Tackling the Implementation

Challenges of Serialization and

Track & Trace programme

exlPharma

May 9-10, 2013 Philadelphia

Presentation Topics

•  Regulatory Status

•  Why an End-to-End T&T approach ?

•  Execution Framework – fokus on Change management and System Integration

•  Achieving Benefits through T&T

•  Key Learnings

•  Q&A

Classification: xxxx Author xxxx Approved by xxxx Version xx 2

NNIT IT for life sciences

•  NNIT was born as an internal IT department at Novo Nordisk in the pharmaceutical industry

•  +2,000 employees and one of Europe's leading consultancies in life sciences IT

•  Clients served in both Europe, US and Asia

•  Life science IT is our core business with complete, practical experience with the entire pharmaceutical value chain

•  We are the leading consulting and engineering company in the complex field of pharmaceutical and biotech industries

•  We count app. 1,700 professionals with project experience and knowledge related to pharmaceutical and biotech industries

•  More than 200 have hands-on

development or production experience

•  We executed 2,667 projects in 2010

NNIT/NP – Global Delivery approx. 3.800 people at 40 locations

New Jersey (Princeton)

Phillipines (Manila)

China already live and products are rapidly being added to the EDL – by 2015 all products needs to be serialised

US/California Timeline stands at 2015/2016

Europe SecurPharm pilot in 2013, Delegated Acts early 2014, Comply by 2017

Time in running fast – You need to act now !

China already live and products are rapidly being added to the EDL – by 2015 all products needs to be serialised

US/California Timeline stands at 2015/2016

Europe SecurPharm pilot in 2013, Delegated Acts early 2014, Comply by 2017

Implementation typically takes longer than you initially expect. At least 12-16 months from start of planning.

Foresee serious bottlenecks in market for skilled resources / OEM vendors – likely to delay your project

Time in running fast – You need to act now !

Track and

Trace

Track and Trace impacts your business on multiple levels

Counterfeiting

Serialization

Brand and Customer Value Supply Chain Management

Business Intelligence

Track & Trace involves many stakeholders - think end-to-end and involve all early on

Track & Trace

Project

Sales & Mark

IT

Regu-latory

CMO’s

Production Logistic

Artwork

Legal / Costumer Complaint

QA

•  Artwork Changes •  Approvals

•  IT Architecture •  System Integrations •  Master Data Mgmt •  Security •  External data exchange •  Scalability

•  Reg. Roadmap •  Approvals

•  CMO Readiness •  Data Exchange •  Artwork changes

•  Line/Site Changes •  Leverage prior invest •  Warehouse Mgmt •  Training

•  SC Integration •  Data Exchange •  Distributor Readiness

•  Risk •  Contracts •  RfP’s

•  SOP Changes •  Validation •  Training

•  Branding •  Forecasting •  New Markets

Serialisation/T&T programmes are large and complex

Business requirements

Project office

Program Mgt.

Progject Mgt.

Facility Mgt.

Project economy

OCM

Training coordination

Communica-tion

planning

Global communicat.

Training coordination

Solutions implementati

on

Technical experts

Functional experts

Integration and auth. execution

Systems validation

Validation planningb

Test execution

Validation reporting

Quality management

Solution quality

Process quality

Integration overview

Solution issues

Business requirement

s

BPR

Classification: xxxx Author xxxx Approved by xxxx Version xx 10

SAP PI

SAP AII

SAP ECC

Site Systems

Legacy

WMS

SAP OER

AL

BP

AL

BP

AL

AL

Integration governance Integration guidelines = Validated integration

BP BP

AL

PI Enables • Connection Logic and transformation logic is centralized in one system • Data is validated on both recieving and sending end • End-2-End Monitoring is handled via SAP PI PI is governed by • Clearly defined development processes and –guidelines • Clearly defined responsibilities during analysis, design, development and error handling • Validated integration

NNIT Validated Platform

BP AL

Intelligent Integration is key to compliance, robustness and low TCO

BP

Operational Framework for T&T Projects •  Business strategy

•  Vision overview

•  Develop project charter

•  Develop vision charter

•  Change management strategy

•  Stakeholder engagement

•  Application design & implementation

•  System integration & data migration

•  Test and validation

•  Infrastructure

•  Org. Change management

•  Processes and requirements

•  Project management plan

•  Key PM process

•  Refine project charter

•  Business, System & Data analysis

•  Change management strategy

•  Stakeholder Training

•  Application design & implementation

•  System integration & data migration

•  Test and validation

•  Infrastructure

•  Org. Change management

•  Advisory

•  Future roadmap •  Solution strategy

•  KPI’s

•  Application design & implementation

•  System integration & data migration

•  Test and validation

•  Infrastructure

•  Org. Change management

1 mth

3-4 mth

8-12 mth

To add pre-formatted bullets please use the

Increase/Decrease Indent buttons found in the

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Insight into diversion

Minimizing Counterfeit

Impact

Efficient Chargebacks

Effective Recalls

Patient safety Transparency in the supply

chain

Enhancing brand value

Brand

protection

Tangible and intangible benefits

Efficient Clinical trials

Report Adverse

Events

Learnings and Best Practices Track & Trace

Best practices in Serialization Projects

Think end-to-end Involve all stakeholders early on

Think Total Cost of Ownership

Standardize where possible

Select an experienced Partner with global reach

Consolidate the no. of Suppliers

Take-Away Messages

•  Get started now !, - Time is running out

Take-Away Messages

•  Get started now !, - Time is running out

•  Invest significant time in the Analysis Phase

Take-Away Messages

•  Get started now !, - Time is running out

•  Invest significant time in the Analysis Phase

•  Think End-to-End and don’t cut corners ! Engage with an experienced partner.

Torben Vogt Life Science Industry Expert NNIT A/S Østmarken 3A DK – 2860 Søborg +45 44 42 42 42 (phone) +45 30 75 43 38 (mobile) tovo@nnit.com www.nnit.com

Your NNIT Contact

NNIT is one of Europe’s leading consultancies in the development, implementation, validation and operation of IT for the life sciences industry. We create value for our clients by treating their IT as if it were our own and, of course, we meet the industry’s strictest requirements for quality. For nearly two decades, we have applied the latest advances in technology to make our clients’ software, business processes

and communication more effective. NNIT employs 2,000+

people and in 2012, our turnover was €265 million.

Thank You !