1. THE MOVE TO
THE CLOUD FOR
REGULATED
INDUSTRIES
Pharmaceutical, Biotech, and Medical
Device Company Data in the Cloud
San Diego Cloud Computing Conference
Dirk K Beth

2. BACKGROUND
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

3. CREDIT
Andy Harjanto
– Founder of Gestone.com
Drug Information Association www.diahome.org 3

4. BACKGROUND
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.
95%
– Citrix Survey

5. 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
51%
majority of Millennials, believe stormy weather can
interfere with cloud computing.
– Citrix Survey

6. You can either
Build a house or
Rent an apartment

7. If you build a house, there are a
few
important decisions you have to
make…

8. 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

9. Once the house is built,
you’re responsible for
maintenance

10. How about renting ?

12. A unit can easily be
converted
into a 2,3,4 or more units

13. You make fewer,
simpler decisions
You can start with one
unit and grow later, or
downsize

14. But…
You do not have a lot
of options to customize
your unit

15. However, builders provide
you with
very high quality
infrastructure

16. No need toworry about
maintenance cost
No need to Hire
landscapers, electricians,
plumbers

17. Pay as You Go
Just pay your rent

18. As an end-consumer, believe it or not
you’ve been using Cloud for a long time

19. you’ve been enjoying
High Reliability Service
Unlimited Storage
Connecting, Sharing

20. Supporting Enterprise Software
is like Building
Medieval Fortress
Stone Wall | Fire-proof | Moat | Army | Dungeon

21. Requires an Army of IT Engin

22. Let’s Build
An Enormous
Data Center
Capacity Planning
Network availability
Cooling
Management
Disaster Plan
Physical Access Control
Server Crashes

23. Many things have
changed

24. 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)

25. Can we bridge the gap?

26. It Requires
a New Way
of Thinking

28. Your data is replicated
3 or 4 times in a cloud data center
High Availability

29. Adding
Capacity is a
click away or
“just happens”.
Running in just
minutes, not
days

30. The Cloud automatically balances load
And is Always available

31. In many cases you can choose
where your data
and “servers” reside

32. Scale up or down – it’s your call
Just reduce your
computing power, storage

33. Only a handful of major players
can build
this massive infrastructure

34. Limited # line-of-business software providers yet to take
advantage of cloud
infrastructure
Smaller number of cloud
life sciences
providers

35. My Business Needs…
Security
Privacy
Reliability
High Availability
Compliance

36. Yes, you’re releasing
some controls
customization
physical security
data integration

37. Let’s clear common confusions
about Cloud Computing

38. Typical Scenarios
Software/Service
Providers
Cloud/Infrastructur
Provider
Your company
You may also build software
directly on the provider’s platform
pay them directly

39. Do I need to start over?
you could redirect your data to the cloud
Before
Migrate Data to the Cloud

40. In some cases,
you could redirect your data to the cloud
After

41. However, to take
full advantage, migrate all or
create new apps on the cloud
Employees
Consultants
Contractors

42. CLOUD SOFTWARE IS WRITTEN
SPECIFICALLY FOR THE CLOUD
Multi-tenancy | resource pooling
Self service
Elastic storage
Scale up | down
Pay per use
Ubiquitous network access

43. MAGIC BULLET
• No special programming language
• No special hardware
• No cloud magic dust
A intersection of scale, Internet, specific software
solutions that make this work

44. CLOUD STRATIFICATION
Software Platform Infrastructure
as a Service as a Service as a Service
consume build host
Abstraction Control
less IT & lower management costs higher management overhead
& cost

45. 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 vendor
You 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

46. 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 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.

47. 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.
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.

48. 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 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.

49. ALLOCATING RESOURCES: THE
TRADITIONAL VIEW
Load
forecast
Undersupply
Oversupply
Oversupply
IT CAPACITY
Initial
investment
TIME
Allocated IT resources Actual load

50. ALLOCATING RESOURCES: THE CLOUD
VIEW
Load
forecast
No undersupply
IT CAPACITY
Less
Less oversupply
oversupply
Lower initial
investment
TIME
Allocated IT resources Actual load

51. CLOUD BENEFITS
AND
GAME
CHANGERS
The IT Perspective

52. BUSINESS BENEFITS OF CLOUD
COMPUTING
• 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.

53. 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.

54. THE VIRTUAL ADMINISTRATOR
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.

55. …NEEDS CONTINUING EDUCATION
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.

56. WHERE SHOULD MY DATA BE?
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..

57. AND WHAT ABOUT SECURITY?
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.

58. 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.

59. 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.

60. Sensitive Data in the
Cloud?
Are we there yet?
Encryption
Compliance
Audit

62. REQUIREMENTS FOR A REGULATED CLOUD
APPLICATIONS
Govt /
Defense
2 Factor Life Healthcare Financial
Authentication Sciences
Bidirectional encryption
Industry Specific Compliance
FOIA CFR 21 Part 11 HIPAA PCI, FISMA
Audit Non –
Regulated
Vertical Consumer
Qualified Platform Industry
Continuity of Operation
Data Security and Privacy
Platform

63. 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.

64. 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

65. 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.

66. 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.

67. 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.

68. THE FUTURE
FOR LIFE
SCIENCE
CLOUD

69. 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

70. IDEAL FUTURE STATE OF LIFE
SCIENCE 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

71. 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

72. THANK YOU

73. MISSION3 ONDEMAND IS BECOMING CLIREO

74. 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

75. DIRK’S CONTACT INFO
Dirk Karsten Beth | Chief Executive Officer | Mission3, Inc.
@dirkbeth
@regtrack
Group: Registration Tracking
Group: Mission3 User Group
www.mission3.com
dirk@mission3.com