The FDA Mandates XMLMaximize Your Investments through Dynamic Publishing

Thursday, November 5, 200911:00 AM ET / 8:00 AM PT

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Today’s Presenters

Michele CobhamSubmissions Manager, Regulatory AffairsPar Pharmaceutical

Bernie ConeySenior Regulatory SpecialistPfizer

Mukul KrishnaGlobal Director, Digital MediaFrost & Sullivan

Richard BrandtVP of Life SciencesQuark

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Mukul KrishnaGlobal Director, Digital Media

Frost & Sullivan

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What is Dynamic Publishing?

Content

Generation

XML

Publishing

Multi-channel

Delivery

Frost & Sullivan defines Dynamic Publishing as a value chain of software products that enable the creation, repurposing and publication, and delivery of content across a variety of medium.

Web services

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Value Proposition of Dynamic Publishing

• An automatic publishing process significantly reduces time

and costs associated with traditional publishing methods

• Repurposable XML content can be leveraged across multiple content channels

• Dynamic Publishing drives accuracy and consistency,

reducing both errors and the usage of non-compliant,

unauthorized content

• Content can be customized easily on a per customer basis

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What are SPL and PIM?

The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product information.

Product Information Management (PIM) is a project that was initiated in 1999 to develop a new way of handling product information. Its membership has been drawn from EMEA, Member State competent authorities and EFPIA members. It has gone through several phases, which have culminated in the publication of the PIM standard.

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Challenges Faced by Pharmaceuticals Companies

• The Pharmaceutical market is highly regulated

• Manual generation of content is very cumbersome

• Maintaining multiple versions of content increases the likelihood of errors or incompliant content

• Content repurposing is resource intensive

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Simplifying the Process with Dynamic Publishing

• Automatic Conversion of content into XML-based SPL and PIM

• Content can easily be repurposed for usage needs, enabling up-to-date product information

• Content retains integrity across all media channels

• Decreased label submission cycle time

• Information can be easily exchanged with regulating bodies including the FDA and EFPIA

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Michele CobhamSubmissions Manager, Regulatory Affairs

Par Pharmaceutical

Meeting the FDA SPL/PLR & R4 Mandates

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Par Became Involved Early On (2005)

1. Teamed up with IS

2. FDA/HL7 SPL Working Group (Generic Team)

3. Requirements Analysis

4. Demos… Evaluations… Comparisons

5. Decision based on

� Simplicity

� Costs

� ‘Getting the job done’

� Training

� Maintenance and Lifecycle Management

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Progression

2005 – Meets SPL compliance date of 10/31/05

2007 – Meets PLR compliance date of 6/30/07

2009 – Meets the R4 compliance date of 6/1/09

Par Maintains Compliance with Quark XML Author

2005 2007 2009

Quark XML Author Quark PLR Accelerator Quark SPL Accelerator

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XML Solution Benefits to Par’s Business

Cost Effectively Maintain FDA Compliance

Accelerate the Label Submission Process

Improve the Accuracy of Information

Reuse Information Across all Publishing Needs

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Cost Effectively Maintaining FDA ComplianceAll Labels are Done In-house by Par Staff

Quark Solution is a Simple Solution•Microsoft Word-compatible plug-in•Cut/Paste exercise

Easily Submitted Through the Electronic Submissions Gateway (ESG)•Labeling and Drug Listing submitted simultaneously•Establishment/Registration and NDC Labeler Code submitted yearly

Simple and Easy In-House Solution for Par

Drug Label

Drug Listing

ESG

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Improving Accuracy of Information

Cut/Paste

• Easily re-purpose approved Microsoft Word labeling file

• Eliminates typing errors

MS Word Template Provides Structure Format

Reuse Actual Content of Labeling in Most Drug Listing Information

Preview Labeling/drug Listing Content Using the FDA Schema

Content of Labeling/Drug Listing Easily Validated Prior to FDA Submission

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Reusing Information Across all of Par’s Publishing Needs

XML Based eCTD Publishing Tool

Foresee a Mechanism to Tie in all the Various Parts of an eCTD Submission:

• Clinical data from studies Content of Labeling

• CMC document Drug Listing and Drug Establishment information

• Updates to content of labeling can be submitted with relative ease

Prepare for Requirements from Outside Sources for XML Based Labeling such as the PDR

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Content Management, Translation Management, SPL and PIM:An Implementation of XML across US and Europe

Bernie ConeySenior Regulatory Specialist

Pfizer

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Business Drivers

SmPC, Outer & Inner Labelling and Package Leaflet, Annex II

USPI, PPI, Med GuideDocuments Under Focus

XML with componentized Schema (only submit/review) the paragraph impacted

XML with initial monolithic Schema (plan to componentize in time) standards set by HL7

