The document discusses using a tobacco-based manufacturing platform for rapidly and cost-effectively producing vaccines and therapeutics. It outlines the business model, which involves licensing the technology to larger biotech companies, and describes initial customer feedback indicating the flu vaccine market may be difficult to enter but the therapeutics market, such as for alpha-1 antitrypsin, could be more promising. Prototyping efforts involve further characterizing alpha-1 antitrypsin production in tobacco plants.

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 – seasonal & pandemic flu vaccines
alpha-1 antitrypsin
Tobacco Suppliers R&D Speed Publications U.S. Government
Gene Synthesis Manufacturing Cost-Effectiveness Conferences - CDC
Companies Regulatory Approval Robustness Long-Term - HHS BARDA
CMOs 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 and
CROs Emerging Biotech
- Clinical Trials
FDA 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. Customer
Dr. Jeffrey Almond – VP of External Discovery and R&D, Sanofi Pasteur
Dr. 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)

4. 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

5. Customer Decision Making
How 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

6. 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

7. 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

8. 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

9. 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