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FROM THE RESEARCH TEAM TO THE HIGH-TECH ENTERPRISE IN MOLECULAR IMMUNOLOGY:

FROM THE RESEARCH TEAM TO THE HIGH-TECH ENTERPRISE IN MOLECULAR IMMUNOLOGY: WHAT HAVE WE LEARNED IN 20 YEARS?. THE CENTER OF MOLECULAR IMMUNOLOGY THE TIME-LINE OF CIM WHAT HAVE WE LEARNED ALONG THE JOURNEY THE EVOLVING CONTEXT. Dr. Agustin Lage Centre of Molecular Immunology

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FROM THE RESEARCH TEAM TO THE HIGH-TECH ENTERPRISE IN MOLECULAR IMMUNOLOGY:

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  1. FROM THE RESEARCH TEAM TO THE HIGH-TECH ENTERPRISE IN MOLECULAR IMMUNOLOGY: WHAT HAVE WE LEARNED IN 20 YEARS? • THE CENTER OF MOLECULAR IMMUNOLOGY • THE TIME-LINE OF CIM • WHAT HAVE WE LEARNED ALONG THE JOURNEY • THE EVOLVING CONTEXT Dr. Agustin Lage Centre of Molecular Immunology lage@cim.sld.cu

  2. THE CENTER OF MOLECULAR IMMUNOLOGY

  3. CIM: FIELDS OF ACTIVITY • MONOCLONAL ANTIBODIES • CANCER VACCINES BIOTECHNOLOGY OF MAMMALIAN CELLS

  4. A DIFFERENT KIND OF DRUG FIGURA 1. EL TAMAÑO DE LAS MOLECULAS BIOLOGICAS. La figura compara en igual escala, de izquierda a derecha, el tamaño de la molecula de Tetraciclina, el del Interferon alfa, y el de un anticuerpo monoclonal.

  5. BIOCUBAFARMA: CNGM CIGB CENIC CIM I. FINLAY IPK 38 ENTERPRISES 22 000 empl/7000 scientists CIE LIORAD CENSA BioCen CENPALAB NOVATEC CIREN AICA

  6. The “Closed Loop” Organization PRODUCT-ORIENTED RESEARCH MANUFACTURING & MARKETING BASIC RESEARCH

  7. THE TIME-LINE OF THE CENTER OF MOLECULAR IMMUNOLOGY 2013: CIM- THE CURRENT HIGH TECH EXPORTING ENTERPRISE 1994: CONSTRUCTION OF THE FIRST MANUFACTURING FACILITY 1990: THE SCIENTIFIC TEAM INSIDE INSTITUTE OF ONCOLOGY

  8. CIM IN FIGURES • EXPORTS TO 30 COUNTRIES • 3 JV.COMPANIES • 45 PATENTED INVENTIONS • 750 PATENTS ABROAD • >500 PUBLISHED SCIENTIFIC PAPERS • 1100 EMPLOYEES • 4 MANUFACTURING FACILITIES • 25 PRODUCTS IN THE PIPELINE • 6 REGISTERED PRODUCTS • 110 REGISTRIES IN 44 COUNTRIES

  9. EXPORTS : 30 COUNTRIES CONTRATOS COMERCIALES: 87 EMPRESAS: 52 PAISES: 40 (+100) CONTRATOS EN NEGOCIACION: 6

  10. JOINT VENTURE COMPANIES CONTRATOS COMERCIALES: 87 EMPRESAS: 52 PAISES: 40 (+100) CONTRATOS EN NEGOCIACION: 6

  11. 1994: CONSTRUCTION OF THE FIRST MANUFACTURING FACILITY 1990: THE SCIENTIFIC TEAM INSIDE INSTITUTE OF ONCOLOGY • 1994: ALL REASONS TO FAIL: • Biotechnology not a bright success worldwide • No access to risk capital sources • Pharmaceutical highly regulated market • Intellectual Property protection imposed by GATT/WTO • Mammalian cell technology still immature at the time • Cancer treatment as a highly competitive field • Cuba loosing its economic partnership with European Socialist Countries • Reinforcement of USA hostility

  12. FOR WHAT IS BIOTECH BEING USED 352 PhRMA Report 2011 BIOTECHNOLOGY 900 Products • 352 for Cancer • 170 Monoclonal Antibodies • 97 Vaccines 188

  13. 1990 1994 2013 WHAT HAVE WE LEARNED ALONG THE JOURNEY EXPORTS COSTS

  14. 10 LESSONS: • FIRST CONDITION IS HUMAN CAPITAL AND “GOOD SCIENCE” • MOTIVATION AND SOCIAL COMMITMENT ARE THE MOST IMPORTANT “TALENTS”. • THE REAL TASK GOES BEYOND SCIENCE: IT IS THE BUILDING OF CONNECTIONS AMONG SCIENCE, MANUFACTURING AND BUSINESS. BUILDING MANUFACTURING CAPACITY IS A “MUST” • FIRST MILESTONE IS TO “CLOSE THE LOOP”: THEN TO MAKE IT GROW. Market intangibles first but move upward in the value chain as soon as possible • HUMAN CAPITAL IS ESSENTIAL, BUT NOT ENOUGH: A SPECIAL KIND OF ORGANIZATION MUST BE BUILD AND PERMANTENTLY IMPROVED. High-Tech Enterprise is a “different enterprise”

