Clinical Technology and Information Management Modernize Clinical Development

Clinical Technology and Information Management Modernize Clinical Development through New Technology Using social software to accelerate clinical development DIA China 2011 May 17 th 2011, Beijing

Outline The clinical challenges and opportunity What is social software and how are we connected The case for Clinical Sanofi approach 2

The current clinical development model is unsustainable but the opportunity to transform it is available 2/3 of R&D costs spent in clinical trials 8% R&D cost increase per year with -5% probability of success 3 Convergence of Healthcare and Life sciences Increasing complexity of trials to support requirements for safety and efficacy Virtualiz ation of work “Web 2. 0” enables distributed cocreation and activism Cloud Computing accelerates the IT commoditiza tion Opportunity to become a part of the continuum of care of the patient.

The healthcare digital transformation We will all be connected Social networks will enable far-reaching and immediate exchange of clinical/anecdotal experience and information among key healthcare stakeholder communities that have been and will continue to be established. Mobile will reign Mobile devices and patient records will be the standard for recording, tracking, transmitting and receiving healthcare data. Portability = new lifestyle It will be a Digital world The complete migration to digital healthcare technology for healthcare practitioners and patients will enable improved exchange, sharing, and integration of information. Data will be integrated and shared Information across all health data platforms including electronic medical records, patient health records, and “smart” monitoring and diagnostic devices and will be seamlessly integrated. 4

From Consumer to Prosumer - Web 2. 0 is associated with web applications that facilitate participatory information sharing, interoperability, user-centered design, and collaboration on the World Wide Web. A Web 2. 0 site allows users to interact and collaborate with each other in a social media dialogue as creators (prosumers) of user-generated content in a virtual community, in contrast to websites where users (consumers) are limited to the passive viewing of content that was created for them. Examples of Web 2. 0 include social networking sites, blogs, wikis, video sharing sites, hosted services, web applications, mashups and folksonomies. 5

Defining social software – connecting people the social Web is about conversations, interpersonal networking, personalization and individualism…It is the ‘People-centric Web’. Its content can be more easily generated and published by users, and the collective intelligence of users encourages more democratic use Online social interaction has been enriched through the use of wikis, blogs and podcasts Encourages a more human approach to interactivity on the Web, better supports group interaction and fosters a greater sense of community 6 Social Software enable the creation of communities

Creating communities: patients like me www. patientslikeme. com Health data-sharing website with more than 100, 000 patients and 500+ conditions Online communities in which patients monitor and submit data on the effects of novel drugs Enables a matched control group My. Space ‘CURE Di. ABETES group’ - run by patients and supporters Patient. co. uk - readers can record and rate existing ‘Patient Experience’ entries

Online resources for educated patients Library. Thing Medicine Group A library social network site promoting social interactions, book recommendations, self-classification, and monitoring of new books A community of 1. 3 M book lovers A virtual Library w/ more than 61 million books catalogued in 50+ languages

Tweeting for trials Due to the posting of clinical trial information publicly, patients are taking a more active role in their health care decisions. Through public registries and public sites such as Clinical. Trials. gov (NIH trial registry) many patients are seeking their own trial participation. As looking for trial manually can be overwhelming, a new Twitter application by Trial. X (http: //trialx. com/) allows patients to use do-it-yourself social media to find clinical studies that match their health and disease profile. Trial. X also lets patients with electronic personal health records like Microsoft Health. Vault or Google Health import their information instead of filling out online pre-screening forms to be matched for trials. Tweet examples… @trialx CT find studies for my father, 62 with pancreatic cancer in Raleigh area @trialx CT 55 YO female with multiple sclerosis in Chicago, Illinois After sending the Tweet the Trial. X application will send a reply Tweet in about 1 -2 minutes with a link to the Trial. X page listing matching clinical trials. If patients prefer not to divulge their health profile for privacy reasons they can simply "Follow" the @trialx on Twitter and send the Tweet as a direct message. They will then receive a private reply with their matching trials. Content partially extracted from http: // medicinedigest. blogspot. com/ 9