Format

Optional for centralized products beginning 11/21/05 – still in pilot phase

Due for all new labels beginning 10/31/05 (conversion alone due on Annual Report schedule)

Approach

Efficiency in managing large volume of labeling content for industry and regulators (due to translations)

Improve Patient Safety through improved information access & Medicare Modernization Act (e-Healthcare Record)

Driver

Product Information Management

Structured Product Labeling (FDA)

Dimension

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Business Goals and Objectives of Content Management System

• Compliance: provides an immediate and long-term solution

• Operational Efficiency: reduce redundancy in managing

labeling content

• Quality: generate documents from a single source

• Benefits from XML: enables Authors to focus on content rather

than format

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System Architecture

• Content Management = Authoring, versioning and rendering of xml into MS-Word documents for US, EU and Core Data Sheets, as well as PIM and SPL (XML)

• Translation System = Collaborative translation production

system automating the translation through workflow and translation memory

• Implementation: Common technology across US and Europe to

meet business needs for SPL, PIM, Translation and Authoring

CMS CONNECTOR

Content

Management

System

Staging Area

Translation

System

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Process EfficiencyTranslation Tool Integration with Content Management System

Send English content to translators

Classify type of translation request

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Labeling ConsistencyMS Word Renditions for US Labeling (also includes SPL)

Clean and Track-changes versions

of content

Annotations displayed

XML Source

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EU Product Information Consistency: Deployment of Translation Memory

Identifies text to be translated. Displays 100% matches

Similar matches displayed for

selection

And displays % of match

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Lessons Learned

• Labelling Staff had no experience with XML • Most staff use MS Word daily• XML highly structured

• Program Management• Project team deployed multiple tools over time

• Cohesion of project team maintained through Core Team

• Senior Management support for Program

• Change Management

• Adoption of new technology

• Quality control of XML content (100% manual check initially)

• Internal systems not prepared for XML

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Lessons Learned

• Single deployment across regions has been challenging

• 3 software tools were used to create system• Managing upgrades to the software

• Regression testing

• Multiple vendors

• Managing Content in XML format benefited staff, enhanced roles and created greater efficiency

• 50% reduction in turnaround time for final submission documents in the US

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Richard BrandtVP of Life Sciences

Quark

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Key Points

● Market Conditions Are Driving Regulatory Change

● New Standards & Technologies Will Offer Relief

● Downstream Benefits Sweeten the Adoption Pot

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FDA Regulatory Change

Where change is the only constant!

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Why the FDA has adopted XML

“In July 2006, the Institute of Medicine of the National Academy of Sciences estimated that more than 1.5 million people annually are injured due to medication errors.”

“The cost of treating hospital-based medication errors alone is conservatively estimated at more than $3.5 billion annually, and this cost does not include estimates for lost wages and lost productivity.”

Source: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), June 2008, Electronic Submissions, Revision 1

No Tolerance for Errors

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Will the pace of change continue?

• Industry maturing with XML standards

• Where FDA benefits the path is clear

• The only real question is what standards are next…

“Receipt of timely and accurate information will enhance FDA’s efforts to help ensure the integrity of the drug supply and protect public health.”*

*(Source: U.S. Department of Health and Human Services, Food and Drug Administration, Office of the Commissioner, May 2009, Electronic Submission)

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Document Management Technology

What’s all the fuss about?Benefits of XML in Document Management

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Open standards offer superior interoperability

U.S. Food and Drug Association Organizations Hospitals Industry Vendors

Quark XML Authorfor Microsoft® Word

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Enhanced indexing improves search ability

Quark XML Author for Microsoft Word and EMC Documentum

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Content re-use streamlines authoring

<SPL>

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Where does SPL go from here?

• All label content is now structured.

• With a DMS, structured labels can be componentized

• Indications can be used in the medical information system

• Drug listing can be used in the product packaging

• Boxed Warning can be used in magazine ads

• Adverse Reactions can be used on the web site

• And the list goes on…

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What is Quark’s and EMC’s role?

Drogue

Droge

Droga

Снадобье

Drug

MobileMobile

WebWeb

PrintPrint

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Q & A

Submit Your Question Below!

Michele CobhamSubmissions Manager, Regulatory AffairsPar Pharmaceutical

Bernie ConeySenior Regulatory SpecialistPfizer

Mukul KrishnaGlobal Director, Digital MediaFrost & Sullivan

Richard BrandtVP of Life SciencesQuark

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$500 voucher to any upcoming

Executive MindXchangewww.frost.com/cal

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