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TraceLink’s FDA Pilot Project Vision

TraceLink’s “2023 Pilot Project Workgroup” is an end user-driven project designed to create learnings and explore alternative approaches to prepare for DSCSA’s 2023 requirements while laying the foundation for ongoing enhancements to the pharmaceutical supply chain

Deeply analyze and describe the current pharma supply chain
Develop a systems, process, data and network blueprint for the future

TraceLink’s pilot project has two dedicated workstreams to explore key areas identified by the FDA:

Interoperable information sharing: Trace Histories
Verification/notification for patient safety: Digital Recalls

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Pilot Workstream #1: Trace Histories

The problem:

As part of the Nov. 27, 2023 DSCSA requirements, transaction histories sunset and transaction information now includes serialization data (sTI).
Stakeholders will effectively have a “one-forward, one-back” view of products and transactions given sTIs in their systems
What systems/processes are needed by companies to facilitate gathering of transaction information at the package level for each transaction going back to the manufacturer, to investigate suspect product, during a recall, or for other critical supply chain issues, when requested by regulators or trading partners?

Examine a network solution leveraging (1) blockchain/distributed ledger technology (demonstrated by TraceLink’s Trace Histories solution) combined with (2) serialization and traceability solutions of the supply chain stakeholders to enable a “gather upon request” model for securely gathering and connecting one-forward/one-back serialized TIs to meet the 2023 DSCSA requirements.

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Goals

Demonstrate the ability of diverse supply chain members to

Gather sTI upon request to efficiently establish a chain of custody
Implement the associated network and system attributes necessary
Determine the related environmental factors (such as governance and trust) that may be necessary to support the diversified U.S. pharma supply chain

Objectives

Provide insights and a blueprint for the FDA and stakeholders on processes and technologies in:

Interoperability and Integration
Data Management and Ownership
Business Processes and Change Management
Technical Infrastructure
Identify Management
Governance and Trust Models

Evaluation

Deliver detailed impact analysis for the FDA and stakeholders on:

Capability for any member of network to execute a product trace
Cross-network collaboration and consensus needed
Existing business process and data management practices
Timeline planning for start to solution implementation
Deployment, interoperability and cost across diverse stakeholders

Goals, Objectives and Evaluation – Trace Histories

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Pilot Workstream #2: Digital Recalls

The problem:

The current pharmaceutical recall process is manual and time-consuming, often resulting in uncertainty of the status of the recall and in great volumes of impacted product remaining in the supply chain.
The complexity of the U.S. pharma supply chain means that certain members or participants of the chain may be hard to effectively reach with traditional methods of communication.
How can we enhance patient safety by improving recall efficiency and completeness, thus reducing the risk that recalled product will be dispensed to patients?

Examine a network solution that would enable the development and deployment of an standardized, interoperable Digital Recall Network to improve the ability to rapidly and precisely communicate, manage and close product recalls across the pharmaceutical supply chain

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Goals

Evaluate and describe how:

A digital recalls network could be established across the pharmaceutical supply chain leveraging serialization data, traceability information, and interoperable electronic systems; and
Such a recalls network could evolve from today’s as-is process for managing pharmaceutical recalls

Objectives

Provide insights and a blueprint for the FDA and stakeholders on processes and technologies in:

Business Process and Change Management “As-Is” to “To-Be”
Notification and Response Message Choreography
Messaging and Data Model Requirements/Standards
DSCSA 2023 Tools/Tech. Leverage
Benefits and Effectiveness Metrics
Regulatory Impacts and Opportunities for Evolution

Evaluation

Deliver detailed impact analysis for the FDA and stakeholders on:

Recall communication and response times
Product disposition analysis (time, accuracy)
Effectiveness check reporting
Recall product target vs. actual performance
Recall closure time and monitoring

Goals, Objectives and Evaluation – Digital Recalls

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Contract Manufacturer

Pharma Manufacturer/MAH

Wholesale Distributor

A Diversified Set of Pilot Partners Spanning the End-to-End Pharmaceutical Supply Chain

Dispenser

Logistics/Return Provider

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TraceLink Pilot Team

Brian Daleiden – Workshop leader and moderator, pilot community management

John Jacey – Account Executive for both pilot workstreams

Shweta Agarwal – Product Manager for the Digital Recalls pilot workstream

Amanda Bettman – Product Manager for the Trace Histories pilot workstream

Ray Carvill – Solution Consultant for both pilot workstreams

Jan Flaig – Professional Services for both workstreams

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Processes, Methods and Activities to Achieve Success

