Answering the Call for Disruptive Innovation to Transform Clinical Development

9 May 2013 Thomas Krohn, RPh, MBA Eli Lilly and Company

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

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Case for Disruptive Innovation

Productivity Down, Costs Up

Future revenues under pressure

Source: FDA.gov 4/23/13 Eli Lilly and Company 3

Total Cost of Drug Development

The Truly Staggering Cost Of Inventing New Drugs By Matthew Herber Forbes, February 2012

Drug Development

Innovation
Precompetitive
patent

Process
Competitive
$200 $100 $$300

Typical Cost/NME/Phase 4/23/13 Eli Lilly and Company 5

Millions US$

Clinical Research Improvement

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Moores vs. Erooms Law

Derek Lowe, Corante, March 2012

Incremental Improvement

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Disruptive Innovation
to S1'

Performance

to S2 S1
Disruptive Change

Time

Simpler, Faster, Cheaper? Who is being disrupted?

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Todays Model

Innovation
Precompetitive

Process patent
Competitive

Innovation Process patent

Competitive

Process patent
Competitive

Innovation
Precompetitive

Innovation

Process patent

Precompetitive Competitive

Innovation patent

Process

Precompetitive

Precompetitive

Competitive

Third Parties

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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

Worldbank

Motivation
Commons Licensing
Crowd
2. Consume 3. Curate

Uncurated Data

Clinical Knowledge Generation

Curated Data

1. Collect

4. Connect

Public Data

Technology
ROAR

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Open Clinical Intelligence Network

Commons Licensing
Learn & Follow Compare Visualizations Match Export API

Crowd
2. Consume 3. Curate

Tag Annotate Correct Cross Link Engage

Uncurated Data

Clinical Knowledge Generation

Curated Data

Trial Site Publication Drug Disease Regulatory

1. Collect

4. Connect

Public Data

Social Share Collaborate External Data Gamification

Knowledge Generating System

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Krohn & Crist Whitepaper 20

ClinicalTrials.Gov and Patients

2

95,000,000
Pageviews/Month1

45,600,000
Patient driven pageviews/Month

What if.?
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Sources: 1) clinicaltrials.gov site 2) D. Zarin 2007 Overview 21

Patient at the center

Open

Patients
Platform

Follow us at www.lillycoi.com for updates on tool availability 4/23/13 Eli Lilly and Company 22

Patient-Centric Studies
1
Study Representation
PatientCentric Design

Design Challenge

Ct.Gov

Informed Consent Document

Open

Study Design
Patients
Patient Voice
Platform

Open up design process Patient community engagement

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Clear eligibility Risk/Benefit My doctors role Study treatment Time to results Logistics

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Opening up design process

Todays Closed Fortress Model: Internal product teams Advisors Third party organizations Competitive = Secret No patients involved
Reality Distant from practice Small number Slow and expensive Nave Enrollment challenges

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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 (dont 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 Krohn krohnta@lilly.com Eli Lilly and Company www.lillycoi.com 4/23/13 Eli Lilly and Company 28