Evolution Summit 2013 - Thomas Krohn Presentation

Answering the Call for Disruptive Innovation to Transform Clinical Development

9 May 2013

Thomas Krohn, RPh, MBAEli Lilly and Company

Agenda

• Case for change• Disruption in motion• Patient-Centric approach• Changing our course

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Case for Disruptive Innovation

Source: FDA.gov

Productivity Down, Costs Up Future revenues under pressure

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Total Cost of Drug Development

The Truly Staggering Cost Of Inventing New DrugsBy Matthew HerberForbes, February 2012

Drug Development

$- $50 $100 $150 $200 $250 $300

Mill

ions

US$

Typical Cost/NME/Phase

Precompetitive Competitivepatent

Innovation Process

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Clinical Research Improvement

Outsourcing

BPMCritical ChaineDC

Investigator Portal

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Moore’s vs. Eroom’s Law

Derek Lowe, Corante, March 2012

Incremental Improvement

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Disruptive Innovation

to S1'

to S2S1

Time

Performance

DisruptiveChange

Simpler, Faster, Cheaper?

Who is being disrupted?

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Today’s Model

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Third Parties

Precompetitive Competitivepatent

Innovation Process

Precompetitive Competitivepatent

Innovation Process

Precompetitive Competitivepatent

Innovation Process

Precompetitive Competitivepatent

Innovation Process

Precompetitive Competitivepatent

Innovation Process

Christensen on healthcare disruption

Disruption in motion

Generation and Access to Data

Patient Digital Monitoring

Patient Communities

Patients as microexperts – not subjects

Patient-Driven Research

The Disruption

Power to the Patient

Open Clinical Intelligence Network

Commons Licensing

3. Curate

4. Connect1. Collect

ClinicalKnowledgeGeneration

2. Consume

Uncurated Data

Curated Data

Crowd

Public Data

Motivation

Technology

Worldbank

ROAR

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Open Clinical Intelligence Network

Knowledge Generating SystemKrohn & Crist Whitepaper

TrialSite

PublicationDrug

DiseaseRegulatory

Learn & FollowCompare

VisualizationsMatchExport

API

TagAnnotateCorrect

Cross LinkEngage

Social ShareCollaborate

External DataGamification

Commons Licensing

3. Curate

4. Connect1. Collect

ClinicalKnowledgeGeneration

2. Consume

Uncurated Data

Curated Data

Crowd

Public Data

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ClinicalTrials.Gov and Patients

95,000,000Pageviews/Month1

Sources: 1) clinicaltrials.gov site 2) D. Zarin 2007 Overview

45,600,000Patient driven pageviews/Month

2

What if….?

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Patient at the center

Follow us at www.lillycoi.com for updates on tool availability

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Open

Platform

Patients

1

Patient-CentricDesign

PatientVoice

2

Patient-Centric Studies

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Study Representation

Informed ConsentDocumentCt.Gov

Design Challenge

Study Design

Open

Platform

Patients

• Clear eligibility• Risk/Benefit• My doctor’s role• Study treatment• Time to results• Logistics

• Open up design process

• Patient community engagement

Opening up design process

Reality• Distant from practice• Small number• Slow and expensive• Naïve• Enrollment challenges

Today’s Closed Fortress Model:• Internal product teams• Advisors• Third party organizations• Competitive = Secret• No patients involved

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Study Design Feedback

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Changing our course

• Believe current model is unsustainable• Know your business model• Strategic choices, not operational norms• Get close to ground truth• Meet patients where they are• Listen• Embrace (don’t run away) from open data• Collaborate

COI References

• Website: www.lillycoi.com• Whitepaper: link• Public developer API: api.lillycoi.com• Twitter: @Lilly_COI

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Thanks

Thomas Krohnkrohnta@lilly.comEli Lilly and Companywww.lillycoi.com

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