“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)
The Business Model Canvas Target Product – seasonal & pandemic flu vaccines alpha-1 antitrypsinTobacco Suppliers R&D Speed Publications U.S. GovernmentGene Synthesis Manufacturing Cost-Effectiveness Conferences - CDCCompanies Regulatory Approval Robustness Long-Term - HHS BARDACMOs Licensing Scalability Contracts with - DOD DARPA- Purification Marketing Safety Government and Foreign Governments- Fill & Finish Ease of Customization Vaccine NGOs- Packaging U.S. Supply Manufacturers 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
CustomerDr. Jeffrey Almond – VP of External Discovery and R&D, Sanofi PasteurDr. Roman Chicz – Senior Director of External R&D, Sanofi PasteurWho is our customer? Biotechnology startups follow a licensing model, the goal is to develop a working product and seek a big partner that will fund product development through clinical trials and regulatory approval (joint venture for product co- development, startup is acquired if product is successful) Established companies – they rely on startups to broaden their product pipeline and find new technologies (70% of pipeline, 100% of preclinical projects are from partnerships)
Customer RelationshipsHow are they going to hear about us? Vaccine world is small! Conferences and publications – large biotech companies have “scout teams” that attend conferences and read publications to find out about the latest technologies and products BIO (Biotech Industry Organization) International Convention World Congress of Vaccine ImVacs (Immunotherapeutics and Vaccine Summit) ISPE (Pharmaceutical Engineering) Annual Meeting BIO Smartbrief, BioPharm, GEN, Fierce Biotech Direct contact– startups looking to partner with big biotech approach their ventures and partnering division directly
Customer Decision MakingHow do 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
Being Deal ReadyWhat are the terms for the partnership? Collaborations have clear go – no go milestones built into the agreement Customer appoints an alliance manager to work directly with the startup Customer agrees to pay a non-refundable upfront payment, royalties for the technology, and milestones payments once those are achieved Startup agrees to provide an exclusive license to the customer, equity stake depending on the valuation of the startup, stage of product development Terms may be included for acquisition depending on success
Being Deal ReadyHow do customers want our product? As a biotech startup, we have only 1-2 products Must bring value to our customer – expand their pipeline, provide them with new capabilitiesWhat do they want to see in place? Proof-of-concept data IP and Freedom to Operate Preclinical Data – toxicology studies, animal studies Nice to have:Phase I and or Phase II clinical trial dataHow do keep them wanting our product? Partnerships are win-win and long term Joint venture will transition into acquisition if product development is successful
Initial Customer FeedbackDr. Nancy Cox– Director of Influenza Division, CDCWhat are the entry barriers in the flu vaccine market? For seasonal vaccines, process is established and supplies the 250M yearly worldwide demand effectively Opportunity 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 market Unexpected market – pandemic once every 20-30 years Flu vaccines are commodities – low selling price, low profit margins, a lot of competitionLeaning towards a pivot to the therapeutics market Pursue a high-value product that is not been made recombinantly, known market, high selling price, high profit margin Possible new target: alpha-1 antitrypsin (AAT) 2 more meetings with vaccine customers
PrototypeWhat have we done in the lab? For vaccine: Proof of concept in progress For AAT: proven production, years of experienceWhat do we want to do? Product characterization Purification studies Perform pilot scale proof-of-concept
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