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Inserogen lecture 5 cust relationships

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  • 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. 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  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”  Challenging this hypothesis by speaking with as many experts and customers as we can  This week: explored decision making and distribution channels in the case of a pandemic
  • 3. The Business Model Canvas Target Product – seasonal & pandemic flu vaccinesTobacco 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
  • 4. Getting Out of the Lab!Cast a broad net by talking to many different experts and customers:(1) Executives from large companies Name Title Institution Michael Girard Sustainability Manager Aerojet Michael Jacobson Director of Corporate Responsibility Intel Joseph Kieren Director of Corporate Real Estate AT&T(2) Entrepreneurs and angel investors from Sacramento Name Title Institution Andrew Hargadon Professor of Management UC Davis WilAgatstein Professor of Management UC Davis LarryPalley Former General Manager Intel John Selep Operations Manager HP ThomasAlberts Consultant SBDC Cary Adams Head of MedStart Program SARTA
  • 5. Getting Out of the Lab!(3) Experts in the commercialization of biotech platform technologies Name Title Institution Greg McParland Consultant DSM Ventures Fernando Garcia Senior Director Amyris(4) Experts in vaccine manufacturing Name Title Institution Ann Arvin PCAST Vaccinology Working Group Stanford (Key Opinion Leader on Vaccines) Misa Sugui Associate Scientist MedImmune Floro Cataniag Laboratory Manager MedImmune
  • 6. Channels and DistributionConversation with Dr. Ann Arvin – Key Opinion Leader on vaccinesIn the case of a pandemic: Vaccine manufacturers have to be producing vaccines for seasonal flu – regulatory approval, QA, and validation need to be in place When a pandemic occurs, the government (BARDA) negotiates a manufacturing contract with vaccine companies – number of doses, formulation, price, and time are agreed upon CDC provides the elucidated strain to the manufacturer FDA considers the pandemic flu vaccine to be a variation of the seasonal flu vaccine – new regulatory approval is not necessary Vaccine manufacturers work with the new strain to ramp up production as quickly as they can – takes 4-6 months Sterility and quality testing is performed for the produced vaccines – some tests are done in-house and some are done by outside laboratories Vaccine is released
  • 7. Channels and DistributionGetting the vaccines to the patients Vaccine manufacturers have contracts with wholesalers (i.e. McKesson Corp.) to distribute the vaccines – distribution is not a cost for the manufacturers, they hand over the product In the case of a pandemic, vaccines are also distributed through local contracts with the state health departments Theydistribute the vaccines to hospitals and clinics, where they can be administered to the patients
  • 8. Organizational StrategyConversation with Greg McParland – Former CEO of biotech platform company: the virtual biotechnology company model “Starting out and for as long as you can, you should be a virtual company. You can have contracts to outsource the downstream part of the process (purification, fill and finish, packaging, etc.) ” “Keep your core technology and focus on using your manufacturing platform for protein production”. Common practice in biotechnology – almost every company has contracts with CROs, CMOs, marketing and distribution arrangements, etc. More flexibility – move quickly from failed avenues of research to more promising projects Startups partner with big pharma companies to complete clinical trials and take product to market“If you build it, they will come” – but only build the essential core that lets you control your technology platform
  • 9. More FeedbackConversation with Dr. Ann Arvin – Key Opinion Leader on vaccines Pain point: Reliability issues with traditional egg platform - willingness to move away to a different manufacturing platform Pain point: Current platforms are not fast enough, cannot have an impact in case of a pandemic - sense of urgency in finding a manufacturing platform that can produce vaccines faster and at a large scale Given this landscape, we still believe our technology can solve a significant problem in the vaccine marketConversation with Dr. Misa Sugui & Dr. Floro Cataniag – MedImmune Pain point: attenuated virus platform is harder to work with, safety measures are more stringent – would prefer recombinant subunit vaccines Wish: a faster process for vaccine production (our technology can help with this) Wish: a faster process for clinical trials and for approval of new drugs (this we can’t do anything about) MedImmune is a possible partner - always looking for new vaccine production technologies and new products to incorporate in their pipeline
  • 10. More FeedbackConversation with Fernando Garcia – Amyris Biotech platform technology company First target product: drug for malaria, partnered with Sanofi to commercialize Change in strategy: they have transitioned into making biofuels Why have they made this transition? We will follow up with one of the founders of the company to find out
  • 11. Next Steps We believe we have a good feel for our value proposition We need to better understand how we can sell to customers and how to establish these relationships, how decisions are made, distribution channels – build a flowchart Keep searching for a business model that will allow us to commercialize our technology We need to talk to many more experts and customers…

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