inserogen lecture 6 revenue model
Post on 24-May-2015
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Manufacturing platform for rapid, cost-effective, and scalable
production of therapeutics in tobacco
“insero” = to plant ”gen” = gene
Lucas Arzola (EL)Karen McDonald (PI)
Vasilis Voudouris (Mentor)
The Business Model Canvas
SpeedCost-EffectivenessRobustnessScalabilitySafetyEase of CustomizationU.S. Supply
R&DManufacturingRegulatory ApprovalLicensingMarketing
Tobacco SuppliersGene Synthesis CompaniesCMOs - Purification - Fill & Finish- Packaging- QA/QCCROs- Clinical TrialsFDA
IP – Patents, Trade SecretManufacturing Facility
Capital InvestmentsManufacturing CostsLicensing CostsMarketing
Contract Manufacturing Fully Integrated Manufacturing (Sales) Licensing (Royalties)
U.S. Government- CDC - HHS BARDA- DOD DARPAForeign GovernmentsNGOsVaccine Manufacturers- Established and
Emerging Biotech
Distribution through Government and Pharma Companies
PublicationsConferencesLong-Term Contracts with Government and Vaccine Manufacturers
Target Product – seasonal & pandemic flu vaccines alpha-1
antitrypsin
Customer
Dr. Jeffrey Almond – VP of External Discovery and R&D, Sanofi PasteurDr. Roman Chicz – Senior Director of External R&D, Sanofi Pasteur
Who 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 Relationships
How 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 Making
Total time: 6-9 months
How do customers decide if they want our product?
Being Deal Ready
What 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 Ready
How 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 capabilities
What 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 data
How 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 Feedback
Dr. Nancy Cox– Director of Influenza Division, CDC
What 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
competition
Leaning 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
Prototype
What have we done in the lab? For vaccine: Proof of concept in progress For AAT: proven production, years of experience
What do we want to do? Product characterization Purification studies Perform pilot scale proof-of-concept
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