An IBM Perspective: Life Sciences in the Cloud

2. © 2015 IBM CorporationIBM Institute for Business Value2 Cloud in Life Sciences – an overview  Cloud computing offers a powerful service delivery and consumption model that organizations can use to drive business model innovation, enhance revenues and operational efficiency  Strict regulatory control in the life sciences industry has slowed many organizations from adopting cloud; however this is changing fast as with sufficient safeguards implemented, concerns and challenges can be addressed  The life sciences industry is adopting cloud to realize many benefits • Transform its business operations • Enhance efficiency and cost control • Collaborate with different entities across the healthcare ecosystem • Extend its ecosystem from drug discovery to ongoing patient care  IBM believe a well planned cloud strategy focusing on how business can be cloud-enabled will provide life sciences organizations with long term benefits

3. © 2015 IBM CorporationIBM Institute for Business Value3 As they advance along their transformational journey, life sciences leaders focus on three key imperatives CREATE COLLABORATIVE OPERATING MODELS REDUCE COMPLEXITY AND STREAMLINE OPERATIONS DRIVE INNOVATION WHILE MANAGING COST Cloud computing enables collaboration, improves efficiency and expands innovation potential Enhancing collaboration with external partners by breaking the silos that separate internal functions, to solve traditional R&D challenges Use technology and processes to manage the increasing complexity associated with drug and medical device research, development and manufacturing Leverage big data and analytics, and a networked R&D model to expedite new drug research and optimize the costs associated with research and development

4. © 2015 IBM CorporationIBM Institute for Business Value4 Cloud enables life sciences firms to engage, operate and innovate in smarter ways  Resets focus on scientific innovation; reduces time spent on transaction work  Facilitates new, multi-nodal business models  Unlocks tremendous value through use of analytics  Allows rapid and reliable information sharing  Extends knowledge and data networks  Reduces risk associated with compliance and delivery of compliant infrastructure Accelerates innovation and unlocks value Efficient R&D through collaboration Cost reduction and streamlined operations $  Increases resource utilization  Simplifies processes, reducing administration cost  Integrates data silos and optimizes information flow

5. © 2015 IBM CorporationIBM Institute for Business Value5 Coriell Life Sciences (CLS) used a cloud based business process manager (BPM) offering & IBM Watson to find an innovative way to take genetic sequencing information and provide it to the medical community in a usable format. Sources: Please see the notes section Life sciences companies that have embraced cloud based services are already seeing significant performance improvements Unprecedented speed Customer interfaces creation now takes just weeks instead of months NYGC uses an application built on IBM Watson to provide oncologists condensed findings extracted from unstructured textual data embedded in millions of text- based medical studies. Accelerated research Medical findings associated with genetic mutations now available in minutes Physion uses a cloud based solution to allow scientists to manage and share experimental data of any type that is trapped on local systems or in organizational silos and enable scientific collaboration. Scientific collaboration Maximizes value of research data through scientific collaboration

6. © 2015 IBM CorporationIBM Institute for Business Value6 Life sciences is a highly regulated industry requiring a 360-degree view of the entire product development and delivery chain Regulatory and compliance requirements Patient privacy requirements Data security requirements Compliance requirements GMPs, GLPs, GCPs HIPAA FDA’s Part 11 EU Privacy Directive EMA’s Annex 11 Country specific regulations Key challenges  Accountability: Who is legally liable for data management and security?  Providers’ compliance: How do we ensure cloud service provider complies with required regulations?  Inspections and Audits: How can we audit a cloud service provider who has many clients and whose infrastructure we don’t control?  Data security: How can we ensure that our data will be accessed by the right people? How is data protected when it is hosted in remote data center and accessed over Internet?  Traceability: How will we manage the chain of custody of information and document data control throughout the process?  Patient privacy: How do we ensure that patients private / confidential data is protected? Regulatory Authorities  US - FDA  Europe - EMA  MHLW  Country specific authorities Note: The above regulations / guidelines is not the complete list and are shown as examples only

7. © 2015 IBM CorporationIBM Institute for Business Value7 Heather Fraser HFRASER@uk.ibm.com 44-7734-325459 Christopher Hines christopher.hines@us.ibm.com 1-908-963-7237 James McCormack mccormac@us.ibm.com 1-304-942-9172 To find out more about IBM Institute for Business Value’s point-of- view on Cloud in Life Sciences please contact… IBM LIFE SCIENCES INDUSTRY CONTACTSIBM LIFE SCIENCES INDUSTRY CONTACTS Sandip V Patel sandip.patel@us.ibm.com 1-781-472-8200 (T/L: 779-8200) Lauren O’Donnell lhodonne@us.ibm.com 1-310-245-1375 Karen Parrish kaparris@us.ibm.com 1-914-766-1030 [FACE PIC] [FACE PIC] [FACE PIC] [FACE PIC] [FACE PIC] [FACE PIC]

An IBM Perspective: Life Sciences in the Cloud

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An IBM Perspective: Life Sciences in the Cloud