inserogen lecture 8 resources
TRANSCRIPT
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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)
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The Business Model Canvas
Cost-EffectivenessRobustnessScalabilitySafetyU.S. SupplyProduct uniformity
R&DManufacturingRegulatory ApprovalLicensingMarketing
UC DavisTobacco GrowersGene Synthesis CompaniesCMO Clinical CROsAlpha 1 FoundationTobacco Companies
IP – Patents, Trade SecretManufacturing Facility
Capital InvestmentsManufacturing CostsLicensing CostsMarketing
GrantsUpfront/Milestone Payments w/PartnersLicensing (Royalties)Virtual Biotech Company (Sales)Fully Integrated Manufacturing (Sales) (LONG TERM)
WholesalersAAT deficient patients
Distribution through Wholesalers
PublicationsConferencesLong-Term Contracts with Wholesalers
Target Product – alpha-1 antitrypsin (AAT)
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Partners
Why do we need them? Technology license agreement Startup incubator space
Why will they partner with us? Campus becoming more entrepreneurial – new Chancellor is revamping the
technology transfer process, success story for UC Davis and Sacramento area
What’s the cost of the partnership? Licensing costs – upfront payment, assume patent costs Incubator space lease agreement
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Partners
Why do we need them? For the clinical trials – the foundation manages the alpha-1 research registry, a
confidential database of diagnosed alpha-1 deficient individuals and alpha-1 carriers willing to participate in research, from filling a research questionnaire to enlisting in clinical trials
For research funding - they have provided $42M in funding for alpha-1 research and programs to date
Why will they partner with us? Because of their mission – dedicated to providing leadership and resources
that will result in increased research, improved health, worldwide detection, and a cure for the disease. Using our manufacturing platform to make AAT more affordable, safer and reliably available would be an incentive for them to partner with us.
What’s the cost of the partnership? No direct costs, although personnel time for relationship building, grant
writing, etc.
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Partners
Why do we need them? Raw Material Supply and Expertise – they have the infrastructure and know
how to grow tobacco
Why will they partner with us? New Market – they are looking for new, high value markets for their crops in a
declining smoking tobacco market
What’s the cost of the partnership? Research and Development – agricultural practices and germplasm may need
to be modified for new application Long-term contracts – payments for harvested tobacco crops Relationship building, monitoring and development
Tobacco Farmers
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Partners
Why do we need them? Funding – we are repurposing tobacco for the production of therapeutics
Why will they partner with us? Positive PR – they are looking for new and better uses for tobacco (using
tobacco to provide a treatment for hereditary-based emphysema).
What’s the cost of the partnership? Public perception? – associating our company with them might transfer strong
feelings from the public towards us
Tobacco Companies
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Partners
Why do we need them? For product co-development – provide funds and resources for research,
product/process development, clinical trials and regulatory approval
Why will they partner with us? Large pharma companies are constantly seeking new technologies and
products for their pipeline
What’s the cost of the partnership? Exclusive rights to the product – joint venture for product co-development,
startup is acquired if product is successful
Large Biotech Companies
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Partners
Why do we need them? To complete our manufacturing – use our core technology to make AAT,
outsource our purification, fill and finish, we can focus on our core competency without increasing overhead costs, infrastructure and number of staff
Why will they partner with us? Because it’s their business – CMOs act as single source providers, offer
specialized and comprehensive manufacturing services
What’s the cost of the partnership? Service fee – a manufacturing contract is negotiated that specifies process
development work, crude extract to process, amount of product to be purified, quality specifications, formulation, price, and timeline
Contract Manufacturing Organizations
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Partners
Clinical Research Organizations
Why do we need them? Preclinical and human clinical trial expertise and process manufacturing
support for Chemistry, Manufacturing and Control (CMC)
Why will they partner with us? Because it is their business – CROs assist partners in drug discovery and
development by providing them with customized high-quality research models and preclinical and clinical support services.
What’s the cost of the partnership? Consulting and Service Agreements – Preclinical, Phase I, Phase II, and Phase III,
process manufacturing support QC, QA & Regulatory compliance costs of manufacturing facility – we need
qualified staff for internal regulatory oversight
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Partners
Why do we need them? Distribution – get our product to AAT deficient patients
Why will they partner with us? Because it’s their business – wholesalers mark up the product price when it
goes through their channels to the retailers
What’s the cost of the partnership? Long term contracts – assure pricing and steady supply of product
Wholesalers