The Role of University in Clinical Research Training. Jorge Kalil MD, PhD Professor of Medicine University of São Paulo, Brazil

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1 The Role of University in Clinical Research Training Jorge Kalil MD, PhD Professor of Medicine University of São Paulo, Brazil

2 An Old Paradigm KNOWLEDGE The only engagement of the University

3 How to achieve this goal? TEACHING and RESEARCH

4 A New Paradigm Emergence of KNOWLEDGE- BASED Society

5 How to be competitive? INNOVATION

6 New mission KNOWLEDGE INNOVATION Entrepreneurial University

7 Technological routes T cell recognition Basic Research Proteomics Genetic polymorphisms Epidemiology Antibody humanization cdna array DNA vaccine Cellular therapy Therapeutic agents Clinical trial GMP, GLP, GCP Pacient Care Cytokine detection DNA sequencing Recombinant protein production Mass production Animal models

8 New Curriculum for Medical Education in Sao Paulo University (FMUSP) 30% Complementary Segment Nuclear Segment % Revista Brasileira de Cardiologia ; 2( 2):70-77

9 Scientific Initiation More formation than information; research project development; rigorous observation and critical spirit.

10 Laboratories of Medical Investigation (LIM) Published Papers Oo Artigos Originais Publicados em Revistas Indexadas nas Bases do ISI Artigos Originais Publicados em Revistas Não Indexadas nas Bases do ISI Reference: LIMs Annual Reports ISI: Institute for Scientific Information

11 Laboratory of Medical Investigation (LIM) Published Papers cont. Year LIM (1) Brazil (2) Latin America (2) LIM/Brazil (%) LIM/Latin America (%) ,60 0, ,38 0, ,36 0, ,66 1, ,40 0, ,80 1, ,79 1, ,85 1, ,54 1, ,00 1,31 ISI: Institute for Scientific Information

12 Scientific Production and Patent world participation (%) 8% 6% % articles % patents 4% 2% a 0% Brazil USA England Germany France Italy Israel Korea Japan

13 Why Clinical Research at University? Improves Good Clinical Practices; Understands innovation in health; Fosters observation; Engages research and development; Provides science.

14 Clinical Research: A compromise with improvement Engagement of FMUSP in the clinical research setting Standardisation of all study-related procedures Launching of NAPesq (Support Center for Clinical Research)

15 Technological routes T cell recognition Basic Research Proteomics Genetic polymorphisms Epidemiology Antibody humanization cdna array DNA vaccine Cellular therapy Therapeutic agents Clinical trial GMP, GLP, GCP Pacient Care Cytokine detection DNA sequencing Recombinant protein production Mass production Animal models

16 What we can do? TECHNOLOGICAL POLE Administration Pre-clinic GMP laboratory plant Clinical Research REGULATORY QUESTIONS Anvisa Conep INPI Federal Legislation

17 Proposition Technological Pole at FMUSP Cooperation between: FMUSP, Pharmaceutic industry, São Paulo Government Private administration, Basic and Clinical Research in University, Preclinic and GMP Laboratory Plant: Industry Regulatory questions: Technological pole office and State Government.

18 Technical Cooperation for Scientific and Technological Development Science Techology and Development Government Department of São Paulo, FMUSP Brazilian Federation of Pharmaceutical Industries (FEBRAFARMA).

19 Related Interest: Government - University - Industry Innovation for development; Technological development changing scientific knowledge for society benefit; Economic and social improvement through scientific and technological development: knowledge-based society.

20 Thanks!!! Jorge Kalil MD, PhD Medical School University of Sao Paulo