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