evolution summit 2013 - thomas krohn presentation
DESCRIPTION
A look at Clinical Open Innovation as key enabler for disruptive innovation in pharmaceutical research.TRANSCRIPT
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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