Organizing committee at imed.ulisboa/ffulisboa Joao Goncalves (Coordinator) and Paula Brito.

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1 PhD Programme in Medicines and Pharmaceutical Innovation Course BioPharmaceuticals and Advanced Therapies Lisbon, 18, 19, 20 and 25, 26 September 2017 Faculty of Pharmacy Amphitheatre B Universidade de Lisboa, Portugal Organizing committee at imed.ulisboa/ffulisboa Joao Goncalves (Coordinator) and Paula Brito. The FCT PhD Programme in Medicines and Pharmaceutical Innovation (i3du; trains students in target discovery, drug design, preclinical development, and drug safety, bridging the translational gap from discoveries on disease targets and mechanisms into novel diagnostic and therapeutic agents. Programme The Course on BioPharmaceuticals and Advanced Therapies is part of the PhD Programme in Medicines and Pharmaceutical Innovation (i3du), provides an overview of both classical and biotechnology derived medicinal products and on the pathways used for scientific advice, clinical trials and marketing authorizations in Europe. The course will also cover in detail the particular requirements for the CMC section, comparability packages and important safety procedures. The particular aspects of the non-clinical and clinical development of biopharmaceuticals will be presented. Case studies discussing how to develop proteins or cell therapies, such as monoclonal antibodies will illustrate the approach taken to identify benefit/risk ratio. An overview will be given on the most essential issues relating to Advanced Therapy Medicinal Products (ATMPs). A detailed presentation of the specific considerations for the development of biosimilar medicinal products, will be given during the course. The training program welcomes the participation of external academic and scientific community members. The course will be held at the Research Institute for Medicines (imed.ulisboa), Faculdade de Farmácia, Universidade de Lisboa, in Lisbon, 18-20, 25 and 26 September The training program is aimed at PhD students, but welcomes the participation of external academic and scientific community members. Registration ( is free but mandatory. 1

2 September 18, Drug Discovery and Development 9:30h The different classes of biopharmaceuticals 10.30h Discovery of Antibodies by Phage Display Soraia Oliveira - 11:30h Microfluidics as a discovery and diagnostic tool for biopharmaceuticals Joao Pedro Conde INESC-MN and Department of Bioengineering. Instituto Superior Técnico 14:00h Biopharmaceutical discovery in cancer Antonio Duarte- Faculdade Medicina Veterinária da Universidade de Lisboa 15:00h Steps in the discovery of a vaccine: the case of HIV Nuno Taveira Instituto Superior de Ciências da Saúde Egas Moniz Research Institute for Medicines (imed.ulisboa), September 19, Discovery and Therapeutic Applications of Biopharmaceuticals 9:30h Stem cell systems and 3D technologies: Possible application in biopharmaceuticals toxicology Joana Miranda, Research Institute for Medicines (imed.ulisboa), 10.30h In vivo models for biopharmaceutical discovery Sandra Aguiar- Faculdade Medicina Veterinária da Universidade de Lisboa 11:30h Antibody Drug Conjugates Pedro Gois, Research Institute for Medicines (imed.ulisboa), Faculty of Pharmacy, Universidade de Lisboa 14:00h The concept and advancements of Immunotherapy 2

3 15:00h Biopharmaceutical therapy in autoimmune diseases Jose Alves - NOVA Medical School / CEDOC, Lisbon. Director of Internal Medicine Dept. Fernando Fonseca Hospital September 20, Production and development aspects of biopharmaceuticals 9:30h Production methodologies for biopharmaceuticals and regulatory environment Maria Henriques Ribeiro, Research Institute for Medicines (imed.ulisboa), 10.30h Formulation of biopharmaceuticals Joao Nuno Moreira CNC and Faculdade Farmácia da Universidade de Coimbra 11:30h New technologies for biopharmaceutical purification Cecilia Roque - UCIBIO, REQUIMTE, Departamento de Química Faculdade de Ciências e Tecnologia Universidade Nova de Lisboa 14:00h Pre-clinical Development of Biopharmaceuticals Sofia Corte-Real TechnoPhage and Faculty of Pharmacy, Universidade de Lisboa 15:00h Methodologies for Drug Clinical Development Jose Mata Faculdade de Medicina Dentária da Univ de Lisboa September 25, Development Issues of Advanced Therapies 09:30h Pharmacokinetics of Biopharmaceuticals Nuno Elvas - Research Institute for Medicines (imed.ulisboa), Faculty of Pharmacy, Universidade de Lisboa 10:30h Immunogenicity of Biopharmaceuticals. 11:30h Gene therapy and applications in neurologic diseases Luís Almeida, Center for Neurosciences and Cell Biology (CNC) and Faculty of Pharmacy, Universidade de Coimbra 3

4 14:00h Developments of phage therapy, Research Institute for Medicines (imed.ulisboa), 15:10h Regulatory overview of advanced therapies Margarida Menezes Ferreira Infarmed and European Medicines Agency. 16:00h Discussion September 26, Regulatory and Industrial view of Biopharmaceuticals 10:00h First in man testing of biopharmaceuticals Beatriz Lima - Research Institute for Medicines (imed.ulisboa), 11:00h Clinical Development and Medical Affairs in the biopharmaceutical industry Eduardo Ribeiro Medical Director at Abbvie Portugal. 12:00h Cell therapy: The experience from the biopharmaceutical company. Pedro Cruz - ECBio 14:00h The case of biopharmaceutical pipeline for solid tumors Ricardo Pacheco Novartis 15:00h The entrance of biosimilars in the biopharmaceutical industry Cátia Cantante - Biogen 16:00h Discussion Assessment (i3du 1 st Year PhD students ONLY) Assessment of the course consists in the preparation and submission of a research project, characters long (including spaces). Students are grouped to build multidisciplinary teams. Each group works throughout the week on a research project that should reflect the topic of the course, including methodologies and strategies to solve an innovative research question. The project is expected to adhere to the following general structure: a) Title; b) Conceptual hurdle and innovative idea to be tested; c) Plan and methods: d) Relevance of the project (scientific and social impact). 4

5 The students will select a broad topic of research and are expected to propose a specific project. This project will be evaluated according to the following criteria and weight: a) Novelty and relevance (30%); b) approach to the problem (30%); c) multidisciplinarity of the research plan (40%). 5