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About Pfizer Pfizer Inc., a biopharmaceutical company, discovers, develops, manufactures, and sells healthcare products worldwide. Key disease areas of focus in Oncology, Biosimilars, Inflammation and Immunology, Neuroscience & Pain, Vaccines, Rare Diseases, and Cardiovascular & Metabolic Diseases Founded 1849 Revenue (1) $49.60B Headquarters New York, New York Enterprise Value (1) $209.75B Employees 78,300 Source: Finance.yahoo.com as of Dec 31, 2014 3 Industry Challenges DRUG DISCOVERY PRECLINICAL FDA REVIEW CLINICAL TRIALS LG-SCALE MFG 5 250 ONE FDAAPPRO VED DRUG 3 – 6 YEARS PHASE 250 1 PHASE 2 PHASE 3 NUMBER OF VOLUNTEERS 20 - 100 100 - 500 6 – 7 YEARS 1,000 – 5,000 NDA SUBMITTED 5,000 – 10,000 COMPOUNDS IND SUMITTED PRE - DISCOVERY Time (10 – 15 Years) Cost (> $2B) Complexity (Drug Protocol) 0.5 – 2 YEARS SOURCE:INNOVATION.ORG 4 Clinical Trials Journey Study Design Study Startup Study Conduct Study Closeout 5 Driving Site Health Study Design Study Startup Study Conduct Study Closeout 6 Study Design Path to Sustainable Quality As a sponsor, Pfizer is responsible for ensuring appropriate oversight of all its clinical trials Clinical Trials Security and Compliance (CTSC) unit provides oversight and support to Investigators through the Alliance Partner Model to ensure clinical trial quality Study Startup Study Conduct Study Closeout Quality Management Framework Quality Improvement Quality Control Quality Planning 7 Clinical Trials Oversight Challenges Study Design Study Startup Study Conduct Study Closeout • Highly manual processes to share oversight findings with Alliance Partner personnel running the clinical trial • Existing solution offering was antiquated (Microsoft SharePoint/Word) • Limited options to move to the world of centralized and risk-based oversight • Existing system design did not align to increased, centralized and remote oversight business requirements • Existing platform did not integrate easily with other data sources • Existing solution could not deliver the expected web capabilities and platform support desired now, and into the future • Analytics did not exist to identify areas where centralized oversight can substitute for onsite visits 8 Objectives Study Design Study Startup Study Conduct Study Closeout • Increase efficiency of clinical trial execution • Advance Pfizer ahead of industry peers through continuously cumulative insights and experience • Deliver data-driven insights to support Pfizer interactions with investigators and regulators and take targeted actions • Adopt TransCelerate RBM Concepts 9 Business Solution Study Design Study Startup Study Conduct Study Closeout 10 Supporting Technologies 1. Analytics R-Engine 3. Visualization Spotfire Study Design Study Startup Study Conduct Study Closeout 2. Process Orchestration Pega 4. Data Aggregation Data Mart Key Considerations in Choosing Solution • A recognized Market leader in BPM, Dynamic Case Management, CRM based on Pega’s process-centric approach • Create intent-led user experience specialized based on any circumstance • Fully unified solution for automating the development of business applications and the resolution of business processes • Foundation Framework has been developed on industry best practices • Highly configurable, rules-driven system • Specialized for business automation through dynamic case management • No need for a separate Design Application that would require rules and processes to be moved from design time to run time for testing and execution of the applications • • • • • • • • • • • Study Design Study Startup Study Conduct Study Closeout Unified Platform Process Centric Approach Legacy Modernization and Transformation Empower the Business to Own the Change Change the Organization Structure to Meet Market Demands Easily/Quickly innovate with New Products and Services Expand Solutions Globally Drive Agility and Automation Demonstrate ROI and COST Savings Foster Great Customer Experiences Supports widest possible array of integration and connectivity standards 12 Study Design Key Considerations, contd. Requirements Selected Components Study Startup Study