11/15/2017 1 1 Planning for Phase III: Partnering NIH SBIR Conference 2017 Eric Horler, MBA, MEM President and CEO Swallow Solutions JoAnne Robbins, PhD, CCC‐SLP, BCS‐S Professor Emerita UW School of Medicine and Public Health Founder, Inventor, Chief Scientific Officer Swallow Solutions Agenda Clinical need and product development (JoAnne) From necessity to niche to partnering Context: Dysphagia and the market Case Study: Development of dysphagia diagnostic standards From diagnostics to treatments What have I learned? Commercialization (Eric) Commercialization considerations Commercialization examples Partnering examples Other considerations: supply chain, organizational structure, financials Commercialization: What have I learned? Partnering: What have I learned?
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Planning for Phase III: PartneringNIH SBIR Conference 2017
Eric Horler, MBA, MEMPresident and CEOSwallow Solutions
JoAnne Robbins, PhD, CCC‐SLP, BCS‐SProfessor EmeritaUW School of Medicine and Public Health
Clinical need and product development (JoAnne) From necessity to niche to partnering Context: Dysphagia and the market Case Study: Development of dysphagia diagnostic standards From diagnostics to treatments What have I learned?
Commercialization (Eric) Commercialization considerations Commercialization examples Partnering examples Other considerations: supply chain, organizational structure, financials Commercialization: What have I learned? Partnering: What have I learned?
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“Necessity is the mother of invention.”
Ascribed to Plato from translations of Republic, 380 BC
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Frank Zappa/Mothers of Invention, 1960s
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Necessity Leads to New Commercial Niches
"The world is facing a situation without precedent: We soon will have more older people than children and more people at extreme old age than ever before. Population aging is a powerful and transforming demographic force. We are only just beginning to comprehend its impacts at the national and global levels."
Richard Suzman, PhDDirector, Division of Behavioral and Social ResearchNational Institute on Aging/National Institutes of Health
John Beard, MBBS, PhDDirector, Department of Ageing and Life CourseWorld Health Organization
Age <5
Age 65+
Young Children and Older People as a Percentage of Global Population: 1950‐2050
Source: United Nations. World Population Prospects: The 2010 Revision. Available at: http://esa.un.org/unpd/wpp.
Aspiration(food/liquid directed to pulmonary rather than digestive system)
Without effective treatment, dysphagia leads to:• Pneumonia• Malnutrition/ dehydration
• rehab potential• hospital stays
Hospitalization(mean cost of aspiration pneumonia episode is $17,000)
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Partnering
• Commercial experience/success
• Development of the diagnostic standard
• Identification of the treatment ‘’MATCH”
• Communication and transfer of the developments to the public
• Identification of strategic commercial partnerships early will increase likelihood of Phase III success
– Process improvement
– Own “the niche”
– Innovation
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Partnering Team
• Inventor(s)
• University
• Founder
• Attorney
• Investor(s)
• CEO
• Knowledgeable board members
• Business leaders
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Moving the Product to the Patient
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A Related And Necessary Continuum
From chaos to order
The “MATCH”
Diagnostics to the treatment(s)
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Case StudyDevelopment of the Treatment(s)
1. Identified a clinical unmet need
2. Standardized diagnostic imaging materials for swallowing
3. Executed Protocol 201 (largest NIH‐funded clinical trial in dysphagia)
4. Filed patent application (through UW‐Madison)
5. Studied the marketplace of matched beverages
6. Negotiated agreement to collaborate on product development and commercialization
Diagnostic standards for dysphagia
Matched beverages
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To go from a vision and need to an idea that fills a unique niche and is practical:
1. Care!!!
2. Be expert in your area
3. Review the marketplace
4. Early partnering (within the network)
5. Initiative and persistence
6. Seek mentorship
7. Expand partnership
8. Communicate! Communicate!
What have I learned?
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Agenda
Clinical need and product development (JoAnne) From necessity to niche to partnering Context: Dysphagia and the market Case Study: Development of dysphagia diagnostic standards From diagnostics to treatments What have I learned?
Commercialization (Eric) Commercialization considerations Commercialization examples Partnering examples Other considerations: supply chain, organizational structure, financials Commercialization: What have I learned? Partnering: What have I learned?
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Commercialization Considerations
Market Intelligence
Customer Segmentation
Competition
Value Proposition
Buying Process
IP Protection
Go‐to‐Market
Sales Channels
Marketing Strategy
Distribution
Supply Chain
Manufacturing Needs
Org Structure
Hire vs. Buy vs. Partner
Revenue Streams Cost Structure
Financials
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Product Positioning
To _________________________________________
________________ brand of ___________________
is the best choice because
____________________________________________
unlike _______________________________________
that _________________________________________.
CUSTOMER (BE SPECIFIC)
BRAND CATEGORY
VALUE PROPOSITION
COMPETITORS
COMPETITIVE ADVANTAGE
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Product Positioning Example
To _________________________________________
________________ brand of ___________________
is the best choice because
____________________________________________
unlike _______________________________________
that _________________________________________.
dietary managers in hospitals and nursing homesCUSTOMER (BE SPECIFIC)
Swallow Solutions thickened beverages
it provides supplemental protein with excellent taste
other thickened beverages and protein shakes
lack protein, are to thin, and/or are not refreshing