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

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26 Theme 5 This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Interactions with Applicants Developing ATMPs and New Procedures Patrick Celis, Scientific Administrator, Scientific Committee Support, European Medicines Agency, EU The New Certification Procedure for Quality and Pre-clinical Data for SME: What does it look like and what are the first results? Matthias Wilken, Head of Drug Regulatory Affairs Europe, German Pharmaceutical Industry Association (BPI), Germany Tuesday, March 09, 2010 09:00 Session 0502 ATMP BORDERLINES Session Chair: Burkhard Sträter, Lawyer, Kanzlei Sträter, Germany This session will highlight the borderlines between surgery in hospital and manufacturing and application of ATMPs, and discuss the relevance of hospital exemptions. It is becoming a challenge to find the right balance between legitimate interest in driving research forward into uncharted territory and the need for regulatory requirements and control of such products. Various relevant questions will be addressed: At what point does a cell or tissue taken from a patient turn into a medicinal product? What is the regulatory impact for research with regards to product distribution, or the need for a CTA and MA prior to applying the treatment? To what extent does the hospital exemption Art 28 of the ATMP regulation apply? Bedside therapies require the use of medical devices, including any ATMPs. This creates a new type of products which combine an ATMP and medical device. Do these products therefore have different regulatory requirements? Borderlines in Legislation on ATMP and Medical Devices - Relevance of hospital exemption for ATMPs Burkhard Sträter, Lawyer, Kanzlei Sträter, Germany Interaction CAT - Notified Bodies Marie-Hélène Pinheiro, Scientific Administrator, Regulatory Affairs, European Medicines Agency, EU Advanced Therapy Regulation: What products are excluded? Geneviève Michaux, Of Counsel, Covington & Burling LLP, Belgium 11:00 Session 0503 ATMPS AND BIOTHERAPEUTICS – DO THEY REQUIRE CHANGES TO ESTABLISHED QUALITY AND MANUFACTURING CONCEPTS? Session Chair: Lothar Hartmann, Head of External Relations, F. Hoffmann-La Roche AG, Switzerland and Chair, Biomanufacturing Group, European Biopharmaceuticals Enterprises (EBE) The manufacture of advanced therapy medicinal products and biotherapeutics poses particular challenges. This session will focus on the implications of a riskbased approach and will address buildings, facilities and equipment; materials management; production, in-process controls and testing; GMP requirements during development. The Regulatory Perspective on the Risk-Based Approach and the Differences between Cell-Based Products and other Biologicals Paula Salmikangas, Vice Chair, CAT, European Medicines Agency; Associate Professor, University of Helsinki, Senior Researcher, National Agency for Medicines, Finland Developing Advanced Therapy Medicinal Products for Global Market – One system fits all? Karin Hoogendoorn, Regulatory Affairs Manager - CMC, Contocor, The Netherlands Constraints for an SME Entering the Global Market Gemma Fernández, Technical Director (Qualified Person), Cellerix, Spain 14:00 Session 0504 IMPACT OF NEW THERAPIES ON PRE-CLINICAL RESEARCH Session Chair: Beatriz Silva-Lima, CHMP, European Medicines Agency; Professor, Pharmacology, University of Lisbon, INFARMED, Portugal Is the development of advanced therapies creating new paradigms or adapting existing paradigms to the new concepts of non-clinical research? Which are the regulatory/scientific challenges raised by the implementation of the certification procedure? ICH S10? European Regulatory View and Experience Beatriz Silva-Lima, CHMP, European Medicines Agency; Professor, Pharmacology, University of Lisbon, INFARMED, Portugal The Regulatory and Scientific Experience in the US: FDA View FDA speaker invited From Bench to Bedside: Challenges in bringing novel cell-based therapies from experimental studies into successful clinical programmes Marga Oortgiesen, Vice President, Drug Development, Cato Research Ltd., USA 16:00 Session 0505 CLINICAL RESEARCH: NEW THERAPIES - NEW CHALLENGES Session Co-Chairs: Detlef Niese, Head, Development External Affairs, Novartis, Switzerland Katrin Rupalla, Director, Regulatory Affairs, Celgene International SARL, Switzerland Can current clinical trial rules cope with cell- and gene-treatments? How to factor the surgical aspect of advanced therapies into the development process? Ethical aspects of clinical development? Experiences with Scientific Advice and Small Enterprises: Hopes and reality Zaklina Buljovcic, Head of Special Medicinal Products, Medical Devices and Borderline Products, Pharmalex GmbH, Germany Submission of an IMPD for a Multicentre Clinical Trial with an ex vivo Gene Therapy Product Didier Caizergues, Head of International Regulatory Affairs, Genethon, France The Role of the CAT in Scientific Advice and Classification of ATMPs Christian Schneider, Chair CAT, European Medicines Agency, Head, Division EU Cooperation/Microbiology, Paul-Ehrlich-Institut, Germany Wednesday, March 10, 2010 09:00 Session 0506 BIOSIMILARS - FUTURE DEVELOPMENTS AND REGULATORY CHALLENGES Session Co-Chairs: Emmanuel Chantelot, Executive Director, European Biopharmaceutical Enterprises (EBE), Belgium Falk Ehmann, Scientific Administrator, Human Unit, Anti-infectives, Scientific Secretary of BMWP, European Medicines Agency This session focuses on challenges in the regulation and commercialisation of biosimilars products in the European Union while exploring new biosimilar territories in the world of biotherapeutics. Challenges in the Regulation of Biosimilars and Perspectives of the CHMP Working Party on Similar Biological Medicinal Products (BMWP) Falk Ehmann, Scientific Administrator, Human Unit, Anti-infectives, Scientific Secretary of BMWP, European Medicines Agency
