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Cloud-Enabled Pharmaceutical R&D
October 31, 2014
The information and data furnished in this document is Maven Wave Confidential Information not to be disclosed, duplicated, used in whole or part for any purpose other than to evaluate Maven Wave’s business operation and prior experience. This restriction does not limit the recipient’s right to use information contained in the document if it is obtained from another source without restriction.
Shifting Pharmaceutical R&D Operating Models
*Michael Elliott; Virtualized Research Ecosystems (VREs) Presentation 09/10/2014
“Externalization and Virtualization Trends in Pharma and Biotech are Growing at 10-20% per year. Moreover, R&D Spending is shifting (average 44% spent externally) to external small and mid-size companies that provide specialized capabilities”
-Michael Elliott, Atrium Research
Externalization =
Virtualization =
Outsourcing Specific R&D Capabilities to Specialized Contract Research and Manufacturing Partners; Several Different Companies in Partner Ecosystem
Outsourcing All R&D Capabilities to Specialized Contract Research and Manufacturing Partners; Many Different Companies in Partner Ecosystem
As R&D operating models transition to externalization and virtualization; the supporting IT infrastructure must move to the cloud to adequately meet the rapidly evolving needs of the business.
R&D IT Challenges
Opportunities and Challenges for the Cloud
Opportunities Presented By The Cloud
● Biopharma R&D and IT Budget Remains Flat (2005+)
● Opportunistic and Frequent M&A Create Data Integration Challenges
● Applications and Data Integrations vary, further complicated by M&A
● Increase speed of Innovation through better enabled collaboration
● Data Integration across Ecosystems through ease of sharing and management
● Lower entry and support costs free up capital for reinvestment
*
“Strategies to better inform decision making could generate up to $100 billion in value annually across the US health-care system, by optimizing innovation, improving the efficiency of research and clinical trials” – McKinsey
External Data
Evolving Operating Models Create Data Challenges
DMPK & Toxicology
Process Development
Clinical TrialsManufacturing & Distribution
Sales & Marketing
Post-Market Reporting
DiscoveryOperating Model
Internal Data Internal Data Internal Data Internal Data Internal Data Internal Data
External Data
Internal Data
External Data
Traditional -“All capabilities
In-house”
Externalization
Virtualization
Internal Data
External Data
Internal Data
External Data
External Data Internal Data
External Data
External Data
Internal Data Internal Data
External Data
Internal Data
External DataExternal Data
External Data
External Data
External Data
External Data
Internal Data
External Data
Internal Data
External DataExternal Data
External Data External Data
External Data
External Data
External Data
External Data External Data
External Data
External Data
External Data
External Data
External Data
External Data
Evolving R&D operating models have a more complicated partner ecosystem with more external data-sources to be integrated
Value-Chain
Currently, Pharmaceutical R&D Occurs in Data Silos
External Data Sources* Internal Data Sources*
Clinical Supply-Chain
Partner
Clinical Study Recruitment
Partner
As a result, it can be extremely challenging to identify patterns across the drug development value-chain and gain actionable, holistic insights.
Clinical Trial Management
Partner 1
Clinical Trial Management
Partner 2
Clinical Manufacturing
and Distribution
Process Development
DiscoveryInternal
Clinical Trial Management
Group
*Example Data Sources
Opportunity: Cloud Enables Collaboration in Clinical Trials
External Data Sources Internal Data Sources
Clinical Supply-Chain
Partner
Clinical Study Recruitment
Partner
Cloud collaboration capabilities enable more efficient clinical trials: Ex. Collaboration across partner ecosystem enables more accurate prediction of clinical drug supply demand to minimize waste and optimize manufacturing
Clinical Trial Management
Partner 1
Clinical Trial Management
Partner 2
Clinical Manufacturing
and Distribution
Process Development
DiscoveryInternal
Clinical Trial Management
Group
Opportunity: Search Enables FDA Audit Preparation
External Data Sources Internal Data Sources
Analytical Method
Development Partner
Drug Product Development
Partner
API Development
Partner
CMC Submission
PartnerQC/QA Analytical Pharmaceutics Process
Development
Cloud Data-Integrity and Search capabilities enable faster audits:Ex. Elastic search capabilities enable regulatory teams to quickly find, integrate and search documents and data to more efficiently prepare for audits
Opportunity: Data Integration Enables Innovation in Discovery
External Data Sources Internal Data Sources
Library Development
PartnerHTS Partner Bioprofiling
PartnerClinical Trial
Partner Discovery DMPKClinical Trial Management Toxicology
Cloud Data-Integration capabilities enable Innovation:Ex. Data Integration capabilities enable drug discovery teams to compare large, disparate data-sets to understand how laboratory discoveries translate to the clinic (translational informatics)
Opportunity: Cloud Enables Large-File Sharing of Microscopy Images
External Data Sources Internal Data Sources
3-D Imaging Partner
Histology Partner
Published Microscopy
Results
Cell-based Assay Partner Discovery DMPK Toxicology
Cloud Enables Large File-SharingEx. Scientists are able to share and analyze many large-size (GB+) files across partner ecosystems that were previously unshareable due to file-size limitations.
