The development of the
Biosimilars market is growing exponentially with the industry forecast to be worth $25 billion by 2020. With the regulatory landscape evolving rapidly, it is important to understand the developments in the biosimilar guideline framework and the cohesion in legislation between Europe and the US.
With Europe leading the way in the field of
Biosimilar development, it is important to get to grips with all areas in the product lifecycle from early stage developments, protein characterisation and analytical comparability to patent litigation, market access, pricing and reimbursement through to emerging markets and global developments. Every angle should be considered and taken account for through the development process and with the EU the most advanced market for
biosimilars, accounting for 80% of global spending on these molecules, the learning curve for
biosimilars is essentially still building and there are hurdles to overcome.
Unlocking the potential of
biosimilars will require a focused strategy along the whole value chain, from optimizing the clinical development program through developing the most suitable strategy for commercialisation.
Benefits of Attending
- HEAR the latest on the evolving regulatory biosimilar landscape and review the guidelines
- GAIN understanding on the barriers being faced for market access and commercialisation of products through case-study led presentations
- FOCUS on the global market developments with case studies on Emerging Markets of biosimilars and assessing the trends we are currently seeing
- ASSESS and review in-depth protein characterisation and analytical comparability to efficiently and effectively collect data
Two Interactive Half-Day Workshops
Pre-Conference Workshop | Tuesday 29th September 2015A: An Update on Legislative and Regulatory Developments in the United States and Europe affecting approval and market access of biosimilars
Workshop leaders: Lincoln Tsang, Partner, Daniel Kracov, Partner and Jennifer Sklenar, Partner, Arnold & Porter LLP
1.00pm - 5.30pm
Post-Conference Workshop | Friday 2nd October 2015B: Biosimilars - Understanding the Regulatory Processes and the Commercial Realities
Workshop leader: Peter Wittner, Senior Consultant, Interpharm Consultancy
8.30am - 12.30pm
Speakers
- Alan Sheppard, Principal, Global Generics and Biosimilars, Thought Leadership, IMS Health UK
- Albin James Nelson, Senior Principal & Owner, Adversarial Proceedings/ Pharma & Biotech, Schwegman Lundberg Woessner & Kluth
- Bracha Timan, Director Head of Bioassays & Technology, Teva Pharmaceuticals Ltd. Isreal
- Chris Teale, Vice President Europe, GfK NOP Ltd
- Christopher Stothers, Intellectual Property Litigation, Arnold and Porter
- Dirk Kreder, Founder and CEO, Anteris Medical GmbH
- Fiona Greer, Global Director, Biopharmaceutical Services Development, SGS M-Scan SA
- Gerry McGettigan, CEO & Regultory Expert, Kinesys Consulting Ltd
- Jennifer Sklenar, Partner, Arnold & Porter
- Karsten Roth, Director Clinical Operations, Cinfa Biotech
- Kathy Osgerby, Associate, Intellectual Property, Arnold & Porter
- Kei Kishimoto, Chief Scientific Officer, Selecta Biosciences
- Michael Tovey, INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, Ecole Normale Supérieure de Cachan
- Michel Mikhail, Expert in Biosimilars, Consultant, Germany
- Nick Callan, Team Leader, Impurities & Excipients, SGS Life Sciences Services
- Richard Easton, Team Leader, Carbohydrate Analysis, SGS M-Scan Ltd.
- Robin Chadwick, Principal, Biotechnology, Schwegman Lundberg Woessner & Kluth
- Shahin Kauser, Senior Scientific Assessor, MHRA
- Steinar Madsen, Medical Director, Norwegian Medicines Agency
- Uwe Gudat, Head of Safety Biosimilars, Merck Serono
Please fill in your name and email to receive the conference agenda of this event.
The agenda is available as PDF under downloads at the right side of the page.
Venue
Holiday Inn Kensington Forum
97 Cromwell Rd, Kensington, SW7 4DN
London, UK
Who Should Attend
Job titles include but are not restricted to:
CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, from the following roles:
- Biopharmaceuticals/ Biotherapeutics
- Follow on Biologics/Follow on Proteins/Biosimilars
- Biologics/Biotechnology/ Biogenerics
- Legal and Regulatory Affairs
- Intellectual Property
- Health Economics
- Pricing and Reimbursement
- Clinical Immunology
- Process Control and Analytical Technologies
- Analytical Characterisation
- Regulatory Compliance
- Pharmacovigilance
- Drug Safety & Risk Management
- Quality Affairs/ Quality Control
- New Product Development
- Process Science
- Portfolio Management
- Research & Development
- Business Development
- Business Operations
- Scientific Affairs
- Commercial Affairs and Strategic Planning
- Legislation and Policy Advice
Venue
Holiday Inn Kensington Forum97 Cromwell Rd,
London, SW7 4DN
United Kingdom
Nearest Underground Station: Gloucester Road
SMi Special Rates: Standard Room from £139.00
