2nd Biosimilars Congregation 2013 February 19, 2013

2nd Biosimilars Congregation 2013

“Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies of Biosimilars”

February 19th & 20th 2013, Hotel Marriott, London UK

For more info on the event and for event brochure kindly visit –
http://www.virtueinsight.com/pharma/2nd-Biosimilars-Congregation-2013/

Key Themes Discussed at this Summit:

• How should the pharma and generics industries approach the rapidly emerging and developing biosimilar market? The future of next generation Biosimilars
• How are policy makers shaping the contours of this new generic frontier, and what implications they have for current biologic drug development and patent protection?
• Next generation monoclonal antibody development and clinical challenges with biosimilar drug development
• Research-based industry biosimilar strategies
• Commercial challenges and opportunities - strategies to develop Biosimilars
• Learn to implement best practices through recent successful strategies and business models – real time case studies
• Considerations for the analytical similarity assessments when designing a biosimilar development program
• Determining the right investments & potential returns from Biosimilars
• General scientific principles in conducting comparative structural and functional analyses, animal testing, human PK and PD studies, clinical immunogenicity assessment, and clinical safety and effectiveness studies
• Considering the growing importance of biobetters over biosimilars
• Ascertaining the volume and level of safety data that will be required to prove patient safety and efficacy to facilitate approval
• Understanding the current regulatory approval standards for Biosimilars in Europe and the US, including for monoclonal antibodies
• Be part of a major networking opportunity

Key Speakers Include:

• Paul Tredwell, Head of Biopharmaceuticals, Sandoz
• Anne Cook, Biologicals Quality Assessor, MHRA
• Cecil Nick, Vice President, Biotechnology, Parexel
• Alex Kudrin, Medical Assessor in Licensing of Biological Products, MHRA (Former Medical Director, Takeda Pharmaceuticals)
• Malcolm I Mitchell, Senior Medical Fellow, Clinical Pharmacology, Eli Lilly
• Paul Greenland, Biosimilars and Proprietary Marketing Director – EMEA, Hospira
• Jean-Yves le Cotonnec, CEO, Triskel Integrated Services
• Mateja Urlep, Founder & CEO, TikhePharma
• Bruno Flamion, Member, NDA Regulatory Advisory Board
• Steinar Madsen, Medical Director, Norweigen Medicines Agency
• Duncan Emerton, Director and Biosimilars Practice Lead, Datamonitor
• Christopher Holloway, Group Director of Regulatory Affairs, European Regulatory Solutions
• Richard Dennett, Director, Voisin Consulting Life Sciences (France)
• Kristie C. Kuhl, Senior Vice President, Makovsky (USA)
• Lincoln Tsang, Partner, Arnold & Porter
Plus Many More...

Who Should Attend:

CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, and Senior Scientists from the following roles:

• Biopharmaceuticals/ Biotherapeutics
• Follow on Biologics/Follow on Proteins/Biosimilars
• Biologics/Biotechnology/ Biogenerics
• Legal Affairs
• Intellectual Property
• Health Economics
• Pricing and Reimbursement
• Clinical Immunology
• Principal Scientist
• Chief Scientific Officer
• 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
• Marketing

Why Should You Attend:
Biosimilars Congregation 2012 – “Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies of Biosimilars”

Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking drinks time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.

Whether you are on the branded or generic side, you cannot afford to miss this opportunity to benchmark your tactics and strategies against the industry leaders who will be the first to traverse the pathway. Devise an immediate action plan for your biosimilar prosecution and litigation strategies in light of the barriers to entry, research and development costs, and regulatory hurdles, which are balanced against an enormous potential for increased profit margins.

Conference Booking Details:-

Super Early Discount (Till 19th December 2012):- Conference Delegate Pass (£ 500 + VAT per delegate) – You can simply email or call and book your conference delegate seats on TEL (UK): + 44 20 3302 4659. TEL (India): + 91 44 4213 8101. Email – tania@virtueinsightuk.com
Early Discount (20th December 2012 – 19th January 2013):- Conference Delegate Pass (£ 700 + VAT per delegate) – You can simply email or call and book your conference delegate seats on TEL (UK): + 44 20 3302 4659. TEL (India): + 91 44 4213 8101. Email – tania@virtueinsightuk.com
Standard Registration (After 20th January 2013):- Conference Delegate Pass (£ 900 + VAT per delegate) – You can simply email or call and book your conference delegate seats on TEL (UK): + 44 20 3302 4659. TEL (India): + 91 44 4213 8101. Email – tania@virtueinsightuk.com
Conference Sponsor & Exhibition Stall – Should you wish to Sponsor, or purchase a Exhibiton Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to – TEL (UK): + 44 20 3302 4659. TEL (India): + 91 44 4213 8101. Email – tania@virtueinsightuk.com