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

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24 Theme 4 This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. committees, as they make regulatory decisions in product assessment and on guideline development, etc. The inclusion of patients’ perspectives in decisions on benefit/risk assessments will be discussed, as will the balance that needs to be met between those decisions and patients’ subsequent treatment choices. How Much Influence Do and Should Patients Have on Regulatory Decisions? Alistair Kent, Director, Genetic Interest Group, UK Are Patients’ Perspectives Heard and How Can They Be Captured in Benefit/Risk Decisions? Jeremiah Mwangi, Senior Policy Officer, International Alliance of Patients’ Organisations (IAPO), UK (TBC) How Can the Right Balance be Struck between Regulators’ Decisions and Patients’ Choices? Patrick Salmon, CHMP, European Medicines Agency, Senior Medical Assessor, Irish Medicines Board, Ireland Panel with Isabelle Moulon, Head of Medical Information, European Medicines Agency, EU Tuesday, March 09, 2010 09:00 Session 0402 TRANSPARENCY AND RELATED SAFEGUARDS Session Chair: Anne N. Nielsen, Vice President and Senior Counsel, Europe and Asia Pacific, Bristol-Meyers Squibb, USA This session will include an in-depth discussion on how to ensure transparency, but at the same time consider complementary safeguards. Is there a process that could be put in place so that any concerns about how information might be used could be communicated to the relevant authorities? Under what circumstances could or should such a dialogue take place? Could or should a process that focuses on safeguards be implemented? If so, what might such a process look like? I believe that an exchange of views on this subject would provide a platform to further understand whether safeguards are needed, and if so, what they would look like and how they would operate. Aginus Kalis, Director General, Medicines Evaluation Board, The Netherlands European Medicines Agency Perspective Valentina Stamouli, Scientific Administrator, Regulatory Affairs, European Medicines Agency, EU EFPIA Perspective Christine-Lise Julou, Director, Scientific Technical and Regulatory Affairs, EFPIA, Belgium Panel with National Authority to be confirmed 11:00 Session 0403 CONDITIONAL APPROVALS: HOW TO STRIKE THE RIGHT BALANCE BETWEEN EARLY ACCESS, PATIENT SAFETY AND COMMERCIAL REALITY Session Chair: Michael Doherty, Global Head, Pharma Regulatory Affairs, F. Hoffman-La Roche AG, Switzerland The intent of this session is to discuss various challenges with the granting of conditional marketing authorisations, and the decisions associated with those challenges. When should conditional approvals be used - for all products, or only for breakthrough or life-saving products? Do conditional approvals really facilitate early access, or do they just lead to more post-approval commitments? Does a restricted label and/or extensive post-approval commitment have a negative effect on HTA decisions and, if so, would reduced access prevent enough data ever being generated to make the product “unconditional”? Clare McGrath, Senior Director HTA Policy Europe/ROWD, Pfizer Ltd., UK Robert Hemmings, Statistics Unit Manager, MHRA, UK Alison Harrison, Vice President, European Regulatory Affairs, AstraZeneca, UK Session under development. 14:00 Session 0404 CLINICAL TRIALS: THE DEMISE OF TRADITIONAL SURROGATE MARKERS? HOW TO CREATE NEW MARKERS? Session Chair: Spiros Vamvakas, Head of Scientific Advice, Technical Coordinator for ICH, European Medicines Agency, EU This session will discuss regulatory pathways for the development of biomarkers and other novel methodologies in the European environment. It will also address the novel public-private partnerships both in the EU (Innovative Medicines Initiative, IMI) and in the US (C-Path) and the collaboration between industry and regulators in the development of new tools. Progress and Experience with IMI/C-Path Solange Corriol Rohou, Director, Regulatory Affairs, AstraZeneca, France How Best to Identify and Develop New Biomarkers Maria Isaac, Scientific Administrator, European Medicines Agency, EU CSF Biomarkers for Identification of Prodromal Alzheimer's Disease Patients Charles Albright, Group Director, Neuroscience Biology, Bristol-Myers Squibb, USA 16:00 Session 0405 THE TRUE VALUE OF RISK MANAGEMENT FOR DECISION MAKING AND FOR POST-APPROVAL COMMITMENTS Session Chair: Valerie Simmons, EU QPPV Executive, Global Patient Safety, Eli Lilly and Company Ltd., UK The requirement for effective risk management systems in Europe has now been in place since 2005. Whilst all stakeholders intuitively agree that risk management principles are the right way forward for optimising benefit risk, the question remains, have all the activities and efforts invested by all stakeholders in the interim period actually provided true value for patients in mitigating risks and promoting public health? This session will examine these questions from the viewpoint of multiple stakeholders. Effectiveness of Risk Minimisation Plans - Has this actually led to tangible patient outcomes? An Industry perspective Steve Hobbiger, Vice President, Neurosciences and EU QPPV, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, UK Has the Experience of Risk Minimisation Plans led to Changes in Regulatory Expectations or Requirements to Promote Effectiveness? Stella Blackburn, Scientific Administrator, Pharmacovigilance and Risk Management, European Medicines Agency, EU What are the Costs of Fulfilling Risk Management Commitments and are They Justified? A view from the prescriber operating in the new risk management environment Debra Szafir, Head Safety Risk Management Strategy, Roche, France Wednesday, March 10, 2010 09:00 Session 0406 THE BENEFIT/RISK ASSESSMENT OF MEDICINES IN THE APPROVAL PROCESS: DEVELOPING A STRUCTURED APPROACH TO DECISION MAKING?
