XML in Pharma – We’ve Done SPL, What’s
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
=
Desired
Output
Style Sheets
Output presentations
+
Content
Narrative and Data
+
Data Model
Structure and Rules
XML is a means of adding structure and intelligence to typically
unstructured information
Word Processing vs. Structured Authoring
Word Processing
XML Content
ANTIBIOTICX
Centered, 20 pt,
bold, TNR
Centered, 15 pt,
bold, TNR
Title, Centered
15 pt Arial, Blue
Body Text, 12 pt,
TNR, Left
Justified
Figure
(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:
Proprietary
Name
Nonproprietary
Name
Dosage Form
Section Title
Paragraph
Reference to
Graphic file
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
Clinical Research
Nonclinical
Research
Manufacturing &
Quality
Safety & Surveillance
Electronic Submissions
XML Touch Points in Pharma
• SEND
Nonclinical Research
– 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
XML Touch Points in Pharma
• Clinical Research / e-Clinical Trials
Clinical Research
– 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)
XML Touch Points in Pharma
– Structured Protocol
Clinical Research
• 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
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
Electronic Submissions
• PIM
XML Touch Points in Pharma
• Adverse Event Reports
– ICSR
– EVMPD
Safety & Surveillance
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
Let’s Explore
•
•
•
•
eCTD
Labeling (SPL/PIM)
AERs
CMC or Quality Info
• Study Protocols &Reports
• Medical Inquiries
• Promotional Materials
• Correspondence/Q&A
• Presentations
• Meeting Minutes
Module 3 – 3.2.S.2.2
Human Readable
Machine Readable
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?
Strategic Implementation cont.
• 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?
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
Contact Information
e-mail: sarah.powell@thomsonreuters.com
Phone: (916) 797-0137