Downloaded 27 times
Uploaded byStanford University
Inserogen final presentation
Team Inserogen is developing a technology using tobacco plants as biofactories to produce therapeutics like vaccines and alpha-1 antitrypsin (AAT) more cost effectively and at large scale. Their technology could provide a reliable supply of recombinant AAT at lower cost than current treatments derived from human blood plasma. They are seeking funding and partnerships with biotech companies to advance their technology for producing AAT to treat AAT deficiency, a genetic condition affecting lung health.
More Related Content
Similar to Inserogen final presentation
More from Stanford University
Inserogen final presentation
- 1. “insero” = toplant ”gen” = gene Rapid, cost-effective, and scalable manufacturing technology that uses tobacco plants as biofactories of therapeutics “Using tobacco to produce a life-enhancing treatment for emphysema disease” I-Corps Contacts: 52
- 2. Team Inserogen Entrepreneurial Lead 1st Prize, 2010 Big Bang! Business Plan Competition at UC Davis Lucas Arzola Elevator Pitch Award, 2011 UC Ph.D. Candidate, Chemical Engineering Berkeley B-Plan Competition Emphasis in Biotechnology E-Team Grant, National Collegiate Inventors and Innovators Alliance Principal Investigator 25+ years of experience in Plant Made Proteins Research Karen McDonald, Ph.D. UC Davis Professor, Chemical Engineering Inventor in 1 issued patent and 4 patent applications Mentor 20 years of experience in Process Development Manufacturing and Vasilis Voudouris, Ph.D., MBA Strategic Planning Managing Director, Vereniki Solutions
- 3. A Green Multi-ProductManufacturing Platform Harvested tobacco > 90% reduction in capital costs Reduction in operating costs Large scale production in weeks, not months
- 4. The Business ModelCanvas Target Product – seasonal & pandemic flu Version 1 vaccines Tobacco Suppliers R&D Speed Publications HHS BARDA Gene Synthesis Comp. Manufacturing Cost-Effectiveness Conferences DOD DARPA CMO Regulatory Approval Scalability Long Term Contracts CDC CRO Marketing Safety Vax Manufacturers FDA Customization NGOs Intellectual Property U.S. Based Supply Wholesalers Government Manufacturing Facility Contract Manufacturing Facility Investment IP Licensing Costs Fully Integrated Manufacturing (Sales) Manufacturing Costs Marketing Costs Licensing (Royalties)
- 5. The Business ModelCanvas Target Product – seasonal & pandemic flu Version 1 vaccines Speed Cost-Effectiveness Scalability Safety Customization U.S. Based Supply What we thought: these features can meet a need for the influenza vaccine market.
- 6. Getting Out ofthe Laboratory! What we did: Contacted vaccine industry stakeholders What we found: DOSES Unpredictable market 2B Pandemic flu Flu vaccines are commodities Large companies are not willing Surge capacity Opportunity to change their manufacturing platform 250M Seasonal flu Seasonal flu Seasonal flu “This is a billion-dollar investment we are not willing to make” YEAR 1 YEAR 2 YEAR 3
- 8. The Business ModelCanvas Target Product – seasonal & pandemic flu vaccines Version 2 alpha-1 antitrypsin (AAT) Tobacco Suppliers R&D Speed Publications Patients Gene Synthesis Comp. Manufacturing Cost-Effectiveness Conferences Physicians CMO Regulatory Approval Scalability Long Term Contracts Pulmonary Labs CRO Marketing Safety Large Biotech Comp. FDA Reliable Supply Alpha-1 Foundation Intellectual Property U.S. Based Supply Wholesalers Government Alpha-1 Project Manufacturing Facility Customization Direct to Patient Grants Licensing (Royalties) Facility Investment IP Licensing Costs Upfront & Milestone Payments (from Partners) Manufacturing Costs Marketing Costs Lean Biotech Company (Sales)
- 9. What are weselling? First target product: Alpha-1 antitrypsin (AAT) Indication: AAT Deficiency (AATD) – hereditary disorder resulting in low levels of AAT in lungs, leads to emphysema, often before age 40 Less than 10% of AAT Deficiency individuals have been properly diagnosed Worldwide Estimates 3.4 million with AATD 116 million carriers “AAT may be one of the most common serious hereditary disorders in the world” - President, Alpha-1 Europe
- 10. AAT Treatment isExpensive There is no known cure for AAT Deficiency Treatment: Augmentation therapy – weekly AAT infusions 5 g AAT per patient per week Annual: 260 g AAT per patient Competitor Pricing Prolastin - $350/gram Zemaira - $430/gram Aralast - $510/gram Alfalastin - $450/gram Cost per patient: ~$100,000/year for life
