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UCSF Life Sciences Week 1 diagnostics

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UCSF Life Sciences Week 1 diagnostics

  1. UCSF Lean LaunchPad For Life Sciences October 1, 2013 Todd Morrill Diagnostics Cohort Week 1 1
  2. Cohort D-1: LLP-LSdx • What are we talking about? • What are we doing here? • Who are we? • Why bother? 2
  3. What is a diagnostic? What we used to think: Product which attempts to classify of an individual's condition into separate and distinct categories that allow medical decisions about treatment and prognosis to be made. 3
  4. What is a diagnostic? What we used to think: Product which attempts to classify of an individual's condition into separate and distinct categories that allow medicaldecisions about treatment and prognosis to be made. 4
  5. What is a diagnostic? What we now think: Product which attempts to classify of an individual's condition into separate and distinct categories that allow medicaldecisions about treatment and prognosis to be made. Product, service, process, data set Individual, group, population… Medical, nutritional, genetic, social… Decisions, information… Treatment, status, history, future, behavior… Prognosis, history, potential… 5
  6. What changed? • Biology (knowledge and understanding of human and other bio/medical systems) • Technology (PCR, mass spec, TEM, antibodies, PET) • Population – Aging, richer 6
  7. What changed? • Biology (knowledge and understanding of human and other bio/medical systems) • Technology (PCR, mass spec, TEM, antibodies, PET) • Population – Aging, richer, risk averse, and less pizza, dude 7
  8. What changed? • Biology (knowledge and understanding of human and other bio/medical systems) • Technology (PCR, mass spec, TEM, antibodies, PET) • Population – Aging, richer, risk averse, and less pizza, dude 8
  9. And the industry is changing too 9
  10. So what…? So: Value Propositions are Complex • Testing is more varied, complex and generally available than 20 years ago, for example: – – – – • • • • Detection / Change (progression) / Stratification / Prediction / Predilection Lab, home brew, RUO, POC, consumer, pet, vet, food etc. Sensitivity can exceed understanding of meaning Odd value propositions in some markets: “Diagnosis” vs “cleanliness” uses Medical, industrial, consumer, behavioral etc. Tests vsDx: stratification, status, content, etc. In vivo vs. in vitro testing Companion diagnostics, biomarker sets, genetic profiling and unicorns 10
  11. So what…? So: Business Models are changing Largest Dx Companies • • • • • • • • • • • Roche Siemens Danaher Abbott ThermoFisher Becton Dickinson Johnson & Johnson Alere Sysmex bioMerieux Bio-Rad Smaller Dx Companies • • • • • • • • • • • Idexx Digene/Qiagen Genomic Health OraSure Myriad Genetics GE Hologic Complete Genomics Illumina Asuragen Sequenom 11
  12. Executors Technologists Innovators ? Large markets Routine analyses International scope Large distribution networks Manufacturing excellence Established platforms Niche markets Complex analyses Focused sales Technology superiority Novel platforms Entrepreneurial Agile Niche Innovative… …beyond technology 12
  13. Who is Todd and why is he here? NSF National Program Faculty • In vitro diagnostic tests (Bio-Rad Labs $1.3B Dx development, manufacturing, vendor) – Human, animal, food • • • • In vivo diagnostic discovery (Oxford GlycoSciences) Biopharma discovery (Trellis, Lilly, Baxter, Pfizer) Research tools (Novex, Bio-Rad, IO Informatics) What’s fun? – New technology discovery and development – Entrepreneurship: 3 startups • NSF I-CorpsTM National Faculty. Instructor at Berkeley and UCSF . 13
  14. Steve mentioned this… 14
  15. Do Diagnostics fit into the BMC? (or how don’t they fit?) 15
  16. IP REGULATION REIMBURSEMENT CLINICAL TRIALS 16
  17. IP REGULATION REIMBURSEMENT CLINICAL TRIALS 17
  18. How we will fit DX into the BMC CLINICAL TRIALS REGULATION IP REIMBURSEMENT 18
  19. How we will fit DX into the BMC CLINICAL TRIALS REGULATION IP REIMBURSEMENT 19
  20. TAM / SAM / SOM • Established tests – Use the current market size • Novel tests – Use current estimated need • Population is IMPORTANT but money (revenue) is CRITICAL – Always state your markets in dollars – Use current markets, population, etc. – OK to note market growth if it is exceptional 20
  21. The importance of timing 21
  22. What we wish about healthcare 22
  23. What we have in healthcare: multisided markets 23
  24. What we have in healthcare: complex processes 24
  25. What we have in healthcare: regional differences 25
  26. Multisided markets pose special challenges… • Hypothesize about your ecosystem • Hints to solving the ecosystem puzzle: where is the test is performed? • Think reimbursement • Know your regulators Value Propositions: One per Customer/ecosystem Segment • Who wants it. Who doesn’t want it? • Clinical Value vs Insurance Value vs Testing Lab Value vs… 26
  27. Diagnostics and Value Propositions Comes from Technical Insight More Efficient More sensitive Faster New test Lower cost Comes from Market Insight Better Distribution Simpler Better Bundling New user Better Branding
  28. Examples of Market Insight  Masses of people are more likely to microblog than blog  The non-symmetric relationships will allow companies and individuals to self-promote and will impact distribution  European car sharing sensibilities could be adopted in North America  People, particularly in urban environments, no longer wanted to own cars but wanted to have flexibility.
  29. Examples of Market Insight Need vs Want
  30. Why the BMC matters … 1. 2. 3. 4. 5. 6. 7. Value proposition Customer segment Practice of medicine Reimbursement Regulatory clearance Clinical testing OUS markets (Sure, it does what you want, but not how you wanted it to!) 30
  31. So for next week… • Customer segments Which includes (for us)  Reimbursement  Regulation Hypotheses, experiments, results 31
  32. For next week CLINICAL TRIALS IP ECOSYSTEM? 32

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