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© 2017 Cognizant
© 2017 Cognizant
AWS Meeting
January, 2017
© 2017 Cognizant2
Agenda/Objective of today’s discussion
CHALLENGES IN LIFE SCIENCES INDUSTRY
MARKET TRENDS ACROSS INDUSTRY
CLOUD ADOPTION JOURNEY
COGNIZANT AWS READINESS & INVESTMENTS
APPLICATION IN LIFE SCIECNES AND CASE STUDIES
DISCUSSION
Slides 3 & 4
Slides 5
Slides 11 & 12
Slides 13 - 20
Slides 21 & 22
CLOUD SERVICES ACROSS PHARMA VALUE CHAIN Slides 6 - 10
© 2017 Cognizant3
We are looking at rapid infrastructure commoditization across industry
Emerging Players &
Global Competition
Increased People Costs
And Shrinking Margins
Changing Regulations &
Environmental Concerns
Need to Rapidly
Reduce
Production Cycles
Supply-Chain under Severe
Distress and Needs
Remodeling
Fluctuating
Energy Costs
Traditional Path to
Purchase Is Changing
Customers are
Demanding Seamless
Experience
Customers are Embracing
New Technologies Faster
Increased Need To
Multiply Operational
Efficiencies
Need To Reach
Global Markets
Competitors Are Using
Big Data For Advantage
Transforming
Branch/Store Formats
Enabling WorkForce
To Stay Relevant
BFSI RETAIL & CG MANLOG HEALTHCARE LIFE SCIENCESTECHNOLOGYCOMMUNICATION IMET & H
© 2017 Cognizant
A cloud-based planning
layer can enable the
sharing of S&OP data with
key stakeholders: contract
manufacturers, branded
and generic business units,
distributors and retailers.
Cloud CRM
Trends in Life Sciences industry in adaption of ‘Cloud’
Enveloping Core ERP with
Cloud
Improve effectiveness of
the Sales force and
customer complaint
handling through Cloud
CRM
This approach is being
embraced by leading
pharmaceuticals
manufacturers to comply
with mandates around
serialization, extend
compliance to partners and
leverage efficiencies across
the extended supply chain.
Data held in systems
outside of ERP (CAPA, MES
or LIMS, for example) can
be shared on the same
cloud platform. This
enables effective
monitoring of
manufacturing processes
and can provide early
warnings of problems in
internal and external
operations
Companies can use on
demand analytics for more
productive (R&D analysis of
genomic, proteomic and
clinical data) drug discovery
and also in targeted
marketing and sales effort
Cloud-based Master
Data(MDM) for Tracking,
Tracing
Cloud-based collaboration
systems
On-demand Big Data
Analytics
4
© 2017 Cognizant5
How is IT in life sciences is being challenged?
 Regulatory requirements: Ensuring continued regulatory compliance for system related issues along with applicable foreign regulatory guidelines
 Data explosion: The amount of data managed by life science companies almost doubles in 3 months.
 Data protection:
 Fragmented & Siloed data systems: Bespoke applications and Siloed business units, each with its own infrastructure
 High cost of ownership: Heavy upfront(capital) investment in current IT systems Pressure to reduce budgets while meeting increasing needs from
the business for responsiveness and agility
 Elasticity: Low utilization of IT systems which are heavily provisioned to manage high demand during promotions for broadcasting and studios
Partner with other
Research Labs;
Target Identity and
Validation; In-silo
research
Perform initial
laboratory and
animal tests; Clinical
data management
Process
development, scale-
up, commercial
production, Supply
chain management
Submission &
Publication
Management;
Regulatory
compliance
Conduct Clinical Trials
Brand Management;
Collaborate with
Doctors and
Pharmacies;
Market and sell
finished product;
Digital engagements
Aggregate &
Periodic Reporting;
Customer support &
analytics.
Drug Discovery Drug Development Regulatory Manufacturing PharmacovigilanceMarketing & Sales
© 2017 Cognizant
Amazon’s Elastic Cloud Computing
(EC2)
Many Bio-informatics tool for
protein or biologic sequence
analysis have been deployed
on EC2. Amazon, along with
other vendors, maintains
copies of many of the publicly-
available data sets on genomic
and sequence data and makes
them available to their clients
as part of their overall cloud
environment.
In silico or Virtual screening
Screening involves using an
automated tool to test
thousands of compounds for a
specific biological activity.
Virtual screening allow
researchers to greatly increase
the pace of finding new
potential compounds while
reducing costs for lab work.
Protein Docking Simulations
AutoDock is a suite of
automated docking tools. It is
designed to predict how small
molecules, such as substrates
or drug candidates, bind to a
receptor of known 3D
structure.
Data mining/Big-Data Analytics
Cloud Computing – a game changer in Drug Discovery
Big Data Analytics helps to
assess the biological systems,
improve accuracy of target
binding patterns and to simulate
the activity of multiple drugs
simultaneously on many tissues
like in a “virtual” human.
6
© 2017 Cognizant
Shared Investigator Platform
Cloud LIMS allows real time
specimen tracking and enable
researchers to reserve
specimens for a specified time
interval. Seamless lab sample
handling from entry to
disposal, improving efficiency
and reducing turnaround time.
LIMS Electronic Data Capture
Cloud based electronic data
capture allows patients to use
any electronic device to report
their information directly into
the system. It allows real time
tracking of data, also reducing
clinical trial costs by
maximizing data entry and
workflow efficiencies.
