SPL Challenge SPL Working Group Meeting Rockville Maryland

SPL Challenge SPL Working Group Meeting Rockville, Maryland 4 June 2004 1

Overview • Introduction to Intrasphere • Labeling Experience • Our Approach • Data Migration • Demo 2

Introduction to Intrasphere • Vital Statistics – Founded in 1996 – Offices in NYC, London, North Carolina RTP – 200 Employees, high retention rate – Profitable, privately held • Pharmaceutical Focus – Regulatory Reporting and Document Management – Clinical Trial and Data Management – Safety and Pharmacovigilance – Pre-clinical (PK/PD) – Finance and Commercial Operations 3

Introduction to Intrasphere • Clients Aventis CDISC Covance Eli Lilly Merck Novartis Otsuka Pfizer Pharmacia Pharsight Purdue J&J Ranbaxy Roche Sanofi Schering Plough • Partners BEA Pharsight Business Objects Intralinks Waban 4 Oracle Arbortext Informatica Metasolutions Smart Ops Documentum IBM Microsoft Sun Isogen

Labeling Experience • Working with XML & Labeling since 2001 • Developed an XML-based solution for a top 10 Global Pharma • US and EU Labeling/Product Information • Physician, Patient, Carton/Label • Focus on – Global Solution – Content Reuse – Single Source Publishing – Regulatory Compliance • Documentum, Arbortext, web-based application 5

Our Approach - Manage labeling in XML • • • 6 Separation of content from format Interoperability Better data analysis and management Reuse Rendering Tool Independence

Our Approach - Use an authoring DTD or schema • Model the data for authoring and content management • Extend to other document types – Core Data Sheet – Other regions, e. g. EU, Japan, Brazil – Audiences – patient as well as physician – Destinations – marketing, manufacturing – Sources – clinical • Support component-based content management • Support other special features such as variable elements • Support rendering requirements including MS-Word, packaging, PDF, PDA 7

Our Approach - Use the Repository • Versioning at the component level • Integrate with databases for codes (e. g. LOINC) • Creating and maintaining the non-narrative section – More natural to use properties/metadata – Dual purpose – also supports the narrative section – Provides utility in the repository, e. g. searching, categorization 8

Data Migration - What about all those MS-Word docs? • Several options are available – Tools such as Arbortext’s Interchange – MS-Word 2003 with XML capabilities – Services such as DCL § Let them use the tools § Let them deal with the exceptions § Have an process for turning documents around § Have experience with our application, with labeling in general and with SPL 9

Live Demo 10

Summary • Advocate of full XML utilization • Conform to both existing and emerging XML standards – SPL, PIM, others (Japan, Brazil, Sweden…) • Maximize ROI through extended content reuse and single source publishing • Lay foundation for extension into other departments, e. g. Manufacturing, Marketing • Build on standards-based architecture – tool independence 11

For more information Intrasphere Technologies, Inc. Tom Moore tom. moore@intrasphere. com 212 -937 -8253 Jake Nadler jake. nadler@intrasphere. com 212 -937 -8270 Arbortext, Inc. Bob Wass bwass@arborttext. com 732 -493 -1739 12