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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 Business Model
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
• Naïve
Today’s Closed Fortress Model:
• Internal product teams
• Advisors
• Third party organizations
• Competitive = Secret
Time to explore other models
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. Consume
Uncurated
Data
Curated
Data
Crowd
Public Data
Motivation
Technology
Worldbank
ROAR
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
From data to insights
Experiment Portfolio
• Open Clinical Intelligence Network
– Trials, Labels, Sites, CTM Reqs, Stds of Care, OpenAPI
• Protocol Design
– Crowd-based feedback
Protocol Design
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
Predictive Analytics
We’re making data science a sport.™
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
Q&A Forum
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
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
Thanks
Thomas Krohn
krohnta@lilly.com
Eli Lilly and Company
www.lillycoi.com

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Thomas Krohn - Dpharm 2012 - Disruptive Innovation: Moving Beyond the Talk

Notes de l'éditeur

  1. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/ucm259754.htm
  2. 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.
  3. Definition: describing the early stages of the development of a commercial product, during which competitors collaborate
  4. 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