Date

Jun 25, 2019

Attendees

• @Marco Carvalho @Baiju Jacob @jeff stollman @Ben Taylor, Andrew Pisano, Sid Jain, Matt Rosen, ...

Attendees

• Marco

• Baiju (ChainDigit)

• Sid (J&J)

  • Blockchain and IoT solutions

• Ben Taylor (LedgerDomain)

  • Clinical and commercial supplies

  • Pilot for FDA with UCLA, dispensers

• Bret Carpenter

• Matt (Trace Rx)

  • DSCSA compliance

• Jeff Stollman (RMTM)

  • DSCSA

  • Interoperability

• Andrew (Digital Assets)

  • DAML (daml.com)

    • Domain specific

  • Interoperability

Topics

• Using Blockchain for DSCSA

  • How can Blockchain be used to address DSCSA regulation? – If the dispensary of the product to the patient, typically pharmacy, can update the block chain at the end of the sale process to close the loop, it can solve the open loop chargeback, rebate, fee, GTN inaccuracy problem, and a problem for the distributors who like the opacity.

  • Draft: https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/fda-issues-draft-guidance-product-identifier-requirements-under-drug-supply-chain-security-act

  • Pilot programs: https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/dscsa-pilot-project-program

  • Saleable returns verification due Nov 2019: https://www.tracelink.com/insights/preparing-for-dscsa-saleable-returns-verification (Baiju requested)

    • 2% are returned - $$$billions

    • Dispenser purchases too much and sends back to distributor

    • Confirm that the product is authentic

    • Issues with resale that was recalled

    • HDA router service and Mediledger have solutions

    • Tracelink

  • Other blockchain use cases for Pharma

    • CB, GTN, rebates, fee tracking and visibility into the actual sale location/customer.

  • Standards

    • FDA

      • Provided guidance on website – 2D machine code

    • GS1

      • https://www.gs1.org/industries/healthcare/regulations-pharmaceuticals

    • IoT

Discussion

• FDA

  • Stronger roll once pilots are completed

  • Owed report to congress

  • Zero knowledge proof

• Walmart

  • KPMG, Merck, IBM

• Mediledger

  • Meets DSCSA but barebones

  • Verifiable returns

  • Engaged wholesales for cash rebates for used inventory

  • Working with SAP

  • 3 have 90% of business

  • Concerned about sharing data – everyone holds their own data

    • Sharing timing, parties but not what is in

    • Using proofs – fnark

  • Charge manufacturers for downstream info

  • Issues/limitations

    • Cat and mouse

  • SAP

    • Working on internal solutions as well

  • Challenges

    • Traditionally all fields are required

    • 24 hour turnaround – near real-time solution

      • For particular trading partner

    • Industry is against the FDA

Questions

• Jeff – presentations from all different pilots

  • Ben can do presentation on Clinical Supply Blockchain Working Group (CSBWG) on next few weeks

  • UCLA pilot is further out (thanksgiving)

• Hyperledger member forum in Tokyo?

  • August 1^st