Clinical Data Warehouse
Accelerated Drug Development using Cloud
A clinical and scientific data
warehouse is used to manage,
aggregate, and analyze clinical
trial data. It also includes an
operational data warehouse
(ODW) for trial performance
metrics and a custom-
developed trial master file (TMF)
tool to keep a comprehensive
record of all clinical trial
activities.
The Shared Investigator
Platform facilitates interaction
with multiple clinical trial
sponsors, and enable study
planning, study start-up and
study conduct activities while
reducing the administrative
burden on site staff.
7
© 2017 Cognizant
Regulatory Master Data &
Registration Life Cycle
Management
Cloud based publishing
services in combination with
BPS services
“Combining content
management and publishing
capabilities in the cloud offers
a credible and innovative
alternative to the architecture
of the past 15 years,” said
Steve Gens, Managing Partner
of Gens and Associates; a Life
Science benchmark and
consultancy.
Submission
Publishing
Electronic Document
Management & Archiving
Cloud based electronic
document management &
archiving solutions will
implement a centralized
storage repository across all
business entities for corporate
and affiliate dossiers, affiliate
HA submissions
correspondence, all HA
correspondence and archival
requirements by replacing the
existing DMS systems, as well
as other central or affiliate
Document Management
systems in use.
Solutions available e.g. from:
Aris Global, Assured PV, EMC D2, EXTEDO, Lorenz, Mission3,
Qumas, Samarind, Veeva
Regulatory Intelligence Services
Regulatory Affairs Services in the cloud
Provide a Regulatory
intelligence platform
by
gathering & analyzing publicly
available regulatory information.
communicating the implications
of that information,
monitoring the current
regulatory environment
to
Define Regulatory Strategy
Provide guidance for individuals
and projects
On hands support for individuals
Registration Tracking & IDMP
The European Medicines
Agency has mandated that
organizations doing business in
the EU will need to submit
product information according
to the ISO-IDMP standards by
July 2016.
Cloud based master data
management solutions and
services offer not only
compliance to new emerging
standards but also combine
those data standards with
other (global & local) life Cycle
management activities
8
© 2017 Cognizant
Cloud based MES
A cloud based global
serialization platform creates
reusable serial number
generation profiles, support
global standard and country-
specific formats, define serial
number creation rules,
manage serialized inventory
operations and meet
traceability compliance
requirements.
Serialization Quality Management System
Cloud based quality and
compliance software is an end-
to-end solution that
automates all quality
processes and can be accessed
from any location. Quality
processes supported include
audits, change control,
complaint handling, CAPA, and
supplier quality management,
etc.
Supply Chain Management
Pharma Manufacturing using Cloud services
Cloud based SCM tool facilitates
better co-ordination between
pharma company and contract
manufacturers. It provides a
holistic reporting dashboard
which can be utilized by SCM,
the purchasing department,
finance, marketing and others.
It also provides a harmonized
visualization across the
enterprise for merged
organisations having different
SCM tools.
Cloud based MES helps in
coordinating all aspects of
production from tracking
inventory to managing quality
control and can manage
processes across multiple
worldwide facilities. It
facilitates faster deployment,
reduced capital investment,
scalability and access from
digital devices.
9
© 2017 Cognizant
Adverse Event Reporting
It helps in proactively
identifying the safety issues,
continuously assessing their
impact on benefit-risk profile
and effectively mitigating risks
across the product's lifecycle.
It allows seamless integration
with any safety database and
provides support for safety
intelligence and Benefit risk
assessment.
Integrated Signal Detection and
Benefit Risk Assessment
Safety Data Warehouse
Cloud based safety data hub
solution for the safety
operations and periodic
reporting. It has optimized
data model, intuitive web
analytics interface and
intelligent content generation
techniques, which helps
organizations improve
operational efficiencies,
measure compliance and
reduce periodic reporting
workload
Supply Chain Management
Leveraging Cloud Technology in Pharmacovigilance
Cloud enabled Adverse Event
staging platform helps to
reduce the time and effort
involved in processing AEs and
ADRs from start to end. It
helps in standardization of the
intake, triage, case
management, and submission
process of Individual Case
Safety Reports (ICSR) and
allows capturing case
information from any device.
10
© 2017 Cognizant
Sales and Operations Planning
A cloud based Sales and
operations planning helps in
collaborating with external
suppliers and vendors. It
allows real time sales
monitoring and order tracking.
It aids in identifying sales
opportunities with a
comprehensive view of
customers. It provides
flexibility during M&A.
New Product Introduction
Integrated product portfolio
management platform which
helps in planning new product
launch globally. It helps
marketing managers to track
the launch timeline, campaign
planning and other marketing
spend. It also helps in
comparison of actual product
market position, costs, P&L
against expectations.
Patient centric services
Centralised location for all
patient related information
including demographics,
communications, clinical and
non-clinical data, and even
pertinent information from
EHR. It allows real-time
interaction with patients and
family. Also facilitates
monitoring cases and
prioritizing tasks based on
immediate needs and level of
importance to offer
personalized care.
Digital Marketing
Cloud services in Sales and Marketing
Connecting Social media, mobile
applications, wireless access and
evolving technologies and
collaborative approaches to
delivering healthcare. Integrated
communication platform to
deliver information on product
and therapeutic area leading to
11
© 2017 Cognizant
Assessment & Plan
Migrate
Setup
Manage
Define cloud strategies and
create cloud migration plan
How does cloud apply to our
organization and what specific
workloads can we move there?
Setup a secure cloud environment
based on the workload requirements
How can we ensure that the cloud
setup is right for us
Transition workload
to Cloud environment
How can we ensure that we migrate
workloads correctly and quickly to
the cloud?