Conduct Study Closeout Feature Enable management./conduct of oversight activities – Resource assignments, documentation of oversight activities including on-site visits and/or remote risk data review and managing issues and documenting Resolution • Dynamic Case Management Auditable Notifications For FDA purpose ability to capture the change that was made, user who made the change and change time stamp • LS Field Auditing Auditable Notifications • Lifesciences Industry Framework Ability to capture Audit trails on the records • PRPC auditing capability Ability to export a Study Oversight Plan into a PDF format • LS Reports & PDF Form generation Data Analytics and Predictive Modeling (Future) • RBAM – Risk Based Activity Monitoring (Future) • Business Intelligence Exchange Ability to integrate with various components of Health Monitoring into a “one stop shop” for all oversight activities • Connector Support Ability to execute “canned” and “ad-hoc” reports • Reports • PegaRULES Process Commander 13 Driving Site Health Journey Study Design Study Startup Study Conduct Study Closeout 14 Functional Scope Study Design Study Startup Study Conduct Study Closeout 15 Study Design Solution Framework SCOPE UPSTREAM SECURITY Study Startup Study Conduct Study Closeout DOWNSTREAM ENTERPRISE RULESET SYSTEM 1 R-ENGINE … … DATA MART … BIX SITEHEALTH INFORMATICA … DATA MART SYSTEM 3 INFORMATICA SYSTEM 2 SPOTFIRE … OTHERS SCOPE READ WRITE 16 Implementation Methodology An AGILE approach that incorporated business feedback and SDLC procedures throughout the development life cycle. Benefits • Modular methods to design and build • Design patterns to manage complex business needs • Creation of reusable and decoupled components Sprint N • Fosters a Collaborative Working Approach • Handles the Complexity of Business Processes through separation of concerns; Sprint 1 Sprint Mgmt. User Socializations Sprint 2 Sprint 1 Sprint 2 Sprint 3 Sprint N Sprintg 3 Refactoring through continuous business Feedback Test Scripts Functional Testing Integration Testing Change Management & Service Introduction Project Workshops Roadmap & Reconfirm Scope Estimate Sprint Planning User Stories High‐Level Architecture Design Value Framework Project Kickoff User Acceptance Testing Deploy Outcomes • Improved efficiency and productivity • Increased pattern recognition • More effective library maintenance • Component reuse • Higher quality 17 Site Health Foundation Block Study Design Study Startup Study Conduct Study Closeout • Site Health Pega foundation code allowed Pfizer to generate reuse platform for subsequent applications • The reuse saved schedule development time and dollars Continuously Improve QUALITY and Transform Clinical Trials Execution SITE HEALTH Specialize by Customer, Product, Geography & Channel SITE HEALTH FRAMEWORK Reuse PFIZER - ENTERPRISE-WIDE PEGA 18 Solution Summary • Pfizer has a robust tool that will enable their resource to more efficiently assess trends • ~1300 requirement specifications in 5 months with no custom coding • Leveraging out of the box a case management/BPM tool with out-ofthe-box UI, business rule capabilities, reporting functions, work flows • The Manual Review process is retired • There are no significant changes to everyday practices for the study teams Country Rollout 80+ Users Rollout 300+ Assets 190+ Studies 950+ Oversight Plans (Study) 500+ Oversight Reports (Site) 18k+ Issues & Actions 59k+ & 82k+ Take Home Message: Improved data quality thru faster issue identification, and more proactive management of site issues without additive resources 19 Pharmacovigilance Exchange Study Design Study Startup Study Conduct Study Closeout 20 Study Design Business Challenge • Business Challenge – Manually managing individual agreements, with multiple partner organizations, with a significant number of individual products in scope – Continuous assessment of the benefit risk analysis of the overall clinical trial process Study Startup Study Conduct Study Closeout • Solution: – Leverage existing Pega assets and supports to capture Pharmacovigilance agreements – Capture responsibilities of each partner for various activities in Agreements – Periodically monitor these responsibilities. 