Our technology platform has potential market opportunities in producing therapeutics like vaccines. We are testing the hypothesis that our platform can be scaled up and commercialized cost-effectively. We spoke with experts in vaccine manufacturing, distribution, commercialization of biotech platforms, and more. They validated pain points in current vaccine production and interest in faster, more scalable platforms. Next steps are understanding customer relationships and decision-making to establish a commercialization strategy and business model. We will continue engaging experts and customers.

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 vaccines
Tobacco Suppliers R&D Speed Long-Term U.S. Government
Gene Synthesis Manufacturing Cost-Effectiveness Contracts with - CDC
Companies Regulatory Approval Robustness Government and - HHS BARDA
CMOs 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 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

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 Distribution
Conversation with Dr. Ann Arvin – Key Opinion Leader on vaccines
In 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 Distribution
Getting 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 Strategy
Conversation 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 Feedback
Conversation 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 market
Conversation 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 Feedback
Conversation 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…