Innovation in Clinical Innovation in Clinical MedicineMedicine

Arlen D. Meyers, MD, MBAArlen D. Meyers, MD, MBA

University of Colorado University of Colorado

Arlen.meyers@uchsc.eduArlen.meyers@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!

• Arlen.meyers@uchsc.edu