Rethinking Clinical Research with a Clean Slate

1. Rethinking Clinical Research with a Clean Slate I7 May 2011 | Beijing, China Wayne R. Kubick Sr. Director, Product Strategy Oracle Health Sciences wayne.kubick@oracle.com

2. Topics • Old Habits Die Hard • New Habits and Opportunities of a Blank Slate: • Using a 21st Century Technology Infrastructure • Data Standards for Interoperability • Treating Information as a Critical Asset • The Convergence of Healthcare and Research • Conclusions www.diahome.org

3. Old Habits Die Hard It is not sufficient to apply new technology to old processes www.diahome.org

4. The New Drug Development Paradigm Aerospace transformation… Boeing has rapidly shifted the company to embrace a “network” of partners Clinical development transformation… Merck is shifting drug development toward embracing a “network” of partners Piramal PoC Oncology Drug Discovery Ranbaxy Antifungal and Antibiotic Target Programs WuXi AppTec Discovery Chemistry • Patheon • Commercial Manufacturing • Pharmaceutical Dev. Services • PPD • Vaccine Testing • Central Lab and Sample Storage Orchid Chemicals Bacterial and Fungal Infection Dev Advinus Candidate Drugs for Metabolic Disorders Moffitt Cancer Center Total Cancer Care Partners Across the Globe Are Bringing the Boeing 787 Together Merck External Basic Research (EBR) team expects to deliver 25% of early pipeline from external partners by 2013 (Source: Pharma Focus Asia) Source:Oracle Health Sciences www.diahome.org

5. New Habit: Cloud Computing • Faster implementation for less cost and bother • Rapid scalability • Ability to support multiple devices • But real pay-off will be when we can cross-use shared data www.diahome.org

6. Old Habit: Paper CRF Process CRFs CRFs Source Document DB1 Double Data Entry Primary Investigator CRC Master Clinical Data DB Source Verification Data Review DB2 Query Report Form CRA Edit checks Generate Queries Print Query Report Form CDM Query Report Form Query System DB Site Sponsor Source: Paul Bleicher

7. New Habit: EDC Process CRFs Source Document Web Server App Server Primary Investigator CRC Master Clinical Data DB • Run edit checks upon entry • Resolve queries immediately • Create edit checks • Data Review • Enter queries manually Source Verification CDM Internet • Data Review • Enter queries manually CRA CRA Site Sponsor

8. Begin with the End in Mind:Data Standards for Interoperability • Old Habits: • Author each protocol as an individual text document • Collect data on paper source documents and CRFs • New Habits: Begin with the end in mind • Structured protocol drives EDC system setup and analysis plans • Standard metadata represented in a clinical data warehouse • Collect data electronically at source • Avoid transcription • Always use common data standards www.diahome.org

9. Clean Database Old Habit: Data Silos for Each Study Administration & Data Handling 75% Patient Recruitment 25% Investigative Site Workflow 1 Workflow 3 Workflow 2 Workflow 4 Regulatory Documents Management Clinical Data Capture Data Management Randomization Drug Mgmt. Study Tracking • Disparate workflows, systems and views • No holistic view of studies or clinical program • Inability to combine data across studies Source: JagathWanninayake www.diahome.org

10. Old Habit: Disposable Data Standards-based Metadata Repository and Data Warehouse Promotes Re-use www.diahome.org

11. New Habit: Data Standards for Reuse • Standards-based data promotes pooling, • Comparison and reuse • Collect once, use many times • Treat all research data as a critical asset www.diahome.org

12. The Convergence of Healthcare and Clinical Research Personalized Healthcare Translational Med “Precision” Healthcare Targeted Therapies Patient Care and Disease Mgmt DNA chemistry and advanced technology “Evidence Based” Healthcare Analytics Pharmacovigilance and Risk Mgmt Safety at Point of Care Increased regulation and efficacy standards “Managed” Healthcare Electronic Data Capture Electronic Medical Records “Trial and Error” Healthcare Blockbusters and mass-production of novel drugs Paper based Records Paper based Systems HEALTHCARE LIFE SCIENCES LIFE SCIENCES HEALTHCARE Source:Oracle Health Sciences www.diahome.org

13. Gaining Control of Healthcare Data Consumers Healthcare Health Science Cloud Providers Provider Network Life Science Public Data Payers Provider Healthcare Data Model Standards Bodies Provider Catalog Mgmt Academic Research Request Workflow Catalog Content Enrichment App Exchange Provider Public Health Orgs Regulatory Agencies Provider Network Controlled Analytics Standards Bodies Investment Firms Health Consumerism Some provider functions move from enterprise to market, e.g. IRB workflow, Patient consent, common licensing practices Source:Oracle Health Sciences www.diahome.org

14. EHR Linking Healthcare & Research Clinical Research Public Health Quality Safety Case Report Form RFD RFD RFD Outbreak Report Quality Measure Secondary Uses Standards Used: CDISC Structured Protocol Model CDASH forms with ODM Transport Retrieve Protocol for Execution (RPE) Profile Retrieve From for Data Capture (RFD) Profile CDISC ODM Standard messaging and archive Primary Use Source:Landen Bain, CDISC www.diahome.org 14

15. New Habit: Control & Reuse Data www.diahome.org

16. Conclusions • China has a rare opportunity to look forward, rather than back, by applying new technologies to its rapidly growing clinical research and development activities • Some principal opportunities include: • Build a 21st century IT infrastructure: use shared resources in the cloud and mobile technologies. • Become digital – avoid paper wherever possible • Embrace standards to enable interoperability and reuse • Treat all research information as a valued asset – gain control of healthcare/research data from the beginning • Bet on the convergence of healthcare and research • To realize the vision, we will need collaboration and support among sponsors, regulators and vendors. www.diahome.org

17. Rethinking Clinical Research with a Clean Slate: Bad Habits or New? “The fundamental difference between a dog and a human being is simple: When you point with your finger, the dog looks at the tip.” --Nicholas Negroponte www.diahome.org

18. Rethinking Clinical Research with a Clean Slate Thank you. wayne.kubick@oracle.com