The primary approach that pilot project workstream members plan to undertake is to:

As-Is: Develop and document a deep understanding of how the pharmaceutical supply chain operates today in establishing traceability of medicines and executing a recall of pharmaceuticals
To-Be: Describe the potential future state of information management and business process execution leveraging new tools and technologies being developed under DSCSA
Blueprint: Create a forward-looking blueprint to help the FDA and industry stakeholders understand the roadmap and milestones which would be needed to achieve the denoted requirements and sought benefits

>> Develop 360-degree view of the requirements on systems, processes, people and data, resulting in the ability of each workstream to create a blueprint for the future.

Workstream members will be working across a variety of mediums to develop understanding and test assumptions

Virtual Meetings

Focused conversations and analysis to review and document each foundational element

Workshops

Summary review of key findings and test execution of core capabilities

Online Collaboration

Continuous review of research artifacts, process approaches, and business/technical requirements on Trello

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Project Phase Timing and Milestones�Continuous Collaboration Across the Project

Monthly Status Report

Phase 3

Phase 2

Digital Recalls Phase 1

Phase 3

Phase 2

Trace Histories Phase 1

Monthly Status Report

Digital Recalls, Virtual Meetings

Kickoff
As-is Process Limitations
Digital Recalls Communication Process

Trace Histories, Virtual Meetings

Kickoff
As-is Process
Use case Discovery

Monthly Status Report

Digital Recalls Workshop 1

Mock Recall

Trace Histories Workshop 1

Mock Trace

Digital Recalls Workshop 2

Recall Monitoring

Trace Histories Workshop 2

Network Authorization and Reporting

Digital Recalls Workshop 3

Measures of Success and Risk Assessment for Digital Recalls Processes

Trace Histories Workshop 3

Special Scenarios

Digital Recalls, Virtual Meetings

Recall Coordination and Compliance Reporting
Data Ownership and Visibility Controls
Integration

Trace Histories, Virtual Meetings

Network and Participant Validation
Data Ownership and Permissions
Network Authorization and Reporting

Digital Recalls, Virtual Meetings

Interoperability
Business Process Impact
Implementation Needs and Wrap-up

Trace Histories, Virtual Meetings

Business Processes Impact
Technology Evaluation
Change Management and Wrap-up�

June

July

August

September

October

November

Early August

August - September

June - July

Early Oct

October - November

End of Nov

July

August

September

October

November

December

Final Pilot Readout

Final Report

January

Trello Board Continuous Collaboration

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Project Timelines

Phase/Milestone	Date
Start Date	24 June 2019
End Date	30 December 2019
Progress Report (1)	29 July 2019
Progress Report (2)	26 August 2019
Progress Report (3)	30 September 2019
Progress Report (4)	28 October 2019
Progress Report (5)	25 November 2019
Progress Report (6)	30 December 2019
Final Report	27 January 2020

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Trace Histories Workstream Detailed Agenda�A Well-Structured Roadmap for Discussion

Virtual Meeting 1 – Kickoff, overview of tools and resources, and discussion of pilot agenda with focus on goals and metrics
Virtual Meeting 2 – “As-Is” process for suspect product investigations, as well as any other current business processes which will be impacted by Transaction Histories sunset
Virtual Meeting 3 – Use case discovery, focusing on unique perspectives and challenges for each stage of the supply chain
Workshop 1 – Our first workshop will leverage the Trace Histories solution to explore trace processes throughout the supply chain, including requesting, responding to, and concluding a product trace

Use Case Discovery

Business Impact

Industry Network

Virtual Meeting 4 – What will the industry require in terms of participant validation, both within and between various networks, and should distributed identity management play a role
Virtual Meeting 5 – How can data permissions and ownership rules enable collaboration while protecting sensitive commercial data
Virtual Meeting 6 – What will be necessary for interoperability across different supply chain partners and multiple solution providers
Workshop 2 – Our second workshop will take a broader view of the trace process with a focus on the initial steps of partner network authorization and the final steps of trace reporting

Virtual Meeting 7 – How will 2023 affect internal business or shared supply chain processes, and how will participants begin to lay the foundation for planning activities around process adjustments and internal timelines
Virtual Meeting 8 – Technology analysis focusing on the benefits and risks of a distributed solution as well as alternative approaches
Virtual Meeting 9 – Change management and industry next steps
Workshop 3 – The final workshop will focus on special scenarios such as data errors, lapsed licenses, and business mergers or closures, both the technical considerations and the impacts to business processes

