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Thomas Krohn - Dpharm 2012 - Disruptive Innovation: Moving Beyond the Talk
- 1. DISRUPTIVE INNOVATIONS Disruptive Innovation: Moving Beyond the Talk Thomas Krohn Eli Lilly & Company
- 2. Case for Disruptive Innovation Source: FDA.gov Productivity Down, Costs Up Future revenues under pressure Unsustainable Business Model
- 3. The Far Side by Gary Larson
- 4. Drug Development $- $100 $200 $300 MillionsUS$ Typical Cost/NME/Phase Precompetitive Competitivepatent Innovation Process
- 5. 3 Challenges ⢠Incremental vs. Disruptive ⢠Precompetitive vs. Competitive ⢠Closed vs. Open
- 8. Clinical Research Improvement Good, but not sufficient
- 9. Disruptive Innovation to S1' to S2 S1 Time Performance Disruptive Change Simpler, Faster, Cheaper? Who is being disrupted?
- 10. Precompetitive vs. Competitive Precompetitive Competitive Collaboration should and can exist across model patent
- 11. Closed vs. Open Trial Planning & Design Example Reality ⢠Distant from practice ⢠Small number ⢠Slow and expensive ⢠NaĂŻve Todayâs Closed Fortress Model: ⢠Internal product teams ⢠Advisors ⢠Third party organizations ⢠Competitive = Secret Time to explore other models
- 12. Experiment Portfolio ⢠Open Clinical Intelligence Network â Trials, Labels, Sites, CTM Reqs, Stds of Care, OpenAPI
- 13. 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
- 14. 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
- 15. From data to insights
- 16. Experiment Portfolio ⢠Open Clinical Intelligence Network â Trials, Labels, Sites, CTM Reqs, Stds of Care, OpenAPI ⢠Protocol Design â Crowd-based feedback
- 17. Protocol Design
- 18. Experiment Portfolio ⢠Open Clinical Intelligence Network â Trials, Labels, Sites, CTM Reqs, Stds of Care, OpenAPI ⢠Protocol Design â Crowd-based feedback ⢠Site Training & Experience â Credentials, Training, Historical Trials ⢠Predictive Analytics â Kaggle style enrollment projections
- 19. Predictive Analytics Weâre making data science a sport.â˘
- 20. Experiment Portfolio ⢠Open Clinical Intelligence Network â Trials, Labels, Sites, CTM Reqs, Stds of Care, OpenAPI ⢠Protocol Design â Crowd-based feedback ⢠Site Training & Experience â Credentials, Training, Historical Trials ⢠Predictive Analytics â Kaggle style enrollment projections ⢠Q&A Forum â Site to site sharing, clinical research topics
- 21. Q&A Forum
- 22. So What? If... â Incremental improvement is a slow death, â Competitive mindset is stopping collaboration, and, â Closed model is part of the problem⌠ThenâŚcheck your assumptions: â Incremental vs. Disruptive â Precompetitive vs. Competitive â Closed vs. Open
- 23. 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
- 24. Thanks Thomas Krohn krohnta@lilly.com Eli Lilly and Company www.lillycoi.com
Hinweis der Redaktion
- 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
- NaĂŻvea) 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. Â d)same sources for complementary investment funding. Â people are people. Â Â Missing the mark: Operationally: 60% get amendments Scientifically: Patient Impact