DISRUPTIVE
INNOVATIONS
Disruptive Innovation:
Moving Beyond the Talk
Thomas Krohn
Eli Lilly & Company
Case for Disruptive Innovation
Source: FDA.gov
Productivity Down, Costs Up Future revenues under pressure
Unsustainable Bu...
The Far Side
by Gary Larson
Drug Development
$-
$100
$200
$300
MillionsUS$
Typical Cost/NME/Phase
Precompetitive Competitivepatent
Innovation Process
3 Challenges
• Incremental vs. Disruptive
• Precompetitive vs. Competitive
• Closed vs. Open
Incremental Improvement
Clinical Research Improvement
Good, but not sufficient
Disruptive Innovation
to S1'
to S2
S1
Time
Performance
Disruptive
Change
Simpler, Faster, Cheaper?
Who is being disrupted?
Precompetitive vs. Competitive
Precompetitive Competitive
Collaboration should and can exist across model
patent
Closed vs. Open
Trial Planning & Design Example
Reality
• Distant from practice
• Small number
• Slow and expensive
• Naïv...
Experiment Portfolio
• Open Clinical Intelligence Network
– Trials, Labels, Sites, CTM Reqs, Stds of Care, OpenAPI
Open Clinical Intelligence Network
Commons Licensing
3. Curate
4. Connect1. Collect
Clinical
Knowledge
Generation
2. Consu...
Open Clinical Intelligence Network
Knowledge Generating System
Krohn & Crist Whitepaper
Trial
Site
Publication
Drug
Diseas...
From data to insights
Experiment Portfolio
• Open Clinical Intelligence Network
– Trials, Labels, Sites, CTM Reqs, Stds of Care, OpenAPI
• Proto...
Protocol Design
Experiment Portfolio
• Open Clinical Intelligence Network
– Trials, Labels, Sites, CTM Reqs, Stds of Care, OpenAPI
• Proto...
Predictive Analytics
We’re making data science a sport.™
Experiment Portfolio
• Open Clinical Intelligence Network
– Trials, Labels, Sites, CTM Reqs, Stds of Care, OpenAPI
• Proto...
Q&A Forum
So What?
If...
– Incremental improvement is a slow death,
– Competitive mindset is stopping collaboration, and,
– Closed m...
Time to Engage!
Tide is rising for disruptive change.
Are you on board?
The case is clear
The opportunities are many
The q...
Thanks
Thomas Krohn
krohnta@lilly.com
Eli Lilly and Company
www.lillycoi.com
Thomas Krohn - Dpharm 2012 - Disruptive Innovation: Moving Beyond the Talk
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  • http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/ucm259754.htm
  • 60 percent of all protocols for new drugs are amended during the trial, but one-third of those changes could have been avoided and saved countless dollars.More than half of all protocols require one or more amendments, with the higher number occurring duringPhase III.One-third of all amendments involve protocol description and patient eligibility criteria. Median total cycle time to identify and resolve a protocol problem is 61 days.
  • Definition: describing the early stages of the development of a commercial product, during which competitors collaborate
  • Naïvea) Public registries and transparency initiativesb) Public disclosure: part of being a public companyc) People same external advisors such as therapeutic key opinion leaders. same third party organizations such as consultants or CROs, and the same operational sites to execute our research.  d)same sources for complementary investment funding.  people are people.   Missing the mark: Operationally: 60% get amendments Scientifically: Patient Impact
  • Thomas Krohn - Dpharm 2012 - Disruptive Innovation: Moving Beyond the Talk

    1. 1. DISRUPTIVE INNOVATIONS Disruptive Innovation: Moving Beyond the Talk Thomas Krohn Eli Lilly & Company
    2. 2. Case for Disruptive Innovation Source: FDA.gov Productivity Down, Costs Up Future revenues under pressure Unsustainable Business Model
    3. 3. The Far Side by Gary Larson
    4. 4. Drug Development $- $100 $200 $300 MillionsUS$ Typical Cost/NME/Phase Precompetitive Competitivepatent Innovation Process
    5. 5. 3 Challenges • Incremental vs. Disruptive • Precompetitive vs. Competitive • Closed vs. Open
    6. 6. Incremental Improvement
    7. 7. Clinical Research Improvement Good, but not sufficient
    8. 8. Disruptive Innovation to S1' to S2 S1 Time Performance Disruptive Change Simpler, Faster, Cheaper? Who is being disrupted?
    9. 9. Precompetitive vs. Competitive Precompetitive Competitive Collaboration should and can exist across model patent
    10. 10. Closed vs. Open Trial Planning & Design Example Reality • Distant from practice • Small number • Slow and expensive • Naïve Today’s Closed Fortress Model: • Internal product teams • Advisors • Third party organizations • Competitive = Secret Time to explore other models
    11. 11. Experiment Portfolio • Open Clinical Intelligence Network – Trials, Labels, Sites, CTM Reqs, Stds of Care, OpenAPI
    12. 12. Open Clinical Intelligence Network Commons Licensing 3. Curate 4. Connect1. Collect Clinical Knowledge Generation 2. Consume Uncurated Data Curated Data Crowd Public Data Motivation Technology Worldbank ROAR
    13. 13. Open Clinical Intelligence Network Knowledge Generating System Krohn & Crist Whitepaper Trial Site Publication Drug Disease Regulatory Timeline Geographic Network Diagram Scatter Plot Export API Search/Filter Annotate Correct Cross Link API Social Share Collaborate External Data Gamification Commons Licensing 3. Curate 4. Connect1. Collect Clinical Knowledge Generation 2. Consume Uncurated Data Curated Data Crowd Public Data
    14. 14. From data to insights
    15. 15. Experiment Portfolio • Open Clinical Intelligence Network – Trials, Labels, Sites, CTM Reqs, Stds of Care, OpenAPI • Protocol Design – Crowd-based feedback
    16. 16. Protocol Design
    17. 17. Experiment Portfolio • Open Clinical Intelligence Network – Trials, Labels, Sites, CTM Reqs, Stds of Care, OpenAPI • Protocol Design – Crowd-based feedback • Site Training & Experience – Credentials, Training, Historical Trials • Predictive Analytics – Kaggle style enrollment projections
    18. 18. Predictive Analytics We’re making data science a sport.™
    19. 19. Experiment Portfolio • Open Clinical Intelligence Network – Trials, Labels, Sites, CTM Reqs, Stds of Care, OpenAPI • Protocol Design – Crowd-based feedback • Site Training & Experience – Credentials, Training, Historical Trials • Predictive Analytics – Kaggle style enrollment projections • Q&A Forum – Site to site sharing, clinical research topics
    20. 20. Q&A Forum
    21. 21. So What? If... – Incremental improvement is a slow death, – Competitive mindset is stopping collaboration, and, – Closed model is part of the problem… Then…check your assumptions: – Incremental vs. Disruptive – Precompetitive vs. Competitive – Closed vs. Open
    22. 22. Time to Engage! Tide is rising for disruptive change. Are you on board? The case is clear The opportunities are many The question is leadership
    23. 23. Thanks Thomas Krohn krohnta@lilly.com Eli Lilly and Company www.lillycoi.com

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