the move to the cloud for regulated industries
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THE MOVE TO THE CLOUD FOR REGULATED INDUSTRIES
San Diego Cloud Computing Conference
Dirk K Beth
Pharmaceutical, Biotech, and Medical Device Company Data in the Cloud
Dirk K Beth – President & CEO
Mission3 has been providing cloud software for clinical and regulatory operations since 2006
Pioneered Regulatory Document Management in the cloud
BACKGROUND
Andy Harjanto– Founder of Gestone.com
Drug Information Association
3www.diahome.org
CREDIT
Ninety-five percent of those claiming they never use the cloud actually do so via online banking and shopping, social networking, and storing photos and music.
– Citrix Survey
BACKGROUND
95%
National survey showed that most respondents believe the cloud is related to weather, while some referred to pillows, drugs and toilet paper.For Example, 51 percent of respondents, including a majority of Millennials, believe stormy weather can interfere with cloud computing.
– Citrix Survey 51%
You can either
Build a house or
Rent an apartment
If you build a house, there are a few
important decisions you have to make…
How big is the house? are you planning to grow a large family? Remodeling addition typically cost a lot more once the house is built
Once the house is built, you’re responsible for
maintenance
Hire LandscaperElectricianPlumber
Pay property tax
Electricity Water
Gutter CleaningHeating and Cooling House Keeping
How about renting?
Consider a builder in your city builds
a massive number of apartment units
A unit can easily be
converted into a 2,3,4 or more units
You make fewer, simpler decisions
You can start with one unit and grow later, ordownsize
But…You do not have a lot of options to customize your unit
However, builders provide you with very high quality infrastructure
No need to worry about maintenance cost
No need to Hire landscapers,
electricians, plumbers
Just pay your rent
Pay as You Go
As an end-consumer, believe it or not
you’ve been using Cloud for a long time
you’ve been enjoying
High Reliability Service
Unlimited Storage
Connecting, Sharing
Supporting Enterprise Software
Stone Wall | Fire-proof | Moat | Army | Dungeon
is like Building
Medieval Fortress
Requires an Army of IT Engineers
Software Upgrade
Support
Backup/Restore
Service Pack
Custom Development
Network issues
Let’s BuildAn Enormous
Data Center
Capacity Planning
Disaster Plan
Cooling Management
Server Crashes
Network availability
Physical Access Control
Many things have changed
The enterprise world we live in
2012 and beyond
Global Direct, Open CustomersCommunication
TransparencyWork Remotely
Digital Life Convergence
(e.g. Social Media)
(Work and Personal lines are blurring)
(Customers, Resources, IPs are acquired everywhere)
(Mobility Trend)
(Blogs, Social Computing)Brief Collaboration
(Assemble the best, Disassemble upon completion)
Can we bridge the gap?
It Requires
a New Way
of Thinking
Leave it the expertswho have a lot of money to spend to build
giant datacenters across the globe
Your data is replicated3 or 4 times in a cloud data center
High Availability
Adding Capacity is a click away or “just happens”. Running in just minutes, not days
The Cloud automatically balances load
And is Always available
In many cases you can choose
where your data and “servers” reside
Scale up or down – it’s your call
Just reduce your
computing power, storage
Only a handful of major playerscan build
this massive infrastructure
Limited # line-of-business software providers yet to take
advantage of cloud infrastructure
Smaller number of cloud
life sciences providers
My Business Needs…
SecurityPrivacy
Reliability
High Availability
Compliance
Yes, you’re releasing some controls
physical securitycustomization
data integration
Let’s clear common confusionsabout Cloud Computing
Typical Scenarios
Your company
Software/ServiceProviders
Cloud/InfrastructureProvider
You may also build softwaredirectly on the provider’s platform andpay them directly
Do I need to start over?you could redirect your data to the cloud
Migrate Data to the Cloud
Before
In some cases, you could redirect your data to the cloud
After
However, to take
full advantage, migrate all or create new apps on the cloud
Employees
Contractors
Consultants
Multi-tenancy | resource poolingSelf serviceElastic storageScale up | downPay per useUbiquitous network access
CLOUD SOFTWARE IS WRITTEN
SPECIFICALLY FOR THE CLOUD
• No special programming language• No special hardware• No cloud magic dust
A intersection of scale, Internet, specific software solutions that make this work
MAGIC BULLET
CLOUD STRATIFICATION
Software as a Service
consume
Platform as a
Servicebuild
Infrastructure
as a Servicehost
Control higher management
overhead & cost
Abstraction less IT & lower management costs
Cloud Computing Taxonomy
Traditional IT
Storage
Servers
Networking
Operation System
Security, Clustering
Virtualization
Data
Applications
Runtime
You m
anage
IaaS
Storage
Servers
Networking
Operation System
Security, Clustering
Virtualization
Data
Applications
Runtime
Managed b
y v
endor
You m
anage
You m
anage PaaS
Managed b
y v
endorStorage
Servers
Networking
Operation System
Security, Clustering
Virtualization
Applications
Runtime
Data
SaaS
Managed b
y v
endor
Storage
Servers
Networking
Operation System
Security, Clustering
Virtualization
Applications
Runtime
Data
Efficiency + SavingsControl + Cost
PRIVATE CLOUD
A Private Cloud is the creation of a cloud-like environment within an organization’s own IT infrastructure or at a third party facility. A Private Cloud can provide some of the financial values of the Cloud while allowing the organization to control security, governance, availability and reliability.
