FCT PhD Programme Medicines and Pharmaceutical Innovation (i3du)

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1 FCT PhD Programme Medicines and Pharmaceutical Innovation (i3du) Course BioPharmaceuticals and Advanced Therapies 28-2 September/October Auditorium The FCT PhD Programme in Medicines and Pharmaceutical Innovation (i3du) trains students in target discovery, drug design, pre-clinical development, and drug safety, bridging the translational gap from discoveries on disease targets and mechanisms into novel diagnostic and therapeutic agents. The i3du Programme offers a training course that will be held at the Research Institute for Medicines (), Faculdade de Farmácia, Universidade de Lisboa, in Lisbon, 28-2 September/October Course outline The course on Biopharmaceuticals and Advanced Therapies covers critical aspects of biopharmaceuticals and advanced therapies from discovery methods to development of therapies, with emphasis on success cases of antibodies, gene therapy and cell therapy. The aim of this training course is to delivery not only state-of-the-art information but also to give training on the different aspects of biopharmaceuticals. As the functions of biopharmaceuticals are fully explored and utilised, they will become increasingly relevant to the drug development community. The training program welcomes the participation of external academic and scientific community members. Registration is free but mandatory. Organizing committee João Gonçalves, / FFULisboa (Coordinator) Sofia Corte-Real, TechnoPhage Mariana Santa-Marta, / FFULisboa Paula Brito, / FFULisboa 1

2 Discovery of Biopharmaceutical proteins September 28, 2015 Different classes of biopharmaceuticals João Gonçalves In vivo models for biopharmaceutical discovery António Duarte Faculdade de Medicina Veterinária, Universidade de Lisboa Sea as a source of biopharmaceutical leads Helena Vieira Faculdade de Ciências, Universidade de Lisboa Why use Zebrafish as a discovery model for biopharmaceuticals? Sara Sousa TechnoPhage Regulatory overview of biologic advanced therapies Margarida Menezes Infarmed 2

3 Biopharmaceuticals: the success case-study of antibody therapy September 29, 2015 The discover methodology of therapeutic antibodies Diana Ramos FairJourney Biologics Oporto, Portugal Alternative antibody scaffolds for therapy Soraia Oliveira TechnoPhage Chemical Biology and Antibody Drug Conjugates Pedro Góis Therapeutic Antibodies for autoimmunity/inflammation João Eurico Instituto de Medicina Molecular Faculdade de Medicina, Universidade de Lisboa Therapeutic Antibodies for cancer João Gonçalves 3

4 Methodology for Development of Biopharmaceutical medicines September 30, 2015 Production methodologies for biopharmaceuticals and regulatory environment Maria Henriques Ribeiro Formulation of biopharmaceuticals Helena Florindo Pre-clinical trials for biopharmaceuticals Sofia Corte-Real TechnoPhage How to setup and analyze data from clinical trials? António Mata Faculdade de Medicina Dentária, Universidade de Lisboa How biopharmaceutical quality influences safety and efficacy of biopharmaceuticals John Milne National Institute for Biologic Research and Training Ireland 4

5 Advanced Biologic Therapies October 1, 2015 Pharmacokinetics of therapeutic proteins Nuno Elvas Immunogenicity of therapeutic proteins Joana Costa Instituto de Biologia Molecular e Celular Faculdade de Medicina da Universidade do Porto Oporto, Portugal Gene therapy with viral and non-viral vectors Gabriela Silva Centro de Estudos de Doenças Crónicas Faculdade de Ciências Médicas da Universidade Nova de Lisboa Can Phages be biopharmaceuticals? Madalena Pimentel From Bench to patient with cell therapy Afonso Almeida Instituto de Medicina Molecular, Universidade de Lisboa 5

6 The industry view of Biopharmaceuticals October 2, 2015 Worldwide Development of Biosimilars António Silva Sandoz Biopharmaceuticals Austria Differentiation of Human Mesenchymal stromal/stem cells and applications in therapy Pedro Cruz ECBio Portugal How to bring value in the competitive market of biopharmaceutical production Teresa Alves GenIbet Portugal Market access of biopharmaceuticals: The end of the line? Carla Paixão Roche Farmacêutica Portugal Discovery and Development at Centers for Therapeutic Innovation (CTI) Isaac Rondon Pfizer Inc. USA 6

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