Apr 29, 2016 - Thijs Giezen, PharmD, PhD, MSc, Hospital Pharmacist, Foundation ... of New Drugs, CDER, US Food and Drug
14th Annual Biosimilar Medicines Group Conference 28-29 April 2016 Grange Tower Bridge Hotel 45 Prescot Street, London E1 8GP, UK Thursday | 28 April 2016 08:30 - 09:30
Press conference (by invitation only)
09:00 - 10:00
Registration & networking welcome coffee
10:00 - 18:00
DAY I: MARKET AND MARKET ACCESS Questions addressed in the following market and market access sessions can be accessed here
10:00
OPENING KEYNOTE SPEECH - Jacek Glinka, President, Medicines for Europe and President Europe, Mylan
10:10 - 10:15
European Commission Note Celebrating 10 years of Biosimilar Medicines in Europe Video participation: Christian Siebert, Head of Unit, European Commission, DirectorateGeneral Internal Market, Industry, Entrepreneurship and SMEs, Unit "Biotechnology and Food Supply Chain"
10:15 - 12:00
SESSION 1 - EU Success Story: 10 Years of Biosimilar Medicines The Impact and Potential Role of Biosimilar Competition in European Markets and the Global Outlook Chair Adrian van den Hoven, Director General, Medicines for Europe This session looks at market developments of biosimilar medicines over the past 10 years, what can be anticipated for the future and where the global opportunities are. You will also get a deep insight into an IMS Institute report which describes the potential role for biosimilars and their contribution to healthcare systems, the risks for stakeholders not to realize that full potential value and the requirement for a competitive functioning market to capture the full value. Based on all these insights, the session will end with a speaker panel discussion and a dynamic interaction with the audience.
10:15 - 10:30
The Biosimilar Market Leader’s Perspective Carol Lynch, Global Head of Biopharmaceuticals, Sandoz, DE
medicines for europe Rue d’Arlon 50 - 1000 Brussels - Belgium T: +32 (0)2 736 84 11 - F: +32 (0)2 736 74 38
[email protected] - www.medicinesforeurope.com
10:30 - 10:45
IMS Observation of the European Market Per Troein, Vice President Strategic Partners, IMS Health
10:45 - 11:00
An Academic’s Perspective: Key Findings of an Impact Study of Biosimilars on Healthcare Expenditure across Europe Ariel Dora Stern, Assistant Professor, Harvard Business School, USA
11:00 - 11:15
IMS Institute Brief - Delivering on the Potential of Biosimilar Medicines Donal Cumiskey, IMS Consulting Group
11:15 - 12:00
Panel discussion and interactive session with the audience, moderated by Duncan Emerton Senior Director, Syndicated Insights & Analysis, FirstWord
12:00 - 13:15
Lunch sponsored by
13:15 - 14:15
SESSION 2 - Multi-Stakeholder Approach: Key to the Success of Biosimilar Medicines Chair Klaus Martin, Chief Scientific Officer, Polpharma Biologics and Chair of the Market Access Committee, Biosimilar Medicines Group, a Medicines for Europe Sector Group A multi-stakeholder approach supporting the introduction of biosimilar medicines is regarded as the best in order to consolidate the acceptance of biosimilar medicines by patients and prescribers. This session looks into what has been achieved so far and what still needs to be done by national policy makers and key actors in the biosimilar medicines space.
13:15 - 13:30
Presentation of a Case Study of a Managed Switching Programme: University Hospital Southampton NHS Foundation Trust Fraser Cummings, Consultant Gastroenterologist, University Hospital Southampton NHS Foundation Trust, UK
13:30 - 14:15
Panel discussion with Fraser Cummings, Steinar Madsen, MD, FACP (Hon), Medical Director, Department of Drug Information, Norwegian Medicines Agency, NO, Bjørn Gulbrandsen, Member of the Norwegian IBD Patient Organization LMF, Former Chairman of the Board of LMF and Patient Representative on the NOR-SWITCH Study Management Board and Carol Lynch, Sandoz, Chair of the Biosimilar Medicines Group, a Medicines for Europe Sector Group
14:15 - 15:30
SESSION 3 - Key Enabler for Uptake: Reducing the Information Gap on Biosimilar Medicines among Stakeholders Chair Philip Ball, Executive Director, Biologics Policy and Strategy, Allergan and Member of the Biosimilar Medicines Group The most striking outcome of the European Commission multi-stakeholder workshop on biosimilars uptake in October 2015 was the need to reduce the information gap amongst stakeholders. This session brings the various actors together, reveals ongoing initiatives, and stimulates the development of new approaches in order to increase patient access to highly innovative treatments while supporting the sustainability of the national healthcare systems.
patients • quality • value • sustainability • partnership
14:15 - 14:30
Danish Medicines Agency’s Perspective Benedicte Lunddahl, Team Leader, Special Advisor, Division of PhV and Medical Devices, Danish Medicines Agency, DK
14:30 - 14:45
Regulatory Science Ireland (RSI) Project Joan O'Callaghan, Research Scientist for Regulatory Science Ireland
14:45 - 15:30
Panel discussion with speakers, Patricia Gaillard Olokose, Regional Coordinator, International Alliance of Patients’ Organizations, Frank Jørgensen, Board Member, European Association of Hospital Pharmacists (EAHP) and Neil Betteridge, Director, Neil Betteridge Associates
15:30 - 16:00
Networking coffee break and opportunity to visit the exhibitors
16:00 - 17:30
SESSION 4 - Increasing Access to Biosimilar Medicines in the Hospital Settings around Europe Chair Professor Arnold Vulto, Professor of Hospital Pharmacy & Practical Therapeutics, Erasmus University Medical Center, NL Multi stakeholder initiatives and various other innovative approaches are taking place around Europe with the aim of increasing the introduction of biosimilar medicines in hospital settings. This session provides an opportunity to share experiences as well as case studies and to discuss tendering and other procurement practices, hospital switching, national positions on interchangeability and real world evidence gathering.
