accelerating clinical development through oi
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Accelera'ng Clinical Development through Open Innova'on
Thomas Krohn, RPh, MBA Director, Clinical Open Innova'on Eli Lilly and Company Amsterdam, 26 April 2012
3 Goals Today Case for OI in clinical development Leveraging public data and open networks Applied example
Produc'vity Down, Costs Up
Source: FDA.gov
Future revenues under pressure
Source: FDA.gov
Drug Development Why Clinical?
$300 $200 $100 $-
Typical Cost/NME/Phase Source: PhRMA
Millions US$
Protocol Amendments 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 during Phase III. One-third of all amendments involve protocol descrip'on and pa'ent eligibility criteria. Median total cycle 'me to iden'fy and resolve a protocol problem is 61 days. Source: Tu[s Center for the Study of Drug Development
Incremental Improvement
Incremental Improvement
Disrup've Change for S2 Shi[ to S1'
Performance
to S2 S1Disruptive Change
Time
Simpler, Faster, Cheaper
Open vs. Closed Innova'on
Precompe((ve
Compe((ve
Closed/Open Innova'on
Closed Innova'on
Clinical Development Decision Making Key ques(ons: Research landscape? Regulator expecta'ons? How much 'me, how much money? Study Design t to local clinical prac'ce? Tradi(onal model: Internal product teams Advisory Board Precompe((ve Third party organiza'ons
Compe((ve
Closed Innova'on
Slow, Expensive, Myopic and N ave?
Opportunity for Open Innova'on Worldbank
Mo'va'on Commons Licensing Crowd2. Consume 3. Curate
Uncurated Data
Clinic al Knowledge Gener at ion
Curated Data
1. Collect
4. Connect
Public Data
Technology ROAR
Open Clinical Intelligence Network Timeline Geographic Network Diagram Sca`er Plot Export API
Commons Licensing
Crowd2. Consume 3. Curate
Search/Filter Annotate Correct Cross Link API
Uncurated Data
Clinic al Knowledge Gener at ion
Curated Data
Trial Site Publica'on Drug Disease Regulatory
1. Collect
4. Connect
Public Data
Social Share Collaborate External Data Gamica'on
Knowledge Genera-ng System Krohn & Crist Whitepaper
TBCommons.org Disease Commons Fully Open Public Trial Informa'on Ques'on/Answer Forum Public Collabora'on
ClinicalCollec'ons.org Fully Open Public Trial Informa'on Search & Filter Views & Share
Search
Au's'c Disorder Collec'on
Filter
Views - Summary
Views - Outcomes
Views - Timeline
Views - Map
Views - Map
Clinical Collec'ons Value Research Landscape Reference Trials Design Opera'onal Insights
Just the start
Future Direc'on Principle: Enable others to innovate in commons Capabili'es Publish API to data New data sources, cross linking, views Cura'on: annota'on, personal collec'ons
Porfolio of Experiments Open & Collabora've Crowdsourced genera've informa'on projects (e.g. trial design feedback)
More Informa'on www.lillycoi.com Whitepaper Porfolio of COI experiments Links to tools Blog Contact informa'on
Clinical Open Innova'on
Open
Closed Open
Unsustainable Model Commons IP Crowd2. Consume 3. Curate
Shi[ Open to Clinical
Uncurated Data
Clinic al Knowledge Gener at ion
Curated Data
1. Collect
4. Connect
Public Data
Experiment with Knowledge Genera'on Systems
Thank You
Thomas Krohn, RPh, MBA Director, Clinical Open Innova'on Eli Lilly and Company
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