  15. 10 LESSONS: • THE REAL MARKET IS IN EXPORTS, NOT IN DOMESTIC DEMAND • DOMESTIC SUPPLY IS NOT FOR MONEY: IT IS FOR IMPACT IN HEALTH AND “PROOF OF THE CONCEPT”. POC AT POPULATION SCALE IS THE REAL “DRIVING FORCE” FOR EXPORTS. • MARKET FAILURE: SOCIAL OWNERSHIP IS AN ASSET. IT PROVIDES PROTECTION OF THE MIDDLE TERM AND SOCIAL MOTIVATION • COOPERATION MORE EFFICIENT THAN COMPETITION: “NATION PROGRAM” • EXPORTS IS A PERMANTENT “BARRIER TRESPASSING EXCERSICE”

  16. FIRST CONDITION IS HUMAN CAPITAL (índice formado por: PIB, Científicos, Publicaciones, Patentes, Universidades y Centros Científicos)

  17. THERE IS NO SUBSTITUTE FOR “GOOD SCIENCE” IL-2 mutein T-EFFECTOR T-NAIVE IL-2 T-REGULATORY

  18. MANUFACTURING CAPACITY IS A “MUST”: 1994 2000 LABEX (Santiago) -133 trab -Prod para diagnostico 2006 EPOVAC .-157 trab -Eritropoyetina -Vacunas Ter BIOTECH-BPL (Beijing) -300 trab chinos -14 cubanos -Monoclonales 2010 ANTYTER -106 trab -Monoclonales

  19. THE REAL TASK IS BUILDING CONNECTIONS BETWEEN SCIENCE AND INDUSTRY ¿?--- --- ¿?

  20. CLOSE THE LOOP FIRST AND GENERATE POSITIVE CASH FLOW, THEN MAKE IT GROW PRODUCT-ORIENTED RESEARCH MANUFACTURING & MARKETING BASIC RESEARCH

  21. MARKET INTANGIBLES FIRST IS NEEDED BUT MOVE UPWARD IN THE VALUE CHAIN AS FAST AS POSSIBLE THE FINAL PRODUCT IN THE MARKET THE PRODUCT IN DEVELOPMENT THE JOINT PROJECT THE PATENT THE SCIENTIFIC WORK

  22. HUMAN CAPITAL IS AN ABSOLUTE REQUIREMENT, BUT NOT ENOUGH: BUILDING THE ORGANIZATION: THE HIGH TECHNOLOGY ENTERPRISE • CLOSED LOOP ORGANIZATION: RESEARCH-PRODUCTION-EXPORTS • SCIENTIFIC RESEARCH IS INVESTMENT, NOT COST • DIRECT EXPORT ACTIVITY: is a source of information, not just money • BASED ON INNOVATIVE (HIGH VALUE-ADDED) PRODUCTS: fast movement of the PRODUCT PIPELINE • BASED ON INNOVATIVE (and evolving) TECHNOLOGIES • HIGHLY QUALIFIED HUMAN RESOURCES: HIGH PRODUCTIVITY LINKED TO CREATIVITY, AND CREATIVITY LINKED TO MOTIVATION. • LINKED TO FINAL IMPACT IN PUBLIC HEALTH

  23. THE REAL MARKET IN THE EXPORTS: The POSITIVE FEEDBACK LOOP BETWEEN TECHNOLOGY AND GLOBALIZATION + CONSEQUENCES: INCREASING FIXED COSTS AND LOOSE OF ATTRACTIVE POWER OF SMALL DOMESTIC MARKETS

  24. PUBLIC HEALTH IMPACT IS THE REAL DRIVER: VA-MENGOC-BC: Epidemiológy in children below 6 year in Havana. Aplicación masiva de VA-MENGOC- BC (ABRIL DE 1989)

  25. H. INFLUENZAE B. MENINGOENCEFALITIS INCIDENCE AND COVERAGE. 1994-2009

  26. HEPATITIS B. INCIDENCE AND COVERAGE-CUBA 1989-2009

  27. A SUCCESSFUL STRATEGY SHOULD: • Be “Regional” • Include a strong component of Science&Technology capacity building • Aim population-wide coverage and impact in Public Health • Gather the “3-Actors”: -The Industry -The Health System -The Regulatory Authorities

  28. EXPORTS IS A PERMANTENT “BARRIER TRAESPASSING EXCERSICE” CONSTRUCTION OF BARRIERS IS A SELF-REINFORCING PROCESS MANUFACTURING AND MARKETING PRODUCT DEVELOPMENT RESEARCH INTELECTUAL PROPERTY BARRIER REGULATORY BARRIER

  29. THE EVOLVING CONTEXT: 2014 IS NOT 1994 • Globalization: the World getting smaller • The crisis of speculative capitalism and neo-liberalism • Technology driven economy-of-scale. Import substitution approach no longer viable • Innovation crisis in Big-Pharma • Increasing concern on drug prices and affordability • Sources of “capital with patience” scarcer: Dot-com companies financial bubble exploded in 2001 • Emerging countries gaining weight: the BRICS • Mounting political will for regional integration- CELAC • Patent system in place, but under increasing political criticism • Protectionist regulatory environment getting tougher • BUT: THE NEEDS OF EFFORTS, COMMITMENT, AND POLITICAL WILL CONTINUE TO BE THE SAME

  30. “…..étudier l’esprit de ton Pays, connaitre sa pente, de façon qu’il ne laisse jamais ton travail en arrière, sinon qu’il le rencontre en avance. ” Denis Diderot 1713-1784

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