This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Session Chair: Stuart Walker, Founder, CMR International Institute for Regulatory Science, UK Measuring the benefits and risks of medicines is the underlying theme in the development, review and regulation of medicines, but over the last five years the environment for developing medicines has become increasingly risk adverse. Agencies and companies are each developing their own viewpoint on what are appropriate frameworks for assessing benefit/risk. There is a need to encourage an environment in which a more balanced view of risks and benefits is taken. Important progress has been made in the methodology used to assess benefit/risk in the development and review of new medicines but there is a great deal yet to be achieved. In this session, the views of agencies on a framework for benefit/risk will be presented as well as what value parameters are being utilised, how the information can be used to manage risk and how can agencies share best practice. What Are the Issues to Be Addressed? Stuart Walker, Founder, CMR International Institute for Regulatory Science, UK A Systematic Approach to Decision Making – An FDA viewpoint FDA speaker invited How the European Medicines Agency Plans to Develop a Structured Framework for Benefit/Risk Assessment Xavier Luria, Head of Sector Safety and Efficacy of Medicines, European Medicines Agency , EU A Collaborative Pilot Study to Improve the Benefit/Risk Assessment of Medicines by Health Canada, Therapeutic Goods Administration, Australia; Health Sciences Authority, Singapore and Swissmedic Petra Dörr, Head of Management Services and Networking, Swissmedic, Switzerland 11:00 Session 0407/0807 INFLUENCE OF HTA ON REGULATORY DECISION MAKING: REALITY? AN OPPORTUNITY? A THREAT? (JOINT SESSION WITH THEME 8) Session Chair: François Meyer, Director, Health Technology Assessment Division, HAS Haute Autorité de Santé, France European Medicines Agency perspective Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU Getting to the Right Evidence for Licensing and HTA Authorities at the Point of Launch: An achievable endpoint? Franz Pichler, Portfolio Manager, CMR International Institute for Regulatory Science, UK 14:00 Session 0408 COMPANY DECISION MAKING DURING DRUG DEVELOPMENT Session Chair: Jacques Mascaro, Senior Vice President, Global Regulatory Affairs, Pharmacovigilance and Quality, Elan Pharma International Ltd., Ireland The session will integrate a strategic review of decision making during drug development and registration. The importance of early global regulatory and safety strategies for decision making in development and filing will be discussed: What elements need to be taken into account? How can new tools, such as modelling, be best used in decision making during development? How does their use impact the decisions made later by the “gatekeepers” for access (regulators and HTAs)? How do companies ensure optimal drug development to satisfy both regulators and HTAs? Adequate and Well-Controlled Confirmatory Clinical Trials with Adaptive Design Reflections about Similarities and Options in Two Regulatory Guidance documents FDA Perspective FDA speaker invited Theme 5 Quantitative Approaches to Decision Theory and Scenario Evaluation Speaker invited The Integrated Drug Development and Regulatory Strategies – From TPP to Risk Management: The industry view on the importance of early global development, regulatory and safety strategies Stephanie Krumholz, Associate Director, GRL Taspoglutide, Pharma Development Regulatory, Hoffmann-La Roche Inc., USA Theme 5 Paving the Way for Advanced Therapies - Fostering new generations of biotechnology-derived medicines Theme Leaders: Catarina Edfjäll, Senior Director, Regulatory Affairs Europe, Celgene International SARL, Switzerland Patrick Celis, Scientific Administrator, Scientific Committee Support, European Medicines Agency, EU From recombinant therapeutic proteins and monoclonal antibodies, to advanced therapies like cell-based and gene therapy medicinal products, each new generation of biotechnology-derived medicines comes with great opportunities and interesting challenges. In Europe, the Advanced Therapies (ATMP) legislation was implemented in December 2008 and it has brought a new Committee for Advanced Therapies (CAT) and novel regulatory procedures for advanced therapies to the European Medicines Agency. Additionally, biosimilars have been evaluated and regulated in Europe for a few years now, as several biosimilar recombinant therapeutic proteins have been approved and are being commercialised in Europe. The theme will address the opportunities and challenges raised by today’s innovative breakthroughs using new biotechnology platforms and novel treatment approaches. This theme will specifically discuss how the evolving regulatory environment impacts on companies working in this cutting-edge research area and on regulators performing the assessment of such products, which sometimes come with highly specific requirements. The experience in the first year of the ATMP legislation and the CAT will be reported, as we get closer to seeing new advanced therapies available to patients. Specific case studies and examples will be shared. Borderline areas in the legislation around medical devices and combination products will also be examined. Biotechnology-derived medicines have opened and will continue to open up huge treatment opportunities for patients, and we need to understand if the complexity of new generation medicinal products could impact the responsibilities of healthcare professionals and requirements for risk management plans. Monday, March 08, 2010 16:30 Session 0501 CAT EXPERIENCE IN THE FIRST YEAR Session Co-Chairs: Christian Schneider, Chair CAT, European Medicines Agency, Head, Division EU Cooperation/Microbiology, Paul-Ehrlich-Institut, Germany Patrick Celis, Scientific Administrator, Scientific Committee Support, European Medicines Agency, EU The Committee for Advanced Therapies (CAT) is operational from January 2009 onwards. In this session, the functioning and experience to date will be presented of the work of the CAT on the evaluation of marketing authorisation applications for advanced therapy products, on scientific advices, certification and classification procedures. Industry's initial experience with the new procedures and the interactions between applicants and CAT will be discussed. Experience from CAT Christian Schneider, Chair CAT, European Medicines Agency, Head, Division EU Cooperation/Microbiology, Paul-Ehrlich-Institut, Germany 25
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Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

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