLedger?
• The Drug Supply Chain Safety Act (DSCSA) goes into effect this year to
improve drug security, but lacks controls to prevent counterfeits and protect
patients.
• By 2023 the law requires that all prescription drugs can be tracked and
traced through the supply chain using an interoperable system. However,
there is no defined interoperable system today.
• The FDA is looking for the industry to develop their own solution. Existing
solutions are designed to meet today’s regulation, but do not have
interoperability.
9. What is the Opportunity?
To deliver an interoperable system leveraging blockchain
technology that enables a trusted consortium of drug
manufacturers, distributors, and dispensers to:
• Reduce cost and effort of regulatory adherence while
improving security and improving public safety.
• Stop the counterfeit / adulterated product from entering
the US supply chain.
• Improve overall business operations of the
pharmaceutical supply chain.
11. How is MediLedger the Solution?
It has brought together industry leading companies to
establish vision and a path forward in two distinct areas:
• Industry Vision
How could a blockchain platform be established for
the Pharma supply chain?
How could it operate to maximize participation, and
how can an open system architecture deliver a
competitive market for companies to deliver services
to industry?
12. • Technology Development
It has identified industry’s requirements to meet track
and trace compliance, as well as operate in a shared
ecosystem.
It is working to deliver solutions to demonstrate the
value blockchain solutions can add to the existing
solutions industry has today.
13.
14. Current Focus
• Saleable Returns
2019 requires all saleable returns must verify that the
serial number is authentic.
It is building the interoperable system that can
quickly identify originating manufacturer’s GTIN /
serial numbers as authentic.
15. • Exception Management
As inventory is moved using serial numbers,
industry needs a solution that can reconcile
exceptions based on available data
automatically.
16. • Interoperable DSCSA system
We know the future is a system that verifies and authenticates
medicine with each transaction.
• Our blockchain solution will enable improved supply chain
security: no illicit product can enter the trusted network, or if it
tries it will be identified.
• Investigations and recalls will be fast and accurate.
17. Pharma Industry Working Group
• We know that the real value in industry will come with
widespread adoption of blockchain technology, working on a
common platform to provide true interoperable capability that
never existed before.
• We are excited to have brought together a consortium of
leading Drug Manufacturers and Distributors to drive the
industry conversation of solutions that can allow the industry
to operate together in one system.
18. MedliLedger 2018 Pilot Goals
Establish framework for Pharma industry governance for
blockchain track and trace solution.
• Drive structure of industry blockchain platform, including
standards, functionality, business priorities.
19. • Continued guidance/influence on the requirements and
direction of DSCSA and related product solutions.
Ensure company specific requirements are included in design.
Opportunity to test data/product ownership transfer between
partner companies.
Opportunity to establish nodes and gain experience through
node management Service Provider Integration.
20. • Determine path forward for service provider
integration of a block chain platform.
Ability to design for multi-use business applications.
21. Total Number of Fraudulent Incidents
Internationally
CY 2012- CY 2016
23. The Supply Chain should be 100 Secured!
MediLedger does that better than anyone else!
24. Team
MediLedger is supported by the software, engineering,
product, IoT, and applied cryptography teams
at Chronicled and the supply chain experts at The
LinkLab.
Address
121 Minna, 2nd Floor
San Francisco, CA 94105
info@mediledger.com
Editor's Notes
The incidents involving counterfeit medicines has been rising year on year as seen in the above chart.