21 Study Design Pharmacovigilance Exchange Study Startup Study Conduct Study Closeout Continuously Improve QUALITY and Transform Clinical Trials Execution SITE HEALTH 2.0 SITE HEALTH PvX Specialize by Customer, Product, Geography & Channel SITE HEALTH FRAMEWORK PFIZER - ENTERPRISE-WIDE Reuse ~30% reuse PEGA Benefits: • Implemented a more holistic risk based auditing system of PVA partners through capturing the contractual agreements between the Marketing Authorization Holders (MAH) and their Pharmacovigilance responsibilities • Centralized tracking and monitoring of Agreements as per customer’s SOPs and procedures and execution of those commitments contained within PVAs on a global basis 22 Randomization Schedules Study Design Study Startup Study Conduct Study Closeout 23 Study Design Randomization Schedules • Business Challenge – Various tools and procedures are in place to create and maintain Randomization Schedules – Need to standardize and automate Randomization Schedule process. – Controlling access to these randomization codes Study Startup Study Conduct Study Closeout • Solution: – Currently automating 7 manual processes through GRAABS system using Pega Life Sciences Industry Foundation (LSIF) and Dynamic Case Management frameworks and Pega reusable assets as a base 24 Study Design GRAABS PvX 2.0 SITE HEALTH 2.0 SITE HEALTH GRAABS PvX Study Startup Study Conduct Study Closeout Continuously Improve QUALITY and Transform Clinical Trials Execution Specialize by Customer, Product, Geography & Channel SITE HEALTH FRAMEWORK PFIZER - ENTERPRISE-WIDE Reuse ~50% reuse PEGA • Benefits: – Authoritative and Administrative Source for Randomization Schedules – Enable distribution of treatments among the study’s patients without any bias – Provides users with an audit trail of the process – Efficiency in randomization scheduling process 25 Informed Consent Document (Pilot) Study Design Study Startup Study Conduct Study Closeout 26 Study Design Business Challenge • An ever-increasing number of locations, people and resources to acquire information to – Improve on “getting things done” • The situation is an ongoing challenge of balancing resources to meet the ultimate goal of providing solutions for the unmet needs of our patients Study Startup Study Conduct Study Closeout • Solution – Using Informed Consent Documentation as a Pilot Process • Provide a centralized and a single point of access for the tools, knowledge, and metrics and measures to the colleagues • Transform the way Pfizer and vendors work, and access information and resources critical to clinical development while enhancing data quality and ensuring patient safety 27 Study Design Quality Connect – ICD Pilot In Progress PvX 2.0 SITE HEALTH 2.0 SITE HEALTH GRAABS QC Pilot (ICD) PvX Study Startup Study Conduct Study Closeout Continuously Improve QUALITY and Transform Clinical Trials Execution Specialize by Customer, Product, Geography & Channel SITE HEALTH FRAMEWORK PFIZER - ENTERPRISE-WIDE Reuse ~50% reuse PEGA • Benefits* – One Place for Knowledge (Quality & Process) - Provide a single point of access and show a comprehensive view of processes – Enhance Clinical Development – Simplify the documentation landscape and provide in-time and relevant information tailored to users to perform their roles an responsibilities – Enhanced process controls – Reduced effort to locate necessary information – Reduced effort and cost in automated process 28 NEXT 29 Study Design Pega Reuse & Specialize At Pfizer PROPOSED SITE HEALTH Study Startup Study Conduct Study Closeout Continuously Improve QUALITY and Transform Clinical Trials Execution GRAABS QC Pilot (ICD) PvX SITE HEALTH FRAMEWORK Specialize by Customer, Product, Geography & Channel Reuse PFIZER - ENTERPRISE-WIDE PEGA 30 Conclusion Study Design Study Startup Study Conduct Study Closeout FUTURE PROPOSED 2013-14 SITE HEALTH 2014-15 GRAABS 2015 QC Pilot (ICD) 2014-15 PvX 2013-14 SITE HEALTH FRAMEWORK Continuously Improve QUALITY and Transform Clinical Trials Execution Specialize by Customer, Product, Geography & Channel 2013-14 Reuse PFIZER - ENTERPRISE-WIDE PEGA 31 Q&A
