DSCSA & BLOCKCHAIN: Study Phases in Context


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Phase 1: Exploration & experimentation

With the team's initial understanding of working with many unknowns, our Phase 1 Study was chartered as an exploratory examination into three complex subjects:

  1. The US Pharma Supply Chain and the existing nuanced relationships of its stakeholders
     
  2. The Drug Supply Chain Security Act (DSCSA) and the varying interpretations of its language
     
  3. Blockchain concepts and platforms and their evolving native and add-on capabilities

Working together, the team established a set of
seven goals (or challenges) outlined here.

As weekly team meetings and discussions unfolded, several test scenarios were explored. In fact, at one point, we conducted nine separate experiments.

Ultimately, this  experimentation resulted in the Study's three final working ReferenceModelsTM that be viewed here.

Phase 2: From exploration to PoC

Chartered as a Proof-of-Concept (PoC) Pilot Study, Phase 2 was launched with the understanding that few supply chain participants are currently capable of exchanging serialized product data or connecting to a blockchain.

Creation of the PoCs. 
The PoCs were designed to be demonstrated in the solution provider's own test environments. These initial walkthroughs were presented at Johns Hopkins University on April 30th, 2018. Six teams exhibited their blockchain solution concepts detailed here.

Value beyond compliance.
During this Phase 2 stage, PoC teams also have been working to identify potential benefits for the industry beyond DSCSA compliance and were encouraged to present some of this work in their PoCs at the Walkthrough Meeting.

An industry call for DSCSA Roadmaps.
A key take-away from the meeting was the stakeholders' desire for roadmaps that focus on achieving industry goals to support DSCSA compliance for 2019 & 2023 and separate roadmaps for value-added uses.

What comes next?

Our work continues.
Throughout Study Phases 1 & 2, both teams worked diligently to balance DSCSA requirements along with supply chain best practices and individual needs of stakeholders.

This approach will continue as teams begin the process of creating and implementing the roadmaps and will proceed at a pace aligned with the industry.

New explorations ahead!
The discovery and experimentation that took
place in Phases 1 & 2 generated a wealth of new
ideas and concepts that may ultimately benefit supply chain stakeholders and patients.

Those concepts with the highest levels of interest and viability for further exploration will be chartered as new Studies open to all stakeholders in the
supply chain.