In the Future, Cloud-Enabled Pharmaceutical R&D
Cloud-enabled pharmaceutical R&D will provide accessible data across partner ecosystems and evolving operational models.
Seamless Drug Development Data Across Partner Ecosystems
DMPK & Toxicology
Process Development
Clinical TrialsManufacturing & Distribution
Sales & Marketing
Post-Market Reporting
DiscoveryValue-Chain
Cloud-based ELN / LIMS
Cloud-based ELN/LIMS
Cloud-based ELN/LIMS/LES
Cloud-based eTMF
Cloud-based ERP/MES/SCM
Cloud-Based CRM/B.I
Cloud-based Med Comm
Data Ecosystem
Why the Cloud for Pharmaceutical R&D?
+ Frequent; Opportunistic Mergers and Acquisitions + Complicated; Quickly Evolving R&D Ecosystems+ Disparate Data Sources + Large Data Volumes + Challenges with IT Budget and Resource Allocation
= Major Opportunity for the Cloud
● Data volumes require new technologies and skillsets
● Need to revisit core IT infrastructure - cloud-based laboratory informatics tools should be deployed across partner ecosystems
● More life science and data science domain knowledge is required than traditional pharma IT projects
● Disparate data sources can be difficult to combine
So Why Isn’t Everyone Already Doing This?
For the past 15 years, Google has been building out the world’s fastest, most powerful, highest quality cloud infrastructure on the planet.Solutions for Life Sciences on the
Google Cloud Platform
● Leverage the same Big Data platform that Google operates its business on
● Greatly reduce both initial capital & operating costs
● Reduce technology complexity and risk
● Focus on the analysis rather than on the infrastructure
● Benefit from continuous innovation
● Reduce dependency on limited IT resources
● Speed-to-value is 1-3 months vs 6+ months
Benefits of the Google Cloud
Why Maven Wave and Google for Pharma R&D?
How It Works: Collaboration in Clinical Trials
How It Works: Search Enabled Audit Preparation
How It Works: Data Integration Enables Innovation in Discovery
How It Works: Cloud Enables Sharing of Large Microscopy Images
Getting Started
Get started with a 3-4 week pilot, demonstrating value on 1-2 data sources.
Automate loads of pilot data sources and create templates for future data loads within 6 weeks.
Initiate projects to expand data sources and scale platform for increasing volumes.
A look inside Google Cloud Platform
Cloud Platform is built on the same infrastructure that powers Google.
Cloud Platform
Storage App ServicesCompute
Cloud Storage
Cloud SQL
Cloud Datastore
Compute Engine
App Engine
BigQuery
Cloud Endpoints
• Flexible and Familiar Infrastructure
• High Data Security
• Connect with the Google Network
• Fast and Easy Provisioning
• Flexible Billing
• Large and Powerful Disks
• Green Computing
• Partner Powered
Value
Compute Engine
Features
• Sub-hour Billing
• Up to 10TB Persistent Disk
• Over 44 Instance Types
• Advanced Networking
• Instance Metadata and Startup Scripts
• Load Balancing
• Monitoring
• Snapshotting
Compute Engine
• Fully Managed Platform
• Easy Development & Deployment
• Focus On Your Code Not Your Server
• Automatic Scaling
App Engine
Value
Cloud StorageCloud SQLCloud Datastore
NoSQL SQL Blob Block
• Secure Sharing
• Huge Storage Capacity
• Speed
• SLA
• Cost
• Support
Cloud Storage
Value
• Versioning
• Static Sites
• Resumable Transfers
• Object Change Notifications
• Durable Reduced Availability
• More Coming Soon
Cloud Storage
Features
• Accessible Anywhere• Secure Sharing
• Same High Replication Datastore Used By App Engine Apps Today
• Equally Fast Queries For Any Sized Dataset
• Data is Replicated Across Several Data Centers
• Use From Any Application or Language
• Serving 4.5 Trillion Requests Per Month
Cloud Datastore
Value
• Auto-scale
• Schemaless Access
• SQL-like Capabilities
• Authentication That Just Works
• Fast and Easy Provisioning
• RESTful Endpoints
• ACID Transactions
• Local Development Tools• Built-in Redundancy
Cloud Datastore
Features
• Fully managed
• Ease of Use
• Highly Reliable
• Flexible Charging
• Security, Availability, Durability
• EU and US Data Centers
• Easy Migration & Data Portability
• Control
Cloud SQL
A look inside Maven Wave’s Experience
Maven Wave assists clients in creating and capitalizing on change opportunities through a unique blend of strategic insight, business
knowledge, and technology expertise.
