# Presentation: 791899

## SPL Challenge

- SPL Working Group Meeting
- Rockville, Maryland
- 4 June 2004

## Overview

- Introduction to Intrasphere
- Labeling Experience
- Our Approach
- Data Migration
- Demo

## 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

## Introduction to Intrasphere

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

## Our Approach- Manage labeling in XML

- 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

## 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

## 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

## Live Demo

## 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

## 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**