Moving toward integrated patient centric Information Google Health (https: //www. google. com/accounts/Service. Login? service=health&nui=1&continue=https: //health. g oogle. com/health/p/&followup=https: //health. google. com/health/p/&rm=hide) Manage your health history online Set personal health and wellness goals Track and monitor your progress Micro. Soft Health Vault (http: //www. microsoft. com/en-us/healthvault/) Electronic Medical Records are in use by 40% of US physicians Source: Taking the Pulse® US v 10. 0. 10

How social software can be a differentiator? 11

Collaboration and social media: one of the pillars of sanofi clinical technology strategy Sanofi Clinical Team is developing 9 technology domains to accelerate Development - Collaboration and Social Media is one major pillar. Innovation Advanced scientific techniques -Use of omics -Adaptive Trials -Translational medicine Enabling Technologies -Mobility, e. HR, devices -Natural language query and processing - Visualization, Image Interoperability - Modeling and simulations Process Excellence Analytical Excellence -Process modeling and -Data integration and mining -Data visualization and analytics -Predictive analytics and optimization -Process automation -Business activity monitoring simulation Collaboration -Portal and mobility -B 2 B - Knowledge Management - Social Software/Media System Integration & Interoperability -Scalability -Flexibility, Agility with SOA, CBA - Standardization (HL 7, CDISC, BRIDG, CMR) Operational Excellence Enhancing Existing Capabilities 12 -Invoice checking; remote site monitoring; Performance Management study optimization -Patient Enrollment optimization - Portfolio mgmt and capacity planning management (dept, CSU), site, vendor/lab, partners -Dashboards available for Cost and Risk Control -Cloud computing -Application landscape rationalization - Application lifecycle management - Strategic partners (technology, sourcing)

Sanofi global clinical collaboration platform Strengthening the investigator-sponsor collaboration Training & Investigator Meetings Collection of 1572, CV, Financial Disclosure, etc. IRB Approval Documentation Budget & Contract Negotiation Finalize Outstanding Recruitment Study Library Materials with Items, Calendar, (key reference Sites / IRBs Messages/Alerts, documents) Dear Investigator Enrollment Letters, newsletters, Performance communications e. TMF / Documentum Clinical Team Documents Select Sites / Investigators Feasibility Surveys (Trial, EDC) New Trial Information 13 IWRS Integration, Drug Shipment & Reconciliation, Patient Visit Schedules Collaboration Portal Interim safety reviews, queries, drill-down reports Study Planning & Management (CTMS) Sponsor Activities Only Select Countries Contact Management Potential Investigator Registration Electronic Data Capture (EDC) Payment Detail Reports Collaboration, Study-Specific Site Personnel Tools, Other changes, lab licenses, etc. (ongoing)

Clinical Trial Portal – a new approach to Trial Management

Building patient centricity and connecting healthcare and life sciences with mobile apps Eases the work of scheduling meds, measurements, and healthy habits Daily view of scheduled medications, measurements and diet/exercise routines Detailed logs of patient measurements Patients access to all medical records View health status of family and dependents Information shared with Doctors Browser and all mobile platform support Integrate with Online Records Application integrates with both Google Health and Microsoft Health. Vault. These services are leading the way in putting medical records online -- everything from X-rays and prescriptions to hospital visits and blood tests. 15

Take away: at sanofi, social software is expected to be an accelerator of clinical development Social software is setting the way forward For faster patient recruitment For patients to find the right trials For sponsors to move into a service mode and increase patient retention As part of this environment, collaborative portals in particular increase the productivity of the sponsor-investigator working relationships and will continue to be an important investment area over the next few years Mobile apps are a new norm and a key vehicle in this new digital social environment. These apps will contribute to: Strengthen the patient-investigator relationship The healthcare and life sciences convergence Improve overall the quality of healthcare hence, contribute to cost reduction 16

Thank you ! 17