These disciplines are inextricably linked together in successful change efforts; change drives value, and value is driven by innovation.
Clients increasingly want solutions that are more social, mobile, and rooted in analytics. To deliver on the promise of the cloud, Maven
Wave fuses traditional consulting discipline with cutting-edge technology development.
Our solutions capitalize on the evolution of technology trends to foster innovation to help grow your business into the future.
About Us
Cloud
Mobile
Apps
Data
Design
Strategy-Led, Results-Focused ConsultingCloud • Mobile • Apps • Data • Design
________________________________________________________________________________
#2 on Crain’s Chicago Business Fast Fifty - 2014
101 Best and Brightest Companies to Work For - 2014
Google Enterprise North America Innovation Partner of the Year - 2013
About Us
Company History
2008 2009 2010 2011 2012
Triton-Tek AcquiredApp Dev, Hosting and Offshore
2013
Biersma Creative AcquiredCreative design agency
Fin Tech Unit LaunchedMajor client signed
Maven Wave LaunchedClient #1 signed
Google Unit LaunchedPartnership agreement signed
ILM Unit LaunchedStrategic partnership
Maven Wave
2014
101 Best Places to WorkAward received
Google North Central Partner of the YearAward received
101 Best Places to WorkAward received
Inc 500/5000#641 on the list
Google Innovation Partner of the YearStrategic partnership
Crain’s Fast 50#2 on the list
Services
Data management solutions to take control over growing data and
storage costs.
Big Data
Globally deliver unique, innovative cross-device
& platform business solutions with leading
technologies.
UX design integrating fluid aesthetics with
functional solutions to create powerful
engagement.
Identify critical drivers & align solutions providing
most impactful performance returns.
Migration, integration and change
management to leverage best of SaaS,
PaaS & IaaS.
Technology SolutionsConsulting Cloud User Experience & Design
Geographic Footprint
West - Business DevLos Angeles, CA
Corporate Headquarters Chicago, IL
Development and QA CenterChandigarh, India
United States & Canada India
Business Dev, DeliveryToronto, ON
Midwest - DeliverySt. Louis, MO
Management Consulting
ClientsMaven Wave assists clients in creating and capitalizing on change opportunities through a unique blend of strategic insight, business knowledge, and technology expertise. Our approach focuses on identifying the right problems, sequencing them in a way that yields the highest impact first, and objectively measuring and managing to successful outcomes.
● Business Case Development
● Roadmap Development
● Transformation Planning
● Program Management Office
● Business Requirements
● Change Management
● Operational Performance and Process Engineering
What We Do
Services
Technology Solutions
Clients
Maven Wave specializes in solution-based software development, integration and delivery that can solve your most complex enterprise problems. Our consultants offer industry best practices including Agile project execution that provides working software every two weeks while leveraging proven development patterns and practices.
● Enterprise Agile Advocacy & Delivery
● Native & Hybrid Mobile Solutions
● Multi-Platform Custom Development
● Data Analytics & Business Intelligence
● Premise & Cloud Centric Solutions
● Application Maintenance / Outsourcing
What We Do
Services Technology
User Experience & Design
Maven Wave’s user experience and design expertise enables us to better deliver social, collaborative and mobile solutions that translate into intelligent, functional and brand-conscious experiences on any device.
● User Experience
● Website/Mobile/Application Design
● Responsive Design
● Visual Design
● Brand Design
● Marketing Strategy
What We Do
Services
Clients
Google Cloud
Maven Wave is a Google Enterprise Premier Partner, offering cloud services that span the Google enterprise portfolio. We combine Google technology, experienced consultants and a wide range of capabilities to deliver innovative solutions in the cloud.
