Innovation at the “Edge”

Chris L. Waller, Ph.D.

(with help from Jack and Hunter)

Platforms and the “Edge”

The “Edge”

Insert picture of kid solutions crossing canyon

Now What?

That’s a jet pack!

A portal.

A robot shark.

Create and Capture ValueOnStar Platform

• OnStar will give certified developers “safe access” to ATOMS, OnStar’s Advanced Telematics Operating System, the car industry’s largest cloud-based automotive platform.

• The information includes status about the car such a its exact GPS location, whether doors are locked, condition of the battery if it’s a hybrid or EV, even the ability to remotely unlock the car.

• Those attributes made for a happy first partner, RelayRides, a community car-sharing service.

Platform Economics

14

Pric

e

• Platforms drive out point solutions and application silos• Platform adoption drives down the cost of new services• Lower cost of service development drives innovation• APIs allow for third party contribution

Platform Layer 1Platform Layer 2

Quantity

Enterprise platforms drive economies of scale, business agility, rate of innovation, and information velocity across divisions … eats points solutions for lunch.

App

1

App

2

Adapted from Marshall Van Alstyne

Platforms and MSD (Merck & Co.)

Platform Definition

Types of IT Platforms• Business Capability – Software, data and integrations that directly

enable a set of business functions & activities (e.g., ERP, Customer Engagement)

• Application Delivery - Software and data services on top of which Business Capability platforms or stand-along applications are designed, built and deployed (e.g., Data Analytics, Web/Collaboration)

• Infrastructure – Core, ubiquitous foundational network, hardware, and system software (e.g., Network, UC)

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PlatformDevelopers

Interface

Developers, Customers / Users

New Features and functionality

Platform Ecosystem

A set of highly-related information and technology capabilities that when combined, provide economic value to Merck’s business through faster speed to market and reduced unit costs . They should be planned, delivered and managed as a whole set of capabilities (rather than independently).1

Platforms create and capture new value for Merck

The Global Innovation Network

The Scientific Modeling Platform

“Analytics” Continuum at MRLA

naly

tical

co

mpl

exity

/dep

th

Descriptive Analytics

Prescriptive Analytics

Predictive Modeling / Simulation / Optimization

What will happen if ..? What’s the best choice? What are the alternatives?What should we do?

Statistical and Mathematical Analysis

What is the cause? Is my hypothesis correct?

Enquiry AnalyticsData Exploration & Mining Analysis / Visualization / Query / Drill down / Alerts

Hypothesis generation What is the problem? Is there a pattern? What is a good question to ask? When is action needed?

Ad hoc and Custom Reports How did it happen?

Standard Reports and Dashboards What happened?

JM Johnson, DRAFT 6/5/2014Based on a similar slide from Booz Allen Hamilton

PredictiveAnalytics

Anatomy of Analytics

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Shared libraries, models, algorithms, indexes and self-service

IT as Platform

Liberation and integration of data (internal and external)

Standard Processes . Data Stewardship . Unified Software

Bigger questions, actionable insights

Fraud Detection

Real World Evidence

Molecule Simulation

Pricing / Promotion

Inventory / Working Capital

Over-Payments

Imagine a world where…• …primary activity, pharmacokinetic, and pharmacodynamic models are

linked and support early discovery programs.• …comparator models support programs in discovery and development.• …model supported trial design, clinical planning and trial avoidance are

integral parts of all our early and late stage development programs.• …real-time visualization and simulation allow us to see impact of

assumptions, comparison of models, and understand uncertainty.• …quantitative decision making is routinely used integrating knowledge across

the discovery / development continuum and regulatory and patient decisions.• …model aided drug approvals are achieved.• …models can be ultimately be used at the “bedside” to optimally inform

dose selection, patient selection and that the models update in real-time with each patient.

Level 4Level 3Level 2Level 1

What Keeps Us From Doing This Today?

EDDS Data

EDDS Models

PCD Data

PCD Models

Clinical Data

Clinical Models

Real World Data

Real World

Models

Discovery Pre-clinical Clinical Outcomes

While we are beginning to see sharing of models and integration of data WITHIN functional domains, we are still advancing sub-optimal POC entities.

Technology: Siloed information and model management solutionsProcess: Siloed workflows

People: Siloed thinkingRoot Causes

What Does the Future Look Like?

EDDS Data

EDDS Models

PCD Data

PCD Models

Clinical Data

Clinical Models

Real World Data

Real World

Models

Discovery Pre-clinical Clinical Outcomes

Cultural, behavioral, and technical barriers between functional domains are eliminated and data, models, and knowledge are used holistically to advance the most promising entities.

