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How data integration can change clinical development and pharmacovigilance

Mike Grossman VP Clinical Warehousing and Analytics

Challenges in the Life Sciences Industry

Pipeline Failures and Delays

Rapid Generic Erosion

Neurontin®

Blockbuster US Patent Expiries

Safety-Based Drug Withdrawals

VIOXX
2004
Combined peak sales were in excess of $11 Billion
This slide courtesy Oracle Corp

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Development Trends for Successful Survival
• Virtual Development
– Each departmental business process may be performed in house our externally for optimal program delivery

• More Targeted Development Plans
– Full knowledge of previous experiences in similar compounds – Comparative Effectiveness Studies test hypotheses – Outcomes data used to simulate development plans
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Development Trends for Successful Survival
• Proactive Pharmacovigilance
– Continuous monitoring of Adverse Events along side other clinical data including:
• Clinical Trials Safety Data • Outcomes Data Mining

• Flexible and Adaptive Trials
– Continuous analysis of blinded data – Rapid reactions to changes in protocol arms – End-to-end regulatory compliance

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Keys for Implementing Virtual Development
• Standard approach to using collected clinical trial data independent of collection method
– Common integrated reporting for statistical analysis – Common integrated reporting for Clinical Operations and Data Management – Both patient data and metrics data included together – Standard representation of study meta data and data
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Keys for Improving Development Plans
• Pooled data marts available for scientists of past experience of all clinical data based on patent subsets • Comparative effectiveness studies test hypotheses without running a formal trial • Pooled outcomes data used to predict study feasibility
There us a very useful document entitled: “Improving Medical Decisions Through Comparative Effectiveness Research: Cancer as a Case Study” (http://focr.org/files/CER_REPORT_FINAL.pdf)
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Keys for Proactive Pharmacovigilance
• Integrated clinical trials patient data and Adverse Events data • Integrated ongoing data mining of outcomes data combined with formal clinical data

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Holistic Reference Clinical IT Reference Architecture
Ad-Hoc Query Dashboards Structured Reports Analytical Tools

Inbound Data Sources
CTMS CDMS/ EDC Central Labs LIMS/PK External Study Data Outcomes

Staging Area
Trials Management Study Specific Data Staging Shared Study and Project Meta Data Source Specific Outcomes Data AES & Complaints

Operational Area
Operational Trial Metrics Conformed Study Data Value Added Study Data Project level Conformed Data Outcomes Common Data Model

Warehouse Area
Clinops Data Marts Patient Sub Setting and Safety Warehouse Specialized Data Data Specialized Data Specialized for Marts for Marts Marts for Scientific Scientific Scientific Exploration Exploration Exploration and and Mining and Mining Mining

Strategic Analysis Regulatory Reporting Data Mining Clinical Development Planning

AES & Complaints Master Meta Data Meta Data Libraries, Version Control, Compliance Change Mgt

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Service Oriented Architecture for Clinical Meta Data Integration
Inbound Data Sources
CTMS CDMS/ EDC Master Meta Data LIMS/PK External Study Data Outcomes AES & Complaints Central Labs Ad-Hoc Query Dashboards Structured Reports Analytical Tools Meta Data Libraries, Version Control, Compliance Change Mgt Regulatory Reporting Strategic Analysis

Standard Messages and Terminology for Studies, Sites, Investigators, Subject Data Structures

Enterprise Service Bus

Staging Area

Operational Area

Warehouse Area

Data Mining Clinical Development Planning

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Solution Components
– To achieve operational efficiency, meta data and data must be put to a common definition for maximum reuse. – To look across many studies that share characteristics, the common data must be viewable in a way that allows for modeling and scenario building – To continuously monitor safety, specific domains must be combined and monitored in an ongoing manner – To understand observational data from multiple sources it must be brought together to allow for common tools and methods to be applied across sources.
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Clinical Data Integration Definer User Communities
• Study Data Conformers
– Needs knowledge of each study’s details
• Re-use standard transformations • Understand study specific use of meta data driven transformations

• Statistical Programmers
– Focus on executing on analysis plans for submissions – Primary and initial customer for conformed data

• ETL (Extract Transform Load) IT Developers
– IT Warehouse and SOA designers and implementers

• Exploratory Scientists
– Non-structured, non-validated exploration using a variety of tools – Once a useful method is found it needs to be parameterized and established for re-use and mining
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Practical Considerations
• Design a scalable regulatory compliant enterprise reference architecture • Select focused project within that architecture that have stand alone wins and return on investment • Manage each project by establishing formal processes, SOPs, roles and responsibilities etc • Once the basic architecture is in place get immediate wins and add automation in subsequent phases • Start new projects as existing projects go-live • Make full use of shared meta data • Do not lock into a single standard - design for change • Do not lock user types into unfamiliar tools
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Questions and Contact
If you have additional questions please contact: Mike Grossman Vice President, Clinical Data Warehousing and Analytics BioPharm Systems, Inc. Tel. (617) 447-2603 (Eastern Time) Fax (617) 447-2604 mgrossman@biopharm.com www.BioPharm.com

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