Sanofi – The ENCORE Platform Enterprise Content Optimization& Reuse Engine

Joan Affleck - Head, Clinical Documentation

Bhanu Bahl – Business Project Manager

Vasu Ranganathan – Senior Consultant

2012

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CRUISE Program Charter

Delivery of a highly adaptable and accountable service based platform enabled by innovative knowledge management tools and efficient, reusable processes.

Structured authoring and re-use of both content and processes as well as separating content from presentation while proactively ensuring compliance

Reduction of the effort required to prepare, compile and analyse content and documents through a synergy of optimized processes and enabling technology proactively scoped for value by a defined service catalog

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Approach – CRUISE Program implementation

Agile program execution for

all activities

Agile playbook and tools

facilitate common goals and

improve information sharing

Key benefits:

Delivers functionality and business

value incrementally, in time-boxed

releases

Create a Structured Clinical

content Hub

Produces results in faster time

Improves risk mitigation by

correcting direction iteratively

Fosters innovation between the

broader team

Improves team collaboration and

ownership

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Clinical Documentation at Sanofi

• Integral department of Clinical Science and Operations platform

• Highly flexible global team of document specialists

• Service focus: state of the art expertise and resources for

– management of clinical content

– strategic production of submission-ready clinical documents

– disclosure of clinical study protocols and results

• Goals – Innovative and strategic solutions

for global life-cycle documentation

– Accelerate and improve document preparation

– Anticipate strategic documentation roadmap

– Meet documentation needs across product life cycle

– Build a structured library of product-specific content for intelligent reuse

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Clinical Documentation – Timeline

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Business Drivers

ENSURE CONSISTENCY WITHIN THE ORGANIZATION AND BETWEEN PUBLIC DISCLOSURE AND REGULATED REPORTS (NDA, IND, CTA, PSUR...) AGAINST DATABASES

REDUCE CYCLE TIMES, ENABLE EARLIER AND MORE EFFECTIVE DECISION-MAKING AROUND CLINICAL DEVELOPMENT PROGRAMS, AND REDUCE TIME TO MARKET

QUICKLY ASSESS VALUE AND NON-VALUE ADD ACTIVITIES AND MANAGE THE SOURCING OF THOSE ACTIVITIES WITHIN THE CAPABILITIES PORTFOLIOS BALANCING FIXED AND VARIABLE COSTS

SHARE KNOWLEDGE BY MOVING TOWARD REUSABLE COMPONENTS OF INFORMATION THAT CAN BE MANAGED AND REUSED ACROSS PUBLICATIONS, DEPARTMENTS AND AUDIENCES.

BUSINESS DRIVERS

Deliver a highly adaptable and accountable service based platform enabled by innovative knowledge management tools and efficient, reusable processes.

Perform structured authoring by enabling re-use of both content and processes as well as separating content from presentation while proactively ensuring compliance

Reduce the effort required to prepare, compile and analyse content and documents

Lead, change and innovate within the transforming enterprise

PROGRAM PRINCIPLES

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Program Impact

Situation

Refine submission documents preparation and

review processes

Structure scientific information delivered

throughout development to all stakeholders

Define process for preparation of source

documents and summaries across product

development including identification of

process ownership of various documents

Refine CTA/IND review process

Develop content re-use and structured

authoring information system tool

Manage content and ongoing updates of

CTA/CTD documents

Automate publishing of documents into

different formats

Transform to a service based model in Clinical

Documentation as an enabling team

Defects

Unnecessary workload and time

delays

Study reports & appendixes

finalized late / not e-compliant

CTD lack of scientific

consistency

No standard methodology nor

tools for data collection &

aggregation

Lack of structure in CTA/CTD

document review process leading

to long review cycles

Multiple iterations

Recurrent remarks at different

stages of review

1

2 B

A

Over

processing

CTA = Clinical Trial Application, including Investigational New Drug (IND). This remarks applies to the entire document CTD = Common Technical Dossier HA = Health Authorities

C

Impact: Increased Quality, Faster and Cheaper

Change

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What does content reuse look like?

ENTERPRISE CONTENT

Description • Title • Number • ...