● Google Apps Planning, Deployment & Advocacy
● Collaboration Solution Development
● Google Big Data Analytics & Integration
● Enterprise Search Solutions
● Google Maps for Location Based Services*
What We Do
Services
Technology
Clients
Google Partnership Highlights
Maven Strategic Drivers
▪ Embrace "Cloud" solutions to drive sustained business value
▪ Synergistic with core consulting business & resources
▪ Transformational not transactional solution focus
▪ Fosters long-term client relationships
▪ Provides exposure to broader services capabilities
Partnership Highlights
▪ Google Premier Partnership across Apps, Platform, Search, Geo* and Chrome
▪ Exclusive strategic focus on large enterprise customers
▪ Embraced by Google for transformational situations & solutions
▪ Provide NA coverage along with Global solution support
"We are proud to recognize Maven Wave as our 2013 Innovation Partner of the Year. Maven Wave has consistently demonstrated
sales, deployment and support excellence to our customers throughout 2013.”
Mark HodgsonHead of Global Partner Programs at Google
Global Delivery Services
Project Manager
Technical Architect
Business Analyst
Technical Architect
Developer
Quality Assurance
Maven Wave Pod System
Well suited to Agile development
▪ Lower leverage ratio reduces risk
▪ Google enables high level of daily, live, interaction
▪ Maximize time zone overlap
Flexible structure reduces cost
▪ Blended on/off shore teams yield cost advantages
▪ Blend can be changed to manage cost
▪ Blended rates can yield flexible scale up/down
Clients
Financial Services Health Care & Life Sciences Consumer
Transportation and Manufacturing
Life Sciences & Healthcare
Life Sciences Perspective
Life Science - Delivering In a New Ecosystem
SOFTWARE
Package
CustomCloudLegacy
QUALITY
Company
VendorConsultancy
Offshore
DELIVERY
Ecosystem of Talent
NetworkArchitects & Craftsmen
Healthcare & Life Science - Electronic Lab Notebook
Situation
The Global Pharmaceutical R&D group needed to migrate from a paper-based lab notebook to an electronic lab notebook (ELN) system to better support process optimization, knowledge sharing, intellectual property protection, and innovation.
ResultsMaven Wave supplied a cross-functional team of business system analysts, ELN configurators, and a project manager. The team successfully deployed ELNs across multiple business units. These Deployments successfully passed both FDA and EU (German Authority) audits, an industry first for an ELN in a Life Sciences Discovery R&D department. Each business unit saw a marked increase in process throughput, error decreases, and tightly integrated intellectual property controls.
Company
Formerly a unit of Abbott Laboratories, AbbVie was spun off as a separate public company in January of 2013 and is a global life sciences and biotech company with revenue in excess of $18B.
Healthcare & Life Sciences - “Closed Loop” Analytics
SituationThe biologics pre-formulation group hypothesized better Design of Experiment (DoE) could be positively impacted if they had a holistic view of their work after technology transfer to formulation. Such a view would require a common data ontology, data integration, and organizational agreement.
ResultsThe team quickly recognized that the challenges were not solely technological, but one of bridging gaps between different business units. By basing the project on shared, linked business objectives, development of queries and visualizations across common data-sets was managed via structured stakeholder management, agile processes, and iterative development. By the end of the project, a set of repeatable queries and visualizations were developed that were valuable across drug product development.
CompanyFormerly a unit of Abbott Laboratories, AbbVie was spun off as a separate public company in January of 2013 and is a global life sciences and biotech company with revenue in excess of $18B.
Healthcare & Life Sciences - Portal and Mobile App
SituationThe Catamaran member portal site and mobile app provided a robust client implementation offering but was lacking in user experience. An evaluation of today’s digital trends and an increased interest in online health offerings led to the need for a new digital member experience, a conceptual solution design, and a roadmap for realization.
ResultsMaven Wave developed and delivered a new member portal and mobile application with an enhanced user experience and design. This improved digital experience increases customer acquisitions, revenue from existing clients, and cost savings to serve customers.
CompanyCatamaran is a pharmacy benefit management company that sells services related to pharmacy benefit management and medical record keeping to businesses in the United States.
Healthcare & Life Sciences - New Product Development
SituationThe AMA continuously seeks deeper engagement with its members to assist them in the practice of medicine. After careful market research, the AMA decided to release a physician physician portal called AMAGINE.
ResultsMaven Wave engaged with AMA in a number of areas in the product development process including identification of key functions and needs for the product, logical product groupings; worked with sales, marketing, IT, and development to lay out a phased release plan for the product; designed the roll out planning process to be used by physicians and staff as the product is integrated into everyday operations. This product was later sold to AT&T and is now a part of the AT&T Healthcare Community.
