Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

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18 Theme 1 This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Theme 1 Innovation Theme Leaders: Jackie Hunter, Senior Vice President, Science Environment Development, GlaxoSmithKline, UK Damian O’Connell, Vice President Clinical R&D, Global Research and Development, Pfizer, Ltd. UK New medicines development is going to require innovation at all stages of the drug discovery and development process. The challenges that companies face in bringing medicines to the market, in ways that are both time and cost effective, are huge. These challenges are driving new ways of working both within companies, between companies and between academia and industry. The Innovative Medicines Initiative is a public-private partnership that will drive pre-competitive data sharing and new ways of working between industry and academia. Open innovation has produced demonstrable benefits for other industries – could it do the same for pharma? This theme will examine where the boundaries might lie for both pre-competitive data sharing and open innovation. New clinical designs and methodologies are being employed both for clinical trials and experimental medicine studies and some of these approaches will be discussed. Finally some examples of innovation in translational medicine and pre-clinical studies will be described. Monday, March 08, 2010 16:30 Session 0101 THE INNOVATIVE MEDICINES INITIATIVE Session Chair: Michel Goldman, Executive Director, IMI, EU The Innovative Medicines Initiative (IMI) is a public-private partnership aiming at boosting drug innovation across Europe. With the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Commission as stakeholders, IMI will launch collaborative R&D, and education and training projects on key issues of common interest to industry, academia and patients. In this framework, new approaches to pharmacovigilance will be an important aspect of IMI activities. This session will present the current status of IMI development with a focus on the projects related to pharmacovigilance. On the Way to a New Pharmacovigilance Model through the Innovative Medicines Initiative: Protect Elizabeth Swain, Director, Medical Advocacy, Policy and Patient Programmes, GlaxoSmithKline, UK On the Way to a New Pharmacovigilance Model through the Innovative Medicines Initiative: EU2P Debra Szafir, Head Safety Risk Management Strategy, Roche, France Lessons learned from the IMI - Inception to implementation Jonathan Knowles, President of Global Research, F. Hoffmann-La Roche AG, Switzerland Panel discussion with Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU Tuesday, March 09, 2010 09:00 Session 0102 IS AN OPEN INNOVATION PARADIGM THE WAY FORWARD FOR PHARMA? Session Chair: Susie Stephens, Director of Biomedical Informatics, Johnson & Johnson Pharmaceutical Research & Development, USA What is open innovation and why is it relevant to the pharmaceutical industry and biomedical research? An open innovation approach has provided benefit for other industries such as electronics and telecommunications. Many of these industries faced similar issues to those currently experienced by the pharmaceutical industry. What Are the Lessons for Pharma from Other Industries? Wil Schoenmakers, Partner, PA Consulting Group, UK Gaining Efficiencies through Open Innovation Susie Stephens, Director of Biomedical Informatics, Johnson and Johnson Pharmaceutical R&D, UK Getting More with Less: Leveraging communities to build enterprise research systems Claus Stie Kallesoe, Chief Specialist, Global Head of Research Informatics, H. Lundbeck A/S, Denmark Toward a Shared Data Element Dictionary: Conversion to ODM Bruce R. Basson, Data Standards Consultant, Eli Lilly and Company, France 11:00 Session 0103 THE IMPORTANCE OF PRE-COMPETITIVE DATA SHARING TO ACCELERATE DRUG DEVELOPMENT Session Chair: To be confirmed • What are the issues around data sharing? • Successful examples of pre-competitive data sharing – Clinical and pre-clinical A Pharmaceutical Consortium: An innovative approach to risk mitigation for a rare event: PML Sophie Banzet, Clinical Scientist, F. Hoffmann-La Roche AG, Switzerland Pre-Clinical Pre-Competitive Standards, Data Sharing and Integration – Pistoia: A new paradigm Bryn Williams-Jones, eBiology Group, Pfizer, UK 14:00 Session 0104 WHAT IS AN INNOVATIVE MEDICINE? Session Chair: To be confirmed • How do we measure innovation? • How will payers reimburse innovation? • What does innovation look like from the patient perspective? • Where are the incentives for developing novel anti-infectious agents? Where Is the Future Innovation for New Medicines Going to Come from? Tacye Connolly, Director, RRG Consultancy, UK Does Nanomedicine Need a Specific Regulatory Framework? Linda Lebon, Project Director, Voisin Consulting, France Is the EU Environment Sufficient Incentive to Develop New Indications for Well-Established Drugs? Merete Schmiegelow, Director, Regulatory Intelligence, Novo Nordisk A/S, Denmark 16:00 Session 0105 INNOVATION IN EARLY AND LATE PHASE CLINICAL TRIALS I Session Chair: Judith A. Quinlan, Vice President, Adaptive Clinical Trials, Cytel, Inc., USA • What impact can adaptive designs have on timelines and cost? • Can innovative trial design reduce risk? Recent Advances in Adaptive Clinical Trial Designs William Sietsema, Vice President, Regulatory Consulting and Submissions, Kendle International Inc., USA.
