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Principles and Pratice in Drug Development
 
February 2 - 13
Optional Course

João Nuno Moreira, Conceição Pedroso de Lima, Sérgio Simões, Luís Almeida
MIT-PT and BEB Ph. D. PROGRAMME 2008/2009
PRINCIPLES AND PRACTICE IN DRUG DEVELOPMENT
CNC, University of Coimbra - February 2-13, 2009
Âmbito
O curso avançado intitulado Principles and Practices in Drug Development pretende proporcionar aos alunos formação abrangente em diferentes áreas do desenvolvimento farmacêutico de medicamentos. Serão abordados temas que vão desde o design e síntese de fármacos, a toxicologia molecular em ensaios pré-clínicos, vectorização de fármacos e genes (incluindo vectores virais e não virais), medicamentos biológicos (proteínas recombinantes e anticorpos monoclonais), até a aspectos relacionados com o desenvolvimento clínico de medicamentos e com assuntos regulamentares. São intervenientes neste curso Professores do MIT, Professores da Universidade de Coimbra, especialistas em diferentes áreas do desenvolvimento de medicamentos e também empresários/bio-empreendedores.
 
·         February 2
9 h – Introduction to the course
Conceição Pedroso de Lima, Ph. D.
Sérgio Simões, Ph. D.
João Nuno Moreira, Ph. D.
Luís Almeida, Ph. D.

10 h - The Pharmaceutical Industry and the Drug Development Process
Stan N. Finkelstein, M.D., Ph. D.

14.30 h – Discussion Forum

16 h - Basic Science I – Discovery Innovation and Emerging Technologies; Basic Business
Anthony J. Sinskey, Ph.D.
 
·         February 3
9 h – Drugable biological targets and concept design
Patrício Soares da Silva, Ph. D. (from BIAL, Indústria Farmacêutica)

10 h – Development of new chemical entities: from bench to industrial production
David A. Learmonth, Ph. D. (from BIAL, Indústria Farmacêutica)

11 h - Pharmacology and toxicology of new chemical entities
Lyndon C. Wright, Ph. D. (from BIAL, Indústria Farmacêutica)

14 h – Clinical development of CNS active drugs
Luis Almeida, Ph. D. (from BIAL, Indústria Farmacêutica)

16 h - Basic Science II – Molecular Toxicology in Preclinical Studies
Anthony J. Sinskey, Ph.D.
 
·         February 4
9 h – Biological Medicines
Duarte, A, Ph. D. (CEO from GenIBET, Portugal)

16 h – Management of scientific and clinical decision
Robert Gould, Ph. D.
 
·         February 5
9 h - FDA Process, Off-Label Prescribing, Insurance Coverage
Stan N. Finkelstein, M.D., Ph. D.

16 h – Clinical trials
Robert Gould, Ph. D.
 
·         February 6
9 h – Regulatory Affairs – the perspective from EMEA
Rogério Gaspar, Ph. D.

14 h – Visit to Bluepharma, Pharmaceutical Industry SA
 
·         February 9
9 h – Alfama – the entrepreneurial side of drug development
Nuno Arantes-Oliveira, Ph. D. (President and CEO from Alfama, Portugal)

14.30 h – Discussion Forum

16 h -Biotech Cluster Study and Related Issues
Thomas J. Allen, Ph.D.
 
·         February 10
9 h – Drug and gene targeting
Conceição Pedroso de Lima, Ph. D.
Sérgio Simões, Ph. D.
João Nuno Moreira, Ph. D.
Luís Almeida, Ph. D.

10 h - Drug and gene targeting (cont.)

11.30 h - Discussion Forum

14.30 h – Visit to Biocant Park – Innovation Center in Biotechnology
 
·         February 11
9 h – Technology transfer – the perspective from MIT
Lauren Foster

16 h -Establishing the Value of Pharmaceuticals and Drug Firms
 
·         February 12
9 h – Manufacturing I
Charles L. Cooney, Ph. D.

16 h – Manufacturing II
Charles L. Cooney, Ph. D.
 
·         February 13
Students’ presentations
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