Upload
mars-discovery-district
View
3.978
Download
1
Embed Size (px)
DESCRIPTION
Part of the MaRS Entrepreneurship 101 series: http://www.marsdd.com/ent101 Speaker: Michael H. May PhD President & Co-Founder, Rimon Therapeutics Ltd. This is available as an audio presentation: http://www.marsdd.com/ent101 and click on the October 10, 2006 session, "Entrepreneurship 101 - Science and business do mix: success story"
Citation preview
Entrepreneurship 101: Dancing in the Gap
October 10th, 2006, MaRS Discovery District, Toronto
Michael H. May PhDPresident & Co-FounderRimon Therapeutics Ltd
If medicine is the next driver of wealth…
Juan Enriquez, As The Future Catches You, 2000
Knowledge-Driven Wealth
Companies like Rimon will be the vehicles
According to Enriquez, wealth can be measured by thenumber of people it takes to generate a patent:• USA – 5,000• Canada 8,000• Mexico 1.2 million• Rimon – 0.6
Companies like Rimon and science-basedentrepreneurs like you will drive future wealthgeneration for Canada
Dancing in “The Gap”
Excellentscience
Viableproductsthat helppeople
Business
Scie
nce
“The Gap”
“The Gap” is a all about…
$
timeThe GapHigh Risk of Failure
1 in 3000
…risk mitigation, survival and endurance
The value of your “idea”….
Market Size - $1 billionGrowth – 5 % annuallyLicensing partner’s share – 33 %Adoption rate – 75 %License fee – 20 %Number of key technologies – 2Cost to market - $4 million over 3 yearsTimeline – 10 yearsNet Present Value (NPV) - $30 million
Example: Rimon’s focus in “The Gap”
PolymerDesign
ProductFocus
Pre-clinicalValidation
ClinicalValidation
Proof-of-conceptmaterial development
Proof-of-applicationmaterial development
Proof-of-productmaterial development
Execution lowers uncertainty
PolymerDesign
ProductFocus
Pre-clinicalValidation
ClinicalValidation
Proof-of-conceptmaterial development
Proof-of-applicationmaterial development
Proof-of-productmaterial development
p < 25 %
p < 50 %
p < 80 %
There is much uncertainty (risk)
PolymerDesign
ProductFocus
Pre-clinicalValidation
ClinicalValidation
Proof-of-conceptmaterial development
Proof-of-applicationmaterial development
Proof-of-productmaterial development
p < 25 %
p < 50 %
p < 80 %
IP ProtectionFreedom to Operate
Bench studiesAnimal efficacyAnimal safety
Scale-upManufacturingRegulatoryRe-imbursementLicensing deal
p < 10 %
p < 10 %
p < 80 % p < 50 %
True value is discounted by risk
• NPV of idea discounted for risk (80%) - < $200,000• NPV is negative with less than 1 year delay in plan• NPV is negative if costs underestimated by < 10%
$
timeThe Gap
RISK
1 in 3000
“The Gap” is about risk mitigation
• Value creation is risk mitigation• Execution mitigates risk• One idea/technology/product is not enough• Ideas are worth very little – don’t get greedy• If you can get early stage financing – take it• One financing will not get you out of “The Gap”• Survival is a great accomplishment
Step 1: Generate a business plan
• Understand your audience• Keep it simple, clear and brief
– Create a 1-page strategic plan first• Focus on people, plan, cash and the wow!• Focus on products• Under promise and over perform• Note: BP are easier to craft when something has
been accomplished – execution brings credibility
Step 2: Execute, execute, execute
Do you what you said you were going to do!!!