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Digital Recalls Workstream Detailed Agenda�A Well-Structured Roadmap for Discussion

Virtual Meeting 1 – Kickoff, presentation on digital recalls vision, and overview of pilot scope with focus on goals, metrics, and tools
Virtual Meeting 2 – Discuss “As-Is” recall processes, and analyze gaps in the current processes for each stage of the supply chain
Virtual Meeting 3 – Envision future recalls communication processes focusing on leveraging digitization infrastructure to efficiently notify affected partners and gather responses with product disposition status and recall action taken
Workshop 1 – The workshop will leverage digital recalls process mockups to demo the ability to send targeted recall notifications to all affected customers, and ability to receive digital communication from all customers on the recall acknowledgement and response

Recall Comms.

Recall Execution

Recall Monitoring

Virtual Meeting 4 – Envision digital recall processes that enable recalling firm to coordinate with supply chain partners, digitally monitor reverse logistics and destruction of recalled product, and record all information in a system for compliance and reporting
Virtual Meeting 5 – Discuss required user roles & permissions for managing recalls, and identify business rules to share recall notification and response information across the supply chain and within company’s internal locations
Virtual Meeting 6 – Identify the existing systems that should integrate with digital recalls system to drive automated efficiencies
Workshop 2 – The workshop will leverage digital recalls process mockups to take a broader view of the recall coordination phase with focus on the metrics required for recall monitoring and reporting

Virtual Meeting 7 – Identify the need for, purpose of, and scope of interoperability for implementation of Digital Recall processes
Virtual Meeting 8 – Understand roles and departments whose processes are impacted upon adoption of digital recalls methodology
Virtual Meeting 9 – Determine how participants will lay the foundation for planning activities, process adjustments and timelines
Workshop 3 – The final workshop will focus on outlining measures of success and risk assessment for Digital Recalls Processes

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FDA Design Strategy Workshop Update

FDA held its two-day DSCSA Pilot Project Program Design Strategy Workshop on May 8-9 at FDA headquarters
The Workshop was designed to:

Provide a summary overview from the FDA of the Pilot Program process and the FDA/USDM team managing the program
Enable selected participants (incl. TraceLink) to review their projects with the FDA/USDM team
Ensure alignment between pilot teams and the FDA for these 2019 projects

FDA had multiple team members from several Centers (CDER, CBER) and other FDA organizations participating in the project briefing

It was a very interactive discussion regarding the goals and projected outcomes from the pilot project
It is clear that the FDA is looking upon these pilots as not only informing 2023 compliance but also resources that they can use in their larger mission in support patients and the overall pharmaceutical supply chain

Bob Celeste (USDM/C4SCS) is our program manager for the FDA Pilot Project Program
FDA (Connie Jung) asked if the FDA could participate in our Pilot workshops (as an observer)

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FDA Kickoff Meeting Update

The TraceLink team held the FDA Pilot Project Program kickoff meeting with the FDA/USDM team on June 5^th, 2019
The primary goal of this meeting was to update the FDA/USDM team on:

Any logistical changes to the previously presented project plan
Provide updates to the team on specific timelines for project reports
Discuss any questions on the content for the project reports

Intermediate progress reports:

Simple updates on activities, initial insights, new issues or questions

Final report:

Goals and objectives
Description of process and activities
Evaluation methods and key findings
Other data and insights (costs, challenges, etc.)

Discuss processes for sharing of information with the team

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Pilot Project Deliverables for Tangible Insights

Trace Histories

“As is” product tracing process map and potential future state
Gap analysis: current state versus future state
Current industry perspectives on industry structure, participant validation, and data ownership, and implications for solution design
Technology evaluation
Data exchange models and areas for future industry standards development
A look forward to 2023, including assessment of risk areas and metrics of success

Digital Recalls

“As is” Recalls business processes map
Gap analysis: current state versus potential future state
Digital recalls business processes map: immediate and post 2023 DSCSA serialization
Digital recalls business rules: partner validation, data ownership, permissions and service level agreements
Potential Digital recalls systems integration and data exchange models
Digital recalls solution design: benefit-risk assessment and measures of success
Areas identified for future industry standards development for Recalls

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Questions

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TraceLink Community – PIM / VRS Interoperability Virtual Workshops

Kickoff and Alignment Meeting

September 11, 2019

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Anti-Trust Reminder

We ask everyone not to engage in discussions regarding pricing, deal-making, selling, promoting or other activities which could be viewed as anti-competitive

If anyone believes the discussions are approaching these boundaries, please say so and the discussion thread will be halted until TraceLink legal counsel is consulted before proceeding

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Disclosure Statement

The information on products, technology or customers contained in this presentation is proprietary to TraceLink and is offered in confidence. This information may not be further distributed to other parties.

