The Move to the Cloud for Regulated Industries


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  • Cloud computing can offer many benefits. One of the most appealing is illustrated here: the ability to allocate computing resources more effectively.To build an application or solution in a legacy world, you have to think about network, OS, storage, and scale. But they have little to do with what you really want to build, an application.But what if there were a different way.
  • Cloud computing can offer many benefits. One of the most appealing is illustrated here: the ability to allocate computing resources more effectively.To build an application or solution in a legacy world, you have to think about network, OS, storage, and scale. But they have little to do with what you really want to build, an application.But what if there were a different way.
  • The Move to the Cloud for Regulated Industries

    1. 1. THE MOVE TOTHE CLOUD FORREGULATEDINDUSTRIESPharmaceutical, Biotech, and MedicalDevice Company Data in the CloudSan Diego Cloud Computing ConferenceDirk K Beth
    2. 2. BACKGROUNDDirk K Beth – President & CEOMission3 has been providing cloud software for clinical and regulatoryoperations since 2006Pioneered Regulatory Document Management in the cloud
    3. 3. CREDITAndy Harjanto – Founder of Gestone.comDrug Information Association 3
    4. 4. BACKGROUNDNinety-five percent of those claiming they never usethe cloud actually do so via online banking andshopping, social networking, and storing photos andmusic. 95% – Citrix Survey
    5. 5. National survey showed that most respondents believethe cloud is related to weather, while some referred topillows, drugs and toilet paper.For Example, 51 percent of respondents, including a 51%majority of Millennials, believe stormy weather caninterfere with cloud computing. – Citrix Survey
    6. 6. You can eitherBuild a house orRent an apartment
    7. 7. If you build a house, there are afewimportant decisions you have tomake…
    8. 8. How bigis thehouse?are youplanning togrow a largefamily?Remodeling additiontypically cost a lotmore once thehouse is built
    9. 9. Once the house is built,you’re responsible formaintenance
    10. 10. How about renting ?
    11. 11. A unit can easily beconvertedinto a 2,3,4 or more units
    12. 12. You make fewer,simpler decisionsYou can start with oneunit and grow later, ordownsize
    13. 13. But…You do not have a lotof options to customizeyour unit
    14. 14. However, builders provideyou withvery high qualityinfrastructure
    15. 15. No need toworry aboutmaintenance cost No need to Hire landscapers, electricians, plumbers
    16. 16. Pay as You Go Just pay your rent
    17. 17. As an end-consumer, believe it or notyou’ve been using Cloud for a long time
    18. 18. you’ve been enjoyingHigh Reliability Service Unlimited Storage Connecting, Sharing
    19. 19. Supporting Enterprise Software is like Building Medieval Fortress Stone Wall | Fire-proof | Moat | Army | Dungeon
    20. 20. Requires an Army of IT Engin
    21. 21. Let’s Build An Enormous Data Center Capacity PlanningNetwork availability Cooling Management Disaster PlanPhysical Access Control Server Crashes
    22. 22. Many things havechanged
    23. 23. The enterprise world we live in 2012 and beyond Global Direct, Open Customers Communication (e.g. Social Media)(Customers, Resources, IPs are acquired everywhere) Digital Life Convergence (Work and Personal lines are blurring) Work Remotely (Mobility Trend) Transparency (Blogs, Social Computing) Brief Collaboration (Assemble the best, Disassemble upon completion)
    24. 24. Can we bridge the gap?
