Should You Start A Company Moa Presentation


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HEre\'s a talk on bioentrepreneurship

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Should You Start A Company Moa Presentation

  1. 1. Innovation in ClinicalInnovation in Clinical MedicineMedicine Arlen D. Meyers, MD, MBAArlen D. Meyers, MD, MBA University of ColoradoUniversity of Colorado
  2. 2. Did You Know?Did You Know? • It takes science grad students a half-year longer to complete their doctorates than it did in 1987 • The number of bioscience grad students has doubled in 20 years. Faculty positions have remained the same • Despite a 2x increase in the NIH budget since 1998, the chance of a young scientist getting a grant has dropped. • Chronicle of Higher Education, Sept 21, 2007
  3. 3. Take Home PointsTake Home Points • Bioentrepreneurship should be the fourth mission of academic medicine-and community based medicine as well • Like anything else, a few people will be good at it and will be motivated to do it • For those who want to do it, barriers need to be removed and incentives provided
  4. 4. Top 5 Entrepreneurial StatesTop 5 Entrepreneurial States • Connecticut • Delaware • COLORADO • Massachusetts • MINNESOTA • (Corp for Enterprise Development)
  5. 5. Yes or No?Yes or No? • Do I have the personal character traits and skills to be successful? • Am I willing to make the necessary sacrifices? • Am I sufficiently motivated? • Do I have the support of my family? • Do I have enough connections? • Do I have the know-how?
  6. 6. DefinitionDefinition • Entrepreneurship is THE PROCESS of CREATING VALUE from INNOVATION • Change creates opportunities that create the potential for innovations • The process is the same whether you are trying to commercialize a new device, process or service
  7. 7. Why Do It?Why Do It? • You don’t fit into a bureaucratic rules- based culture • Clinical care just isn’t enough anymore • Your passion is somewhere else • You want to make more money • You want to make more of a difference • You want to satisfy psychic needs
  8. 8. Personal Traits that HelpPersonal Traits that Help • Passion • Perseverence • Personality • Profile for risk • People skills
  9. 9. Entrepreneurial mythsEntrepreneurial myths • Lone Ranger v team player • Risk taker v risk manager • Problem solver v problem seeker • Brains v brawn: IQ v EQ • Born v made v self made • Money v meaning
  10. 10. Complications of poor planningComplications of poor planning • Ideas that never get off the ground • No prioritization for resources • A solution looking for a problem • Plans that don’t get funded • Plans that are poorly conceptualized • No validation of assumptions • Not cutting your losses early enough
  11. 11. Reduce the RiskReduce the Risk • Technological Risk: Will it work? • IP Risk: Patents, Trademarks, Copyright and Trade Secrets • Market Risk: Who are your customers? • Financial Risk: Big enough ROI? • Implementation risk: Do you have the people to pull it off?
  12. 12. Value inflection pointsValue inflection points • Demonstrate proof of concept is tissue, animals and people • Raise enough money • Protect the IP • Demonstrate a positive clinical trial • Get FDA or other reg approval • Recognize sales revenue
  13. 13. ““Technology Commercialization RelayTechnology Commercialization Relay Race”Race” (each “runner” is essential)(each “runner” is essential) Universities Federal Labs Small Businesses Individuals Spectrum from idea to money Idea $ $ $ Govt. $$ Some Private $$ 4F $$ Early Stage Research Angel $$ VC $$ Investment Bankers $$ Large Businesses $$ Sales, Operational Infrastructure and Early Growth Major Production And International Sales “Escapees” Chasm to Success SBIR/STTR $$ Other Govt. $$ Private $$ Research, Lots of Development, Prototype and Market Validation Emerging Small Businesses Support Services
  14. 14. Technology Readiness LevelsTechnology Readiness Levels 1. Basic principals observed 2. Concept formulation 3. Proof of concept 4. Validation in Laboratory 5. Validation in a relevant environment 6. Prototype demo in relevant environment 7. System prototype demo in operational environment
