Takeda UPI Contribution to Conference. Vendor selection process for Serialization and product Tracking. May Authors: Bahman Didar

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1 Takeda UPI Contribution to Conference Vendor selection process for Serialization and product Tracking May 2014 Authors: Bahman Didar Delivering the Unified Product Identifier Program at Takeda

2 Agenda 1. A few words about Takeda Pharmaceuticals 2. The Takeda UPI program initiative from the humble beginnings 3. The evolution of vendor selection a) Initial vendor selection strategy for local pilots b) Experience with vendors from local pilots c) Revised vendor selection strategy for global program 4. Current status and the road ahead 5. Questions and answers 2 Conference - Takeda UPI - Vendor selection

3 About Takeda The largest pharmaceutical company in Asia Ranked number 12 globally Founded in Osaka, Japan in 1781 The Takeda Group consists of 161 companies Market presence in over 70 countries employees Worldwide 21 R&D Sites 19 Production Sites 3 Conference - Takeda UPI - Vendor selection

4 Agenda 1. A few words about Takeda Pharmaceuticals 2. The Takeda UPI program initiative from the humble beginnings 3. The evolution of vendor selection a) Initial vendor selection strategy for local pilots b) Experience with vendors from local pilots c) Revised vendor selection strategy for global program 4. Current status and the road ahead 5. Questions and answers 4 Conference - Takeda UPI - Vendor selection

5 Pharmaceutical world coding & serialization requirements (GS1, August 2013) Cyprus 2010 Product Code Denmark 2011 Product Code Brazil 2011 Track & Trace Argentina 2012 Canada 2012 Serialization 2 Vx Batch Variable nd product group India 2011 Batch Variable France 2011 Batch Variable Denmark 2011 Product Code Thailand GTIN Korea 2013 Batch Variable Ethical drugs India Jan Serialization for export - 2 nd level USA 2013 Federal Track & Trace Taiwan 2013 Regulation Barcode req. - India July 2014 Serialization for export 1 st level Ukraine Jul Serialization manufacturers & wholesalers Korea 2015 Serialization Slovenia 2015 Product code & Batch/Expiry date China 2015 Serialization all products Saudi Arabia 2016 Serialization Libya 2017 Serialization EU 2016 EU Compliance to Pharma Directive Turkey 2010 Track & Trace India 2012 Serialization Nigeria Jan 2013 Algeria 2014 MAS all Serialization anti-malarial EU 2014 Delegated acts finalised California 1 Jan % Mfg Product California 1 Jul 2017 Retail/Hosp/Pharmacies 5 USA 2010 FDA SNI guidance India 2011 Serialization for export Serbia 2010 Traceability regulation EU 2011 EU Legislation China 2011 Track & Trace Korea 2012 Batch Variable Specified drugs Argentina 2012 Serialization for traceability specific products Netherlands/NVZ 2012 Product code England/NHS 2012 Product Code Brazil 2013 Revised Serialization Japan 2012 Revised MHLW Barcode Guidelines Australia 2013 registration revised TGO for medicine labelling California 1 Jan % Mfg Product Denmark 2014 & 2015 AMGROS : DataMatrix or barcode on injection & infusion Ukraine 2013 /2014 Legislation on traceability Mexico 2014 Regulation on traceability Saudi Arabia 2015 DataMatrix California 1 Jul 2016 Wholesalers Australia 2016 implementation revised TGO for medicine labelling Ukraine Jul Serialization - retailers Regulated requirement Tender requirement Important development Emerging Regulatory req.

6 Project plan: Phasing & timelines (Updated: May-2014) < CY2013 CY2014 CY2015 CY2016 CY additional products (Ebrantil & Gutron) on EDL lists as of all drugs December 2015 Saudi Arabia, Datamatrix Korea 2015 Serialisation Aggregation: Expected Debate on safety features China all products incl. OTC Libya& Jordan, Serialization, 2017 Ukraine: Serialization, 2017 EU: Serialization, Jan 2018 Brazil Qualification batches: Full roll out: Full tracking and aggregation needed Brazil Qualification batches: Full roll out: Full tracking and aggregation needed Saudi Arabia, SERI Mar Serialization deadline: T&T deadline: PHASE 1 - Cover 4 sites 8 packaging lines COUNTRIES W/ REQUIREMENTS AND TIMING IN PLACE MARKETS : China PHASE 2 Cover 15 sites 98 packaging lines COUNTRIES W/ REQUIREMENTS DEFINED AND LATER DEADLINES OR TIMING NOT YET FINALIZED MARKETS : South Korea, Saudi Arabia, Brazil, Turkey, Ukraine & Europe, etc PHASE 3 - Cover 3 sites 11 lines COUNTRIES W/ POTENTIAL FURTHER REQUIREMENTS MARKETS : Indonesia, Russia, 6 Conference - Takeda UPI - Vendor selection