    25. 25. It Requiresa New Wayof Thinking
    26. 26. Your data is replicated3 or 4 times in a cloud data center High Availability
    27. 27. AddingCapacity is aclick away or“just happens”.Running in justminutes, notdays
    28. 28. The Cloud automatically balances load And is Always available
    29. 29. In many cases you can choose where your data and “servers” reside
    30. 30. Scale up or down – it’s your call Just reduce your computing power, storage
    31. 31. Only a handful of major players can buildthis massive infrastructure
    32. 32. Limited # line-of-business software providers yet to take advantage of cloud infrastructure Smaller number of cloud life sciences providers
    33. 33. My Business Needs… SecurityPrivacy Reliability High Availability Compliance
    34. 34. Yes, you’re releasingsome controls customizationphysical security data integration
    35. 35. Let’s clear common confusions about Cloud Computing
    36. 36. Typical Scenarios Software/Service Providers Cloud/Infrastructur ProviderYour company You may also build software directly on the provider’s platform pay them directly
    37. 37. Do I need to start over?you could redirect your data to the cloud Before Migrate Data to the Cloud
    38. 38. In some cases,you could redirect your data to the cloud After
    39. 39. However, to takefull advantage, migrate all orcreate new apps on the cloud Employees Consultants Contractors
    40. 40. CLOUD SOFTWARE IS WRITTENSPECIFICALLY FOR THE CLOUDMulti-tenancy | resource poolingSelf serviceElastic storageScale up | downPay per useUbiquitous network access
    41. 41. MAGIC BULLET• No special programming language• No special hardware• No cloud magic dustA intersection of scale, Internet, specific softwaresolutions that make this work
    42. 42. CLOUD STRATIFICATION Software Platform Infrastructureas a Service as a Service as a Serviceconsume build host Abstraction Control less IT & lower management costs higher management overhead & cost
    43. 43. Cloud Computing Taxonomy Traditional IaaS PaaS SaaS You manage IT Applications Applications Applications Applications Data You manage Data Data Data Runtime Runtime Runtime Runtime Managed by vendorYou manage Security, Security, Security, Security, Managed by vendor Clustering Clustering Clustering Clustering Operation Operation Operation Operation System System System System Virtualizatio Virtualizatio Managed by vendor Virtualizatio Virtualizatio n n n n Servers Servers Servers Servers Storage Storage Storage Storage Networking Networking Networking Networking
    44. 44. PRIVATE CLOUDA Private Cloud is the creation of a cloud-like environment within an organization’sown IT infrastructure or at a third party facility. A Private Cloud can provide someof the financial values of the Cloud while allowing the organization to controlsecurity, governance, availability and reliability. Private Cloud Benefits Private Cloud Risks • You control the growth. • High initial capital needs. • You control the security. • You must manage growth. • You can maximize the value of • Assembling the right mix of your capital equipment through infrastructure and virtualization virtualization that reacts to tools, and the appropriate immediate workload needs, procedures to get the full giving high resource utilization advantage either internally or by thus reducing cost. your Cloud Provider. • Technology obsolescence. • Hard to integrate social media.
    45. 45. PUBLIC CLOUDThe Public Cloud provides resources from a Cloud Service Provider that aredynamically provisioned on a self-service basis over the Internet, via web-basedapplications or web services. The Cloud Service Provider shares resources amongmany customers, and bills on a fine-grained utility pricing basis. Public Cloud Benefits Public Cloud Risks • Low upfront costs. • Security. • Clear relationship between cost and • Performance and availability. benefit with pay-for-use model. • Can be hard to bring data back in-house • Easy to try new projects, easy to make or to another Cloud Service Provider. change. • Long term viability of the Cloud Service • Flexible. Provider. • A wide choice of Service Level • Quality of support. Agreement choices (SLAs). • Easy to provide a world-wide presence. • Access to traditional, service-oriented, and new Web 2.0 services. • Easy to integrate social media.
    46. 46. HYBRID CLOUDThe Hybrid cloud environment consists of multiple Private Cloud and Public Cloudenvironments. By integrating multiple Cloud services, you can take advantage ofPublic Cloud services where appropriate and use Private Cloud services wheresecurity, performance or availability constraints require more control. Hybrid Cloud Benefits Hybrid Cloud Risks • Maximize operational efficiency and • Moving resources between private flexibility of both internal and and public Clouds. external resources. • Managing and operational controls. • Adopt only the best delivery model • Requires expertise and solutions that for each application or solution. function in both Public and Private • Leverage Cloud Bursting and handle Cloud models. excess demand beyond what a Private Cloud or your own infrastructure can handle. • Lower cost options for disaster recovery.
    47. 47. ALLOCATING RESOURCES: THE TRADITIONAL VIEW Load forecast Undersupply Oversupply Oversupply IT CAPACITY Initialinvestment TIME Allocated IT resources Actual load
    48. 48. ALLOCATING RESOURCES: THE CLOUD VIEW Load forecast No undersupply IT CAPACITY Less Less oversupply oversupplyLower initial investment TIME Allocated IT resources Actual load
    50. 50. BUSINESS BENEFITS OF CLOUDCOMPUTING• Almost zero upfront infrastructure investment.• Just-in-time Infrastructure – By deploying applications in-the-cloud with just-in-time self-provisioning, you do not have to worry about pre-procuring capacity for large-scale systems. This increases agility, lowers risk and lowers operational cost because you scale only as you grow and only pay for what you use.• More efficient resource utilization: – With the cloud, IT can manage resources more effectively and efficiently by having the applications request and relinquish resources on-demand.• Usage-based costing: – With utility-style pricing, you are billed only for the infrastructure that has been used. You are not paying for allocated but unused infrastructure. Optimizing your applications/solutions can drastically reduce your costs if they use system resources more efficiently.• Reduced time to market: – Having available an elastic infrastructure provides the application with the ability to exploit parallelization in a cost-effective manner reducing time to market.