Analysis plan

• ... • ...

Results

• ... • ...

Administrative information

• ... • ...

Study report

Appendices

Body

DALA

DRMP

IB

CVD

Pediatric Plan

...

CTD

CTA

Appendices

Section 5

Protocol

Protocol (pdf format)

Disclosure (XML format)

Online protocol (html)

clinicaltrial.gov EMEA

Investigators online help ICTM

Investigators Ethics committees Health authorities

CTA = Clinical Trial Application, CTD = Common Technical Dossier, DALA = Drug Abuse Liability Assessment, DRMP = Development Risk Management Plan, CVD = Core Value Dossier, IB = Investigational Brochure, ICTM = International Clinical Trial Manager

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• Release 1 2011 – baseline platform in place • Extended Synopsis and Protocol Authoring basic service

• Begin Change Management

• Release 2 - Feb 2012 – expand capabilities • Improve Information model and search

• Start operational use of system for authoring

• Continue Change Management

• Release 3 – In progress • Continue authoring of Synopsis and Protocol (several documents

authored in platform)

• Narratives Service – stage 1

• Operational use of system for Narratives

• Continue configuration/ implementation of usability features

Program Status

<<Your Logo>> Business Challenges

• REUSE: Value and benefits increase as content is repurposed across the product and clinical development lifecycle. How to author for reuse?

• DELIVERY: Program implementation iterative based on business priorities, capacity of business to absorb the changes

• PROCESS: Process simplification needs to be incremental and aligned with the SCM roadmap

• STANDARDS: Alignment with enterprise and industry standards namely the HL7, SDTM for narratives

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<<Your Logo>> Technical Challenges

• ENVIRONMENT: WORD and SharePoint 2010 - First at sanofi ; K2 integration

• DELIVERY: Fast-paced Agile approach to delivery - Quarterly releases stretch the testing resources and capabilities

• PERFORMANCE: Complex data in contents poses performance and optimization needs especially in the Publishing engine

• INTEGRATION: real-time Data integration needs in embedded content to other sanofi systems like biostatistics tables, document management systems

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<<Your Logo>> Key SCM Principles

• Improve efficiencies – Separating content from context and presentation

• Improve quality, consistency and accuracy – Reuse of content across deliverables in the product or study

lifecycle

• Ability to incorporate data, un-structured and structured content into output

• Component Content Management – Content managed and stewarded at a more granular level -

Lifecycle policy applied to content across the product or study lifecycle

– Governance/ stewardship of components

• Improve traceability – linkage to outputs – Improve managing changes

– Visibility to impacts of change

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Project Acknowledgements

• Core team leads: – Joan Affleck: Sponsor – Michael Robbins/ Bhanu Bahl: Program Manager – Mitzi Allred: New Services/ Information Design – Mike Kinney/ Sandrine Avaro-Coutant: Product Development – Cynthia Deparis/ Beth Brooks: Change Management – Product Vendor: DITA Exchange/ MicroSoft – Development Partner: ArborSys Group – Mary McKenna, Sarah Larson: Operations/ Engagement

Managers – Clinical Documentation/ CSDs: Users and support team

members who have been critical to roll-out and operationalization

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Technical Solution and Demo

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Intelligent Content Framework

• SharePoint & Office 2010

• DITA Exchange

End-to-end XML Content Component Management System

Single-source-publishing via style sheets

Authoring Interfaces

Word 2010 with DE Plug-in for OXML to DITA XML

Word 2010 “XML interface” for Technical Experts

Re-using existing SharePoint standard features: Sites, Lists, Libraries, Lifecycle, Workflow, Versioning, BDC, Managed Metadata, Search

Third-party Workflow and Rules Engine

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Maps, - Viewed and edited through a Editor interface (Web part)

DITA Exchange – Manage Maps, Topics, Authoring

Maps, Topics, Publications – Managed in libraries

Maps, - Topics edited through a Word Editor interface (Web part)

<<Your Logo>> SCM Key Needs

• Search and Consuming Component Content – Improved and easy ways to search for information

– Easy ways for assembly/ consumption of component content during the output configuration, as well as authoring and review/ approval processes

2012