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October 2013

October 2013. OUTLINE. Introduction about the Instituto Butantan Infrastructure at Instituto Butantan Translational medicine at Instituto Butantan. ABOUT US. The Instituto Butantan is a biomedical research and biological product manufacturing center founded in 1901.

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October 2013

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  1. October 2013

  2. OUTLINE • Introduction about the Instituto Butantan • Infrastructure at Instituto Butantan • Translational medicine at Instituto Butantan

  3. ABOUT US The Instituto Butantan is a biomedical research and biological product manufacturing center founded in 1901. Mission: “To develop research and products that contribute with health access, and to share knowledge with the society”

  4. IMMUNOBIOLOGICAL PROGRAM OF BRASIL • Self-sufficiency as a public policy in Brazil since 1984 • It is incumbent upon the Unified Health System (… ) to participate in the production of drugs, equipment, immunobiological products, blood products and other inputs. (Federal Constitution of Brazil, Art.200) • National Immunization Program is the major customer of products from public manufacturers licensed by the national regulatory agency (ANVISA) • Public manufacturers • Sera and immunoglobulins • Vaccines • Blood derivatives (projected) • Biological drugs (ongoing) • Synthetic drugs

  5. OUR PRODUCTS – Sera and immunoglobulins 400.000 vials per year

  6. OUR PRODUCTS – vaccines 150 millions of doses per year

  7. PIPELINE PRODUCTS In partnership with other manufacturers and institutions > 50 PATENTS

  8. OUTLINE • Introduction about the Instituto Butantan • Infrastructure at Instituto Butantan • Translational medicine at Instituto Butantan

  9. Scientific research and development • 21 research laboratories • 1 Biotechnology center • 1 Hospital specialized in Envenomation treatment • 1 Housing and care facility for research animals • +150 Researchers (PhD level) • 500 Postgraduate students • 2 Postgraduate MSc/PhD programs (Toxinology and Biotechnology) 8

  10. Manufacturing • 7 Main manufacturing plants • Serum. Quality control . Formulation , filling and packaging. • Anaerobic vaccines and anatoxin purification (tetanus and botulism) • Aerobic vaccines (diphtheria and pertussis) • Hepatitis B • Influenza • Rabies • Blood derivatives (in process) • 6 Pilot plants 1 Farm with 600 equines + 2 third part farms

  11. Clinical Trials and Pharmacovigilance • Clinical trials • Design and analysis of clinical studies • Electronic Data Capture (21CFR11) & Risk-based monitoring system • Partnership with University Hospitals research centers • Pharmacovigilance • Collaboration with the National Immunization Program • Safety Data Exchange Agreements with partner manufacturers. • SAC – Consumer Service 10

  12. Diffusion and Culture • 4 Museums • 300.000 visitors per yeas • Didactic materials • Courses and trainings 11

  13. OUTLINE • Introduction about the Instituto Butantan • Infrastructure at Instituto Butantan • Translational medicine at Instituto Butantan

  14. R&D of new products • Demand pull Product life cycle Technology Transformation Idea Tech. R&D Candidate Product R&D Product • Supply push

  15. R&D infrastructure at InstitutoButantan • Partners Technology Transformation Product life cycle GMP industrial plants Pre-clinical GLP labs Pilot plants (cGMP) Pharmacovigilance Basic research labs Academic interface Clinical trial sponsor Clinical trial sponsor • Partners

  16. Sanofi-Pasteur/Butantan influenza vaccine tech transfer • Demand pull • MoH • Sanofi-Pasteur Technology Transformation Product life cycle GMP industrial plants Pilot plants (cGMP) Pharmacovigilance Clinical trial sponsor

  17. NIH/Butantan Dengue vaccine R&D process • Demand pull • MoH/DVI Technology Transformation Product life cycle GMP industrial plants Pilot plants (cGMP) Pharmacovigilance Clinical trial sponsor Clinical trial sponsor • NIH/NIAID

  18. Butantan pulmonary sufactant R&D process • Demand pull • MoH Technology Transformation Product life cycle GMP industrial plants Pre-clinical GLP labs Pilot plants (cGMP) Pharmacovigilance Basic research labs Academic interface Clinical trial sponsor Clinical trial sponsor

  19. Butantan/Cristália Silica adjuvant R&D process Technology Transformation Product life cycle GMP industrial plants Pre-clinical GLP labs Pilot plants (cGMP) Pharmacovigilance Basic research labs Academic interface Clinical trial sponsor Clinical trial sponsor • Supply push • Cristália

  20. Butantan MPLA adjuvant R&D process Technology Transformation Product life cycle GMP industrial plants Pre-clinical GLP labs Pilot plants (cGMP) Pharmacovigilance Basic research labs Academic interface Clinical trial sponsor Clinical trial sponsor • Supply push

  21. SUMMARY • The Unified Health System of Brazil is creating a vertical integration aiming self-sufficiency in vaccines and immunobiologicals • Public manufacturers, such as Butantan, have infrastructure to develop and partner from tech transfer to technological/product R&D • Capacity is not restricted to supply but also pointed toward development of new products for the Unified Health System

  22. Av. Vital Brasil, 1500 - ButantãSão Paulo – SPZip Code - 05503-900(+ 55 11) 2627-9300www.butantan.gov.br

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