    51. 51. TECHNICAL BENEFITS OF CLOUD COMPUTING• Automation – “Scriptable infrastructure” – You can create repeatable build and deployment systems by leveraging programmable (API- driven) infrastructure.• Auto-scaling – You can scale your applications up and down to match your unexpected demand without any human intervention. Auto-scaling encourages automation and drives more efficiency.• Proactive Scaling – Scale your application up and down to meet your anticipated demand with proper planning understanding of your traffic patterns so that you keep your costs low while scaling.• More Efficient Development Lifecycle, Improved Testability – Production systems may be easily cloned for use as development and test environments. Staging environments may be easily promoted to production.• Disaster Recovery and Business Continuity – The cloud provides a lower cost option for maintaining DR servers and data storage. With the cloud, you can take advantage of geo-distribution and replicate the environment in other location within minutes.
    52. 52. THE VIRTUAL ADMINISTRATORThe Cloud is changing the role of System Administrator to a “VirtualSystem Administrator”. • The System Administrator no longer needs to provision servers and install software and wire up network devices. • The cloud encourages automation because the infrastructure is programmable. • System administrators need to move up the technology stack and learn how to manage abstract cloud resources using scripts. • Application developers must work closely with system and network administrators to ensure optimizations are made at the application and network layer.
    53. 53. …NEEDS CONTINUING EDUCATIONSystem Administrators must learn… • How the business uses the applications today, and tomorrow. • New deployment methods (virtual machines) • New models (query parallelization, geo-redundancy and asynchronous replication), • Rethink the architectural approach for data • Leverage different storage options available in the cloud for different types of datasets. When architecting future applications, companies need to encourage more cross-pollination of knowledge between roles and understand that they are merging.
    54. 54. WHERE SHOULD MY DATA BE?Keep dynamic data closer to the cloud and static data closer to theend-user • Keep your data as close as possible to your processing elements to reduce latency. • You are paying for bandwidth in and out of the cloud by the gigabyte of data transfer and the cost can add up very quickly. • If a large quantity of data that needs to be processed resides outside of the cloud, it might be cheaper and faster to “ship” and transfer the data to the cloud first and then perform the computation. • If the data is generated in the cloud, then the applications that consume the data should also be deployed in the cloud. • If the data is static and not going to change often (for example, images, video, audio), it is advisable to take advantage of a content delivery service so that the static data is cached at an edge location closer to the end-user to lower the access latency..
    55. 55. AND WHAT ABOUT SECURITY?Security should be implemented in every layer of cloud applicationarchitecture. Protect Data as it Moves • Encrypt data as it moves between the web servers and browsers. • With a certificate from an external certification authority, the authentication of both server and browser creates a shared session key used to encrypt the data in both directions. Protect Data as it Rests • If you are concerned about storing sensitive and confidential data in the cloud, you should encrypt the data before uploading it to the cloud.
    56. 56. WHAT DOES THIS MEAN TO ME?• “Cloud” is actually about SERVICE, not technology. It’s not our day job to be hung up on technology. • Our focus is to ensure the: » Global delivery of our applications to our end users. » Sharing of data between systems and users. » Building of global communities to optimize business processes and capabilities. » Meet (and drive) existing and emerging Health Authority guidance and regulations.Internal IT becomes more “high value”. Moving from IT to CTO.From keeping the systems running to ensuring optimal business value.
    57. 57. TRENDS IN OUR INDUSTRY• Many factors are pushing Life Science companies to adopt cloud technologies including: ‣ Need to be more agile. ‣ Need to be more cost effective (do more with less). ‣ Need to work with more global partners and virtual teams. ‣ Need to better protect IP (Data/Documents). ‣ Consumerization of IT.