16:00 - 16:20
Biosimilars and NHS Perspective Maggie Dolan, Regional Pharmacy Procurement Specialist, NHS Commercial Solutions Surrey, UK
16:20 - 16:40
The Important Role of the Hospital Pharmacist: Availability of medicines above price-only procurement Thijs Giezen, PharmD, PhD, MSc, Hospital Pharmacist, Foundation Pharmacy for Hospitals in Haarlem, NL
16:40 - 17:00
Real World Evidence Gaining Momentum: The Hungarian Experience Dr. Krisztina Gecse, Gastro-Enterologist, 1st Department of Medicine, Semmelweis University Budapest, HU
17:00 - 17:30
Panel discussion with speakers and Rüdiger Jankowsky, Managing Director, Cinfa Biotech GmbH and Biosimilar Medicines Group Representative
17:30 - 18:30
End of day one cocktail
patients • quality • value • sustainability • partnership
Friday | 29 April 2016 08:25 - 14:30 DAY II: SCIENCE and REGULATORY 08:00 - 08:25 Networking coffee 08:25 - 08:30 Opening DAY II Julie Maréchal-Jamil, Director Biosimilars Policy & Science, Medicines for Europe Questions addressed in the following science & regulatory sessions can be accessed here 08:30 - 08:40
WELCOME KEYNOTE ADDRESS - Christian Schneider, MD, PhD, Director, National Institute for Biological Standards and Control (NIBSC), UK and Chair of the EMA Working Party on Similar Biological Medicinal Products (BMWP) of the CHMP
08:40 - 11:00
SESSION 5 - Surfing the Wave of International Regulatory Convergence Chair Ildiko Aradi, PhD, Head, Clinical Development of Biologics, Gedeon Richter Hungary and Vice-Chair of the Biosimilar Medicines Group This session brings together key international regulators from the European Union, Japan, South Korea and the United States. The aim is to present the latest regulatory developments of these key regions, identify remaining hurdles for true global development and to discuss the way forward. The session will also provide an insight into the various forums and platforms supporting international regulatory convergence efforts.
08:40
Peter Richardson, PhD, Head of Quality, European Medicines Agency (EMA) and Vice-Chair of the International Pharmaceutical Regulatory Forum (IPRF) Biosimilars Working Group
09:10
Leah Christl, PhD, Associate Director for Therapeutic Biologics - Therapeutic Biologics and Biosimilars Team, Office of New Drugs, CDER, US Food and Drug Administration (FDA), USA
09:40
Younjoo Park, PhD, Director, Division of recombinant protein products, Ministry of Food and Drug Safety (MFDS) and Alternative Chair of IPRF Biosimilar Working Group, KR
10:10
Daisaku Sato, PhD, Director, Office of Cellular and Tissue-based Products, Pharmaceutical and Medical Devices Agency (PMDA), JP
10:40
Panel discussion on international regulatory convergence with Leah Christl/US FDA, Younjoo Park/MFDS, Peter Richardson/EMA, Daisaku Sato/PMDA, Christian Schneider/BMWP and Martina Weise/BMWP
11:00 - 11:30
Networking coffee break
11:30 - 12:45
SESSION 6 - Evolving Landscape on Data Requirements to Demonstrate Biosimilarity
patients • quality • value • sustainability • partnership
Chair Frits Lekkerkerker, PhD, Member NDA Advisory Board, NDA Regulatory Science Ltd, UK and Rapporteur of the first EU Biosimilar Medicine in 2006 The first biosimilar medicine was approved in 2006. Within 10 years, the biosimilar paradigm has evolved from a science-driven conceptual approach to a science-driven knowledge-based approach. This session discusses the evolving data requirements to demonstrate biosimilarity in the light of continuous advances in science and technology and regulators’ experience with biosimilar applications and overall comparability exercises. Circumstances where a confirmatory clinical trial may not be necessary as well as today’s clinical development strategies will be in the spotlight. The EU perspective: Martina Weise, MD, Head, Unit on Diabetes/Cardiology, Federal Institute for Drugs and Medical Devices, Vice-Chair of the EMA Working Party on Similar Biological Medicinal Products (BMWP) of the CHMP and German CHMP Alternate, DE Panel discussion on evolving data requirements with Leah Christl/US FDA, Younjoo Park/MFDS, Peter Richardson/EMA, Daisaku Sato/PMDA, Christian Schneider/BMWP, Martina Weise/BMWP and Karl Heinz Emmert, PhD, Project Champions Biosimilars, Teva Group and Vice-Chair of the Biosimilar Medicines Group 12:45 - 13:30
Sandwich break
13:30 - 14:30
SESSION 7 - Ask the Regulators Chair Ingrid Schwarzenberger, Global Head Regulatory Affairs Biopharmaceuticals, Sandoz, AT and Member of the Biosimilar Medicines Group This session offers the opportunity to address scientific and regulatory questions directly to the International Regulators. Panel of Regulators: Leah Christl/US FDA, Younjoo Park/MFDS, Peter Richardson/EMA, Daisaku Sato/PMDA and Martina Weise/BMWP Closing remarks Suzette Kox, Senior Director International, Biosimilar Medicines Group, Sector Group of Medicines for Europe
14:30
End of conference coffee and dessert
EVENT SPONSORS AND MEDIA PARTNERS
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[email protected] - www.medicinesforeurope.com patients • quality • value • sustainability • partnership