This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Adaptive Development: A leap forward in efficiency Michael J Rosenberg, President and CEO, Health Decisions Inc., USA Logical Considerations in the Implementation of Adaptive Trial Designs Eva R. Miller, Director, Biostatistics, ICON Clinical Research, USA Wednesday, March 10, 2010 09:00 Session 0106 INNOVATION IN EARLY AND LATE PHASE CLINICAL TRIALS II Session Chair: Michael Krams, Vice President, Adaptive Trials and Applied Program Strategies, Wyeth Research, USA • What impact can adaptive designs have on timelines and cost? • Can innovative trial design reduce risk? Adaptive Design in Confirmatory Trials: A way forward Solange Corriol Rohou, Director, Regulatory Affairs, AstraZeneca, France Flexible Trial Design: New techniques in interim analysis John Whitaker, Vice President, Biostatistics and Scientific Programming, Kendle, USA Exploiting Scientific Intent of ICH Guidelines to Accelerate Proof of Concept Richard Williams, Vice President, Regulatory and Strategic Drug Development, INC Research, USA Adaptive Trials: Too complicated for too little return? Bill Byrom, Senior Director, Product Strategy, Perceptive Informatics, UK 11:00 Session 0107 HAVE THE BENEFITS OF TRANSLATIONAL MEDICINE BEEN REALISED? Session Chair: Damian O’Connell, Vice President, Clinical R&D, Global Research and Development, Pfizer, Ltd. UK Developments in translational medicine, triggered in response to the pharmaceutical industry's ongoing attrition, have come to the centre of many companies exploratory development paradigms. These translational strategies have been highlighted by both the European Innovative Medicines' and FDA’s Critical Path Initiatives as means to catalyse new opportunities for innovation in early clinical R&D and help select mechanisms most likely to lead to breakthrough therapies. This session will look at how various companies have implemented translational medicine strategies in different therapeutic areas to make better and more informed choices around candidates to accelerate from research to proof of concept and the impact of translational medicine on their success rates in achieving positive POCs. Pre-Clinical and Clinical Development of Anticancer Pharmaceuticals Klaus Olejniczak, Scientific Director, Department of Drug Toxicology, BfArM, Germany Translational Research in the Pharmaceutical Industry: From theory to reality Damian O’Connell, Vice President Clinical R&D, Global Research and Development, Pfizer, Ltd. UK Experimental Models of Pain Boris Chizh, Platform Director, Pain & Neurophysiology, GlaxoSmithKline, UK 14:00 Session 0108 INNOVATION TO REDUCE ATTRITION Session Chair: Jackie Hunter, Senior Vice President, Science Environment Development, GlaxoSmithKline, UK Theme 1 - Theme 2 • Predictive validity in animal models • Innovations in target discovery and validation • Updates on clinically relevant animal models • Novel methods to identify clinically important new treatments pre-clinically Addressing the Impact of Protocol Complexity on Clinical Trial Performance Kenneth A. Getz, Senior Research Fellow, Center for the Study of Drug Development, Tufts University; Chairman, CISCRP, USA Regulatory View Spiros Vamvakas, Head of Scientific Advice, Technical Coordinator for ICH, European Medicines Agency, EU Theme 2 Staying in Business: How to make sure you comply with all rules and regulations, quality, compliance and external challenges Theme Leaders: Beat Widler, Global Head, Clinical Quality Assurance, F. Hoffman-La Roche AG, Switzerland Gabriele Schwarz, Head, GCP Inspection Services, BfArM, Germany In the EU, the Pharmaceutical Package and in other countries, other new rules and regulations have created new obligations. Also, advocacy groups, the public and the media – the scientific as well as the general press – are becoming more active and questioning. This makes the development of new medicines more and more demanding, not only from a clinical and scientific perspective but also from a process and regulatory aspect. Globalisation is, for instance, seen by some as progress as patients in developing countries are getting access to innovative medicines through earlier involvement in clinical trials and because of a strengthening of local economies through improved healthcare systems. Others are fearful that there is a shift in the focus of clinical development from industrialised countries to Asia and Latin America, thus depriving investigators in these “traditional” regions of access to clinical trials, and trials in developing countries are a new form of colonialism and result in the exploitation of vulnerable populations. The counter argument to this is a not uncommon topic in the debate about development: protection of patients in developing countries by well-intentioned and often self-nominated advocates from the so-called industrialised countries is nothing other than paternalism. Two sessions will look at this conflict and give background information about patients, the healthcare system and risks and benefits when conducting clinical trials in India and Latin America. In this context the expectations by the public for transparency do not come as a surprise and will be the topic of another session. Misuse of medicines and counterfeiting are other facets of globalisation and closely linked to the widespread use of the Internet. A session will review the so far rather neglected topic of misuse of therapeutic agents in doping. Doping would not be made so easy without manufacturing capacities in countries with weaker regulatory controls and e-commerce, and this leads to another session about counterfeiting. New regulations and mounting pressure are also an opportunity for smarter strategies and the use of “intel-ligence” for study management and quality oversight: progress of the Clinical Trial Transformation Initative (CTTI), innovative approaches to quality risk management that make extensive use of computerised processes and in the management of partners will be the focus of three sessions. Monday, March 08, 2010 16:30 Session 0201 TRANSPARENCY: A PANDORA’S BOX OR A PANACEA? Session Chair: Greg Koski, Associate Professor of Anesthesia, Massachusetts General Hospital Partners Healthcare System, USA 19
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