A new safety model – how will the interaction model change?

1. A new safety model – how will the interaction model change? EHR workshop 12th October 2007

2. Table of Contents When two industries converge A framework for transformation Presentation Title | Document ID | 19-Dec-19

3. Two Industries in Transformation The information explosion will reshape business models… Research cannot be confined to centres of excellence Pharma Providers • Understand disease, targets and potential treatments/risks • Take more informed decisions in development based on better target product profiling • Use new techniques such as predictive modelling to profile treatments • Conduct and update risk/benefit reviews on a regular basis • Target care and minimise risk through access to a complete medical history • Identify potential safety issues and understand them in real-time Research Clinical Trials Outcomes Research Patient Tracking Payers • Reimbursement for treatments based on full understanding predicted outcomes in target groups • Profile incentives for better outcomes and value Source: Adapted from IBM Study: “Interoperability between healthcare and the pharmaceutical industry”, 2006 Presentation Title | Document ID | 19-Dec-19

4. When two industries converge > Potential Inhibitors However, there are a number of potential inhibitors to the converged state • Silos of data and multiple systems exist both within and across the industries with the following implications • It is difficult and/or time consuming to find data, ADRs may get inadequate follow-up • The potential to investigate safety concerns is not realised • People are ‘protective’ of their data creating competition and inhibiting collaboration • Data standards are lacking in many areas • It is either impossible or very time consuming and costly to combine data for research purposes • Security, compliance and privacy issues require trust to be built between the Pharma and healthcare industry and must ensure patient confidentiality and intellectual property protection • People will need to change the way they work • Safety reviews are conducted largely in isolation, there is a lack of trust that inhibits collaboration • People within and across organisations are ‘protective’ of ‘their’ information – yet a the information explosion requires greater collaboration Source:IBM Study: “Interoperability between healthcare and the pharmaceutical industry”, 2006 Presentation Title | Document ID | 19-Dec-19

5. When two industries converge > Potential Inhibitors > R&D model The existing R&D model does not encourage trust and close collaboration between people “When it comes to researchers, they don’t like to share data because they are sensitive to how it will affect their careers. The big problem can’t be resolved until we do this.” (Interviewee, Karolinska Institute) Interoperability does not necessarily mean a different way of doing the job – it is more about how you work within different boundaries. We will need more people who are skilled in networking. So there will be a shift from being introverted towards interacting with people outside the organization.” (Interviewee, AstraZeneca) “If we are more integrated with the external world then an absolute pre-requisite for this is mutual trust between partners.” (Interviewee, AstraZeneca) An IBM study found strong support for closer collaboration through interoperability while recognising that trust is an important barrier to overcome Source:IBM Study: “Interoperability between healthcare and the pharmaceutical industry”, 2006 Presentation Title | Document ID | 19-Dec-19

6. When two industries converge > scope for interoperability IBM research found that researchers rated the benefits of interoperability and collaboration highly… High Adhoc partners Collaborators • AstraZeneca Average • Karolinska Institute • Karolinska University Hospital Desired position Average score for potential benefits with interoperability Discrete specialists Efficient integrators Low Average level of integration of information today No integration Extensive integration Today organisations can only hope to partner on an adhoc basis. Data integration opens the way for true collaboration Source:IBM Study: “Interoperability between healthcare and the pharmaceutical industry”, 2006 Presentation Title | Document ID | 19-Dec-19

7. Table of Contents When two industries converge A framework for transformation Presentation Title | Document ID | 19-Dec-19

8. A framework for transformation > Framework for convergence The following framework describes the activities that will be required to create a converged environment Governance and Strategy • Implement shared governance across the organizations for business & technical requirements • Agree role for individual organizations within the converged environment • Define and put in place performance metrics • Set scope & strategy and secure finance Organization & People Processes • Set up a stakeholder management plan • Implement communication strategy for players in the interoperable environment and the outside world • Develop a change management program to reinforce culture of shared values and trust • Put in place code of conduct to ensure confidentiality is maintained • Conduct a skills assessment and train/recruit to fill the gap • Set up relationship with trusted third party • Adopt an eClinical environment across R&D • Ensure consistent data standards • Align complimentary business processes • Ensure flexibility of processes Technology / Infrastructure • Store all records electronically • Set up trusted virtual domains • Work with trusted third party • Architect systems for efficient extraction of data • Secure systems that maintain patient confidentiality • Enter data only once and customised single point of access for users In more detail… Source: IBM Institute for Business Value analysis Presentation Title | Document ID | 19-Dec-19

