crowdsourcing clinical drug development in a transparent model tomasz sablinski m.d., ph.d. founder,...
TRANSCRIPT
Crowdsourcing Clinical Drug Development
in a transparent model
Tomasz Sablinski M.D., Ph.D.
Founder, Transparency Life SciencesHead of Development, Celtic Therapeutics
Open Science SummitMountain View, CA
Oct 23, 2011
Perspectives
- clinical investigator
- basic researcher
- biotech consultant
- CRO
- big pharma
- investor
- entrepreneur
the drug development industry is facing extinction
psychotherapy is not an answer
intensive care is the only hope
“open innovation”
the abuse of terminology
Obvious fields:
- pre-competitive space- sharing data on:
placebo responsefailed 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………
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Pharma CompanyInfrastructure
+
Multiple Patient Visitsto Expensive Sites
High-Cost Patient Recruitment
Insular Approach toProtocol Design
+
20th Century Data Capture & Analyses
+ =+
Attacking the sources of waste
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
secrecy = legacy
transparency = currency
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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.
FoundersTomasz Sablinski, MD, Ph.D. – Harvard, Novartis, Celtic RxMarc Foster – FoldRx, Schrodinger, multiple exits in high
techGareth Hicks, Ph.D. – Cambridge, GSK, Novartis, TiogaLawrence Steinman, MD – Professor - Stanford, multiple
biotechs
AdvisorsKarim Lakhani – Harvard Business SchoolBernard Munos – Former strategist, Eli LillyJohn L. Brown – Former President, Health Properties, Time-
WarnerScott Becker – Co-Founder, Invite Media (acquired by Google)
Passionate About Changing the World of Drug
Development
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Three major enablers:
technologysocial changes / culture
crisis
TLS Approach
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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 timeBuilds trust in TLS, provides best analyses
How Will it Work in Practice?High-Level View
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ProtocolDesign
Patient Recruit-ment
StudyExecution
DataCollection
Analysis
Crowd-Sourcing
OnlineGroups
Tele-medicine
Secure,Open
Vendors
MoreCrowdInput
Trial Step
Key Leverage Point
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!)
For TLS partnerships are essential
Patients web groups
Disease foundations
Telemedicine companies
Genetic testing enterprises
Bioinformatics companies
Focus: Clinical studies
Welcome to our project collaborative space !