How do we run and operate cloud
based ecosystems? Manage cloud based systems
including Service Delivery
What is a typical cloud adoption journey
12
© 2017 Cognizant© 2017 Cognizant13
Cloud Integration Challenges - Example
STRUCTURED
DATA SOURCES
Liquid Insight
Manager
Documentum
ERP(SAP)
AUTOMATIKA
UNSTRUCTURED
DATA EXTRACTION
Unstructured Data
Reader
NLP Based Entity
Extraction
Rule Based Entity
Extraction
Document
Classification With
ML Model
UNSTRUCTURED
DATA
SOURCES
SmPC
File Share
Share Point
Database
Publish
Publish in
form of
JSON
Data Management UI (Search, View, Edit)
IDMP Hub
Global Unique ID Maintenance
IDMP Data Model
Substances Packages
Medicinal
products
Pharmaceutical
Products
Marketing Authorization
Clinical Particulars
Materialized
View
EMA
FDA
Other
DataConsumingSystems
OtherSystems
SAP
Submission
ARISGlobal
DATA
COLLECTION AND
CLEANSING
Data
Collection
Data
Validation
Data
Cleansing
RIMS
CTMS
HL7
File Extracts
Hosted On-
Premise
FileExtracts
Audit Trail
Workflow
Cross
Reference
Product
Attributes
Hosted on AWS
Control Vocabulary Maintenance
De
Duplication
Product
Relationship
Business
Rules
© 2017 Cognizant14
Appendic – if needed
© 2017 Cognizant
Cognizant Cloud Steps - A comprehensive tool-based framework that accelerates cloud enabled transformations by 25%-40%
• Application Migration Solutions
to AWS
• Engineering Optimization
Solutions for AWS
• Business Innovation Solutions for
AWS
• Assess & Plan
• Set Up
• Migrate
• Manage
• Cloud Assessment Engine
• Hybrid Cloud Governance
Foundation
• Cloud App Migration Foundry
• Hybrid Cloud Management
Platform
• Cloud @ Customer
• Cloud @ Partner (AWS)
• Cloud @ Cognizant
Cognizant Cloud Steps- simplifying your cloud journey
15
© 2017 Cognizant
• AWS’s Premier Consulting Partner
• Cognizant in the top 1% of all AWS partners
globally
• Cognizant internal applications run on AWS
• Transformational work across industries and
geographies
• Funded Center of Excellence for Cloud Services
• Co- Executive sponsorship, dedicated technical and
support resources, innovation fund
Partnership
Accelerators / Toolkits
Offering
Solutions and Platforms
• Cloud Workshop & Cloud Advisory Board
• AWS Suitability Assessment Transformation services End
to end offering to help enterprise IT transformation
• AWS Cloud Architecture Definition
• Application Transformation & Migration
• Cloud Environment Design & Provisioning
• Cloud Auditing and Optimization Service
• Cloud Applications Management
• Cognizant Cloud Pattern Studio
• Cognizant’ CloudStepsTM Migration framework
• AWS Assessment Kit – Assessment framework for AWS
suitability
• Selenium Test Automation Platform
• Cognizant Cloud Audit Ready
• BigDecisions – Business Solutions Platform
• Cognizant Cloud Steps: a comprehensive Cloud
transformation framework.
• Cognizant Cloud360 – Enterprise-class cloud management
‘hyper platform’
• Cognizant asset Serv – Digital Asset Management Solutions
• Cognizant Cloud Set: Software engineering platform that
accelerates development & testing
• Cognizant Video as a Service – Cloud enabled Video platform
• Cognizant Social Prism- social sentiment analysis platform
Cognizant - AWS Strategic Relationship
16
© 2017 Cognizant
AWS Cognizant
Economies of scale and efficiencies.
Only pay for what you use.
40+ cost reductions
Up to 71% on Infra Cost saving!
Technology platform with industry-
recognized certifications and audits
SoX, PCI, PHI, HIPAA, FISMA , ITAR, ISO
Provision systems in minutes vs. days,
weeks or months
Scale resources automatically
Virtual unlimited compute, storage and
network capacity
Reduce dependency on Infra
Free internal Infra resources
to focus on innovation
Focus on business goals and
Improvements
Cognizant Cloud Steps
Transformation Framework
Cognizant Assessment Engine
Accelerators and libraries
Cognizant Cloud Pattern Studio
Cognizant Audit Equip
Cognizant Trail Digest
Cloud PCI & PHI framework
Data masking , Data fabric
Cognizant Cloud 360 tool for
provisioning, orchestration, , monitoring
and reporting
Rich Domain expertise to support
business demand and goals
Library of Best practices and automation
scripts
Client
Lower TCO
Secured and Standardized
platform
Rapid Provisioning &
High Availability
Time to Market
Align with Business Growth
Cognizant and AWS : Joint Value Proposition
17
© 2017 Cognizant
HIPAA Fabric-Security
Solution
Jump start solution to
manage HIPAA
compliance
requirements in cloud
infra
READY
Expedited cloud
adoption Roadmap
with suitability
assessment Engine for
Workloads
READY
TCO Calculator
Standardized TCO
calculation suitable
across all applications
READY
PCI Compliance Fabric
Jump start solution to
manage PCI(1,2,3)
compliance
requirements in cloud
infra
READY
OCM framework for cloud
adoption
OCM framework
definition to support
enterprise plan ahead
of time on new needs
post cloud adoption
W I P
Cloud Suitability Framework
AWS - Cognizant Unique Initiative : Solution Accelerators Build
18
© 2017 Cognizant
CLOUD TRANSFORMATION STRATEGY
Build multi-stage cloud
transformation/migration roadmap
and strategy
1. WORKLOAD ASSESSMENT*
2. TRANSFORMATION ROADMAP*
3. CLOUD GOVERNANCE MODEL
4. APPLICATION READINESS
ASSESSMENT*
5. MIGRATION WAVES & EXECUTION
PLAN*
* Assessment & planning work
would be done for few limited
workloads
ARCHITECTURE
Build Reference Architecture
1. AWS NETWORK ARCHITECTURE*
2. AWS SECURITY ARCHITECTURE*
* Based on the workloads assessed
in the previous steps
PILOTS
Launch key application workload
migration pilots as evidence of
enterprise value and viability
1. APPLICATIONS
2. DATABASES
CLOUD EVANGELIZATION & TRAININGS
