Planning for Phase III: Partnering NIH SBIR Conference 2017

Transcription

1 Planning for Phase III: Partnering NIH SBIR Conference 2017 JoAnne Robbins, PhD, CCC SLP, BCS S Professor Emerita UW School of Medicine and Public Health Founder, Inventor, Chief Scientific Officer Swallow Solutions Eric Horler, MBA, MEM President and CEO Swallow Solutions 1 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? 1

2 Necessity is the mother of invention. Ascribed to Plato from translations of Republic, 380 BC 3 Frank Zappa/Mothers of Invention, 1960s 4 2

3 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, PhD Director, Division of Behavioral and Social Research National Institute on Aging/National Institutes of Health John Beard, MBBS, PhD Director, Department of Ageing and Life Course World Health Organization Young Children and Older People as a Percentage of Global Population: Age <5 Age 65+ Source: United Nations. World Population Prospects: The 2010 Revision. Available at: 5 Healthy Swallow 6 3

4 Swallowing and Aspiration Thin liquid Thickened liquid 7 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) 8 4

5 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 9 Partnering Team Inventor(s) University Founder Attorney Investor(s) CEO Knowledgeable board members Business leaders 10 5

6 Moving the Product to the Patient 11 A Related And Necessary Continuum From chaos to order The MATCH Diagnostics to the treatment(s) 12 6

7 Case Study Development of the Treatment(s) 1. Identified a clinical unmet need 2. Standardized diagnostic imaging materials for swallowing 3. Executed Protocol 201 (largest NIHfunded 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 13 What have I learned? 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! 14 7

8 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? Commercialization Considerations Market Intelligence Competition Customer Segmentation Value Proposition Go to Market Marketing Strategy Sales Channels Distribution Supply Chain Manufacturing Needs Org Structure Hire vs. Buy vs. Partner Buying Process IP Protection Revenue Streams Financials Cost Structure 16 8

9 Product Positioning To brand of BRAND is the best choice because CUSTOMER (BE SPECIFIC) CATEGORY VALUE PROPOSITION unlike COMPETITORS that. COMPETITIVE ADVANTAGE 17 Product Positioning Example To dietary managers in hospitals and nursing homes Swallow Solutions brand of thickened beverages BRAND is the best choice because CUSTOMER (BE SPECIFIC) it provides supplemental protein with excellent taste VALUE PROPOSITION unlike other thickened beverages and protein shakes COMPETITORS CATEGORY that. lack protein, are to thin, and/or are not refreshing COMPETITIVE ADVANTAGE 18 9

10 Thickened Beverages Go to Market Example Vendor Redistributor Large food distributor Facility (Dietary Mgr) information Product eval Catalog Contracting assign cat # placement cat/ordering system product Inventory product Inventory product Inventory payment Margin payment Margin payment Dietary budget promotion (direct sales force, advertising, etc.) 19 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 20 10

11 Commercialization Considerations Market Intelligence Competition Customer Segmentation Value Proposition Go to Market Marketing Strategy Sales Channels Distribution Supply Chain Manufacturing Needs Org Structure Hire vs. Buy vs. Partner Buying Process IP Protection Revenue Streams Financials Cost Structure 21 Why partner? (In commercializing products) 22 11

12 Partnering for Commercial Success Example: Swallow Solutions Medical Device Galileo Consulting CFO Accounting Payroll Regulatory Affairs Quality Assurance Compliance Reimbursement Manufacturing Sustaining Engineering Sales Distribution Note: Does not include service providers who provide support on an ad hoc basis, such as law firms, ad agencies, etc. 23 Partnering for Commercial Success Example: Swallow Solutions Beverages UNIVERSITY OF WISCONSIN-MADISON Actively Searching Actively Searching CFO Accounting Payroll Expert advice Product development User testing Manufacturin g Marketing Distribution Note: Does not include service providers who provide support on an ad hoc basis, such as law firms, ad agencies, etc

13 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) 25 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 26 13

14 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 27 Planning for Phase III: Partnering NIH SBIR Conference 2017 JoAnne Robbins, PhD, CCC SLP, BCS S Professor Emerita UW School of Medicine and Public Health Founder, Inventor, Chief Scientific Officer Swallow Solutions Eric Horler, MBA, MEM President and CEO Swallow Solutions ehorler@swallowsolutions.com 28 14