EuroMEEting - Genetic Alliance UK

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26 THEME 6 This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Theme 6 | Engaging the Research World! Non-Clinical Research and Development Per Spindler, Director, Biopeople, University of Copenhagen, Denmark Nancy Claude, Director of Drug Safety, IRIS, France Pre-clinical research and development is central to product innovation in the healthcare business. The stakeholders involved are academics, contract research, regulators and industry. They need in many cases to work together to leverage on synergies enabling smarter and faster early product development. Product innovation in our sector is massively embedded in regulatory and streamlined processes; however to do the early steps smarter and faster the research world must be engaged. A pallet of contemporary topics have been selected that will guide and inspire you in the pre-clinical research and development of novel healthcare products. Tuesday, 29 March 2011 09:00-10:30 Session 0601 INTERNATIONAL STRATEGY FOR NON-CLINICAL CONSULTANTS Session Chair: Elisabeth C. Goodman, Principal Consultant, RiverRhee Consulting, UK This session presents three case studies which address respectively: The challenges of building a non-clinical drug safety business in an international context; how using an organised global network of expert level consultants can facilitate successful navigation of the regulatory requirements for entry into Phase 1; and how a CRO can engage its whole organisation in creating greater value for its customers, streamlining its processes and building a stronger people and culture infrastructure. International Strategy: Experience of a Non-clinical CRO Roy Forster, Scientific Director, CIT, France Using an Organised Global Network of Experts to Address Regulatory Requirements for Entry into Phase 1 Maurice G. Cary, CEO and founder, Pathology Experts LLP, Switzerland Building Quality in a Time of Change Mark S. Duxon, Chief Executive Officer, Porsolt and Partners Pharmacology, France 11:00-12:30 Session 0602 NON-CLINICAL EVALUATION OF DRUG-INDUCED HEPATOTOXICITY Session Chair: Beatriz Silva Lima, Chair SWP; Professor, Pharmacology, iMED-UL, Lisbon University and INFARMED, Portugal Hepatotoxicity constitutes one of the major causes for late attrition during the development process of pharmaceuticals. In addition, many drugs have been withdrawn from market due to liver toxicity. The need for earlier and better prediction is needed. Recently, the EMA/CHMP/SWP issued a discussion paper where the approaches and strategies for prediction of hepatotoxicity in animal studies are discussed. The session will address current discussions and progress in the area. The views of industry and regulatory scientists will be explained Impact of Hepatotoxicity on the Attrition of Drug Development - Lessons learned in the Post-marketing Setting Marku Pasanen, Professor, University of Eastern Finland, Finland Reinforcing the Predictive Role of the Non-Clinical Testing: The CHMP/SWP discussion paper on hepatotoxicity Klaus Olejniczak, Scientific Director, Department of Drug Toxicology, BfArM, Germany The Joint Efforts of Industry and Academia to Reinforce Hepatotoxicy Prediction Including the Value of Regulatory Measures Speaker to be confirmed 14:00-15:30 Session 0603/1303 SAFETY ASPECTS IN THE DEVELOPMENT OF VACCINES (JOINT WITH THEME 13) Session Chair: Jan Willem van der Laan, Senior Assessor Section on Safety of Medicines and Teratology Centre, National Institute for Public Health and the Environment (RIVM), The Netherlands There is an increasing awareness that vaccines have their own characteristics in safety aspects. The recent introduction of adjuvants in marketed products has underlined this. The risk of an increase in autoimmune phenomena and the safe use of vaccines during pregnancy are hot topics. The WHO will present its perspective on the use of adjuvants. WHO Perspective on Adjuvants in Vaccines Martin Howell Friede, Technical Officer, Initiative for Vaccine Research, WHO, Switzerland Adjuvants and the Potential Risk of Autoimmunity Sarah Gould, Non Clinical Safety Division, Sanofi Pasteur, France Vaccines and Pregnancy Jan Willem van der Laan, Senior Assessor Section on Safety of Medicines and Teratology Centre, National Institute for Public Health and the Environment (RIVM), The Netherlands 16:00-17:30 Session 0604 BIOBANKING: LOGISTICS AND SAMPLES HANDLING Session Chair: Hermann Schulz, Chief Executive Officer, INTERLAB Central Lab Services GmbH, Germany Handling frozen specimens is of increasing importance in clinical research. This session willo present strategies and solutions in order to ensure both that frozen specimens are correctly collected, shipped and stored and that these samples arrive in stable condition at the laboratory where reliable lab results are expected. A Biopharmaceutical Company Perspective: Strategies for improving the management of global samples Julie Corfield, Biobank Head, AstraZeneca R&D, UK A Biorepository Perspective: How the development of global standards for sample management could improve clinical trial outcomes Lori Ball, Chief Operating Officer, BioStorage Technologies, USA A Central Laboratory Perspective: How to successfully handle pre-analytical factors such as logistics and frozen storage to achieve reliable laboratory results Hermann Schulz, Chief Executive Officer, INTERLAB Central Lab Services GmbH, Germany