Value analysis, trainings and
business stakeholder
evangelization
1. AWS VALUE ANALYSIS*
2. AWS ESSENTIALS*
3. AWS ARCHITECTURE TRAINING*
4. AWS SYSOPS TRAINING*
* As determined by previous
workloads
Transformation Program Work Streams
19
© 2017 Cognizant
Reusable Framework/accelerators availableCognizant experience
Corporate FunctionsManufacturing & Supply ChainSales & Marketing R&D
• SAP BW & Hana
• Cognos
• WordPress
• Sitecore
• Myday
• PriceRight
• QlikView
• Revitas
• SAP (G)
• Trackwise (G)
• Oracle (G)
• Maximo
• Rockwell (G)
• Lorenz Docubridge (G)
• LIMS (G)
• Wonderware (G)
• MDM Informatica
• Kronos
• Smart Source
• Hyperion
• PeopleSoft
• Safety (Argus) (G)
• LIMS (G)
• Empower (G)
• EDC (InForm/Oracle/Rave) (G)
• CTMS (G)
(G) GxP applications
Typical COTS applications landscape ( Life Sciences – Example )
20
© 2017 Cognizant
Periodic Reviews/
Mock-Audits
SLA/OLA/
Metrics Reporting
Vendor
Reassessment
Testing
(Vulnerability,
Performance, Backup, BCP & DR)
Perform Cloud vendor
Assessment on parameters
such as quality, information
security, data privacy/ policies,
procedures, standards, data
center levels and certifications
Qualify Cloud
Evaluate Information Security,
Data Privacy, Compliance,
Technology Risks and arrive at
Quality assurance approach
Risk Assessment &
Validation Plan
Validate to ensure that the entire
system (hardware/ software) is
installed and operating correctly
and meets user requirements
Ensure effective change control
Perform Validation
Verify risk-based acceptance test
strategy and ensure successful
installation and operational
qualification, BCP and DR testing
is conducted
Governance –
Quality Assurance
Data center/ infrastructure
maintenance, Change
Management and User Access
provisioning procedures
Establish Support
Procedures
Methodology
Governance
Technology
The Transformation SolutionSaaS PaaS
IaaS
Goal : Ensure regulatory, information security and data privacy compliance of cloud hosted applications in a regulated business environment through a risk based
validation framework and streamlined SDLC. The desired business outcome will be a high quality, cost efficient inspection ready cloud hosted solution.
Validation Framework for Cloud Hosted Applications
21
© 2017 Cognizant
Provisioning &
Orchestration
Monitoring &
Auto-Remediation
Metering & Chargeback
Analytics and Advisory
Transformation Advisory, Strategy,
Business Case, Architecture Planning,
Transformation execution, Change
Management, Program Management ,
ERSS Security and Compliance offerings
Transformation Services
Cloud governance Foundation, Application
Migration Foundry, Cloud Management
Fabric, SLAs, Monitoring & Billing,
Integration with On-Premise resources
Managed Services
Framework
Cloud Steps Transformation
Framework
Tools
AWS Global
Infrastructure
EC2
Auto
Scaling
S3
EBS
Import/
Export
Storage
Gateway
DynamoDB RDS
ElastiCache
Route
53
Elastic Load
Balancing
Direct
ConnectVPC
IAM
CloudSearch
SES
SNS
SQS
SWF
AMI
EMR
Kinesis
WorkSpaces
GlacierCloudFront
Elastic
Beanstalk
CloudFormation
CloudWatch
Management
Console
Deployment
& Management
Computing
& Networking
Application
Services
Storage & Content
Delivery
Cloud Transformation with Cognizant & AWS
22
© 2017 Cognizant
Applications ON Cloud
• Re-Host
• Migrate
• Build
• Extend
• Test
Applications on
IaaS or PaaS,
Hybrid, SaaS,
BPaaS
Cloud Application Services
Approach TO Cloud
Cloud Strategy & Roadmap
Services
• Assess
• Select
• Plan
Applications,
Cloud, Software
Management OF Clouds
Cloud Management Services
• Monitor
• Manage
• Automate
Applications,
VMs, Storage
Cognizant’s AWS Transformation Services
23
© 2017 Cognizant24
The applicability of Cloud
Data Centre
Consolidation Reduce
TCO and improve
agility for the large
R&D IT Infra
EHR, Sensors Data
Archival &
Disaster Recovery
with reduced TCO
through cloud
containers
Account based
SellingPlanning
Cloud Platform to
enable account based
selling
Sales & Patient
Analytics
on-demand Big Data
Analytics Platform on
cloud
Research
Collaboration
Cloud Collaboration
Platform for global
workforce and partners
HPC on Cloud
Genomics sequencing
and other heavy
computing
requirements on
cloud
Marketing and Sales
Cloud based SaaS
solutions for managing
products M&S
Multi-channel Customer
Engagement Services
integrate and
manage new channels
on Cloud
Web Scale Apps
Cloud powered
web applications
ex: app for fast
and efficient drug
trial analysis
© 2017 Cognizant25
Executed/ In-Flight Cloud Engagements in LS
A multinational
pharmaceutical and
biologics company
Cloud enabled agile
research environment
A Pharmaceutical
contracting solutions
provider helped
leverage a SaaS based
Purchasing portal(GPO)
to widen its coverage
of alliance partners-
manufacturers, buyers,
alliances
A medical devices,
pharmaceutical and
CPG manufacturer-
Cloud Consulting
services for Data
Centre Consolidation
A multinational
pharmaceutical, and
consumer healthcare
company- migrating
SharePoint to cloud
A Pharmaceutical
Major
CRM application
migration to Cloud
An American
pharmaceuticals and
health care products
company
Cloud based
Healthcare Internet of
things( IoT) solution
© 2017 Cognizant26
Thank You

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Trends und Anwendungsbeispiele im Life Science Bereich

  • 1. © 2017 Cognizant © 2017 Cognizant AWS Meeting January, 2017
  • 2. © 2017 Cognizant2 Agenda/Objective of today’s discussion CHALLENGES IN LIFE SCIENCES INDUSTRY MARKET TRENDS ACROSS INDUSTRY CLOUD ADOPTION JOURNEY COGNIZANT AWS READINESS & INVESTMENTS APPLICATION IN LIFE SCIECNES AND CASE STUDIES DISCUSSION Slides 3 & 4 Slides 5 Slides 11 & 12 Slides 13 - 20 Slides 21 & 22 CLOUD SERVICES ACROSS PHARMA VALUE CHAIN Slides 6 - 10
