Bob Celeste from the Center for Supply Chain Studies. Bob is the founder of the Center for Supply Chain Studies. His focus has primarily been in the Healthcare industry, specifically around its supply chain. He has also worked at GS1 US for 13 years. Bob will be completing the presentation he gave at our last Pharma/DSCSA meeting on August 20th. You can watch that presentation here. The last presentation focused primarily on the pharmaceutical supply chain, its challenges and the DSCSA. For this session, we plan to have a brief recap, discuss key takeaways and have an open Q&A discussion around blockchain being a solution to these challenges, DSCSA pilots, etc. so please bring your questions and ideas!
Presentation
DSCSA challenges
Different points in time
Implemented over 10 year period
2023 supply chain partners need to have their products serialized, but will need to get transaction information to show the history/lineage where the item has been in the supply chain
Challenges are the supply chain itself
97% of all products are broken apart by 3 major pharma companies
Need to track all the units as it breaks down in the supply chain
One of the major issues
Is it 1up 1 down?
FDA requires leading back to the manufacturer
Criminals have operator as wholesalers to be able to counterfeit
Potential:
How does a dispenser actually find a manufacturer
They are who they are and they should be able to have access to their requests
Credentials for companies in BC
Citizen access experiment
Verifiable credentials - Decentralized identity
British Columbia government is providing email verification service
Steps with credentials? Registered on the blockchain?
Performed 2 years ago in a simulation, issues encountered:
Patterns of shipments, receipts
Too much data
Slow
Issues on confidentiality
AI can tell about the enterprises based on the data
Group mentioned most of these issues have been addressed in the past year
THE law requires that upon a request from a regulatory body, that anyone of the supply chain partners must be able to produce previous transaction information
Trusting inquiries - did the wholesaler actually own the product?
Put information on the blockchain but it hasn't worked
150 million fine to large wholesaler by FDA for not taking steps
Holding DSCSA transaction information (TI) does not working
EPCIS is one of 5 technologies that FDA is looking into