Innovation in Clinical Innovation in Clinical MedicineMedicine
Arlen D. Meyers, MD, MBAArlen D. Meyers, MD, MBA
University of Colorado University of Colorado
[email protected]@uchsc.edu
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
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
Top 5 Entrepreneurial StatesTop 5 Entrepreneurial States
• Connecticut
• Delaware
• COLORADO
• Massachusetts
• MINNESOTA
• (Corp for Enterprise Development)
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?
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
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
Personal Traits that HelpPersonal Traits that Help
• Passion
• Perseverence
• Personality
• Profile for risk
• People skills
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
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
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?
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
““Technology Commercialization Relay Technology Commercialization Relay Race”Race”
(each “runner” is essential)(each “runner” is essential)
UniversitiesFederal Labs
Small BusinessesIndividuals
Spectrum from idea to money
Idea $ $ $
Govt. $$ Some Private $$
4F $$
Early Stage
Research
Angel $$ VC $$Investment Bankers $$
Large Businesses $$
Sales, Operational Infrastructure
and Early Growth
Major ProductionAnd
International Sales“Escapees”
Chasm to Success
SBIR/STTR $$Other Govt. $$
Private $$
Research, Lots of Development,Prototype and
Market Validation
Emerging Small Businesses
Support Services
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
8. End user test and evaluation
9. Full production and distribution
Favorable Funding PointsFavorable Funding PointsTRL levels 1 2 3 4 5 6 7 8 9
SBIR ISBIR II
“SBIR” III (Non-SBIR $)
Other Govt. R&D
Angels
VCs
Strategic Partners
4 F
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
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
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
Society of Physician Society of Physician EntrepreneursEntrepreneurs
www.sopenet.orgwww.sopenet.org
OncoLight Inc.OncoLight Inc.Corporate OverviewCorporate Overview
AAllaan n MMicickkeelslsoonn, , PPhhD D aammicickkeelslsoonn@@oonnccooliligghht.t.ccoomm AArlrleen n MMeeyyeerrss, , MMDD, , MMBBA A aammeeyyeerrss@@oonnccooliligghht.t.ccoomm SSttaan n SSwwirirhhuunn, , PPhhD D sssswwirirhhuunn@@oonnccooliligghht.t.ccoomm
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 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
• 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 tissuestructure & function; no tissue/cellular disruption
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
Stan Swirhun, PhD CEO
Funding2005 CU Tech Transfer Office
Proof of Concept Award
Normal Tissue
Benign Lesion
Squamous Cell Carcinoma
400 500 6000
50
100
400 500 600
2
3
4
Flu
ore
scen
ce (
A.U
)
Wavelength (nm)
Ab
sorp
tio
n (
A.U
.)
Next Steps, Business Next 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- Simple, focused ‘Diagnostic Medical Device’ business concept
real-time, non-invasive, Class-2, near-surface cancer detection- Strong clinical need & large market opportunity – 1st oral cancer
screening & diagnostic tool extendable to … cervical, skin- Proprietary, barriered technical approach- Experienced, connected, uniquely-qualified team
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
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
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
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
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
And,finallyAnd,finally
• Put yourself in a place where luck will come your way
• Thank you!