- 11. Value Proposition Problem: CommercialAAT for augmentation therapy is derived from donated human blood Cost Reliable Supply: “There are problems with supply. We need new ways of making AAT.” – Scientific Director, Alpha-1 Foundation Safety: “The risk of transmission of infectious agents cannot be completely eliminated.” – Prescribing information for Zemaira Value proposition: We can provide recombinant AAT (we’ve already produced it in the lab!) Reliable and scalable supply Safer production Cost reduction – we believe we can substantially reduce treatment cost
- 12. Target Market AAT deficiency in the United States New indications for AAT Diabetes, cystic fibrosis, others Under Total treatment 6,000 patients $600M 100,000 patients $10B Cost per patient: $100,000/year Millions of patients Billions “As diagnosis improves and new indications are found, we will need more AAT produced.” – Scientific Director, Alpha-1 Foundation
- 13. Business Model andCustomer Archetype Lean biotech business model “Starting out and for as long as you can, be a lean biotech company.” – CEO, Biotech Company Core technology Outsource to CMO Finished Drug Product + Patent protection Customer: Established biotech company (for clinical development) Interested in blood proteins and/or alternative manufacturing platforms Looking to increase their pipeline, gain market share Hundreds of millions (not billions) in revenue Hundreds (not thousands) of employees
- 14. Customer Decision Making Howdo customers decide if they want our product? • 400-500 opportunities per year Initial Evaluation • 1-2 weeks • 80-100 opportunities Detailed Analysis • 2-3 months • Internal innovation committee meeting Go – No Go Decision • Once a month • 25-30 opportunities Due Diligence • 2-3 months • Agree to terms, business development team approval Business Discussions • 2-3 months • Establish work plan and define milestones Deal is signed • Project starts Total time: 6-9 months
- 15. Revenue Model = money = relationship = information = AAT Patient Large Pharma Private Payor Employer Government Payor Wholesalers Hospital/Clinic Government Physicians Taxpayer Pulmonary Function Lab INFLUENCER
- 16. The Business ModelCanvas Target Product – seasonal & pandemic flu vaccines Version 3 alpha-1 antitrypsin (AAT) Tobacco Suppliers R&D Speed Publications Patients Gene Synthesis Comp. Manufacturing Cost-Effectiveness Conferences Physicians CMO Regulatory Approval Scalability Long Term Contracts Pulmonary Labs CRO Marketing Safety Large Biotech Comp. FDA Reliable Supply Alpha-1 Foundation Intellectual Property U.S. Based Supply Wholesalers Government Alpha-1 Project Manufacturing Facility Customization Direct to Patient Grants Licensing (Royalties) Facility Investment IP Licensing Costs Upfront & Milestone Payments (from Partners) Manufacturing Costs Marketing Costs Lean Biotech Company (Sales)
- 17. Next Steps Alpha-1 Project NSF SBIR Phase I Funding Venture Philanthropy Program Grant Licensing agreement Freedom to IP of core technology Operate analysis Join Engineering Team Development & Translational Business Incorporation Technology Center
Editor's Notes
- #3 Combined 30 years of experience in the agricultural biotech fieldExperience in failed venture for human vaccine, Ready to challenge barriers, know what the pitfalls areBest scientific board, 30 years in industry, know what barriers are, helping us with go to market strategy
- #4 Lucas, can you move the boxes on the right so that the Proteins for diagnostics is at the top, followed by animal and human vaccines?
- #7 For seasonal vaccines, process has been established for decades, supplies the 250M yearly worldwide demand effectivelyOpportunity is in the lack of surge capacity of current platforms to deal with the 2B doses needed for a pandemic – however, you need to have approval for seasonal to have a shot at the pandemic marketUnpredictable market – pandemic once every 20-30 yearsFlu vaccines are commodities – low selling price, low profit margins, a lot of competitionLarge companies are not willing to change their manufacturing platform – “this is a billion-dollar investment we are not willing to make”
- #17 Lessons LearnedStarting with a high-value product is better for a biotech startup – value for our investors and patientsWe can provide a solution for AAT – high growth market