    58. 58. Sensitive Data in theCloud? Are we there yet? Encryption Compliance Audit
    59. 59. REQUIREMENTS FOR A REGULATED CLOUDAPPLICATIONS Govt / Defense2 Factor Life Healthcare FinancialAuthentication SciencesBidirectional encryptionIndustry Specific Compliance FOIA CFR 21 Part 11 HIPAA PCI, FISMAAudit Non – Regulated Vertical ConsumerQualified Platform IndustryContinuity of OperationData Security and PrivacyPlatform
    60. 60. EXAMPLES OF CLOUD USE IN PHARMA• Drug discovery and bio-informatics applications.• Collection and cleaning of clinical data.• High volume simulated data generation to validate statistical methods.• Gene sequencing processing.• Offsite datamarts and data storage.• Collaboration with partners / providers.• Hosting of business applications.
    61. 61. LIFE SCIENCES LINE OF BUSINESS APPLICATIONS“LOOKING FOR” A CLOUD HOME Collaboration Clinical Global Access Ease-of-use Non-clinical Speed / • CTMS Performance • Laboratory Information Proprietary information • EDC Management • ePRO • Lab notebook • IVR / IWR • Toxicology • eTMF Patient Information Marketing Sales and • Secure Global Payments • CRM Safety • Digital Asset Management • Pharmacovigilence • eMPM (Management of Regulatory Promotional Materials) Time-critical Information • Submission Management • Sunshine law compliance • Regulatory Information Management • xEVMPD (Europe) Large Volume Data and Documents
    62. 62. BENEFITS OF CLOUD USE IN PHARMA• Increased ROI• Security and Compliance through Specialized Clouds.• Established concept matured by a multitude of industries. ‣ Cloud customers leverage the knowledge and activities performed by previous tenants to streamline design, deployment, and support.• Moving the focus from Technology capability, into Application capabilities.• Sharing technology platforms unifies the industry, driving the innovation and evolution of cloud technologies to meet the needs of true, global organizations in the Life Sciences industry.
    63. 63. OUR FUTURE• Global Accessibility • Ability to use the same tools in multiple regions, simultaneously, around the world.• Global High-Availability • Ability to meet requirements for system stability and availability to enable the organization to meet deadlines.• Collaborative Environments • Manage user interaction and knowledge to streamline training, enhance productivity, and build global communities with internal and external stakeholders. • Use of Social Networking Tools across the enterprise.
    64. 64. OUR RESPONSIBILITIES• Define clear and achievable short, medium, and long term requirements for the technological infrastructure.• All parties involved in providing the infrastructure should be assessed on a regular basis to ensure compliance with regulations and business requirements.• Ensure change and configuration control procedures are in place at all levels.• Ensure proper risk and impact assessment is undertaken when changing infrastructure.• UNDERSTAND OUR USERS. Ensure that systems are implemented to enhance the quality and productivity of user experience; to increase user adoption, build communities, and retain key talent.
    66. 66. GENERAL CLOUD NEEDS • Cloud solutions will all be “Valideatable” • Cloud solutions will be industry standard aware – eCTD, eVMPD, CDISC, SEND, SPL, STF, … – eDM Reference Model, eTMF Reference Model, others • Cross-cloud authentication / deactivation • Cross-cloud data integration, workflow triggers, etc
    67. 67. IDEAL FUTURE STATE OF LIFESCIENCE CLOUD • Provide real business value by – Easily exchanging similar data across systems, companies – Business Intelligence across entire continuum – Reduce vast amounts of time and manual effort in the continuum • Speed to market • Reduced cost – Support REAL personalized medicine drug development by • reducing the cost of small population drug development
    68. 68. IDEAL FUTURE STATE OF LIFESCIENCE CLOUD • Provide real business value by – Utilizing data from cloud based health records to recruit patients into trials – Ease enrollment – Mine data ANONYMOUSLY from health records to support drug data in trials, regulatory approval, and post market safety and monitoring • More drugs approved on market for more diverse populations and disease states = – Better medicine – Easier for prescribers to select the right therapy for specific patients – Improved health and quality of life – At a lower costs
    69. 69. THANK YOU
    71. 71. CLIREO • Integrated – eDMS • eTMF • Virtual Data Room • EDM Regulatory DMS – Project Management – Global Regulatory Submission Management • eCTD, 510k, PMA support – Regulatory Information Management • Tracking • Planning • Health Authority Correspondence Management
    72. 72. DIRK’S CONTACT INFO Dirk Karsten Beth | Chief Executive Officer | Mission3, Inc. @dirkbeth @regtrack Group: Registration Tracking Group: Mission3 User Group