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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
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Perspectives - clinical investigator - basic researcher - biotech consultant - CRO - big pharma - investor - entrepreneur
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the drug development industry is facing extinction psychotherapy is not an answer
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intensive care is the only hope
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“open innovation” the abuse of terminology
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Obvious fields: - pre-competitive space - sharing data on: placebo response failed clinical studies
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Obstacles to crowdsourcing and transparency in pharma - legal - IP - arrogance of experts - fear for loosing jobs - secretive culture - antiquated computer sciences - development / marketing confluence
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Drug Development - Sources of Waste partial list……… 8 Pharma Company Infrastructure + Multiple Patient Visits to Expensive Sites High-Cost Patient Recruitment Insular Approach to Protocol Design + 20 th Century Data Capture & Analyses + = + Attacking the sources of waste
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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
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secrecy = legacy transparency = currency
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11 Transparency Life Sciences is 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.
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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) Passionate About Changing the World of Drug Development 12
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Three major enablers: technology social changes / culture crisis
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TLS Approach 14 1.Crowd-Sourcing – an approach to protocol design and data analysis, allowing for input from all available stakeholders “10,000 minds are better than 10” 2.Data & Technology Platform – web-based platform integrating multiple real-time data inputs via telemedicine Enhance trial cost-efficiency, safety, data 3.Transparency – Plans, data, analyses are shared openly, in real time Builds trust in TLS, provides best analyses
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How Will it Work in Practice? High-Level View 15 Protocol Design Patient Recruit- ment Study Execution Data Collection Analysis Crowd- Sourcing Online Groups Tele- medicine Secure, Open Vendors More Crowd Input Trial Step Key Leverage Point
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Why do people “go to” work? because of the context ($$ is the major incentive)
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Why do people contribute? because of their passion for the content ($$ is NOT the major incentive!)
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For TLS partnerships are essential Patients web groups Disease foundations Telemedicine companies Genetic testing enterprises Bioinformatics companies Focus: Clinical studies
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Welcome to our project collaborative space !
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