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Open Source Pharma: The future of drug development

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Presented by Tomasz Sablinski at the Open Source Pharma Conference in July 2014 at Rockefeller Foundation Bellagio Center.

Tomasz Sablinski's bio: http://www.opensourcepharma.net/participants/tomasz-sablinski

Conference agenda: http://www.opensourcepharma.net/agenda.html

Published in: Health & Medicine
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Open Source Pharma: The future of drug development

  1. 1. July 2014 Open Innovation: The Future of Drug Development Tomasz Sablinski, MD Co- Founder, CEO “Toward a New, Open Source Pharmaceutical Industry” July 16, 2014 Bellagio, Italy #opensourcepharma
  2. 2. Does TLS Model Apply to Global Health ? 1. transparency 2. crowdsourcing 3. telemonitoring
  3. 3. Sixty Years of Declining Productivity
  4. 4. Dismal Success Rate in Late Development
  5. 5. The World of Computing Power vs. Pharma The world of Pharma: CRF Books
  6. 6. Technology Today most clinical studies are conducted as if we were still in the 1980s yet technologies exist to move clinical research into the 21st century
  7. 7. Technology Today The first electronic medical record system was installed at Akron Children Hospital in 1962 February 17, 2012
  8. 8. Drug Development – Current Model Multiple Patient Visits to Expensive Sites High-Cost Patient Recruitment Insular Protocol Design Driven by Market Access + 20th Century Data Capture & Analyses + = + Pharma Company Infrastructure + Exorbitant Wasted Costs
  9. 9. Does This Look Familiar? After: Henry Chesbrough, 2007 The closed innovation paradigm
  10. 10. The Open Innovation Paradigm
  11. 11. Open Innovation… …Connecting Problems with Solutions
  12. 12. From Open Innovation to Crowdsourcing one-on-one cooperations crowdsourcing consortia
  13. 13. Transparency Life Sciences Transparency Life Sciences is the world’s first drug development company based on open innovation We are revolutionizing drug development by transforming clinical trials – the most expensive & inefficient element
  14. 14. Drug Development – TLS Model Get protocol input from global community of patients, MDs, researchers; facilitates patient recruitment Minimize site visits, Improve data quality, Execute at fraction of usual cost + = Deliver more drugs with optimal labels 1. Crowdsourcing 2. Telemonitoring/ eHealth Impact 3. Transparency – Build trust & participation
  15. 15. Crowdsourcing – “10,000 Minds Are Better than 10” Context • Web-based approach solicits global input from researchers, patients, MDs • Applies proven open innovation methodologies to clinical protocol design • Opportunity to gain from expertise in and outside drug development • Tiered incentives to participate: • Professional development (researchers) • Impact / Belonging (patients) • Community, financial (everyone) Impact • More relevant protocols, lower costs, patient and researcher engagement
  16. 16. TLS Crowdsourcing Stats – As of July, 2014 Visits: over 34,000 Unique visitors: 21,8000 Registered users: 1,100 + Contributors: 370 +
  17. 17. TLS Protocol Builder – Sample Feedback Protocol Builder (MS) “Real advances in one's ability to walk, use hands, reduction in stiffness are key endpoints that I would like to see in studies.” - Patient X Crowd Input - Patients “Metabolic response from Phase II would be required and useful for Phase III response ranges “ - Researcher Y Crowd Input - Researchers
  18. 18. TLS Platform in Action – Metformin in Prostate Cancer
  19. 19. TLS Protocol Builder – Sample Researcher Feedback
  20. 20. The Long Tail Model, Chris Anderson - 2004 think of: Amazon or Netflix vs. brick and mortar retailers
  21. 21. The Long Tail Model in Clinical Research design: KOLs only participation: few easily accessible patients I G N O R E D
  22. 22. The Long Tail Model – Transparency LS design: patients and physicians involved; head or long tail execution of clinical trials: making it possible for the long tail patients to participate: telemedicine
  23. 23. Growth of Telemedicine The Wireless Revolution Hits Medicine
  24. 24. Telemonitoring – Riding the Wave Context • Remote patient-monitoring device market will reach $1.9 billion in 2014 (Juniper Research) • By 2020, 160 million Americans will be monitored and treated remotely for chronic conditions (Nerac) Impact • Goal: slash costs, improve quality • Circumvent high fixed costs of hospitals, clinics (cost) • Eliminate observer bias (quality) • Baseline assumption is first/last visit in clinic, balance of data collection via telemonitoring • TLS leverages expanding ecosystem of FDA-compliant telemonitoring service providers
  25. 25. Benefits of Telemonitoring in Clinical Research Quantitative Obvious – less expensive trials Qualitative Non-obvious – new endpoints, novel designs
  26. 26. Three Reasons to be Optimistic 1. social changes / culture 2. technology 3. crisis
  27. 27. TLS Model Does Apply to Global Health 1. transparency - essential to do good 2. crowdsourcing - motivated contributors 3. telemonitoring - cost efficiency, operational facility

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