About Pfizer. Founded 1849 Headquarters New York, New York. Enterprise Value (1) $209.75B Employees 78,300

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3 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 Headquarters New York, New York Revenue (1) $49.60B Enterprise Value (1) $209.75B Employees 78,300 Source: Finance.yahoo.com as of Dec 31,

4 Industry Challenges DRUG DISCOVERY PRE- CLINICAL CLINICAL TRIALS FDA REVIEW LG-SCALE MFG Time (10 15 Years) PRE - DISCOVERY 5,000 10,000 COMPOUNDS 250 IND SUMITTED PHASE YEARS 6 7 YEARS 5 PHASE PHASE 3 NUMBER OF VOLUNTEERS ,000 5,000 NDA SUBMITTED YEARS ONE FDA- APPRO VED DRUG Cost (> $2B) Complexity (Drug Protocol) SOURCE:INNOVATION.ORG 4

5 Clinical Trials Journey 5

6 Driving Site Health 6

7 Path to Sustainable Quality As a sponsor, Pfizer is responsible for ensuring appropriate oversight of all its clinical trials Quality Management Framework Quality Improvement Clinical Trials Security and Compliance (CTSC) unit provides oversight and support to Investigators through the Alliance Partner Model to ensure clinical trial quality Quality Control Quality Planning 7

8 Clinical Trials Oversight Challenges 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

9 Objectives 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

10 Business Solution 10

11 Supporting Technologies 1. Analytics 2. Process Orchestration R-Engine Pega 3. Visualization 4. Data Aggregation Spotfire Data Mart

12 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 Application that would require rules and processes to be moved from design time to run time for testing and execution of the applications 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

13 Key Considerations, contd. Selected Components PegaRULES Process Commander Lifesciences Industry Framework Business Intelligence Exchange Requirements 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 For FDA purpose ability to capture the change that was made, user who made the change and change time stamp Ability to capture Audit trails on the records Ability to export a Oversight Plan into a PDF format Data Analytics and Predictive Modeling (Future) Ability to integrate with various components of Health Monitoring into a one stop shop for all oversight activities Ability to execute canned and ad-hoc reports Feature Dynamic Case Management Auditable Notifications LS Field Auditing Auditable Notifications PRPC auditing capability LS Reports & PDF Form generation RBAM Risk Based Activity Monitoring (Future) Connector Support Reports 13

14 Driving Site Health Journey 14

15 Functional Scope 15

16 Solution Framework UPSTREAM SCOPE DOWNSTREAM SECURITY ENTERPRISE RULESET SYSTEM 1 SYSTEM 2 R-ENGINE SYSTEM 3 INFORMATICA DATA MART SITEHEALTH BIX INFORMATICA DATA MART SPOTFIRE OTHERS SCOPE READ WRITE 16

17 Implementation Methodology An AGILE approach that incorporated business feedback and SDLC procedures throughout the development life cycle. Benefits Modular methods to design and build patterns to manage complex business needs Creation of reusable and decoupled components Fosters a Collaborative Working Approach Handles the Complexity of Business Processes through separation of concerns; Sprint N Sprint 1 Sprint Mgmt. Sprintg 3 Sprint 2 User Socializations Sprint 1 Sprint 2 Sprint 3 Sprint N Refactoring through continuous business Feedback Project Roadmap & Estimate Workshops Reconfirm Scope Sprint Planning User Stories High Level Architecture Value Framework Project Kickoff Test Scripts Functional Testing Integration Testing Change Management & Service Introduction User Acceptance Testing Deploy Outcomes Improved efficiency and productivity Increased pattern recognition More effective library maintenance Component reuse Higher quality 17

18 Site Health Foundation Block 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 PFIZER - ENTERPRISE-WIDE Reuse PEGA 18

19 Solution Summary Pfizer has a robust tool that will enable their resource to more efficiently assess trends The Manual Review process is retired There are no significant changes to everyday practices for the study teams ~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 Country 80+ Users Rollout 300+ Rollout Assets 190+ Studies 950+ Oversight Plans () 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

20 Pharmacovigilance Exchange 20

21 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 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

22 Pharmacovigilance Exchange SITE HEALTH 2.0 SITE HEALTH SITE HEALTH FRAMEWORK PvX Continuously Improve QUALITY and Transform Clinical Trials Execution Specialize by Customer, Product, Geography & Channel 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

23 Randomization Schedules 23

24 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 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

25 GRAABS SITE HEALTH 2.0 SITE HEALTH GRAABS SITE HEALTH FRAMEWORK PvX PvX 2.0 Continuously Improve QUALITY and Transform Clinical Trials Execution Specialize by Customer, Product, Geography & Channel 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

26 Informed Consent Document (Pilot) 26

27 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 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

28 Quality Connect ICD Pilot SITE HEALTH 2.0 In Progress PvX 2.0 Continuously Improve QUALITY and Transform Clinical Trials Execution SITE HEALTH GRAABS SITE HEALTH FRAMEWORK QC Pilot (ICD) PvX Specialize by Customer, Product, Geography & Channel 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

29 NEXT 29

30 Pega Reuse & Specialize At Pfizer PROPOSED Continuously Improve QUALITY and Transform Clinical Trials Execution SITE HEALTH GRAABS QC Pilot (ICD) SITE HEALTH FRAMEWORK PvX Specialize by Customer, Product, Geography & Channel PFIZER - ENTERPRISE-WIDE Reuse PEGA 30

31 Conclusion FUTURE PROPOSED SITE HEALTH GRAABS QC Pilot (ICD) Continuously Improve QUALITY and Transform Clinical Trials Execution SITE HEALTH FRAMEWORK PvX Specialize by Customer, Product, Geography & Channel PFIZER - ENTERPRISE-WIDE Reuse PEGA 31

32 Q & A