TraceLink makes no warranty regarding this information. TraceLink, in its sole discretion and with no notice, may revise, eliminate or otherwise alter any functionality or product plan to which the information disclosed is related.

This information is presented solely for discussion purposes.

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Agenda

PIM / VRS Interoperability Workshops Overview
PIM – Product Verification Solution Recap
VRS Interoperability Testing Status
Preparing for Interoperability Testing – Manufacturers

Guidelines, Documentation, Data

Preparing for Interoperability Testing – Wholesale Distributors

Guidelines, Documentation, Data

Workshop Testing Meeting Process and Cadence
Continuous Sharing and Collaboration – PIM Solution Interoperability Trello Board
Next Steps

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PIM / VRS Interoperability Virtual Workshops�September/October Sprint for DSCSA Readiness

TraceLink is kicking off a focused series of online interoperability workshops to help accelerate and secure interoperability between companies and systems for DSCSA 2019 saleable returns verification
Through a combination of online workshops and offline collaboration, we want to ensure that our customers are ready for the deadlines across the variety of supply ecosystem in which you operate
Operational use cases upon which we expect to collaboration include:

TraceLink PIM Manufacturer customers with TraceLink PIM Distribution customers
TraceLink PIM Manufacturer customers with distributors using other VRS systems
TraceLink PIM Distribution customers with manufacturers using other VRS systems
TraceLink PIM Manufacturer and Distributor customers working with trading partners who have created their own VRS system

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PIM / VRS Interoperability Virtual Workshops�September/October Sprint for DSCSA Readiness

Interoperability testing is based on four core areas

Roundtrip verification inquiry interoperability from operational VRS Requestor services to operational VRS Responder services and back again

Full request / response from a distributor who has a product identifier needing verification with a manufacturer who has the right and responsibility for responding to such a verification request

Lookup Directory data interoperability between VRS systems

Publication of information into an LD and push/synchronization of that information with other LDs
Request for information updates or synchronized receipt of information from another LD

VRS Requestor services to internal business/operational systems interoperability

Integrated or manual capture of DSCSA product identifier information for submission as a verification request

VRS Responder services to internal business/operational systems interoperability

Integrated or manual preparation of DSCSA product identifier data for verification readiness
Capture and vetting of a verification request against the product identifier verification repository

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Product Information Manager�VRS Verification and Master Data Sharing Solution (recap)

Note: The diagram doesn’t represent out-of-network links for Manufacturers that are using other VRS solutions. These are part of the overall interoperable solution and part of the testing scenarios

Manufacturer

Serialization

Repository

3^rd Party VRS

Wholesaler /

Dispenser

Master Data Repository

Non-TraceLink Party

Wholesaler /

Dispenser

1

All companies are verified before defined on the TraceLink Network

Product Master Data

2

Manufacturer publishes GTIN and product master data to Product Information Manager

GTIN/SN/Lot/Expiry

3

Manufacturer publishes GTIN/SN/Lot/Expiry to Product Information Manager

Look Up Directory

Synchronization

4

GTIN information synchronized with other industry lookup directories

GTIN

Product Master Data

GTIN Product �Master Data

5

GTIN and product master data is pushed to subscribed wholesalers and dispensers

In-Network

Request / Response

6

In-Network verification request received from TraceLink customer is authenticated and processed

Out of Network

Request / Response

7

Out-of-network verification request received from third party VRS is authenticated and processed

Product Information Manager

PV / MDS

PIM

Master Data

SN/Status Repository

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VRS Interoperability Testing Updates – iTest Environment

VRS Entity	Notes	Generate and Route Ver. Request to VRS Entity.	Respond to Verification Request from VRS Entity.	Out-Bound LD Sync to VRS Entity.	In-bound LD Sync from VRS Entity.
ABC	Leveraging MediLedger Network	N/A	Testing pending	N/A	N/A
McKesson	Leveraging SAP	N/A	SAP env under construction	N/A	N/A
Cardinal	Leveraging MediLedger Network	N/A	Targeting end of Sep for test env up	N/A	N/A
SAP	Leveraging MediLedger Network – their test env is under construction	SAP env under construction	SAP env under construction	SAP env under construction	SAP env under construction
Chronicled (MediLedger Network)	Testing continues with MediLedger Network Gateway
rfXcel	Test env setup ongoing
LSPedia	Testing underway
Adents	Test env setup ongoing