7 Takeda Serialization / UPI Heuristics Takeda UPI transformation from a local serialization pilot to a global Track and Trace program Phase 1 Phase 2 Phase Pilot project projects across 10 sites 3 years deployment 2 work streams projects across 15 sites, 135 external sites 3 years deployment 3 work streams Today 27 projects across 19 sites, 99 external sites 5 years deployment 6 work streams Key focus: Scope Key focus : Scope + Cost Key focus : Scope + Cost + Rollout Strategy Key focus : Scope, + Cost + Rollout Strategy + Governance + Support 7 Conference - Takeda UPI - Vendor selection

8 Example 2: Takeda UPI Program humble beginnings NOW: A global program covering 19 production sites and 100 external business partners BEFORE: Local project team in Singen, Germany 8 Conference - Takeda UPI - Vendor selection

9 KPI s for vendor selection follow the program maturity The key challenge was to develop and refine a complete toolkit to address the following key areas: 1. Scope Control 2. Cost Control 3. Rollout Strategy 4. Governance 5. Support Strategy And for vendor selection criteria to match the overall program maturity. Vendor Selection 9 Conference - Takeda UPI - Vendor selection

10 Complexity of Takeda s overall business model add to the complexity of the program Takeda SC/LOCs 11 Takeda Site 1 Takeda Site 2 10 Takeda Turkey Pack WH Pack WH Takeda Sites Takeda Operatins External Suppliers Other Pharma Company External Packager External Pack 5 External Distributor External SC/LOCs 6 External Warehouse 7 External Partners # Complexity Examples (1) Preprint of package material: SN exchange, feedback Takeda examples: Faller, Ladegast (2) External packaging (OES) and delivery to internal WH: SN exchange, feedback, delivery, shipment (3) Same process as (2) but different target site (4) Shipment to ext. WH: shipment, reporting DHL (Turkey) (5) Externally handled shipment: shipment, reporting, SN exchange, feedback USA (6) Externally handled shipment: shipment, reporting, SN exchange, feedback USA, DHL (7) Externally handled shipment: shipment, reporting USA, DHL (8/9) Direct delivery to DC (10) Shipment to other site: shipment, reporting CHN (11/14/1 5) Multiple production request: Internal sites external packager TR (TSI, TOB, 3M) (16/17) Multiple production request: Internal sites external packager OES (for example CERANO) (18/19) Multiple production request from external partner: Multiple internal sites Pfizer 10 Conference - Takeda UPI - Vendor selection

11 Agenda 1. A few words about Takeda Pharmaceuticals 2. The Takeda UPI program initiative from the humble beginnings 3. The evolution of vendor selection a) Initial vendor selection strategy for local pilots b) Experience with vendors from local pilots c) Revised vendor selection strategy for global program 4. Current status and the road ahead 5. Questions and answers 11 Conference - Takeda UPI - Vendor selection

12 The evolution of vendor selection Phase 1: Initial vendor selection strategy for local pilots Extensive dialogue with known suppliers and a few market leaders Participation on Serialization related conferences Highly focus on technical solution / Low focus on global challenges Impression from conferences Vision inspection / Serialization capabilities Existing relationship Main solution vendors for UPI 12 Conference - Takeda UPI - Vendor selection

13 The evolution of vendor selection Phase 2: Optimized vendor selection Enhanced focus on integration capabilities Enhanced focus standardization Enhanced focus on local support Development of a series of tools to support local vendor selection Scoring Unweighted scoring Weighted scoring AREAS Criticality / weighing Vendor A Vendor B Vendor C Vendor A Vendor B Vendor C Local Support (incl. go live) 10% Integration to line 10% Functionality 10% Solution Price 5% Service Price 5% Impact to template 10% Economy of scale 5% Integration to SAP 5% Fit to customer culture 5% Experience (Global-non Serialization) 5% Experience (Local Serialization) 5% Site Standards 5% Vision system capabilities incl. range 5% Documentation 5% PM and Delivery 5% Configurability (ease of use) 5% Conference - Takeda UPI - Vendor selection