OrganizationSince 1847 the American Medical Association (AMA) has had one mission: to promote the art and science of medicine and the betterment of public health. Today, the core strategy used to carry out this mission is our concerted effort to help doctors help patients.
Healthcare & Life Sciences - SW Delivery Optimization
SituationDestinationRX needed to increase output of new software functionality to its health insurance clients, but the product management and product development process was a bottleneck. The company needed to improve the speed and efficiency of its technology product development cycle from the identification of customer need through roll out...
ResultsMaven Wave completed an end to end analysis of the product management and software development process and then identified and implemented opportunities for improved throughput, speed, and quality.
CompanyA leading provider of Internet based tools to the nation’s largest health insurance providers. DRX’s platform is an online decision tool used to help consumers make better health care decisions for themselves and their families.
Information Lifecycle Management
Growing Problem with Big Rewards for Solving
Drivers of GrowthAnalytics & intelligence
Big data / real-time processingRegulatory compliance
Social, email, fileshare, sharepoint growthVideo & large media formats
10 % 13 % 16 % 20 % 25 % 32 %
Storage spend as % of IT budget
Growth rate of data volume: 30 %
Growth rate of TCO data spend: 29 %
TCO Data Spend Projection
(in $ millions)
3.5 x
x
Annual Spend on Storage
● Estimated 69% of data being stored today is of NO USE to the company
● Every year, the company continues to spend valuable budget dollars on storage for this same, growing “debris”
Business Units Information Technology (IT)
Legal Corporate Records
EnterpriseBenefits
● Manage clear policy for business utility of all created data
● Commitment to ILM program
● Implement integrated technology solutions in archival, discovery, policy syndication, and disposal
● Enable data source catalog management
● eDiscovery process change and integration
● Commitment to ILM program (e.g. appl decommission)
● Retention policy definition and management
● Process change and integration
● Commitment to ILM program
CoordinatedContribution
● Tremendous cost savings ● Dramatic risk reduction● Convert maintenance budget into strategic investment● Performance - rapid innovation and highly responsive operation
Silo efforts by any single organization provides minimal benefit Coordinated attack generates amplifier effect
A Coordinated Attack is Required
Financial Services ILM
Technology Landscape
CapabilitiesDedicated resources with many years of Information Management experience
Management consulting combined with technology delivery
Established partnerships with leading technology solutions in this space
Proven implementation methodology with solution accelerators
Referenced Success
ILM Practice
Healthcare & Life Sciences - ILM Strategy, Architecture and Process
Situation
Design and implement ILM policies, processes and solutions that allows Cambia to defensibly dispose of structured & unstructured data debris and only retain data that is of business value, on legal hold or required for compliance with retention policies
Results
Created the integrated ILM solution architecture which included more than 10 applications and the integrations between them. Completed data disposal analysis of unstructured data across Cambia’s email and file share. Configured and deployed the first application on the roadmap, the Atlas legal hold suite.
Company
Cambia Health Solutions provides a wide range of healthcare information technology and software development, retail healthcare, health insurance, life insurance, pharmacy benefit management, consumer engagement and wellness.
Situation
As part of the divestiture from Abbott, AbbVie is creating enterprise capabilities for structured data disposal and archiving. The initial phase will target ~50 Finance applications and over 500 Lotus Notes databases.
Results
Gather decommissioning requirements from the business units (e.g. Finance, Quality, etc.). Develop and execute a process to decom approximately 50 Phase 1 Finance applications. Develop and execute a process to archive hundreds of Phase 1 Lotus Notes databases. Lead cross-functional teams through execution of archive initiatives.
Company
Formerly a unit of Abbott Laboratories, AbbVie was spun off as a separate public company in January of 2013 and is a global life sciences and biotech company with revenue in excess of $18B.
Healthcare & Life Sciences - ILM Strategy, Architecture and Process
Situation
Sanofi needed to upgrade its core ILM platform, IBM Atlas Process Manager, create a QA/Test environment, and then design, develop and rollout classes to attorneys and paralegals in both US and in Canada.
ResultsEnsured clear business understanding of functional and design issues. Developed UAT criteria, and templates to capture test results and then guided customer through acceptance testing cycles. Authored and delivered full-day and abridged Atlas courses covering four different roles. Instantiated the Atlas configuration in production, ensuring as-built environment was consistent with QA deployment used in user acceptance testing.
Company
Sanofi is an integrated global healthcare leader that discovers, develops and distributes therapeutic solutions focused on patients’ needs with over € 32.9 billion in revenue.
Healthcare & Life Sciences - ILM Strategy, Architecture and Process
Questions / Comments?Thank You
