Planning for Phase III: Partnering
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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?
Transcript of Planning for Phase III: Partnering
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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
Founder, Inventor, Chief Scientific OfficerSwallow 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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“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.
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Healthy Swallow
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Thin liquid Thickened liquid
Swallowing and Aspiration
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Causes and Effects of Dysphagia
Poor bolus control caused by:• Stroke• Head/neck cancer• ALS• Parkinson’s• Sarcopenia
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
BRAND CATEGORY
VALUE PROPOSITION
COMPETITORS
COMPETITIVE ADVANTAGE
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Thickened Beverages Go‐to‐Market Example
Re‐distributor
Large food distributor
Vendor Facility(Dietary Mgr)
Product evalContracting
Catalog placement
information assign cat # cat/ordering system
Inventory Inventory Inventoryproduct product product
Dietary budget
MarginMargin paymentpaymentpaymentpayment
promotion (direct sales force, advertising, etc.)
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Financial Considerations
Revenue Stream• How will you charge for your product?
• How much do customers value it?
• How much can you sell?
Cost Structure• Manufacturing costs• Sales & Marketing costs• Distribution costs• Administrative costs• Ongoing R&D costs
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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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Why partner?(In commercializing products)
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Partnering for Commercial Success
Example: Swallow Solutions Medical Device
GalileoConsulting
CFOAccountingPayroll
Regulatory AffairsQuality AssuranceCompliance
Reimbursement ManufacturingSustaining
Engineering
SalesDistribution
Note: Does not include service providers who provide support on an ad hoc basis, such as law firms, ad agencies, etc.
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Partnering for Commercial Success
Example: Swallow Solutions Beverages
CFOAccountingPayroll
Expert advice Product developmentUser testing
Manufacturing
MarketingDistribution
Note: Does not include service providers who provide support on an ad hoc basis, such as law firms, ad agencies, etc.
UNIVERSITY OF WISCONSIN-MADISON
ActivelySearching
ActivelySearching
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NIH Phase III Resources
NIH Technical Assistance Programs ‐ Transition to Phase III
• NIH SBIR/STTR Niche Assessment Program (NAP)
• I‐Corps at NIH
• NIH SBIR/STTR Commercialization Accelerator Program (CAP)
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Commercialization: What have I learned?
Common threads from commercializing multiple, very different products:
1. Start by thoroughly defining customer needs/wants
2. Do not assume you know what customers want—find out!
3. Listen actively
4. Understand the buying process
5. Be willing to pivot
6. Understand the financials early
7. It is not easy, but it can be done!
8. THE RIGHT PEOPLE ARE CRITICAL
Recommended reads
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Partnering: What have I learned?
Common threads from managing various partnerships:
1. Be careful selecting when to partner
2. Have clear agreements up front (contract)
3. Predefine exit criteria and implications
4. Treat partners and their employees as if they were direct employees
5. ALWAYS act with fairness and understanding
6. Build your partner’s business
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Planning for Phase III: PartneringNIH SBIR Conference 2017
Eric Horler, MBA, MEMPresident and CEOSwallow [email protected]
JoAnne Robbins, PhD, CCC‐SLP, BCS‐SProfessor EmeritaUW School of Medicine and Public Health
Founder, Inventor, Chief Scientific OfficerSwallow Solutions
