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MIT- Drug Development
 
January 17 - 28
Responsible: João Nuno Moreira (Optional Course for BEB students, open to Other Programs)
MIT-PT PROGRAMME 2010/2011

PRINCIPLES AND PRACTICE IN DRUG DEVELOPMENT  ELECTIVE COURSE

Center for Neuroscience and Cell Biology (CNC) - University of Coimbra

January 17-28, 2011

João Nuno Moreira, Luís Pereira de Almeida, Sérgio Simões, Stan Finkelstein

January 17

09.00 h - Introduction to the course

João Nuno Moreira - PhD (CNC and Faculty of Pharmacy, University of Coimbra)

Luís Pereira de Almeida - PhD (CNC and Faculty of Pharmacy, University of Coimbra)

Sérgio Simões - PhD (CNC and Faculty of Pharmacy, University of Coimbra)

Stan N. Finkelstein - MD, PhD (Senior Research Assistant in the MIT Engineering Systems Division and Associate Professor of Medicine at Harvard Medical School)

 

 

10.00 h - The Pharmaceutical Industry and the Drug Development Process

Stan N. Finkelstein - MD, PhD

 

 

16.00 h - Basic Science I – Discovery Innovation and Emerging Technologies; Basic Business

Anthony J. Sinskey - PhD (Professor of Biology at MIT)

 

 

January 18

10.00 h - Regulatory Affairs – the perspective from EMA

Rogério Gaspar - PhD (iMed.UL and Faculty of Pharmacy, University of Lisbon)

 

16.00 h - Technology transfer – the perspective from MIT

Lauren Foster - PhD (MIT)

 

 

January 19

10.00 h - Modeling chemistry and biology in drug discovery

Nuno Palma - PhD (BIAL, Indústria Farmacêutica, Portugal)

 

11.00 h - Clinical development of CNS active drugs

Roberto Pinto - MD (BIAL, Indústria Farmacêutica, Portugal)

 

14.00 h - Development of new chemical entities: from bench to industrial production

David A. Learmonth -  PhD (BIAL, Indústria Farmacêutica, Portugal)

 

 

16.00 h - Pharmacology and toxicology of new chemical entities

Lyndon C. Wright - PhD (BIAL, Indústria Farmacêutica, Portugal)

 

 

January 20

9.00 h - FDA Process, Off-Label Prescribing, Insurance Coverage

Stan N. Finkelstein - MD, PhD (Senior Research Assistant in the MIT Engineering Systems Division and the Harvard-MIT Division of Health Sciences and Technology)

 

16.00 h - Drug development and the supply chain for drugs in developing countries

Prashant Yadav - PhD (Professor at the Zaragoza Logistics Center in Spain)

 

January 21

10.00 h - Some issues in drug development: discussion of case studies

Miguel Prazeres - PhD (Instituto Superior Técnico, Technical University of Lisbon)

 

14.30 h - Alfama – the entrepreneurial side of drug development

Nuno Arantes-Oliveira - PhD (President and CEO of Alfama)

 

January 24

9.30 h - Bluepharma Pharmaceutical Industry SA: from development of generics to innovative research - site visit

 

16 h - Biotech Cluster Study and Related Issues

Thomas J. Allen -  PhD (Howard Johnson Professor Emeritus of Management at MIT)

 

January 25

11.00 h – The Pharmaceutical Industry in the 21st century

Guy Villax - CEO from Hovione

 

16.00 h - Manufacturing I

G. K. Raju - PhD (Research Associate at MIT)

 

January 26

10 h- Manufacturing II

G. K. Raju - PhD (Research Associate at MIT)

 

16.00 h - Building Merrimack Therapeutics

Robert Mulroy - CEO of Merrimarck Therapeutics

 

January 27

09.00 h - Nanotechnology for drug and gene targeting and the impact on drug development

João Nuno Moreira - PhD

Luís Pereira de Almeida - PhD

Sérgio Simões - PhD

 

 

14.30 h - Visit to Biocant Park – Innovation Center in Biotechnology

 

 

January 28
Student’s presentations

Example of Final Presentation

Introduction to the course

Rogue APIs

CO Rev Ryter Otterbein 2004

Drews-Magic bullets

Motterlini review ExpOp 2005

Soares EAE JCI 2007

Alves2010HMG2380

BBA10

JNN08

Liposomal and Viral Vectors for Gene Therapy of the Central Nervous

Edwards-Value-Creation

Finkelstein-Pharma-Industry-Today

Kishimoto-Contaminated

Laurencin-The-FDA

Leiden-Canaries

Livingston-Toward-Mechanism

Posner-First-Admin-Guide-2000

Radley-Off-Label

Rang-Chapter-1-Development

Rang-Chapter-2-Nature-Disease

Rang-Chapter-3-Therapeutic-Modal

Schiff-Biotechnology

Schwartz-Heparin

Walsh-Chapter1-Pharmaceuticals

Walsh-Chapter2-Drug-Develop

Zivin-Understanding

Apresentação RP- CoimbraMIT2011

ReasonableRx.PPDD.Portugal.2011

Econ.Hist.Pharma.PPDD.Portugal.2011

DrugReg.PPDD.Portugal.2011

Coimbra 25Jan2011

110127_Drug Devel_JN Moreira

Alfama Coimbra 21Jan11 public

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