This presentation and all information contained herein is the confidential and proprietary information of Kalypso L.P. and its affiliates and subsidiaries (collectively, “Kalypso”) and is intended solely for the person(s) to whom it is transmitted by or on behalf of Kalypso. As such, no information contained herein shall be reproduced, copied, quoted, circulated, relied upon, or disclosed without the express written consent of Kalypso. With receipt of the information contained herein, the recipient acknowledges and agrees to at all times abide by the aforementioned non-use and non-disclosure obligations and any applicable written non-disclosure agreement(s).

Connecting the Dots from Idea to Market with Oracle Cloud

Sachin MisraKalypso

Renee S. DukeshireEli Lilly

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In this session you will learn how to

Avoid launching me-too products or products that fail to meet core requirements and cause companies to miss innovation revenue targets.

Unlock continuous connectivity and insightsflow between market, engineering, and manufacturing to further innovation and improve operational efficiency

Streamline the discover to make process with Oracle Cloud and Kalypso

Hear from industry leaders who are on this journey

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Introductions

Sachin MisraKalypso

Renee S. DukeshireEli Lilly

Kalypso is a professional services firm. We help our clients discover, create and make better products with digital.

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Established in 2004

4 Innovation Centers and Studios

280+ Professionals

350+ Clients Served

Privately Held

INDUSTRY FOCUS

COM

PREH

ENSI

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APAB

ILIT

IES

Enterprise Technology

Business Process Management& Managed Services

Consulting

Digital

Consumer LifeSciences

IndustrialHigh Tech

FinancialServices

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PLM has provided efficiency and productivity benefits helping manufacturers shorten design cycles,

but it has not helped deliver more innovation or improve the design to manufacturing integration

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Emerging technologies like IoT, Adaptive Intelligence, and Cloud provide new mechanisms for increasing connectivity and insights in the product value chain

ERP

Establishing a digital platform can enable the transformation of product design and development, production management, and customer service models

The Digital Value ChainK

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Product Service and Work Management

Health & Condition

Design/Engineering/ Manufacturing Documentation(P-BOM, E-BOM, M-BOM)

Engineering

Traditional/ Additive Manufacture

Prototype & Collaboration

Engineering Simulation& FEA

Ideation

Supply Chain Optimization

Analytics & Prediction

Generative Design

Augmented Reality (AR)

Virtual Reality (VR)

3DPrinting

Internet of Things (IoT)

ConceptPDM

PLMProductRecord

MES

Digital Twin

In Market

Productivity

Create MakeDiscover Sell

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What if you could connect the dots from discover to sell?

Social responsibility expectations

Price transparency moves to the statehouse

Product liability litigation

Natural disaster risks to value chain Product, process and

material innovation

Industry-wide collaboration

Personalized medicine

Disruptive emerging technologies

Patient experience as a priority and not just a patient portal

Real-world evidence – Cures Act

EUDAMED and rest of world

Audit readiness

Partnership models

Line blurring between electronics and medical

Challenging 510K approvals

Leveraging analytics and AI to gain a competitive edge

FDA case for quality

Acquisition activity

Better regulatory management is becoming a differentiator

Digital disruptors with the potential to impact patient lives

Robotic surgery

Remote monitoring and intervention

Pill/medicine compliance technologies

Patient biology specific 3D Printed pills

Line blurring between electronics and consumer

Industrial

Life Sciences

Consumer

FSMA Compliance

In-Sourcing

Embedded product IoT

DevSecOps and Cyber imperatives

AR and VR

Personalization at Scale

Additive manufacturing

Robotics and AI

Mass customization

Digital twins

Value chain traceability Budget conscious millennials

Rise of private labels

Consumer shift to fresh foods

Online shopping displacing brick and mortar

Compression of product cycles

Digital shopping channels

Lowered barriers of entry for small startups

Direct to consumer brands sold online only

IP protection

Counterfeits and adulteration Autopilot

consumptionsConvenience craves

Combination products

Subscription pricing

Everything as a service

Cost pressures

The Digital Value Chain enables you to address challenges from a holistic perspective.

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The availability of intelligent data and providing it to the right functions at the right time creates new opportunities to reduce risk, improve quality, and accelerate innovation

? ? ?

? ? ?

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Smart Connected Discover to Make answers common needs

How does smart connectivity accelerate innovation through real-time feedback?

How does smart connectivity boost effectiveness in manufacturing i.e. predictive maintenance?

How is manufacturing yield and throughput affected by design decisions?

How do you improve design with VOC, social trends and evolving regulatory requirements?

How do we shift to proactive instead of reactive?

How do you predict the impact of changes in design or manufacturing?

a

PRODUCT DEVELOPMENT

INNOVATION MANAGEMENT

QUALITY MANAGEMENT

MANUFACTURING & SUPPLY CHAIN

SMART MANUFACTURING (SCO)

Smart Connected Discover to Make

Smart Connected Operationsvs.

Market Insights

Multicolored Vitamins –Y/N?

Concept Setup

Item Setup

(Re)Formulate

Release New Product & Equipment Design

Setup New Item for Manufacturing

Equipment Configuration

Innovation Mgmt.

Product Development & Formulation

Product Hub

Manufacturing / Production Line

IoT AI

Monitor Color Accuracy, Temperature, Humidity

Analyze Accuracy Deviations and Correlate to Environmental Conditions, Shifts, Resources, Suppliers and others.

Project Management: Manage new product and equipment project

Product QualityCapture Audit Results Create CAPA

InMarket

Smart Connected Discover to Make

Product Lifecycle Intelligence – Predict cost of change, time to implement change, resource by region etc.

