XML in Pharma – Weve Done SPL, Whats Next? SCIENTIFIC SARAH POWELL EXECUTIVE DIRECTOR, REGULATORY STRATEGIES PHILADELPHIA, PA. FEBRUARY 2006

Agenda What is XML? Review of XML-related regulatory initiatives Other potential uses of XML Path forward for your organization

What is XML? Extensible Markup Language –Developed to aid creation, sharing and publishing of information A global standard for adding structure to content –Open standard of the W3C (World Wide Web Consortium) –Extensible: User-defined and industry standard vocabularies –Markup: Defines a hierarchical structure via embedded instructions Meaning (semantics) vs. Presentation (format) XML describes what content is; HTML describes what it looks like –Language: A meta-language - syntax & rules on which other languages can be based

Data Model Structure and Rules Content Narrative and Data + Style Sheets Output presentations + = Desired Output XML is a means of adding structure and intelligence to typically unstructured information

Word Processing XML Content Centered, 20 pt, bold, TNR Centered, 15 pt, bold, TNR Title, Centered 15 pt Arial, Blue Body Text, 12 pt, TNR, Left Justified Proprietary Name Nonproprietary Name Dosage Form Section Title Paragraph Reference to Graphic file Figure Word Processing vs. Structured Authoring ANTIBIOTICX (cephakillitall) TABLETS ANTIBIOTICX (cephakillitall) ORAL SUSPENSION DESCRIPTION To reduce the development of drug-resistant bacteria and maintain the effectiveness of ANTIBIOTICX Tablets and ANTIBIOTICX Oral Suspension and other antibacterial drugs, ANTIBIOTICX Tablets and ANTIBIOTICX Oral Suspension should only be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ANTIBIOTICX® (cephakillitall) Tablets and ANTIBIOTICX® (cephakillitall) Oral Suspension are synthetic broad spectrum antimicrobial agents for oral administration…and its chemical structure is:

Agenda What is XML? Review of XML-related regulatory initiatives Other potential uses of XML Path forward for your organization

XML Touch Points in Pharma Nonclinical Research Clinical Research Manufacturing & Quality Electronic Submissions Safety & Surveillance

SEND –Standard for Exchange of Nonclinical Data –Defines domains and variables for submitting data generated from animal toxicity studies Initiative began in July 2002 SEND model v.1 released Aug 2003 Current version is 2.3 –Domain categories: Interventions Findings Special Purpose –A list of variables are used to define specific domains: Body Weights, Clinical Pathology, Microscopic Findings, etc. –References Study Data Tabulation Model (SDTM) –XML format will replace SAS Transport files Nonclinical Research XML Touch Points in Pharma

Clinical Research / e-Clinical Trials –ODM (Operational Data Model) –LAB (Laboratory Standards Model) –SDTM (Submission Data Standards) –ADaM (Analysis Dataset Model) –CRT-DDS (Case Report Tabulation) Related Healthcare Initiatives (Clinical Care) –CDA (Clinical Document Architecture) Clinical Research XML Touch Points in Pharma

–Structured Protocol Protocol elements based on ICH and Agency Standards Organization based on HL7 Reference Information Model (RIM 3) Transport in XML Viewing tools and repository available to reviewers –Study Reports – Study Tagging Files Based on ICH E3 and eCTD Guidance Information related to study report Clinical Research XML Touch Points in Pharma

Stability –Standard for submission of stability data to FDA –Implementation Guide available Manufacturing & Quality XML Touch Points in Pharma

eCTD SPL PIM Electronic Submissions XML Touch Points in Pharma

Adverse Event Reports –ICSR –EVMPD Safety & Surveillance XML Touch Points in Pharma

Agenda What is XML? Review of XML-related regulatory initiatives Other potential uses of XML Path forward for your organization

XML Authoring Possibilities eCTD Labeling (SPL/PIM) AERs CMC or Quality Info Study Protocols & Reports Medical Inquiries Promotional Materials Correspondence/Q&A Presentations Meeting Minutes

Standard Driven eCTD Labeling (SPL/PIM) AERs CMC or Quality Info Study Protocols & Reports Medical Inquiries Promotional Materials Correspondence/Q&A Presentations Meeting Minutes

Lets Explore eCTD Labeling (SPL/PIM) AERs CMC or Quality Info Study Protocols &Reports Medical Inquiries Promotional Materials Correspondence/Q&A Presentations Meeting Minutes

Human Readable Machine Readable Module 3 – 3.2.S.2.2

US Submission

EU Submission Step Details excluded

Agenda What is XML? Review of XML-related regulatory initiatives Other potential uses of XML Path forward for your organization

Organizational Focus Strategic Thinking –Implementation provides an opportunity to gain efficiencies while improving quality –Approach as business strategy Focus on solving business problems not just compliance Identify opportunities and prioritize –Choose technologies that have scalability and flexibility –Select Quick Wins to build internal confidence and solution credibility SPL is best thing to raise awareness of XML

Strategic Implementation Document enterprise view of strategic approach to XML implementation: –Document Analysis: Which documents share information? How much reuse does the content offer? Can information be structured and delivered via publishing? –Common business processes How is content utilized by various stakeholders? What are the lifecycle requirements of the content? –Publishing Who requires access to the final documentation? What publishing formats are needed and when? Are separate controls (lifecycle, archiving, etc.) needed?

Identify tools that are scalable and flexible to support the enterprise –Authoring and publishing Implementation based on company priorities –Which document types to tackle first? Strategic Implementation cont.

Conclusions SPL and PIM are the first of many XML initiatives affecting life sciences organizations. Plan for enterprise adoption –Establish business rules around the creation, use, reuse, and lifecycle of content –Embrace the technology and the opportunity to gain efficiencies

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