14 The evolution of vendor selection Experience with vendors from local pilots Strong internal knowledge about Serialization / Track & Trace challenges and solutions is key Thorough preparation before involving external vendors is key Strong local presence from main vendors is key The market is overheated and it will only get worse from here => strong relation to key vendors is key Senior advisor(-s) from vendor needs to have the right profile Projects / solutions can be high cost remember to prepare all key decision for ongoing approval of investments in order to maintain focus at vendor Strength of local team is crucial to project success

15 Agenda 1. A few words about Takeda Pharmaceuticals 2. The Takeda UPI program initiative from the humble beginnings 3. The evolution of vendor selection a) Initial vendor selection strategy for local pilots b) Experience with vendors from local pilots c) Revised vendor selection strategy for global program 4. Current status and the road ahead 5. Questions and answers 15 Conference - Takeda UPI - Vendor selection

16 Current status and the road ahead: Global site assessment We needed to know more about the individual sites in order to: Enhance and strengthen communication with key stakeholders at the sites Ensure program feasibility though timely booking of internal & external resources (in high demand): Lock down scope of equipment requirements including need for technical support & services for the packaging lines Lock down key resources to ensure feasibility of UPI program To avoid a substantial impact on local Operational Efficiency and need for additional resources in production Gaining better purchase prices by using a consolidated approach and economy of scale Provide a stronger initial Global Solution design to ensure rollout momentum across the different sites with a strong variety in business processes To create additional basis and confirmation on overall estimated UPI budget costs Preparatory visit On Site Survey and Data Gtathering Data analyses and Consolidation Phase 2A level 0 Plan 16 Conference - Takeda UPI - Vendor selection

17 The evolution of vendor selection Revised vendor selection strategy for global program Enhanced focus on: global reach top management capabilities experience with program governance size of resource pool immediate scalability quality of resources Ability to execute quality support long-term Extensive dialogue with peers on vendor performance 17 Conference - Takeda UPI - Vendor selection

18 Current status and the road ahead Phase 3: Enhanced Vendor Management Strong working relationship with key vendors Takeda management face-2-face meeting with top management Bi-weekly telephone conference call with Follow up on overall vendor performance Follow up on individual resource performance Follow up on all key milestones and tasks Continuous improvement of roll-out approach 18 Conference - Takeda UPI - Vendor selection

19 19 Conference - Takeda UPI - Vendor selection Questions?

20 20 Conference - Takeda UPI - Vendor selection Appendix

21 Complexity of scope Control: From China pilot to global rollout Snapshot of Regulatory Requirements vs. Constant regulatory update based on GS1 vs. in house RA vs. EFPIA vs. combination Define frequency of scope update and mechanisms Inventory of Production Define split Internal (60%) vs. external (40%) production and effect on rollout strategy Listing of Internal Production sites, forecasted volume and destination markets Listing of external Production sites and external partners Readiness assessment of Internal Sites (Business Impact Assessment) Readiness assessment of External Sites Categorization based on matrix, based on survey feedback received Prioritisation of external partners based on destination markets and forecasted volume Agree which partners to include as dedicated projects and which to exclude (e.g. Business Case based on forecasted volume vs. Project cost) Define strategy for external partners not included (collateral pack for hosted solution 21 Conference - Takeda UPI - Vendor selection

22 Rollout Strategy: From tactical pilot to simultaneous external + internal rollout executions Flat structure vs. Matrix project organization Alignment of rollout plan with line organization based on global site scanning Consecutive planning vs. Integrated planning on 4 levels (Level 0 to Level 4) Internal vs. External project resources Multi vendor strategy vs. Central vendor approach Identification of A team resources vs. what can I get once my budget is approved Development of Global Template with key technology vendors vs. local, preferred solution Merge with similar projects (product tampering, distribution centre changes etc.) vs. Reduction of complexity External dependencies and related projects 22 Conference - Takeda UPI - Vendor selection

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