• Make milestones achievable and measurable
Step 2: Execute, execute, executeThis is difficult when you are responsible for…• Business plan and vision• Financials and budgeting• Human resources and team-building• Financing• Management and administration• Business development and deal-making• Research and product development• Intellectual property protection• Regulatory and re-imbursement• And everything else that must be done…
Step 2a: Know that you don’t know
And focus your first sales pitch on those thatcan help:• Lawyers• Accountants• Directors• Investors• Service providers• Anyone that has done it before
Step 3: Be innovative
There is always a way…
Build scientific and business “metaphors”
ofondisenregneristehfogsarsthefnceeoreth
Of on side greener is of fence the grass other the
The grass is greener on the other side of the fence
• Scientists are great at reduction, less skilled atinnovation
• Metaphors contain the greatest amount of valueusing the least number of resources
• Metaphors are built, not discovered
Step 4: Strategize for survival• Much assistance is available for
start-up companies
• The stakeholders, rules, andconstraints are often the focus ofdiscussions about commercialization(e.g., money, people, facilities, IP)
• Heavily constrained systems can be “played” an infinitenumber of ways
• Strategy is critical
• Control the centre and think three steps ahead
Step 5: Manage stakeholder risk
Scientific
Business
Financial
Entrepreneur
Step 5: Managing Stakeholder Risk
Important considerations:• Determine stakeholder risk tolerance, objectives,
limitations and agendas• Manage expectations
– Under promise, over perform• Communication is key
– Disclose everything (good and bad) quickly– Interact regularly
• Include stakeholders in solutions and decisions• Stay calm
Everyone Will Take Risks…
…it just depends on the song and the partner…
Step 6: Network
• Networking is difficult, but gets easier over time• It is a great way to get help (which we all need)• Buzz = success = air time
– “The medium is the message”– Example: http://rimon.blogware.com
• “Small world phenomenon” depends on:– Inner network built on trust (e.g., links through
volunteerism)– Broad network created by few highly linked individuals
(e.g., Kevin Bacon)
Rimon Started from …
…a single experimental observation
A New Paradigm – Polymers that Heal
Theramers™ are novel medical polymers that havedrug-like properties
– Next generation materials that are active - not simplydrug delivery vehicles
Theramers™ are regulated as devices– Drug-like products in 2-5 years for a fraction of the
development cost of conventional therapeutics
Rimon’s portfolio of Theramers™ target largemarkets with significant unmet needs
– Initial targets are all multi-$ billion markets– Versatility of polymer chemistry enables broad
application
The Theramer™ Company
Unique Value Proposition
Drug-likeDrug-like
MarginsMargins
DeviceDevice
TimelinesTimelines
Versatility ofVersatility of
PolymersPolymers
The Theramer™ Company
Corporate Overview• Spun-out of the University of Toronto in 2000;
strong ties to local biomaterials centre of excellence• 5 core technologies, 4 products in development• Potential partners engaged for all product concepts• 11 patents issued or pending, own rights to all IP• Revenue generation through licensing• Extensive research network:
The Theramer™ Company
Commercial Strategy
Advance a robust pipeline that offers products atvarious stages of development:• unique medical products that are close to market
• novel polymers that enhance the value of existingmedical devices, and
• novel polymers for co-development of partner-defined product concepts
The Theramer™ Company
Core Technologies
• MI Theramer™Activity: Inhibits the degradation of tissueMechanism: Binds matrix metalloproteases (MMPs)
selectively and stronglyApplications: Wound healing, joint injectables for
osteoarthritis and rheumatoid arthritis, coating forstents and ophthalmology products
• AM Theramer™Activity: Kills bacteria without harming human cellsMechanism: Disrupts bacterial cell membraneApplications: Medical device related infections (e.g.,
wound dressings, in-dwelling catheters, contact lenses)
The Theramer™ Company
Core Technologies
• Angiogenic Theramer™Activity: Induces development of new blood vesselsMechanism: Stabilization of endogenous growth factors,
stimulation of macrophagesApplications: Wound healing, regenerative medicine, and
implant integration into tissue
• ThermaGel™Activity: Changes from liquid to soft gel reversibly
around body temperatureApplications: Wound healing, biological filler, drug
delivery
The Theramer™ Company
Initial Focus on Chronic Wound Healing
Rationale:• Significant unmet needs in wound care market• Best prospect for validating Theramer™ concept and
generating revenue in the near-term– Fast track to human trials and the market
Theramer™-based wound care “toolkit”
AM Theramer
Angiogenic TheramerMI Theramer
The Theramer™ Company