  15. 15. Favorable Funding PointsFavorable Funding Points TRL levels  1 2 3 4 5 6 7 8 9 SBIR I SBIR II “SBIR” III (Non-SBIR $) Other Govt. R&D Angels VCs Strategic Partners 4 F
  16. 16. The 12 step roadmapThe 12 step roadmap 1. Idea generation 2. Concept development and testing 3. 7 Step opportunity evaluation 4. Model opportunity 5. Business opportunity assessment 6. Market validation
  17. 17. The 12 Step roadmapThe 12 Step roadmap 7. Revise business opportunity assessment 8. Prioritize and develop plan 9. Write the business plan 10. Revise the business plan 11. Pitch your idea 12. Execute the plan
  18. 18. The 12 Step SolutionThe 12 Step Solution • A process for refining your idea • Prioritizes resources • Helps to sell to stakeholders • Helps to cut your losses and move on • Validates assumptions • Identifies and quantifies market pain
  19. 19. Society of PhysicianSociety of Physician EntrepreneursEntrepreneurs
  20. 20. OncoLight Inc.OncoLight Inc. Corporate OverviewCorporate Overview AlAl aa nn MiMi ckck elel ss oo n,n, PP hh DD aa mm icic kk elel ss oo
  21. 21. Market Opportunity &Market Opportunity & NeedNeed • Poor early oral cancer detection – Current detection techniques: difficult, expensive, inaccurate, painful, invasive, not timely – 30,000 new cases/yr; 8000 deaths/yr; 50% 5-yr survival – American Dental “I can’t always tell which mouth lesions may be pre-cancerous … tiny white, pink and red areas are hard to tell apart from normal tissue” Dr. Anne Gillenwater, MD, Otolarngologist
  22. 22. • Working hardware/software - fiber-probe for stimulus/detection - focus on ‘near surface’ cancer Tissue Sample Absorption Multiple Scatter Single Scatter Fluorescence Hand Held Fiber Probe Product & TechnologyProduct & Technology • Optical diagnosis technique - Light interaction with tissue gets information about tissue structure & function; no tissue/cellular disruption
  23. 23. Development Stage &Development Stage & StatusStatus Technology & Market Status - ‘Proof of Concept’ stage - Promising results on Tissue samples - Defining market, product Founding Team Alan Mickelson, PhD CTO Arlen Meyers, MD, MBA CMO Normal Tissue Benign Lesion Squamous Cell Carcinoma 400 500 600 0 50 100 400 500 600 2 3 4 Fluorescence(A.U) Wavelength (nm) Absorption(A.U.)
  24. 24. Next Steps, BusinessNext Steps, Business SummarySummary • Next Steps ~6-9 months – Validate market, Define product; Strategy & Business Model – Complete prototype R&D (tissue-bank); set path to clinical – Assemble FOO Friends of Oncolight advisor/endorser network – Seek funding • OncoLight: Business Summary
  25. 25. Future directionsFuture directions • Technique for frozen section determination of molecular margins, biostaging and detection of micrometastases in neck nodes • Identification of appropriate marker • Correlation to response to therapy • Automated slide scanning • Other optical detection techniques
  26. 26. What if takesWhat if takes • A technology or solution that provides compelling value • A way to protect your idea • A market that demands your product or service • A business plan that describes a way to make money • A team that can execute the plan
  27. 27. Lessons LearnedLessons Learned • Don’t expect your boss to understand why you want to do this • There are significant institutional barriers to innovation • Learn to take no for an answer • Go where others don’t • Don’t quit your day job
  28. 28. Lessons LearnedLessons Learned • Network like crazy • Get your first failure out of the way early • Do, don’t think • Do what’s important, not interesting • Surround yourself with smart people • Know thyself • CYA
  29. 29. Causes of NPD FailureCauses of NPD Failure • Technical or production • Launch timing • Amount of marketing effort • Product function and performance • Inadequate understanding of market • Higher costs than anticipated • Competitive strength or reaction
  30. 30. And,finallyAnd,finally • Put yourself in a place where luck will come your way • Thank you! •