  • 3. © 2017 Cognizant3 We are looking at rapid infrastructure commoditization across industry Emerging Players & Global Competition Increased People Costs And Shrinking Margins Changing Regulations & Environmental Concerns Need to Rapidly Reduce Production Cycles Supply-Chain under Severe Distress and Needs Remodeling Fluctuating Energy Costs Traditional Path to Purchase Is Changing Customers are Demanding Seamless Experience Customers are Embracing New Technologies Faster Increased Need To Multiply Operational Efficiencies Need To Reach Global Markets Competitors Are Using Big Data For Advantage Transforming Branch/Store Formats Enabling WorkForce To Stay Relevant BFSI RETAIL & CG MANLOG HEALTHCARE LIFE SCIENCESTECHNOLOGYCOMMUNICATION IMET & H
  • 4. © 2017 Cognizant A cloud-based planning layer can enable the sharing of S&OP data with key stakeholders: contract manufacturers, branded and generic business units, distributors and retailers. Cloud CRM Trends in Life Sciences industry in adaption of ‘Cloud’ Enveloping Core ERP with Cloud Improve effectiveness of the Sales force and customer complaint handling through Cloud CRM This approach is being embraced by leading pharmaceuticals manufacturers to comply with mandates around serialization, extend compliance to partners and leverage efficiencies across the extended supply chain. Data held in systems outside of ERP (CAPA, MES or LIMS, for example) can be shared on the same cloud platform. This enables effective monitoring of manufacturing processes and can provide early warnings of problems in internal and external operations Companies can use on demand analytics for more productive (R&D analysis of genomic, proteomic and clinical data) drug discovery and also in targeted marketing and sales effort Cloud-based Master Data(MDM) for Tracking, Tracing Cloud-based collaboration systems On-demand Big Data Analytics 4
  • 5. © 2017 Cognizant5 How is IT in life sciences is being challenged?  Regulatory requirements: Ensuring continued regulatory compliance for system related issues along with applicable foreign regulatory guidelines  Data explosion: The amount of data managed by life science companies almost doubles in 3 months.  Data protection:  Fragmented & Siloed data systems: Bespoke applications and Siloed business units, each with its own infrastructure  High cost of ownership: Heavy upfront(capital) investment in current IT systems Pressure to reduce budgets while meeting increasing needs from the business for responsiveness and agility  Elasticity: Low utilization of IT systems which are heavily provisioned to manage high demand during promotions for broadcasting and studios Partner with other Research Labs; Target Identity and Validation; In-silo research Perform initial laboratory and animal tests; Clinical data management Process development, scale- up, commercial production, Supply chain management Submission & Publication Management; Regulatory compliance Conduct Clinical Trials Brand Management; Collaborate with Doctors and Pharmacies; Market and sell finished product; Digital engagements Aggregate & Periodic Reporting; Customer support & analytics. Drug Discovery Drug Development Regulatory Manufacturing PharmacovigilanceMarketing & Sales
  • 6. © 2017 Cognizant Amazon’s Elastic Cloud Computing (EC2) Many Bio-informatics tool for protein or biologic sequence analysis have been deployed on EC2. Amazon, along with other vendors, maintains copies of many of the publicly- available data sets on genomic and sequence data and makes them available to their clients as part of their overall cloud environment. In silico or Virtual screening Screening involves using an automated tool to test thousands of compounds for a specific biological activity. Virtual screening allow researchers to greatly increase the pace of finding new potential compounds while reducing costs for lab work. Protein Docking Simulations AutoDock is a suite of automated docking tools. It is designed to predict how small molecules, such as substrates or drug candidates, bind to a receptor of known 3D structure. Data mining/Big-Data Analytics Cloud Computing – a game changer in Drug Discovery Big Data Analytics helps to assess the biological systems, improve accuracy of target binding patterns and to simulate the activity of multiple drugs simultaneously on many tissues like in a “virtual” human. 6
  • 7. © 2017 Cognizant Shared Investigator Platform Cloud LIMS allows real time specimen tracking and enable researchers to reserve specimens for a specified time interval. Seamless lab sample handling from entry to disposal, improving efficiency and reducing turnaround time. LIMS Electronic Data Capture Cloud based electronic data capture allows patients to use any electronic device to report their information directly into the system. It allows real time tracking of data, also reducing clinical trial costs by maximizing data entry and workflow efficiencies. Clinical Data Warehouse Accelerated Drug Development using Cloud A clinical and scientific data warehouse is used to manage, aggregate, and analyze clinical trial data. It also includes an operational data warehouse (ODW) for trial performance metrics and a custom- developed trial master file (TMF) tool to keep a comprehensive record of all clinical trial activities. The Shared Investigator Platform facilitates interaction with multiple clinical trial sponsors, and enable study planning, study start-up and study conduct activities while reducing the administrative burden on site staff. 7