9. Business development Customer relationship Clinical care Business operations Financial management Health information technology Operational Levels Business Administration Drug Discovery Drug Development & Approval Distribution Sales, Marketing & Medical Manufacturing Pricing and reimbursement strategy Clinical process best practices and outcome improvement planning Physical plant planning Consumer strategy Information technology strategy Service line planning Corporate Strategy & Planning Brand Strategy Research & Development Strategy Manufacturing Strategy Supply Chain Strategy Preclinical Development Strategy & Planning Payer strategy Risk Management Supply chain strategy Marketing/brand strategy Channel Strategy EHR strategy Budget and capital planning Patient safety strategy Alliance Strategy Therapeutic Area Development Strategy Clinical Development Compliance Strategy Supply Chain Planning HR Strategy and Planning Pricing & Contracting Strategy Direct (strategy, planning) Discovery Science Strategy Drug Development Technology Strategy Outcomes Research Joint venture, shared service and acquisition planning Physician strategy HR planning IT Planning Compliance and regulatory reporting planning Department strategies Collaboration strategy Sales & Account Planning Supplier Relationship Management Research Org. Operations Strategy Regulatory Submissions Quality & Compliance Strategy Continuing Medical Education Strategy Financial Planning and Policy Discovery IT/KM Strategy Pharmaconvigilance Production & Material Planning Information architecture Marketing and sales program management Revenue cycle management Clinical KPIs and process management Customer satisfaction monitoring Plant management Quality improvement program mgmt Strategic Publication Planning IP Strategy Regulatory Affairs Security and privacy monitoring Discovery Proj. & Portfolio Mgmt. HR Management & Control Contact/Account Management Resource Management Distribution Oversight Manufacturing Oversight Procurement and supply chain mgmt Opportunity/contact management Financial accounting Finance and Accounting Management Joint venture contract and performance mgmt. Campaign Management Operations management Management Discovery Resource Mgmt. Regulatory compliance and accreditation mgmt Project & Portfolio Management Utilization and case management Cost accounting Inbound Logistics Supplier Control IT Management Physician relationship and contract mgmt. Contract Management HR Management Research Alliance Management Collaboration management Control (manage, monitor, track) Legal and IP Management Payer Relationship Management Service line performance management. Sales Force Management Financial performance management Admissions management Payer relationship and contract mgmt. Outbound Logistics Plant Management Discovery Science Management Quality & Compliance Management Application portfolio management Analytics Management Centers of Excellence mgmt. (Oncology, Radiology, etc.) Department management Advocacy Group Management Business Performance Management Informatics & Knowledge Mgmt. Consumer relationship mgmt. Life Cycle Management Scheduling management Acquisition management Manage Wholesaler/Other Relationships Internal Audit Project portfolio management Knowledge Management Regulatory Affairs IT Management Clinician Management Corporate Real-Estate Management Service line implementation Consumer services IT Operations R&D Competitive Intelligence Billing, collections and bad debt ED operations Patient registration/ admissions Clinical resource scheduling Emerging Science & Discovery Technology HR Administration Contact Center Execution Technical Development Order Management/Customer Service Information analysis and reporting Acquisition activities Marketing Execution Business Development Target Discovery Insurance verification & certification Denial Processing Plant/Inventory Management Payer services Distribution Center Operations Market & Competitive Research Nursing unit operations IT Systems & Operations Marketing/advertising program delivery Delivery Chemical Library Dev. & Synthesis Appl. maintenance/ development Radiology operations Finance and Accounting Transactional Processing Contracts Administration & Settlement HR functions Execute Coding, abstracts and transcription Make & Package Products Physician services Lead Identification & Validation Deployment Quality & Compliance Performance Indigent Assistance Program Lead Optimization General Ledger Other dept operations Lab Testing Facility and equipment mgmt Project activities Regulatory compliance and accreditation activities Patient services Property and Facilities Management Sales Execution Joint venture implementation Informatics & KM Operations Business resilience Audit functions Corporate Communication Information Integration Product Tracking/Documentation Information Technology Operations Medical Information Services External Relations A framework for transformation > CBM As a first step, component business models can be used to identify the ‘hot spots’ in pharma and healthcare … The Converged Ecosystem Identifying the hotspots helps to set the scope for change and allows appropriate strategies to be put in place and actions taken Source: IBM Institute for Business Value analysis Presentation Title | Document ID | 19-Dec-19

10. A framework for transformation > Converged ecosystem The converged ecosystem will exist with distinct roles for each stakeholder… Healthcare • Patient Safety Strategy • EHR Strategy & Operations • Clinical Outcomes Strategy & Management • Performance Management • Security & Privacy Monitoring • Pharma • R&D and Alliance Strategy • Informatics & Knowledge Management Operations • Clinical Development and Outcomes Research • Emerging Science and Discovery The Converged Ecosystem …creating increased value for each partner and ultimately benefiting the health of the patient Source: IBM Institute for Business Value analysis Presentation Title | Document ID | 19-Dec-19

11. A framework for transformation > Best practice Finally a full transition to the converged ecosystem will be realised when… Source: IBM Institute for Business Value analysis Presentation Title | Document ID | 19-Dec-19