Private Cloud Benefits
• You control the growth.• You control the security.• You can maximize the value
of your capital equipment through virtualization that reacts to immediate workload needs, giving high resource utilization thus reducing cost.
Private Cloud Risks
• High initial capital needs.• You must manage growth.• Assembling the right mix of
infrastructure and virtualization tools, and the appropriate procedures to get the full advantage either internally or by your Cloud Provider.
• Technology obsolescence.• Hard to integrate social
media.
Public Cloud Benefits
• Low upfront costs.• Clear relationship between cost
and benefit with pay-for-use model.
• Easy to try new projects, easy to make change.
• Flexible.• A wide choice of Service Level
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.
Public Cloud Risks
• Security.• Performance and availability.• Can be hard to bring data back in-
house or to another Cloud Service Provider.
• Long term viability of the Cloud Service Provider.
• Quality of support.
PUBLIC CLOUD
The Public Cloud provides resources from a Cloud Service Provider that are dynamically provisioned on a self-service basis over the Internet, via web-based applications or web services. The Cloud Service Provider shares resources among many customers, and bills on a fine-grained utility pricing basis.
HYBRID CLOUD
The Hybrid cloud environment consists of multiple Private Cloud and Public Cloud environments. By integrating multiple Cloud services, you can take advantage of Public Cloud services where appropriate and use Private Cloud services where security, performance or availability constraints require more control.
Hybrid Cloud Benefits
• Maximize operational efficiency and flexibility of both internal and external resources.
• Adopt only the best delivery model for each application or solution.
• Leverage Cloud Bursting and handle excess demand beyond what a Private Cloud or your own infrastructure can handle.
• Lower cost options for disaster recovery.
Hybrid Cloud Risks
• Moving resources between private and public Clouds.
• Managing and operational controls.• Requires expertise and solutions that
function in both Public and Private Cloud models.
TIME
IT C
APA
CIT
Y
ALLOCATING RESOURCES: THE TRADITIONAL VIEW
Allocated IT resources
Oversupply
Undersupply
Load forecast
Initial investme
nt
Oversupply
Actual load
TIME
IT C
APA
CIT
Y
ALLOCATING RESOURCES: THE CLOUD VIEW
Allocated IT resources Actual load
Lower initial
investment
Less oversupply
Load forecast
Less oversupply
No undersupply
CLOUD BENEFITS AND GAME CHANGERS
The IT Perspective
• 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.
BUSINESS 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.
TECHNICAL BENEFITS OF CLOUD COMPUTING
The Cloud is changing the role of System Administrator to a “Virtual System 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.
THE VIRTUAL ADMINISTRATOR
System 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.
…NEEDS CONTINUING EDUCATION
Keep dynamic data closer to the cloud and static data closer to the end-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..
WHERE SHOULD MY DATA BE?
Security should be implemented in every layer of cloud application architecture.
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.
AND WHAT ABOUT SECURITY?
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.
• 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.
TRENDS IN OUR INDUSTRY
Sensitive Data in the Cloud?
Are we there yet?
Encryption
ComplianceAudit
Non – Regulate
d Vertical Industry
Govt / Defense
Consumer
REQUIREMENTS FOR A REGULATED CLOUD APPLICATIONS
Life Sciences
Healthcare
Financial
Qualified Platform
Audit
Data Security and Privacy
Industry Specific Compliance FOIA CFR 21 Part 11 HIPAA PCI, FISMA
Bidirectional encryption
Continuity of Operation
2 Factor Authentication
Platform
• 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.
EXAMPLES OF CLOUD USE IN PHARMA
LIFE SCIENCES LINE OF BUSINESS APPLICATIONS “LOOKING FOR” A CLOUD HOME
Non-clinical• Laboratory Information
Management• Lab notebook• ToxicologySales and Marketing• CRM• Digital Asset Management• eMPM (Management of
Promotional Materials)• Sunshine law compliance
Clinical• CTMS• EDC• ePRO• IVR / IWR• eTMF• Secure Global PaymentsSafety• PharmacovigilenceRegulatory• Submission Management• Regulatory Information
Management• xEVMPD (Europe)
Proprietary information
Patient Information
Time-critical Information
Large Volume Data and Documents
Collaboration Global Access
Ease-of-use Speed / Performance
• 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.
BENEFITS OF CLOUD USE IN PHARMA
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.
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.
THE FUTURE FOR LIFE SCIENCE CLOUD
• 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
GENERAL CLOUD NEEDS
• 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
IDEAL FUTURE STATE OF LIFE SCIENCE 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
IDEAL FUTURE STATE OF LIFE SCIENCE CLOUD
THANK YOU
MISSION3 ONDEMAND IS BECOMING CLIREO
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
DIRK’S CONTACT INFO
Dirk Karsten Beth | Chief Executive Officer | Mission3, Inc.
@dirkbeth
@regtrack
Group: Registration Tracking
Group: Mission3 User Group
www.mission3.com