  • 8. © 2017 Cognizant Regulatory Master Data & Registration Life Cycle Management Cloud based publishing services in combination with BPS services “Combining content management and publishing capabilities in the cloud offers a credible and innovative alternative to the architecture of the past 15 years,” said Steve Gens, Managing Partner of Gens and Associates; a Life Science benchmark and consultancy. Submission Publishing Electronic Document Management & Archiving Cloud based electronic document management & archiving solutions will implement a centralized storage repository across all business entities for corporate and affiliate dossiers, affiliate HA submissions correspondence, all HA correspondence and archival requirements by replacing the existing DMS systems, as well as other central or affiliate Document Management systems in use. Solutions available e.g. from: Aris Global, Assured PV, EMC D2, EXTEDO, Lorenz, Mission3, Qumas, Samarind, Veeva Regulatory Intelligence Services Regulatory Affairs Services in the cloud Provide a Regulatory intelligence platform by gathering & analyzing publicly available regulatory information. communicating the implications of that information, monitoring the current regulatory environment to Define Regulatory Strategy Provide guidance for individuals and projects On hands support for individuals Registration Tracking & IDMP The European Medicines Agency has mandated that organizations doing business in the EU will need to submit product information according to the ISO-IDMP standards by July 2016. Cloud based master data management solutions and services offer not only compliance to new emerging standards but also combine those data standards with other (global & local) life Cycle management activities 8
  • 9. © 2017 Cognizant Cloud based MES A cloud based global serialization platform creates reusable serial number generation profiles, support global standard and country- specific formats, define serial number creation rules, manage serialized inventory operations and meet traceability compliance requirements. Serialization Quality Management System Cloud based quality and compliance software is an end- to-end solution that automates all quality processes and can be accessed from any location. Quality processes supported include audits, change control, complaint handling, CAPA, and supplier quality management, etc. Supply Chain Management Pharma Manufacturing using Cloud services Cloud based SCM tool facilitates better co-ordination between pharma company and contract manufacturers. It provides a holistic reporting dashboard which can be utilized by SCM, the purchasing department, finance, marketing and others. It also provides a harmonized visualization across the enterprise for merged organisations having different SCM tools. Cloud based MES helps in coordinating all aspects of production from tracking inventory to managing quality control and can manage processes across multiple worldwide facilities. It facilitates faster deployment, reduced capital investment, scalability and access from digital devices. 9
  • 10. © 2017 Cognizant Adverse Event Reporting It helps in proactively identifying the safety issues, continuously assessing their impact on benefit-risk profile and effectively mitigating risks across the product's lifecycle. It allows seamless integration with any safety database and provides support for safety intelligence and Benefit risk assessment. Integrated Signal Detection and Benefit Risk Assessment Safety Data Warehouse Cloud based safety data hub solution for the safety operations and periodic reporting. It has optimized data model, intuitive web analytics interface and intelligent content generation techniques, which helps organizations improve operational efficiencies, measure compliance and reduce periodic reporting workload Supply Chain Management Leveraging Cloud Technology in Pharmacovigilance Cloud enabled Adverse Event staging platform helps to reduce the time and effort involved in processing AEs and ADRs from start to end. It helps in standardization of the intake, triage, case management, and submission process of Individual Case Safety Reports (ICSR) and allows capturing case information from any device. 10
  • 11. © 2017 Cognizant Sales and Operations Planning A cloud based Sales and operations planning helps in collaborating with external suppliers and vendors. It allows real time sales monitoring and order tracking. It aids in identifying sales opportunities with a comprehensive view of customers. It provides flexibility during M&A. New Product Introduction Integrated product portfolio management platform which helps in planning new product launch globally. It helps marketing managers to track the launch timeline, campaign planning and other marketing spend. It also helps in comparison of actual product market position, costs, P&L against expectations. Patient centric services Centralised location for all patient related information including demographics, communications, clinical and non-clinical data, and even pertinent information from EHR. It allows real-time interaction with patients and family. Also facilitates monitoring cases and prioritizing tasks based on immediate needs and level of importance to offer personalized care. Digital Marketing Cloud services in Sales and Marketing Connecting Social media, mobile applications, wireless access and evolving technologies and collaborative approaches to delivering healthcare. Integrated communication platform to deliver information on product and therapeutic area leading to 11
