Takeda UPI Program - ISPE

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
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
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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
• 30.500 employees Worldwide
• 21 R&D Sites
• 19 Production Sites
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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
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Pharmaceutical world coding & serialization requirements
(GS1, August 2013)
Cyprus 2010
Product Code
India July 2014
Argentina 2012
India Jan. 2013
Libya 2017
Slovenia 2015
Canada 2012
Serialization for export
Serialization 2nd
Serialization
for
Serialization
Product code &
Vx Batch Variable product group
Denmark 2011
st level
1
export - 2nd level
Batch/Expiry date
Product Code
Saudi Arabia 2016
India 2011
Ukraine Jul. 2015
USA 2013
Serialization
Batch Variable
Serialization –
Federal Track & Trace
manufacturers &
Denmark 2011
China 2015
Brazil 2011
wholesalers
EU 2016
Korea 2013
Product Code
Serialization
Track & Trace
EU Compliance to Pharma
Batch Variable
all products
Korea 2015
Thailand - Ethical drugs
Directive
France 2011
2012
Taiwan 2013 Serialization
Batch Variable
GTIN
Regulation
Barcode req. -
2010
2011
2012
India 2012
Serialization
Turkey 2010
Track & Trace
China 2011
Track & Trace
USA 2010
FDA SNI guidance
India 2011
Serialization
for export
EU 2011
EU Legislation
Serbia 2010
Traceability regulation
5
Korea 2012
Batch Variable
Specified drugs
2014
2013
Nigeria
Jan 2013 Algeria 2014
MAS all
Serialization
anti-malarial
EU 2014
Delegated acts
finalised
2015
2016
California 1 Jan 2016
100% Mfg Product
Brazil 2013
Saudi Arabia 2015
Revised Serialization
DataMatrix
Japan 2012
California 1 Jan 2015
Revised MHLW Barcode
50% Mfg Product
Guidelines
Argentina 2012
Serialization for Netherlands/NVZ 2012
traceability
Product code
specific products
Denmark 2014 & 2015
AMGROS : DataMatrix or barcode
on injection & infusion
Ukraine 2013 /2014
Legislation on
traceability
Australia 2013
England/NHS 2012 registration revised TGO
Mexico 2014
Product Code
for medicine labelling
Regulation on
traceability
2017
California 1 Jul 2017
Retail/Hosp/Pharmacies
California 1 Jul 2016
Wholesalers
Australia 2016
implementation revised TGO
for medicine labelling
Ukraine Jul. 2016
Serialization - retailers
Regulated requirement
Tender requirement
Important development
Emerging Regulatory req.
Project plan: Phasing & timelines (Updated: May-2014)
<
CY2013
CY2014
2 additional products
(Ebrantil & Gutron) on EDL
lists as of 7-2014
all drugs December 2015
CY2015
CY2016
CY2017
China all products incl. OTC
Saudi Arabia, Datamatrix
Libya& Jordan, Serialization, 2017
Ukraine: Serialization, 2017
Korea 2015 Serialisation
Aggregation: Expected 2017.
Debate on safety features
Brazil
– Qualification batches: 2015.12.11
– Full roll out: 2016.12.11
– Full tracking and aggregation needed
EU: Serialization, Jan 2018
Brazil
– Qualification batches: 2015.12.11
– Full roll out: 2016.12.11
– Full tracking and aggregation needed
Saudi Arabia, SERI Mar. 2017
Serialization deadline: 2017.11.27
“T&T” deadline: 2023.11.27
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, …
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Takeda Serialization / UPI Heuristics
Takeda UPI transformation from a local serialization pilot to a global Track and Trace
Phase 1
Phase 2
Phase 3
program
2011
1 Pilot
project
2012
Key focus:
Scope
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•13 projects
across 10
sites
•3 years
deployment
•2 work
streams
Key focus :
Scope +
Cost
2013
•18 projects
across 15
sites,
•135
external
sites
•3 years
deployment
•3 work
streams
Key focus :
Scope +
Cost +
Rollout
Strategy
Today
•27 projects
across 19
sites,
•99 external
sites
•5 years
deployment
• 6 work
streams
Key focus :
Scope, +
Cost +
Rollout
Strategy +
Governance
+ Support
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
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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.
2.
3.
4.
5.
Scope Control
Cost Control
Rollout Strategy
Governance
Support Strategy
And for vendor selection
criteria to match the overall
program maturity….
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Vendor Selection
Complexity of Takeda’s overall business model add to
the complexity of the program
Takeda SC/LOCs
Takeda
Turkey
11
14
External SC/LOCs
Takeda
Operatins
External
Suppliers
16
15
Other Pharma
Company
(1)
Preprint of package material:
SN exchange, feedback
Takeda examples: Faller, Ladegast
(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
1
(6)
WH
2
External
Pack
Pack
6
(7)
WH
Externally handled shipment:
shipment, reporting
USA, DHL
4
Takeda Site
2
Externally handled shipment:
shipment, reporting, SN exchange, feedback
USA, DHL
3
10
External packaging (OES) and delivery to internal WH:
SN exchange, feedback, delivery, shipment
External
Packager
Pack
Takeda Site
1
Complexity Examples
(2)
1819
17
#
External
Warehouse
8
9
Takeda Sites
(8/9)
Direct delivery to DC
(10)
Shipment to other site:
5
External
Distributor
shipment, reporting
CHN
(11/14/1
5)
Multiple production request:
(16/17)
Multiple production request:
7
External Partners
Internal sites
external packager
TR (TSI, TOB, 3M)
Internal sites
external packager
OES (for example CERANO)
(18/19)
Multiple production request from external partner:
Multiple internal sites
Pfizer
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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
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
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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
AREAS
Local Support (incl. go live)
Integration to line
Functionality
Solution Price
Service Price
Impact to template
Economy of scale
Integration to SAP
Fit to customer culture
Unweighted scoring
Criticality /
weighing
Vendor A Vendor B Vendor C
1300
1300
1300
Weighted scoring
Vendor A Vendor B Vendor C
100
100
100
10%
10%
10%
5%
5%
10%
5%
5%
5%
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
10
10
10
5
5
10
5
5
5
10
10
10
5
5
10
5
5
5
10
10
10
5
5
10
5
5
5
Experience (Global-non Serialization)
Experience (Local Serialization)
Site Standards
5%
5%
5%
100
100
100
100
100
100
100
100
100
5
5
5
5
5
5
5
5
5
Vision system capabilities incl. range
Documentation
PM and Delivery
Configurability (ease of use)
5%
5%
5%
5%
100
100
100
100
100
100
100
100
100
100
100
100
5
5
5
5
5
5
5
5
5
5
5
5
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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
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
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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
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Data analyses and
Consolidation
Phase 2A level 0 Plan
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
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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
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Questions?
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Appendix
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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
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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
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