MI-Sorb™/MI-Gel™ Dressings
• Inhibit enzymes (MMPs) that chew apart woundsfaster than they can heal
• Positive preliminary clinical data
MI-Sorb™ MI-Gel™
The Theramer™ Company
MI-Sorb™ Clinical Trial
Objectives:• Safety• Reductions in MMP activity• Trends towards healingWound Types:A) Venous stasis ulcers (VSU)B) Diabetic ulcers (DU)C) Pressure Sores (PS)D) Miscellaneous (Misc)
A
B
C
D
The Theramer™ Company
MI-Sorb™ Clinical Trial Design
Measure (versus baseline):• MMP levels in wound fluid (weekly) and tissue (as possible)• Wound size, characteristics of exudate and quality of wound bed• Bacterial colonization by swab and biopsy• Nurse and patient satisfaction
Baseline
2 wk Visit 6 wk Visit
Secondary Dressing
N=32
MI-Sorb* & Secondary Dressings* N=24
Secondary Dressings* N=8
* Dressings changed every 2-3 days
The Theramer™ Company
Clinical Data Summary – P19
0.00
0.50
1.00
1.50
2.00
2.50
3.00
3.50
4.00
0 1 2 3 4 5 6 7
Time (weeks)
Wo
un
d V
olu
me
(c
m3)
Baseline MI-Sorb™ Treatment
The Theramer™ Company
• Male, 43 yrs old, MVA paraplegic• Pressure sore – 2 years old• Multiple previous clinical trials• 85% reduction in wound volume• 52% reduction in MMP activity• Enhanced wound bed quality• Strong endorsement from patient,
primary caregiver and study nurse
Trends Towards Healing
Patient MMP-2 intissue
(brown stain)
MMPactivity inexudate
Presence andappearance of
collagen (blue stain)
Week 0 Week 6
↓3DU
4DU ↑
↓14VSU
Week 0 Week 6
The Theramer™ Company
Trends Towards Healing
Patient MMP-2 intissue
(brown stain)
MMPactivity inexudate
Presence andappearance of
collagen (blue stain)
↓15VSU
26Misc
27Misc
↓
↔
Week 0 Week 6 Week 0 Week 6
The Theramer™ Company
Pipeline Products
MMP-Inhibiting Joint InjectableMarket:• Potential revenues of ~ $30-60 million in 2-4 years with single partner
Competitive Advantages:• Compatible with existing products• Should not compromise device designation of existing products• Clear and testable therapeutic effect
Key Results:• Validation from wound healing application• Demonstrated enhancement of existing products in vitro• Demonstrated activity using human synovial fluid
The Theramer™ Company
Pipeline Products
Anti-Microbial Catheter CoatingMarket:• Potential revenues of $12-15 million in 2-4 years based on a single
catheter product (e.g., venous access catheters)
Competitive Advantages:• Long-lasting• Compatible with medical device regulatory and technical experience• Non-toxic to human cells
Key Results:• Up to 99.9% reductions in viability of gram +ve and –ve bacteria (for
up to 60 days)• Low hemolysis, and good blood compatibility• Synthesized numerous versions with varying physical properties• Independently validated by a potential partner
The Theramer™ Company
Pipeline Products
MMP-Inhibiting Stent CoatingMarket:• Potential revenues of $60 million with single partner
Competitive Advantages:• No drugs (regulatory and commercial advantages)• More compatible with medical device culture and processes• Less expensive• Enables other stenting applications (e.g., peripheral stenting)• Compatible with drug delivery, if multiple targets are required
Key Results:• Synthesized materials with excellent mechanical properties and
durability• Demonstrated in vitro inhibition of relevant MMPs
The Theramer™ Company
Key Milestones Achieved
With $3.5 million, we have executed our plan to:• Scale-up and manufacture clinical batch of MI-Sorb™• Commence clinical trial of MI-Sorb™ with world-
renowned dermatologist, Dr. Gary Sibbald• Obtain device designation for MI-Sorb™ from the
USFDA and commence regulatory approval in Canadaand US
• Build pipeline through invention, in-licensing andinitiating product development
• Demonstrate pre-clinical efficacy and safety of all coretechnologies
• Engage partners in product development
The Theramer™ Company
Key Upcoming Milestones
During the next 12 months, we plan to:• Conclude the MI-Sorb™ clinical trial• License MI-Sorb™ to global wound care company• Raise $5 million• Advance and expand pipeline products through co-
development/licensing agreements with partners• Generate new Theramers™ and build Theramer™
brand
The Theramer™ Company
Summary
• Building a company is hard and is not a part-time job• Mixing science and business is exhilarating• The role of entrepreneur is to manage risk and survive
“the Gap”– execution– innovation– networking– persistence
Business
Scie
nce
Summary
• Take care of hard science first• Seek out coaches and help from others• Polish communication skills• Learn to negotiate• Develop a thick skin
Business
Scie
nce
Need Inspiration?
Quotations from Helen Keller:
• “Life is either a daring adventure or nothing”
• “No pessimist ever discovered the secret of the starsor sailed an uncharted land, or opened a newdoorway for the human spirit”
• “The most beautiful world is always entered throughthe imagination”
Entrepreneurship 101
Imagine the possibilities if some of you try“Dancing in the Gap”….
MaRS circa 2010