  • 12. © 2017 Cognizant Assessment & Plan Migrate Setup Manage Define cloud strategies and create cloud migration plan How does cloud apply to our organization and what specific workloads can we move there? Setup a secure cloud environment based on the workload requirements How can we ensure that the cloud setup is right for us Transition workload to Cloud environment How can we ensure that we migrate workloads correctly and quickly to the cloud? How do we run and operate cloud based ecosystems? Manage cloud based systems including Service Delivery What is a typical cloud adoption journey 12
  • 13. © 2017 Cognizant© 2017 Cognizant13 Cloud Integration Challenges - Example STRUCTURED DATA SOURCES Liquid Insight Manager Documentum ERP(SAP) AUTOMATIKA UNSTRUCTURED DATA EXTRACTION Unstructured Data Reader NLP Based Entity Extraction Rule Based Entity Extraction Document Classification With ML Model UNSTRUCTURED DATA SOURCES SmPC File Share Share Point Database Publish Publish in form of JSON Data Management UI (Search, View, Edit) IDMP Hub Global Unique ID Maintenance IDMP Data Model Substances Packages Medicinal products Pharmaceutical Products Marketing Authorization Clinical Particulars Materialized View EMA FDA Other DataConsumingSystems OtherSystems SAP Submission ARISGlobal DATA COLLECTION AND CLEANSING Data Collection Data Validation Data Cleansing RIMS CTMS HL7 File Extracts Hosted On- Premise FileExtracts Audit Trail Workflow Cross Reference Product Attributes Hosted on AWS Control Vocabulary Maintenance De Duplication Product Relationship Business Rules
  • 15. © 2017 Cognizant Cognizant Cloud Steps - A comprehensive tool-based framework that accelerates cloud enabled transformations by 25%-40% • Application Migration Solutions to AWS • Engineering Optimization Solutions for AWS • Business Innovation Solutions for AWS • Assess & Plan • Set Up • Migrate • Manage • Cloud Assessment Engine • Hybrid Cloud Governance Foundation • Cloud App Migration Foundry • Hybrid Cloud Management Platform • Cloud @ Customer • Cloud @ Partner (AWS) • Cloud @ Cognizant Cognizant Cloud Steps- simplifying your cloud journey 15
  • 16. © 2017 Cognizant • AWS’s Premier Consulting Partner • Cognizant in the top 1% of all AWS partners globally • Cognizant internal applications run on AWS • Transformational work across industries and geographies • Funded Center of Excellence for Cloud Services • Co- Executive sponsorship, dedicated technical and support resources, innovation fund Partnership Accelerators / Toolkits Offering Solutions and Platforms • Cloud Workshop & Cloud Advisory Board • AWS Suitability Assessment Transformation services End to end offering to help enterprise IT transformation • AWS Cloud Architecture Definition • Application Transformation & Migration • Cloud Environment Design & Provisioning • Cloud Auditing and Optimization Service • Cloud Applications Management • Cognizant Cloud Pattern Studio • Cognizant’ CloudStepsTM Migration framework • AWS Assessment Kit – Assessment framework for AWS suitability • Selenium Test Automation Platform • Cognizant Cloud Audit Ready • BigDecisions – Business Solutions Platform • Cognizant Cloud Steps: a comprehensive Cloud transformation framework. • Cognizant Cloud360 – Enterprise-class cloud management ‘hyper platform’ • Cognizant asset Serv – Digital Asset Management Solutions • Cognizant Cloud Set: Software engineering platform that accelerates development & testing • Cognizant Video as a Service – Cloud enabled Video platform • Cognizant Social Prism- social sentiment analysis platform Cognizant - AWS Strategic Relationship 16
  • 17. © 2017 Cognizant AWS Cognizant Economies of scale and efficiencies. Only pay for what you use. 40+ cost reductions Up to 71% on Infra Cost saving! Technology platform with industry- recognized certifications and audits SoX, PCI, PHI, HIPAA, FISMA , ITAR, ISO Provision systems in minutes vs. days, weeks or months Scale resources automatically Virtual unlimited compute, storage and network capacity Reduce dependency on Infra Free internal Infra resources to focus on innovation Focus on business goals and Improvements Cognizant Cloud Steps Transformation Framework Cognizant Assessment Engine Accelerators and libraries Cognizant Cloud Pattern Studio Cognizant Audit Equip Cognizant Trail Digest Cloud PCI & PHI framework Data masking , Data fabric Cognizant Cloud 360 tool for provisioning, orchestration, , monitoring and reporting Rich Domain expertise to support business demand and goals Library of Best practices and automation scripts Client Lower TCO Secured and Standardized platform Rapid Provisioning & High Availability Time to Market Align with Business Growth Cognizant and AWS : Joint Value Proposition 17
  • 18. © 2017 Cognizant HIPAA Fabric-Security Solution Jump start solution to manage HIPAA compliance requirements in cloud infra READY Expedited cloud adoption Roadmap with suitability assessment Engine for Workloads READY TCO Calculator Standardized TCO calculation suitable across all applications READY PCI Compliance Fabric Jump start solution to manage PCI(1,2,3) compliance requirements in cloud infra READY OCM framework for cloud adoption OCM framework definition to support enterprise plan ahead of time on new needs post cloud adoption W I P Cloud Suitability Framework AWS - Cognizant Unique Initiative : Solution Accelerators Build 18