THEME 6 | THEME 7 27 This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Wednesday, 30 March 2011 09:00-10:30 Session 0605 NON-CLINICAL ASPECTS OF FIRST-IN-HUMANS Session Chair: David Jones, Expert Pharmacotoxicologist, MHRA, UK The session will cover non-clinical support for first-in-human trials, including first-in-paediatrics clinical trials. Non-Clinical Aspects of First-In-Humans – Has ICH M3R2 made any difference? David Jones, Expert Pharmacotoxicologist, MHRA, UK First-In-Paediatrics Trials – Are studies in juvenile animals ever needed? Paul Baldrick, Head of Regulatory Affairs, Covance, UK First-In-Human Trials with Biological Compounds Maggie Dempster, Safety Assessment, GlaxoSmithKline, UK 11:00-12:30 Session 0606 BIOMARKERS IN NON-CLINICAL SAFETY ASSESSMENT Session Chair: Gerd Bode, Consultant, Germany The session will provide a comprehensive introduction and global status on the topic and preferably provide one or more examples of biomarkers developed for use in non-clinical safety assessment. Session under development 14:00-15:30 Session 0607 THE NON-CLINICAL DEVELOPMENT OF ANTI-CANCER PHARMACEUTICALS Session Chair: Klaus Olejniczak, Scientific Director, Department of Drug Toxicology, BfArM, Germany The new ICH S9 guideline on 'Non-Clinical Development of Anti-cancer Pharmaceuticals' will be presented and information will be given to assist in the design of an appropriate program of pre-clinical and clinical studies for the development of anticancer drugs. ICH S9: Non-clinical Development of Anti-cancer Pharmaceuticals Klaus Olejniczak, Scientific Director, Department of Drug Toxicology, BfArM, Germany Industry Experience with Non-clinical Development of Anti-cancer Drugs Hermann Schweinfurth, Head of Non-Clinical Drug Safety, Bayer Schering Pharma AG, Germany 16:00-17:30 Session 0608 CONTEMPORARY ISSUES IN NON-CLINICAL DEVELOPMENT OF BIOTECHNOLOGY-DERIVED PRODUCTS Session Chair: Jennifer Sims, Head of Preclinical Development, Novartis Pharma AG, Switzerland This session will review any updates to the ICH S6 guideline and provide one or more cases to illustrate and guide on the principles of safety assessment of biotech products. Session under development Theme 7 | Statistics across the Drug Lifecycle Jürgen Kübler, Global Head, Statistical Safety Sciences, Novartis Pharma AG, Switzerland Robert Hemmings, Statistics Unit Manager, MHRA, UK The current R&D process is facing significant challenges: There is a need to develop efficacious and acceptably safe drugs more efficiently, and to improve in the early identification of drugs that will ultimately fail to prove a favourable benefit/risk profile. Sound statistical methods can play a major role in systematically generating knowledge in terms of both design and conduct of an individual study, and design and decision making across the entire lifecycle of a medicinal product. This theme will explore statistical approaches to improve the efficiency with which medicines are developed and monitored. This includes a thorough discussion of how to optimise implementation of established and new methodology and their applicability in a highly regulated environment. The theme aims to provide a forum for discussion between industry, academic and regulatory thought leaders. Relevant experience will be shared and discussed, reflecting on lessons learned. Recommendations for best practice will be developed. Tuesday, 29 March 2011 09:00-10:30 Session 0101/0701 TRIAL DESIGN AND INTERPRETATION FOR PERSONALISED HEALTHCARE – DELIVERING C21 DRUG DEVELOPMENT (JOINT WITH THEME 1) Session Chair: Aiden Flynn, Director, Biomarkers and Analytics, GlaxoSmithKline, UK The emergence of new complex diagnostic technologies challenges traditional ways of interpreting the output from clinical trials. Successful Personalised Medicine relies on our being able to understand exactly what biomarker data is telling us and apply this to clinical development decisions. Statistic Approaches to Data analysis for PHC- What does the data tell us? FDA speaker invited High Dimensional Data – What do we mean? Bryn Williams-Jones, Associate Research Fellow, Head of e-Biology, Pfizer Global Research & Development, UK Bio Informatic Tools for Complex Data Tom Freeman, Group Leader, The Roslin Institute, R(D)SVS, Division of Genetics and Genomics , University of Edinburgh, UK
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