Inserogen Lecture 4 Channels
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Transcript of Inserogen Lecture 4 Channels
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
Long-Term Contracts with Government and Vaccine Manufacturers
Target Product – therapeutics
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
Challenged this hypothesis by speaking with as many experts and customers as we could
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”
Getting Out of the Lab!
Cast a broad net by talking to many different experts and customers in the following 3 areas:
(1) Experts in commercialization of biotech platform technologies in general
Name Title Institution
Jim Swartz Founder Sutro Biopharma
Peter Gillies Former Senior Scientist DuPont
Steve Burrill CEO Burrill & Co.
Getting Out of the Lab!
(2) Experts in the commercialization of biotech platform technologies for plants
Name Title Institution
James Petell Former Global Director of R&D Dow Agrosciences
Raymond Rodriguez Co-Founder Applied Phytologics/Ventria Biosciences
Peter Matlock Co-Founder Ventria Biosciences
Tom Turpen Founding Scientist Large Scale Biology
(3) Experts in the customer side for specific markets and target proteins
Name Title Institution
Bennie Osburn Former Dean of Veterinary Medicine UC Davis
Jim Cullor Professor in Veterinary Medicine UC Davis
Doug Crawford Associate Director QB3
Kevin Technical Support My BioSource
Customers and users
Figuring out who the customers are Burrill – “For biotech startups, customers are usually big biotech companies
looking to acquire new technologies.” Burrill – “Part of a biotech company’s value is perceived – how strong is the IP,
how innovative is the technology, what is the size of the potential market.” Swartz – “When big pharma partners with you or invests in you, that is a true
validation of your platform”. Crawford – “Focus on technical/manufacturing people within large pharma as
clients. The venturing and licensing offices seem to be more transaction oriented.”
Even for biotech, understanding the customers is very important Gillies – “We spent years doing research to develop a process. Afterwards we
asked ourselves: here’s what we’re making. What is it good for?” Rodriguez - “For our biotech platform company, we did not look at the customers
until after one year. I wish we would have done it on the 1st week.” Rodriguez – “We waited too long to talk to the FDA. I wish we would have done it
sooner.”
Changes in Value proposition
Improved Product – It is better if we can use our platform to make a product that has never been made recombinantly before
Swartz – “To validate a new manufacturing platform and gain acceptance from big pharma and the biotech industry, you have to produce “hard to make” proteins, “biobetters,” or have an enabling recovery/purification characteristic.”
Turpen – “Going after your own product that no one else can make gives you a niche. Having your own market would be a huge competitive advantage”.
Customers’ Problems
Veterinary Vaccines Cullor – “Farmers are always concerned with cost. More preventive vaccination
would be performed on animals if the cost was affordable.” Osburn – “Farmers purchase combination vaccines – you have to be able to
produce more than one product to be able to sell to farmers.”
Proteins for Research Use Kevin – “We only have a very small amount of plant-made proteins for sale.” Kevin – “ For our custom-made recombinant purified proteins, we have a couple
of manufacturing partners that handle production for us.”
General Petell – “Differences in glycosylation between human and plant proteins could be
a problem. You have to find out what the issues are.”
What was it about your platform that makes customers excited? Interested?
Cost-effectiveness Crawford – “The cost-effectiveness of your platform can help you go after non-
therapeutics markets, such as nutrition.” Turpen – “It is great that your platform reduces the equipment and infrastructure
needed to produce therapeutics.” Matlock – “Making big volumes of vaccines so cheaply that you could spit them
down the drain is a big deal.”
Customer decision making
Decision makers - talk with FDA early and often Rodriguez – “Only after we had produced a bunch of protein did we approach the
FDA and told them: look what we have. Not good, they didn’t care.” Rodriguez – “Regulatory review took 5 years. FDA reviewers will not take risks,
they are afraid of losing their jobs.” Rodriguez, on saboteurs – “A competing company convinced the FDA our
approach was too risky. They left us twisting in the wind.”
The “spending” customers/vaccine manufacturersHave not yet met with them, but we have meetings scheduled: Roman Chicz – Sanofi Pasteur, Head of External Research, North America – “I
would be happy to speak with you regarding your plant-based manufacturing platform for vaccine production.” – Meeting scheduled for Oct 28
Misa Sugui – Scientist at MedImmune – “These are very good questions. We may not be able to answer some of them in detail due to the proprietary nature of the business.” – Meeting scheduled for Oct 24
Next Steps
Keep challenging our value proposition Understand why previous companies have failed
We need to better understand how we can sell to customers, how decisions are made
Keep searching for a business model that will allow us to commercialize our technology
Not enough data - we need to talk to many more experts and customers…
More MeetingsName Title Institution Date
Pete Bernardoni Managing Director Wavepoint Ventures Oct 18
John Aikens CTO/Founder Proterro Oct 18
Various Investors Angel Investors Sacramento Angels Oct 18
Michael Plesha Bioprocess Engineer Novartis Oct 19
Ann Arvin Committee Member President’s Vaccinology Working Group
Oct 21
Misa Sugui Scientist MedImmune Oct 24
Roman Chicz Head of External Research, North America
Sanofi Pasteur Oct 28
Ron Levy Professor in Oncology Stanford Nov
Karen Oishi Commercial Development of Plant Biotech Platform Specialist
Philip Morris TBD
Henry Daniell Founder Chlorogen TBD
Mike Murray Former New Technology Leader Dow Agrosciences TBD
James Cregg Professor, Platform Tech Expert Keck Graduate Institute TBD
Eric Langer Managing Partner BioPlan TBD