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Gammaglobulin I-Corps@NIH 121014

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Gammaglobulin I-Corps@NIH 121014

  1. Team 11: Recombinant Gammaglobulin The first pure antibody source for patients who can’t make their own antibodies ($7 billion existing market). We interviewed 163 people to test our business hypothesis. Matt Spindler Principal Investigator PhD UCSF Postdoc Stanford Specialty is immune therapies Copyright © 2014 GigaGen, Inc. David Johnson C-Level MBA UC Berkeley PhD Stanford Specialty is genomics innovation Jennifer Keller Industry Expert MBA UC Irvine MS UC Berkeley Specialty is clinical marketing
  2. Copyright © 2014 GigaGen, Inc. Situation • Millions of sick people can’t make their own antibodies, or they make faulty ones • To stay healthy, these people need to get antibodies from another source • Now, plasma is collected from thousands of healthy people and fractionated to isolate antibodies • The antibodies are then shot back into the sick people • This is called gammglobulin, or IVIG: a $7 billion market! 1000’s of people Plasma collection Plasma fractionation IVIg
  3. Copyright © 2014 GigaGen, Inc. Complication Demand exceeds supply: •Three major shortages in the past 15 years •Strong market growth and off-label use will continue to stress the supply •Serum collection will hit upper limit Quality problems: •Factor XIa contaminants disrupted supply in 2010 and caused significant morbidity •IgA contamination can cause anaphylactic shock •Batch-to-batch variation in genetic content limits efficacy •No ability to engineer isotype or genotype content for particular applications IVIg Shortages Year
  4. Solution: Recombinant Gammaglobulin Remember these guys? If nature doesn’t have enough, make it yourself! •More predictable •More engineerable •More scalable Copyright © 2014 GigaGen, Inc.
  5. Get out of the building? Get out of the country! • Would anyone use recombinant? • Who is the first target patient population • Why would they use recombinant? • Who would we need to work with to make the product? • What are the regulatory risks? • What would clinical trials look like? Copyright © 2014 GigaGen, Inc.
  6. Finding the Key First Customers Copyright © 2014 GigaGen, Inc. Primary immune deficiency patient Immunologist Cancer patient Autoimmunity patient Infectious disease doctor Oncologist
  7. Customers Teach Us What They Value Copyright © 2014 GigaGen, Inc. Primary immune deficiency patient Immunologist Cancer patient Autoimmunity patient Infectious disease doctor Purity Differentiating preclinical and clinical work “Hyperimmune” targeting specific pathogens Oncologist
  8. Learning: Customer Value Proposition Peace of mind Convenience Consistency Copyright © 2014 GigaGen, Inc. Unreliable supply Viral contamination Live freely Survive Blood protein contamination rhIVIg production Home infusion Consisten t product Price uncertainty In vitro In vitro production Clear reimbursement Renewabl e resource Clinical studies Infusions every 3rd week Longer ½ life in vivo Don’t get sick Save money Feel healthy
  9. Which Stakeholders Are Most Important? Copyright © 2014 GigaGen, Inc. Healthcare professionals Patients Pharmas Payer/Regulatory Distribution
  10. Learning: Stakeholder Importance Infectious disease pediatric Biotechs w/innovation programs Copyright © 2014 GigaGen, Inc. Healthcare professionals Patients Pharmas Immunologists IDF Baxter/Grifols/CSL Payer/Regulatory Distribution autoimmunity PID Medicare/private payer CBER Wholesale Specialty pharma Less value More value
  11. Learning: Stakeholder Importance Infectious disease pediatric Biotechs w/innovation programs Copyright © 2014 GigaGen, Inc. Healthcare professionals Patients Pharmas Immunologists IDF Baxter/Grifols/CSL Payer/Regulatory Distribution autoimmunity PID Medicare/private payer CBER Wholesale Specialty pharma Less value More value