Data Models

Integration Layer

Delivery Layer

End User Experience Layer

Merck Scientific Modeling Platform

Merck Information Management Platform

Nirvana

Drug Protein Target Response

Pharma Product Lifecycle Management

System Individuals PopulationsPathway

Research Development Commercial Medical

Data(Internal and External,

Structured and Unstructured)

Models and Simulations(Data)

Workflows (Best Practices)

Learning Loops (DMAIC Cycles) within the functional domains of Pharma R&D Support:• Adaptive Research Operating Plans• Adaptive Clinical Trials• Behavioral Modification…

DesignMeasure

Analyze

ImproveControl

DesignMeasure

Analyze

ImproveControl

DesignMeasure

Analyze

ImproveControl

DesignMeasure

Analyze

ImproveControl

Drug Protein Target Response

Pharma Product Lifecycle Management

System Individuals PopulationsPathway

Research Development Commercial Medical

Data(Internal and External,

Structured and Unstructured)

Models and Simulations(Data)

Workflows (Best Practices)

Cross-domain DMAIC Loops…

Drug Protein Target Response

Pharma Product Lifecycle Management

System Individuals PopulationsPathway

Research Development Commercial Medical

Data(Internal and External,

Structured and Unstructured)

Models and Simulations(Data)

Workflows (Best Practices)

Can we construct pan-R&D workflows that incorporate existing data, predictive models, and best practices to drive design, predict full product lifecycle, and increase probability of success?

Platforms Power Applications and Enable Business Outcomes

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Translational Medicine IT Preclinical Development IT Clinical, Regulatory, & Safety IT

CORE & OCMO ITQSAR Workbench,

ADMET Workbench, Spotfire, Excel

M&S Workbench, Model Explorer,

SpotfireA&R Workbench

HEM Workbench, Excel, Spotfire

Cross-functional Analytics & Predictive Modeling (Scientific Modeling Platform)Validate Model

Cross-functional Information Access & Interoperability (Scientific Information Management Platform)

Business OutcomesDecrease SDV / GCD Cost Decrease Time to Market

Increase in Analysis of Real World Data

Ensure 100% Compliance

Increase Analytics Based Decision Making

Increase Biologics contribution to 40%

Increase use of modeling for trials and submissions

Scientists can find Information they need

Improve POC Success to 60%

Build Model

Store Model

Recall Model

Publish Model

Execute Model

Retire Model

Enhance Data

Ingest Data

Integrate Data

Filter Data

Aggregate Data

Transform Data

Serve Data

Cross-functional Information Creation and Collection (Enterprise and Laboratory Platforms)Enhance

DataCreateData

ImportData

Curate Data

ControlData

Transform Data

Serve Data

Platforms Enable Innovation• New Collaborations: Fundamental to the development of the platform, and an area of

precompetitive interest, is the creation of vocabularies, metadata, and ontologies for the management, integration, and appropriate usage of models. Additionally, APIs for will needed to be standardized to support integration of COTS and custom packages.

• New Capabilities: Once the Scientific Modeling Platform is in place, there will be opportunities to innovate (1) in the data provision/model sources area (e.g., IMI2/RADAR), (2) in the areas of model lifecycle management services (e.g., model validation), statistical/analytical methods (e.g., new algorithms), and (3) in the overall end-user experience through the creation of new applications and user interfaces.

• New Business Models: Additionally, as a cloud-hosted and publically available resource (much like the Google predict API), we envision the Scientific Modeling Platform providing a unique ecosystem for the broad-scale creation and distribution of models to support pre-competition and open science and potential monetization of modeling related assets (e.g., data ingestion services, model-ready data sets, data analysis services, predictive modeling services, models, …).

Key Messages

• Platforms provide stable foundations on which to innovate.• Platforms have edges (APIs) and are open systems.• Platforms provide tremendous financial benefits.• Platforms support agile delivery of applications.• Platforms are transforming Merck & Co. (MSD).

Thanks!My Team

Charlie Chang, Director, Early Discovery Modeling Platforms

Kam Chana, Assoc. Director, Preclinical/QP2 Modeling Platforms

Mark Kruger, Assoc. Director, CORE/HES Modeling Platforms

Eric Gifford, Principal Scientist (On Rotation), Model Standards

Extended Team

Lindsay Augusterfer (Business Analyst)

Nicole Glazer (SIM Interface, Portfolio)

David Kniaz (Business Analysis/Architecture)

Mark Schreiber (Information Architecture)

Greg Tietjen (Clinical Architecture)

Tom Rush (tPKPD, Modeling and Simulation COP)

Daniel McMasters (Early Discovery Modeling SME)

Ryan Vargo (QP2 Modeling SME)

Erik Dasbach (HES Modeling SME)

Matt Walker (GIC/Engineering Interface)

Mike StapletonSusan Shiff

Frank BrownSandy Allerheiligen

Jason Johnson

Special Thanks!

Jim CirielloDoug Redden

Patrick GrazianoClark Golestani

Extra Special Thanks!Jack Waller

Hunter Grossman

Questions?