FCT PhD Programme Medicines and Pharmaceutical Innovation (i3DU) Course BioPharmaceuticals and Advanced Therapies 28-2 September/October 2015 Faculdade de Farmácia, Universidade de Lisboa - Auditorium Lisbon, Portugal 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 (iMed.ULisboa), Faculdade de Farmácia, Universidade de Lisboa, in Lisbon, 28-2 September/October 2015. 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, iMed.ULisboa/ FFULisboa (Coordinator) Sofia Corte-Real, TechnoPhage Mariana Santa-Marta, iMed.ULisboa/ FFULisboa Paula Brito 1 Discovery of Biopharmaceutical proteins September 28, 2015 10h00 Different classes of biopharmaceuticals João Gonçalves iMed.ULisboa Faculdade de Farmácia, Universidade de Lisboa Lisbon, Portugal 11h00 In vivo models for biopharmaceutical discovery António Duarte Faculdade de Medicina Veterinária, Universidade de Lisboa Lisbon, Portugal Lunch Break 14h00 Sea as a source of biopharmaceutical leads Helena Vieira Faculdade de Ciências, Universidade de Lisboa Lisbon, Portugal 15h00 Why use Zebrafish as a discovery model for biopharmaceuticals? Sara Sousa TechnoPhage Lisbon, Portugal 16h30 Regulatory overview of biologic advanced therapies Margarida Menezes Infarmed Lisbon, Portugal 2 Biopharmaceuticals: the success case-study of antibody therapy September 29, 2015 10h00 The discover methodology of therapeutic antibodies Diana Ramos FairJourney Biologics Oporto, Portugal 11h00 Alternative antibody scaffolds for therapy Soraia Oliveira TechnoPhage Lisbon, Portugal Lunch Break 14h00 Chemical Biology and Antibody Drug Conjugates Pedro Góis iMed.ULisboa Faculdade de Farmácia, Universidade de Lisboa Lisbon, Portugal 15h00 Therapeutic Antibodies for autoimmunity/Inflammation João Eurico Instituto de Medicina Molecular Faculdade de Medicina, Universidade de Lisboa Lisbon, Portugal 16h30 Therapeutic Antibodies for cancer João Gonçalves iMed.ULisboa Faculdade de Farmácia, Universidade de Lisboa Lisbon, Portugal 3 Methodology for Development of Biopharmaceutical medicines September 30, 2015 10h00 Production methodologies for biopharmaceuticals and regulatory environment Maria Henriques Ribeiro iMed.ULisboa Faculdade de Farmácia, Universidade de Lisboa Lisbon, Portugal 11h00 Formulation of biopharmaceuticals Helena Florindo iMed.ULisboa Faculdade de Farmácia, Universidade de Lisboa Lisbon, Portugal Lunch Break 14h00 Pre-clinical trials for biopharmaceuticals Sofia Corte-Real TechnoPhage Lisbon, Portugal 15h00 How to setup and analyze data from clinical trials? António Mata Faculdade de Medicina Dentária, Universidade de Lisboa Lisbon, Portugal 16h30 How biopharmaceutical quality influences safety and efficacy of biopharmaceuticals John Milne National Institute for Biologic Research and Training Ireland 4 Advanced Biologic Therapies October 1, 2015 10h00 Pharmacokinetics of therapeutic proteins Nuno Elvas iMed.ULisboa Faculdade de Farmácia, Universidade de Lisboa Lisbon, Portugal 11h00 Immunogenicity of therapeutic proteins Joana Costa Instituto de Biologia Molecular e Celular Faculdade de Medicina da Universidade do Porto Oporto, Portugal Lunch Break 14h00 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 Lisbon, Portugal 15h00 Can Phages be biopharmaceuticals? Madalena Pimentel iMed.ULisboa Faculdade de Farmácia, Universidade de Lisboa Lisbon, Portugal 16h30 From Bench to patient with cell therapy Afonso Almeida Instituto de Medicina Molecular, Universidade de Lisboa Lisbon, Portugal 5 The industry view of Biopharmaceuticals October 2, 2015 10h00 Worldwide Development of Biosimilars António Silva Sandoz Biopharmaceuticals Austria 11h00 Differentiation of Human Mesenchymal stromal/stem cells and applications in therapy Pedro Cruz ECBio Portugal Lunch Break 14h00 How to bring value in the competitive market of biopharmaceutical production Teresa Alves GenIbet Portugal 15h00 Market access of biopharmaceuticals: The end of the line? Carla Paixão Roche Farmacêutica Portugal 16h30 Discovery and Development at Centers for Therapeutic Innovation (CTI) Isaac Rondon Pfizer Inc. USA 6