Day One Wednesday 29 February 2012

• Limited access to biologic therapies is an unmet medical need
• Technical challenges of achieving biosimilarity
• Justification for abbreviated clinical development programs
• Realities of commercialisation - are we successful in meeting patient needs?

• › Dr Joerg Windisch, Global Head of Technical Development, Sandoz Biopharmaceuticals

• With the current regulatory approach to biosimilars, no significant product price difference would be passed on to the ultimate payer or patient
• There is a clear need for more interaction between the regulator and biosmilars industry to harmonise understanding, ensure safety and not over burden the biosimilar company
• Challenges from CMC, clinical, commercialisation, safety and cost effectiveness perspectives
• Challenges in cost containment to make biosimilars more commercially viable and improve access

• › Cyrus Karkaria, President Biotech Division, Lupin Pharmaceuticals

• Update and analysis on the pre clinical regulatory requirements of monoclonal antibody biosimilar drugs

• › Dr Parvinder Phul, Pre-clinical Assessor, MHRA

• Overview of the US biosimilar's legislation and recent FDA activities
• Clinical and analytical challenges to demonstrating the highly similar nature of biosimilar products to their reference products
• Approaches to demonstrating interchangeability

• › William Egan, Vice President, Consulting Division, PharmaNet/i3

• Competitions vs access for affordable medicines
• Update of legislative pathway for biosimilars in USA

• › Henry Waxman, Member of Congress, Congress- United State of America

• Biosimilar developers face unique challenges as they seek to reduce Cost of Goods Sold whilst simultaneously maintaining essential similarity to innovator products
• How advances in biomanufacturing technologies and the design of innovative production strategies can speed development, increase market competitiveness, generate profitability and minimize risk

• › Crawford Brown, Chief Executive Officer, Eden Biodesign, a member of The Watson Group

• Originator selection
• Validating stability
• Stable cell-line process development

• › joe zhou, CEO, Wison/genor pharma

• › Piotr Lassota, Scientific Director, Polpharma Biologics

• The process determines the product
• Risk based approaches in biosimilar development
• Case studies from process development
• Chances and challenges in downstream processing

• › Dr Susanne Richter, Lab Head DSP Development Cell culture, Sandoz Biopharmaceuticals

• Importance of proper analytical techniques
• Reference product selection and analysis
• Manufacturing considerations and challenges for biosimilars Specification

• › Partha Hazra, Senior Scientific Manager, R&D Biologics, Biocon Limited,

Register for the gala dinner to relax and network over a few drinks and great food with your fellow attendees. Hear a truly inspirational speech from Pete Goss MBE who will share his thrilling adventure as the first Brit to complete the Vendée Globe, a nonstop single handed round the world yacht race. (please not this is at an additional cost)

• › Pete Goss, Motivational speaker, Motivational speaker