  • 19. © 2017 Cognizant CLOUD TRANSFORMATION STRATEGY Build multi-stage cloud transformation/migration roadmap and strategy 1. WORKLOAD ASSESSMENT* 2. TRANSFORMATION ROADMAP* 3. CLOUD GOVERNANCE MODEL 4. APPLICATION READINESS ASSESSMENT* 5. MIGRATION WAVES & EXECUTION PLAN* * Assessment & planning work would be done for few limited workloads ARCHITECTURE Build Reference Architecture 1. AWS NETWORK ARCHITECTURE* 2. AWS SECURITY ARCHITECTURE* * Based on the workloads assessed in the previous steps PILOTS Launch key application workload migration pilots as evidence of enterprise value and viability 1. APPLICATIONS 2. DATABASES CLOUD EVANGELIZATION & TRAININGS Value analysis, trainings and business stakeholder evangelization 1. AWS VALUE ANALYSIS* 2. AWS ESSENTIALS* 3. AWS ARCHITECTURE TRAINING* 4. AWS SYSOPS TRAINING* * As determined by previous workloads Transformation Program Work Streams 19
  • 20. © 2017 Cognizant Reusable Framework/accelerators availableCognizant experience Corporate FunctionsManufacturing & Supply ChainSales & Marketing R&D • SAP BW & Hana • Cognos • WordPress • Sitecore • Myday • PriceRight • QlikView • Revitas • SAP (G) • Trackwise (G) • Oracle (G) • Maximo • Rockwell (G) • Lorenz Docubridge (G) • LIMS (G) • Wonderware (G) • MDM Informatica • Kronos • Smart Source • Hyperion • PeopleSoft • Safety (Argus) (G) • LIMS (G) • Empower (G) • EDC (InForm/Oracle/Rave) (G) • CTMS (G) (G) GxP applications Typical COTS applications landscape ( Life Sciences – Example ) 20
  • 21. © 2017 Cognizant Periodic Reviews/ Mock-Audits SLA/OLA/ Metrics Reporting Vendor Reassessment Testing (Vulnerability, Performance, Backup, BCP & DR) Perform Cloud vendor Assessment on parameters such as quality, information security, data privacy/ policies, procedures, standards, data center levels and certifications Qualify Cloud Evaluate Information Security, Data Privacy, Compliance, Technology Risks and arrive at Quality assurance approach Risk Assessment & Validation Plan Validate to ensure that the entire system (hardware/ software) is installed and operating correctly and meets user requirements Ensure effective change control Perform Validation Verify risk-based acceptance test strategy and ensure successful installation and operational qualification, BCP and DR testing is conducted Governance – Quality Assurance Data center/ infrastructure maintenance, Change Management and User Access provisioning procedures Establish Support Procedures Methodology Governance Technology The Transformation SolutionSaaS PaaS IaaS Goal : Ensure regulatory, information security and data privacy compliance of cloud hosted applications in a regulated business environment through a risk based validation framework and streamlined SDLC. The desired business outcome will be a high quality, cost efficient inspection ready cloud hosted solution. Validation Framework for Cloud Hosted Applications 21
  • 22. © 2017 Cognizant Provisioning & Orchestration Monitoring & Auto-Remediation Metering & Chargeback Analytics and Advisory Transformation Advisory, Strategy, Business Case, Architecture Planning, Transformation execution, Change Management, Program Management , ERSS Security and Compliance offerings Transformation Services Cloud governance Foundation, Application Migration Foundry, Cloud Management Fabric, SLAs, Monitoring & Billing, Integration with On-Premise resources Managed Services Framework Cloud Steps Transformation Framework Tools AWS Global Infrastructure EC2 Auto Scaling S3 EBS Import/ Export Storage Gateway DynamoDB RDS ElastiCache Route 53 Elastic Load Balancing Direct ConnectVPC IAM CloudSearch SES SNS SQS SWF AMI EMR Kinesis WorkSpaces GlacierCloudFront Elastic Beanstalk CloudFormation CloudWatch Management Console Deployment & Management Computing & Networking Application Services Storage & Content Delivery Cloud Transformation with Cognizant & AWS 22
  • 23. © 2017 Cognizant Applications ON Cloud • Re-Host • Migrate • Build • Extend • Test Applications on IaaS or PaaS, Hybrid, SaaS, BPaaS Cloud Application Services Approach TO Cloud Cloud Strategy & Roadmap Services • Assess • Select • Plan Applications, Cloud, Software Management OF Clouds Cloud Management Services • Monitor • Manage • Automate Applications, VMs, Storage Cognizant’s AWS Transformation Services 23
  • 24. © 2017 Cognizant24 The applicability of Cloud Data Centre Consolidation Reduce TCO and improve agility for the large R&D IT Infra EHR, Sensors Data Archival & Disaster Recovery with reduced TCO through cloud containers Account based SellingPlanning Cloud Platform to enable account based selling Sales & Patient Analytics on-demand Big Data Analytics Platform on cloud Research Collaboration Cloud Collaboration Platform for global workforce and partners HPC on Cloud Genomics sequencing and other heavy computing requirements on cloud Marketing and Sales Cloud based SaaS solutions for managing products M&S Multi-channel Customer Engagement Services integrate and manage new channels on Cloud Web Scale Apps Cloud powered web applications ex: app for fast and efficient drug trial analysis
  • 25. © 2017 Cognizant25 Executed/ In-Flight Cloud Engagements in LS A multinational pharmaceutical and biologics company Cloud enabled agile research environment A Pharmaceutical contracting solutions provider helped leverage a SaaS based Purchasing portal(GPO) to widen its coverage of alliance partners- manufacturers, buyers, alliances A medical devices, pharmaceutical and CPG manufacturer- Cloud Consulting services for Data Centre Consolidation A multinational pharmaceutical, and consumer healthcare company- migrating SharePoint to cloud A Pharmaceutical Major CRM application migration to Cloud An American pharmaceuticals and health care products company Cloud based Healthcare Internet of things( IoT) solution