Inserogen Lecture 4 Channels


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Inserogen Lecture 4 Channels

  1. “insero” = to plant ”gen” = gene Manufacturing platform for Lucas Arzola (EL) rapid, cost-effective, and scalable Karen McDonald (PI)production of therapeutics in tobacco Vasilis Voudouris (Mentor)
  2. The Business Model Canvas Target Product – therapeuticsTobacco Suppliers R&D Speed Long-Term U.S. GovernmentGene Synthesis Manufacturing Cost-Effectiveness Contracts with - CDCCompanies Regulatory Approval Robustness Government and - HHS BARDACMOs Licensing Scalability Vaccine - DOD DARPA- Purification Marketing Safety Manufacturers Foreign Governments- Fill & Finish Ease of Customization NGOs- Packaging U.S. Supply Vaccine Manufacturers- QA/QC -Established andCROs Emerging Biotech- Clinical TrialsFDA IP – Patents, Trade Secret Manufacturing Facility Distribution through Government and Pharma Companies Capital Investments Contract Manufacturing Manufacturing Costs Fully Integrated Manufacturing (Sales) Licensing Costs Licensing (Royalties) Marketing
  3. What We Know  We have a novel technology platform with numerous market opportunities  Our working hypothesis – that we can scale up and commercialize our platform for production of life-saving therapeutics  Challenged this hypothesis by speaking with as many experts and customers as we could  Jon Feiber – “Since you are a platform technology, it makes sense to engage in ‘market discovery’ and ‘customer discovery’ at the same time during the next weeks”
  4. Getting Out of the Lab!Cast a broad net by talking to many different experts and customers in the following 3 areas:(1) Experts in commercialization of biotech platform technologies in general Name Title Institution Jim Swartz Founder Sutro Biopharma Peter Gillies Former Senior Scientist DuPont Steve Burrill CEO Burrill& Co.
  5. Getting Out of the Lab!(2) Experts in the commercialization of biotech platform technologies for plants Name Title Institution James Petell Former Global Director of R&D Dow Agrosciences Raymond Rodriguez Co-Founder Applied Phytologics/ Ventria Biosciences Peter Matlock Co-Founder Ventria Biosciences Tom Turpen Founding Scientist Large Scale Biology(3) Experts in the customer side for specific markets and target proteins Name Title Institution Bennie Osburn Former Dean of Veterinary Medicine UC Davis Jim Cullor Professor in Veterinary Medicine UC Davis Doug Crawford Associate Director QB3 Kevin Technical Support My BioSource
  6. Customers and usersFiguring out who the customers are Burrill – “For biotech startups, customers are usually big biotech companies looking to acquire new technologies.” Burrill – “Part of a biotech company’s value is perceived – how strong is the IP, how innovative is the technology, what is the size of the potential market.” Swartz – “When big pharma partners with you or invests in you, that is a true validation of your platform”. Crawford – “Focus on technical/manufacturing people within large pharma as clients. The venturing and licensing offices seem to be more transaction oriented.”Even for biotech, understanding the customers is very important Gillies – “We spent years doing research to develop a process. Afterwards we asked ourselves: here’s what we’re making. What is it good for?” Rodriguez - “For our biotech platform company, we did not look at the customers until after one year. I wish we would have done it on the 1st week.” Rodriguez – “We waited too long to talk to the FDA. I wish we would have done it sooner.”
  7. Changes in Value propositionImproved Product – It is better if we can use our platform to make a product that has never been made recombinantly before Swartz – “To validate a new manufacturing platform and gain acceptance from big pharma and the biotech industry, you have to produce “hard to make” proteins, “biobetters,” or have an enabling recovery/purification characteristic.” Turpen – “Going after your own product that no one else can make gives you a niche. Having your own market would be a huge competitive advantage”.
  8. Customers’ ProblemsVeterinary Vaccines Cullor – “Farmers are always concerned with cost. More preventive vaccination would be performed on animals if the cost was affordable.” Osburn – “Farmers purchase combination vaccines – you have to be able to produce more than one product to be able to sell to farmers.”Proteins for Research Use Kevin – “We only have a very small amount of plant-made proteins for sale.” Kevin – “ For our custom-made recombinant purified proteins, we have a couple of manufacturing partners that handle production for us.”General Petell – “Differences in glycosylation between human and plant proteins could be a problem. You have to find out what the issues are.”
  9. What was it about your platform that makes customersexcited? Interested?Cost-effectiveness Crawford – “The cost-effectiveness of your platform can help you go after non- therapeutics markets, such as nutrition.” Turpen – “It is great that your platform reducesthe equipment and infrastructure needed to produce therapeutics.” Matlock – “Making big volumes of vaccines so cheaply that you could spit them down the drain is a big deal.”
  10. Customer decision makingDecision makers - talk with FDA early and often Rodriguez – “Only after we had produced a bunch of protein did we approach the FDA and told them: look what we have. Not good, they didn’t care.” Rodriguez – “Regulatory review took 5 years. FDA reviewers will not take risks, they are afraid of losing their jobs.” Rodriguez, on saboteurs – “A competing company convinced the FDA our approach was too risky. They left us twisting in the wind.”The “spending” customers/vaccine manufacturersHave not yet met with them, but we have meetings scheduled: Roman Chicz – Sanofi Pasteur, Head of External Research, North America – “I would be happy to speak with you regarding your plant-based manufacturing platform for vaccine production.” – Meeting scheduled for Oct 28 Misa Sugui – Scientist at MedImmune – “These are very good questions. We may not be able to answer some of them in detail due to the proprietary nature of the business.” – Meeting scheduled for Oct 24
  11. Next Steps Keep challenging our value proposition  Understand why previous companies have failed We need to better understand how we can sell to customers, how decisions are made Keep searching for a business model that will allow us to commercialize our technology Not enough data - we need to talk to many more experts and customers…
  12. More Meetings Name Title Institution Date Pete Bernardoni Managing Director Wavepoint Ventures Oct 18 John Aikens CTO/Founder Proterro Oct 18 Various Investors Angel Investors Sacramento Angels Oct 18 Michael Plesha Bioprocess Engineer Novartis Oct 19 Ann Arvin Committee Member President’s Vaccinology Working Oct 21 Group Misa Sugui Scientist MedImmune Oct 24 Roman Chicz Head of External Research, North Sanofi Pasteur Oct 28 America Ron Levy Professor in Oncology Stanford Nov Karen Oishi Commercial Development of Plant Philip Morris TBD Biotech Platform Specialist Henry Daniell Founder Chlorogen TBD Mike Murray Former New Technology Leader Dow Agrosciences TBD James Cregg Professor, Platform Tech Expert Keck Graduate Institute TBD Eric Langer Managing Partner BioPlan TBD