This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Lessons Learnt from the First Biosimilars and Challenges for the Future Maria Saurwein-Teissl, Head Regulatory Affairs Group Biopharmaceuticals, Sandoz, Austria Perspectives on the National Experience with Biosimilars in Germany Wolf-Dieter Ludwig, Professor of Hematology and Oncology, Head of Department of Hematology, Oncology and Tumor Immunology, Robert-Rössle Clinic, HELIOS Clinic Berlin-Buch, Germany 11:00 Session 0507 ADVANCED THERAPIES AND MEDICAL DEVICES – LIVING WITH A NEW RISK MANAGEMENT REALITY? Session Chair: Ingemar Persson, Senior Assessor, MPA, Sweden Pharmacovigilance and Risk Management plans – Do Advanced Therapies create specific challenges? Training and education of healthcare providers? The benefit/risk balance: is it manageable? Or should we be happy with risk control? This session will look at traceable requirements for ATMPs. What is different for ATMPs? Jan Petracek, Head of Risk Management, European Medicines Agency, EU Regulator’s View Ingemar Persson, Senior Assessor, MPA, Sweden Industry Experience with RMP for an Approved ATMP Speaker invited 14:00 Session 0508 HEALTH TECHNOLOGY ASSESSMENTS - ARE THEY POSSIBLE FOR ADVANCED THERAPIES? Session Chair: Carolin Miltenburger, Director, HEOR, i3 Innovus, Germany EU institutions have agreed on regulation on advanced therapies designed to ensure access to products within Europe. How will HTA look like and what are the success factors for attaining reimbursement? Can the same methods and principles be used which are now established for other therapies in Europe? Added Value in ATMP and Devices – Strategies for market success Kathy Cargill, Vice President, Reimbursement and Health Economics, International, Medtronic, Switzerland Is There a Role for QALY? Assessing cost effectiveness of therapy in PD Ulf Persson, Professor, Swedish Institute for Health Economics (IHE), Sweden Managing and Monitoring the Appropriate Use of Advanced Therapies: The Anticancer Innovative Medicines Register of the Italian Medicines Agency Luca De Nigro, Project Manager, Italian Medicines Agency, Italy Theme 6 Challenges for Switching from Prescription to Non- Prescription Status through the Centralised Procedure Theme Leaders: Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager, AESGP, Belgium Zaide Frias, Head of Regulatory Affairs, European Medicines Agency, EU With Regulation (EC) Nï 726/2004, the centralised procedure became a new route for the change of legal status of medicines hence allowing their access as a non-prescription medicine across the EU at once. This is breaking new grounds for industry, the European Medicines Agency and national authorities, generating new opportunities but also challenges and question marks. Taking the views of regulators, industry, healthcare professionals and patients/consumers, the theme will reflect on both the experience accumulated so far and on future trends. The impact on national markets and national attitudes will also be an important and interesting question for debate. Ensuring that the patients/consumers get the right level of information is paramount in the self-care context and this may bring new questions and challenges when discussed at the EU level. Lastly, will the centralised procedure give a new chance to well established molecules and/or its combinations? Ultimately, will the centralised procedure, coupled with incentives and better regulation principles, contribute to boost the competitiveness of the European self-care sector? Monday, March 08, 2010 16:30 Session 0601/0901 RISK MANAGEMENT FOR SWITCH PRODUCTS (JOINT SESSION WITH THEME 9) Session Chair: Andrew Rut, Vice President, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, UK This session will cover the challenges of taking prescription products to overthe-counter use at the European level and how these can be addressed with creative pharmacovigilance and risk management approaches. There is an increasing desire for making medicines available without a prescription and for patients to take greater responsibility for their health. The criteria that define a successful OTC switch will be discussed using data collected across key pharma/consumer companies, from a case study and from the perspectives of the European Regulatory Authorities. Current and Optimal Approaches, Including Industry Perspectives for Innovative Switches Chris Holmes, Director, World Class International, UK A Case Study of Risk Management Planning for a Novel Switch: Orlistat Andrew Rut, Vice President, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, UK Regulatory Expectations of Risk Management Programmes for Innovative Switches Jan Petracek, Head of Risk Management, European Medicines Agency, EU Tuesday, March 09, 2010 09:00 Session 0602 ARE THE INCENTIVES PROVIDED IN LEGISLATION SUFFICIENT TO BOOST INNOVATION AT THE EU LEVEL? Session Chair: Hubertus Cranz, Director-General, AESGP, Belgium Significant studies backing the change of legal status may benefit from protection in the EU for one year. In the USA, they benefit from three years. Compared to the US situation, are EU incentives considered sufficient for companies to invest in research and to put on the market more innovative switches? In addition, initiatives aiming at decreasing red tape and regulatory burden may, by freeing up resources, contribute to boost innovation and growth. View of the Industry Speaker invited Theme 6 Better Regulation in the UK: A governmental priority Chris Horsey, Head, Better Regulation, Department of Health, UK Incentives and Better Regulation in the US Andrew Fish, Senior Vice President, Legal and Government Affairs, General Counsel and Secretary CHPA, USA 27
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