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Crowdsourcing Clinical Drug Development in a transparent model. Tomasz Sablinski M.D., Ph.D. Founder, Transparency Life Sciences Head of Development, Celtic Therapeutics. Open Science Summit Mountain View, CA Oct 23, 2011. Perspectives. clinical investigator basic researcher
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Crowdsourcing Clinical Drug Developmentin a transparent model Tomasz Sablinski M.D., Ph.D. Founder, Transparency Life Sciences Head of Development, Celtic Therapeutics Open Science Summit Mountain View, CA Oct 23, 2011
Perspectives clinical investigator basic researcher - biotech consultant - CRO - big pharma investor entrepreneur
the drug development industry is facing extinctionpsychotherapy is not an answer
Obvious fields:- pre-competitive space- sharing data on: placebo response failed clinical studies
Obstacles to crowdsourcing and transparency in pharma legal IP arrogance of experts - fear for loosing jobs - secretive culture antiquated computer sciences development / marketing confluence
Drug Development - Sources of Waste partial list……… Attacking the sources of waste + + Pharma Company Infrastructure High-Cost Patient Recruitment Insular Approach to Protocol Design + + = Multiple Patient Visitsto Expensive Sites 20th Century Data Capture & Analyses 8
New model:a platform for collecting key information, analyzing it, and building knowledge in a transparent, complete, easy to understand format to enable multiple parties to move a project ahead in a virtual global environment
Transparency Life Sciencesis a Drug Development Company We acquire IP and pharmaceutical assets from academia, biotech, and pharma, and add significant value by conducting clinical studies via open-source methods, and by executing with unmatched productivity.
Passionate About Changing the World of Drug Development Founders Tomasz Sablinski, MD, Ph.D. – Harvard, Novartis, Celtic Rx Marc Foster – FoldRx, Schrodinger, multiple exits in high tech Gareth Hicks, Ph.D. – Cambridge, GSK, Novartis, Tioga Lawrence Steinman, MD – Professor - Stanford, multiple biotechs Advisors Karim Lakhani – Harvard Business School Bernard Munos – Former strategist, Eli Lilly John L. Brown – Former President, Health Properties, Time-Warner Scott Becker – Co-Founder, Invite Media (acquired by Google)
Three major enablers:technologysocial changes / culturecrisis
TLS Approach Crowd-Sourcing – an approach to protocol design and data analysis, allowing for input from all available stakeholders “10,000 minds are better than 10” Data & Technology Platform – web-based platform integrating multiple real-time data inputs via telemedicine Enhance trial cost-efficiency, safety, data Transparency – Plans, data, analyses are shared openly, in real timeBuilds trust in TLS, provides best analyses
How Will it Work in Practice? High-Level View Trial Step Protocol Design Patient Recruit-ment Study Execution Data Collection Analysis Key Leverage Point Crowd-Sourcing Online Groups Tele-medicine Secure,Open Vendors MoreCrowd Input
Why do people “go to” work? because of the context ($$ is the major incentive)
Why do people contribute? because of their passion for the content ($$ is NOT the major incentive!)
Patients web groups Disease foundations Telemedicine companies Genetic testing enterprises Bioinformatics companies Focus: Clinical studies For TLS partnerships are essential