	Testing Complete		Testing Underway		Testing Pending

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Preparing for Interoperability Testing – TraceLink Manufacturers

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Helping You Get Started - Guidelines and Documentation

Manufacturers:

Add Master Data

Create Product Directory Records

Enable Serial Number Syncing Rules

Provide Test data to wholesalers:

GTIN
Lot Number
Expiration Data
SNs

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Packaging Information
packagingCodeType	packagingCode	packageTypeCode	totalQuantityOfNextLowerLevelTradeItem	companyPrefix

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Item Information
languageCode	strengthDescription	regulatedProductName	genericName	manufacturerOfTradeItemPartyName (This will map to the company’s name in Company Master data)	tradeItemDescription	dosageFormType	netContentDescription

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Target Market Information
targetMarketCountryCode	productType	exemptedFromRegulatoryReporting	tradeItemDescription	mahIdType	brandOwnerPartyIdentificationValue

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Preparing for Interoperability Testing – TraceLink Wholesale Distributors

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Helping You Get Started - Guidelines and Documentation

Wholesalers:

TL Set Event (REST) Message

Set Event Request with “US” market and “VERIFYING” event type routed to PIE application for verification

{

"t": {

"v": 1,

"m": "sem--set-event--v1",

"app-id": "D29A8B05-F8A7-4F35-9C7D-84344E0BE095"

},

"p": {

"eventTime": "2018-06-05T01:33:35Z",

"serialNumberList": [

{

"serialNumber":"PK009FF8895F416984B",

"lotNumber":"TEST2C9588146D",

"expirationDate":"230531",

"packagingCode":"86740665964858",

"packagingCodeType": "GTIN-14"

}

],

"eventType":"VERIFYING",

"locationType": "SGLN",

"locationValue": "030058.123456.0",

"extensionData":[

{

"extensionKey":"market",

"extensionValue":“US"

}

]

}

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Virtual Workshop Meeting Process and Cadence

We are looking to host 2x a week virtual testing meetings

Next testing web meetings:

Wednesday (Sept. 18, 1pm EDT)
Friday (Sept. 20, 1pm EDT)

During these meetings, we can review:

Updates on interoperability testing status

By Solution Provider, By interoperability scenario

Noted systemic issues being worked on and resolved
Specific customer or VRS solution provider testing scenarios in-flight status

We can share our own internal testing criteria and collaboratively work together on operational testing criteria

Review of any updated TraceLink or industry documentation or guidelines
Review of posted Trello discussions and questions
General testing discussion and collaboration

We also want to support and facilitate interoperability testing 24x7

The PIM Solution Interoperability Trello Board will support this process

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PIM-PV VRS Interoperability Testing Trello Board

The collective team can use this Trello board for working together and collaborating on interoperability testing outside of our live web meetings.
TraceLink will post updates on solutions, testing, preparation/readiness documentation
Members can post questions, share insights, and work together on testing issues

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VRS Accelerator Workshop (October 4)

Location: Loews Vanderbilt Hotel, Nashville TN
Meeting Time: 12:30pm – 2:30pm EDT, October 4^th

Starting at the end of FutureLink Nashville

Goal: To provide the knowledge and expertise to accelerate your VRS projects and reduce the risk of your network implementations
Agenda:

Time	Topic
12:30p – 1:15p	Product Information Manager – PV/MDS Solution Review Capabilities, data, process support, business rules, UI/integration interfaces Solution releases and capability availability
1:15p – 1:30p	Solution Approaches for Operational Use Cases Manufacturer use cases for different technical infrastructures Wholesale distributor use cases for different technical infrastructures
1:30p – 1:45p	Interoperability Testing and Governance Interoperability testing status with VRS systems and solution providers Verification of requestor and responder identity
1:45p – 2:30p	Getting Started and Accelerating Progress on Saleable Returns Verification Projects API and other documentation resources Project management and team organization Preparing for and working with the authorized partner network of requestors/responders

Being held in conjunction with FutureLink Nashville (Oct. 2-4, 2019)

Link: https://www.tracelink.com/futurelink-nashville/vrs

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Questions