AWS Meeting - Amazon Web Servicesaws-de-media.s3.?Cognizant internal applications run on AWS •Transformational work across industries and geographies •Funded Center of

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  • 2017 Cognizant 2017 Cognizant

    AWS Meeting

    January, 2017

  • 2017 Cognizant 2

    Agenda/Objective of todays 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 Cognizant 3

    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

    4

  • 2017 Cognizant 5

    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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    Amazons 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

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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

    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