Trends und Anwendungsbeispiele im Life Science Bereich

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© 2017 Cognizant © 2017 Cognizant AWS Meeting January, 2017

Transcript of Trends und Anwendungsbeispiele im Life Science Bereich

Page 1: Trends und Anwendungsbeispiele im Life Science Bereich

© 2017 Cognizant © 2017 Cognizant

AWS Meeting

January, 2017

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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

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We are looking at rapid infrastructure commoditization across industry

Emerging Players &Global Competition

Increased People CostsAnd Shrinking Margins

Changing Regulations &Environmental Concerns

Need to Rapidly Reduce

Production Cycles

Supply-Chain under SevereDistress and Needs

Remodeling

Fluctuating Energy Costs

Traditional Path toPurchase Is Changing

Customers areDemanding Seamless

Experience

Customers are Embracing New Technologies Faster

Increased Need To Multiply Operational

Efficiencies

Need To Reach Global Markets

Competitors Are UsingBig Data For Advantage

Transforming Branch/Store Formats

Enabling WorkForceTo Stay Relevant

BFSI RETAIL & CG MANLOG HEALTHCARE LIFE SCIENCESTECHNOLOGYCOMMUNICATION IMET & H

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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

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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

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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.

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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.

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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

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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.

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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.

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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

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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 environmentbased 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

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Cloud Integration Challenges - Example

STRUCTURED DATA SOURCES

Liquid Insight Manager

Documentum

ERP(SAP)

AUTOMATIKA

UNSTRUCTURED

DATA EXTRACTION

Unstructured DataReader

NLP Based Entity Extraction

Rule Based Entity Extraction

Document Classification With

ML Model

UNSTRUCTUREDDATA

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

productsPharmaceutical

ProductsMarketing Authorization

Clinical ParticularsMaterialized

View

EMA

FDA

Other

Dat

a C

on

sum

ing

Syst

ems

Oth

er S

yste

ms

SAP

Sub

mis

sio

n

AR

ISG

lob

al

DATA

COLLECTION AND

CLEANSING

Data Collection

Data Validation

Data Cleansing

RIMS

CTMS

HL7

File Extracts

Hosted On-Premise

File

Ext

ract

s

Audit Trail

Workflow

Cross Reference

Product Attributes

Hosted on AWS

Control Vocabulary Maintenance

De Duplication

Product Relationship

Business Rules

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Appendic – if needed

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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

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• 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

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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 auditsSoX, PCI, PHI, HIPAA, FISMA , ITAR, ISO

Provision systems in minutes vs. days, weeks or monthsScale resources automaticallyVirtual unlimited compute, storage and network capacity

Reduce dependency on InfraFree internal Infra resourcesto focus on innovation

Focus on business goals and Improvements

Cognizant Cloud Steps Transformation FrameworkCognizant Assessment EngineAccelerators and libraries

Cognizant Cloud Pattern StudioCognizant Audit Equip Cognizant Trail DigestCloud PCI & PHI frameworkData 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

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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

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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

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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 )

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Periodic Reviews/ Mock-Audits

SLA/OLA/Metrics Reporting

VendorReassessment

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

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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

ToolsAWS Global

Infrastructure

EC2Auto

Scaling

S3

EBS

Import/Export

Storage Gateway

DynamoDB RDS

ElastiCache

Route53

Elastic LoadBalancing

Direct ConnectVPC

IAM

CloudSearchSES

SNS

SQS

SWF

AMI

EMRKinesis

WorkSpaces

GlacierCloudFront

Elastic Beanstalk

CloudFormation

CloudWatch

Management Console

Deployment & Management

Computing & Networking

Application Services

Storage & Content Delivery

Cloud Transformation with Cognizant & AWS

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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

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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 Selling\PlanningCloud 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 SalesCloud 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

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Executed/ In-Flight Cloud Engagements in LS

A multinational pharmaceutical and biologics companyCloud 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

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Thank You