  12. Business Model Canvas: Partners Copyright © 2014 GigaGen, Inc. Primary immune deficiency patient Immunologist Infectious disease doctor Purity Differentiating preclinical and clinical work “Hyperimmune” targeting specific pathogens IDF CBER
  13. Learning: Ecosystem for Development • Yeast library protocol development internal vs. external • Small-scale vs. large-scale cGMP production • cGMP vs. pilot production • US vs. Europe vs. Asia production Copyright © 2014 GigaGen, Inc.
  14. Business Model Canvas: Protein Partners Copyright © 2014 GigaGen, Inc. Primary immune deficiency patient Immunologist Infectious disease doctor Purity Differentiating preclinical and clinical work “Hyperimmune” targeting specific pathogens IDF CBER Small scale GMP (EU) Large scale GMP (EU) Protein library protocol development Protein library protocols
  15. Business Model Canvas: Channels Copyright © 2014 GigaGen, Inc. Primary immune deficiency patient Immunologist Infectious disease doctor Purity Differentiating preclinical and clinical work “Hyperimmune” targeting specific pathogens IDF CBER Small scale GMP (EU) Large scale GMP (EU) Protein library protocol development Protein library protocols Distributer Specialty pharma Hospitals GPO
  16. Learning: Distribution Models Copyright © 2014 GigaGen, Inc. Sp Pharmacy patient Distributer Lg Hosp Pharm GPO (Manages pricing for Sp P/Pharm) Greatest volume Some volume Very little volume
  17. Business Model Canvas: Channels Copyright © 2014 GigaGen, Inc. Primary immune deficiency patient Immunologist Infectious disease doctor Purity Differentiating preclinical and clinical work “Hyperimmune” targeting specific pathogens IDF CBER Small scale GMP (EU) Large scale GMP (EU) Protein library protocol development Protein library protocols Distributer Specialty pharma Hospitals Group purchasing organization
  18. Learning: Ecosystem for Development Resources Activities Partners <100pt study for launch Copyright © 2014 GigaGen, Inc. Physician channels for clinical studies Regulatory Consultant Recombinant Ig library IP protecting in vitro production process Microfluidic chip designs Pre-clinical assays SOPs IDF Clin Study sites (PID) Med Ad Board GMP production facilities Human Blood Source Build rIg library pipeline Pre-clinical studies for IND Informatics for library QC Microfluidic chip foundry GLP rodent CRO Distribution Specialty Pharmacy or Wholesaler
  19. Copyright © 2014 GigaGen, Inc. Conclusion: Next Steps Path to Revenues, OP Plan, Cust Data points High Fidelity MVP Business Case Defined Left-side of the Canvas Right-side of the Canvas Product/Market Fit Problem/Solution validation Low Fidelity MVP, Clinical Paths ID’d First Pass Canvas Verdict on Phase II Grant: •NCI Phase I is a separate program from IVIG •Definitely moving forward on that separate program •Separate program supports big pharma partnering Investment Readiness Verdict: 7 •MVP is our big hurdle •Financing with pending Phase I SBIR and profit from two big pharma deals •Looking for $15-20MM Series A in 2015
  20. Post-Script: Hyperimmune Directed IVIG Copyright © 2014 GigaGen, Inc. Primary immune deficiency patient Immunologist Infectious disease doctor Purity Differentiating preclinical and clinical work “Hyperimmune” targeting specific pathogens IDF CBER Small scale GMP (EU) Large scale GMP (EU) Protein library protocol development Protein library protocols Distributer Specialty pharma
  21. Business Model Canvas: Week 1 Copyright © 2014 GigaGen, Inc.
  22. Business Model Canvas: Week 3 Copyright © 2014 GigaGen, Inc.
  23. Business Model Canvas: Week 5 Copyright © 2014 GigaGen, Inc.
  24. Business Model Canvas: Week 6 Copyright © 2014 GigaGen, Inc.

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