How about…?

Market Insights

Multicolored Vitamins –Y/N?

Concept Setup

Item Setup

(Re)Formulate

Release New Product & Equipment Design

Setup New Item for Manufacturing

Equipment Configuration

Innovation Mgmt.

Product Development & Formulation

Product Hub

Manufacturing / Production Line

IoT AI

Monitor Color Accuracy, Temperature, Humidity

Analyze Accuracy Deviations and Correlate to Environmental Conditions, Shifts, Resources, Suppliers and others.

Project Management: Manage new product and equipment project

Product QualityCapture Audit Results Create CAPA

InMarket

Smart Connected Discover to Make

Product Lifecycle Intelligence – Predict cost of change, time to implement change, resource by region etc.

How about…?

Develop and launch a products into market

Market Insights

Multicolored Vitamins –Y/N?

Concept Setup

Item Setup

(Re)Formulate

Release New Product & Equipment Design

Setup New Item for Manufacturing

Equipment Configuration

Innovation Mgmt.

Product Development & Formulation

Product Hub

Manufacturing / Production Line

IoT AI

Monitor Color Accuracy, Temperature, Humidity

Analyze Accuracy Deviations and Correlate to Environmental Conditions, Shifts, Resources, Suppliers and others.

Project Management: Manage new product and equipment project

Product QualityCapture Audit Results Create CAPA

InMarket

Smart Connected Discover to Make

How about…?

Product Lifecycle Intelligence – Predict cost of change, time to implement change, resource by region etc.

Manufacture higher quality products more efficiently

Market Insights

Multicolored Vitamins –Y/N?

Concept Setup

Item Setup

(Re)Formulate

Release New Product & Equipment Design

Setup New Item for Manufacturing

Equipment Configuration

Innovation Mgmt.

Product Development & Formulation

Product Hub

Manufacturing / Production Line

IoT AI

Monitor Color Accuracy, Temperature, Humidity

Analyze Accuracy Deviations and Correlate to Environmental Conditions, Shifts, Resources, Suppliers and others.

Project Management: Manage new product and equipment project

Product QualityCapture Audit Results Create CAPA

InMarket

Smart Connected Discover to Make

Product Lifecycle Intelligence – Predict cost of change, time to implement change, resource by region etc.

How about…?

Monitor and change products in the market

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Insight Data

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SITE

PLCs

Line 1.A

PHYSICAL EQUIPMENT LAYER(All line assets and PLCs)

Product-specific/ Work Order-specificSensor parameters

Humidity Vibration Temperature

IoT Gateway Provider

PLM

under change controlin

Production Monitoring

Adaptive Intelligence

IoT Apps PlatformOracle IoT Cloud

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Supply chain • Supplier

performance• Material availability• Material quality• On-time delivery• Non-conformance• Corrective actions• Change orders

Production• Yield• Throughput• Exceptions• Shift and worker

performance• Change orders

Regulatory / CompliancePeak Operating efficiency, rate of rejection, adverse events, supplier performance, , non-conformance, corrective actions, change orders,

Procurement• Supplier performance• Material availability• Material quality• On-time delivery• Non-conformance• Corrective actions• Change orders

Quality control• Peak operating

efficiency• Rate of rejection • Adverse events• Supplier

performance• Non-conformance • Corrective actions• Change orders

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Digital opportunity is built upon a solid product record foundation

PLM

Product PackagingProcessing

Finished Product

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"We’re trying to change the frontiers of what’s possible in medicine. Our vision is to change patients’ expectations – to provide a new sense of hope for people suffering from some of the world’s most debilitating diseases."

David A. Ricks Chairman and CEO, Lilly

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Over the past three years we have partnered to drive and deliver key initiatives

2016 2017 2018 2019

+

PLM Requirements Management Design and Implementation

PLM Design History FileDesign and Implementation

PLM Upgrade and Regression Testing SupportIn Progress

2010-2011

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vTeam full PLM Suite implementationConducted by current team members

Portfolio processes design for active projectsin the Elanco development pipeline

Requirements and Digital content management

Virtual/Digital clones and digital verification and validation

Virtual/Digital models

Systems Engineering approach to medical device development adapted by the FDA and the medical device industry is achieved through the utilization of the digital tools aligned with the process below

Digital product creation and validation

N E E D S S Y S T E M

Requirements

System Architecting

SubsystemDesign

ComponentDesign

ComponentTest

SubsystemIntegration

System Integration

System Validation

Process, Manufacture,

Assembly

M E S MES

Definition &Decomposition Integration

& Verification

Simulation& Verification

User Needs

Design Input

Design Process

Design Output

MedicalDevice

VERIFICATION

VALIDATION

REVIEW

+ +

Linkages between the system engineering components provide traceability at any point in the device lifecycle

Digital product creation and validation

SystemLevel

SubSystemLevel

Risks Controls Evidence

PHA

SRA

FMEAs

User Needs / Requirements

System Requirements

Sub-SystemRequirements

Detailed Design Specifications

Design Validation

Design Verification

Design Characterization

Testing

Analysis & Inspection

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Digital twin for drug and device manufacturing

Combination product innovation

Efficient regulatory management

Lilly is now poised to break through barriers

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Attend our session with ICU Medical tomorrow at 4:15pmSouth Pacific B – North Convention Center

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We work with our clients to lay the right foundation, set the course and take the first steps. 1

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We think of Digital as both strategic and practical.

Visit our booth PLM-01 to experience Smart Connected Discover to Make in real-life