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Should You Start A Company Moa Presentation

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HEre\'s a talk on bioentrepreneurship

HEre\'s a talk on bioentrepreneurship

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  • 1. Innovation in Clinical Medicine Arlen D. Meyers, MD, MBA University of Colorado [email_address]
  • 2. 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. Take 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. Top 5 Entrepreneurial States
    • Connecticut
    • Delaware
    • COLORADO
    • Massachusetts
    • MINNESOTA
    • (Corp for Enterprise Development)
  • 5. 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. Definition
    • 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. 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. Personal Traits that Help
    • Passion
    • Perseverence
    • Personality
    • Profile for risk
    • People skills
  • 9. Entrepreneurial 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. Complications 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. Reduce 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. Value 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. “ Technology Commercialization Relay Race” (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. Technology Readiness Levels
    • Basic principals observed
    • Concept formulation
    • Proof of concept
    • Validation in Laboratory
    • Validation in a relevant environment
    • Prototype demo in relevant environment
    • System prototype demo in operational environment
    • End user test and evaluation
    • Full production and distribution
  • 15. Favorable 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. The 12 step roadmap
    • Idea generation
    • Concept development and testing
    • 7 Step opportunity evaluation
    • Model opportunity
    • Business opportunity assessment
    • Market validation
  • 17. The 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. The 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. Society of Physician Entrepreneurs www.sopenet.org
  • 20. OncoLight Inc. Corporate Overview Alan Mickelson, PhD amickelson@oncolight.com Arlen Meyers, MD, MBA ameyers@oncolight.com Stan Swirhun, PhD [email_address]
  • 21. Market Opportunity & Need
    • 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 Association: Oral-cancer screening code starts Jan’05
      • 600M/yr dental visits … potential
      • 250k primary care MDs + dentists
    • Clinical need for: real-time, non-invasive, cost-effective, accurate screen to distinguish benign from cancerous oral tissue
    “ 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. Product & Technology
    • Working hardware/software
    • - fiber-probe for stimulus/detection
    • - focus on ‘near surface’ cancer
    • Optical diagnosis technique
      • Light interaction with tissue gets information about tissue
      • structure & function; no tissue/cellular disruption
    Tissue Sample Absorption Multiple Scatter Single Scatter Fluorescence Hand Held Fiber Probe
  • 23. Development Stage & Status
    • 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
    • Stan Swirhun, PhD CEO
    • Funding
    • 2005 CU Tech Transfer Office
    • Proof of Concept Award
    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. Next Steps, Business Summary
    • 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
      • Simple, focused ‘Diagnostic Medical Device’ business concept
      • real-time, non-invasive, Class-2, near-surface cancer detection
      • Strong clinical need & large market opportunity – 1 st oral cancer
      • screening & diagnostic tool extendable to … cervical, skin
      • Proprietary, barriered technical approach
      • Experienced, connected, uniquely-qualified team
  • 25. Future 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. What 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. Lessons 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. Lessons 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. Causes 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. And,finally
    • Put yourself in a place where luck will come your way
    • Thank you!
    • [email_address]