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

dirk@mission3.com