Biosimilars 2008

With a variety of different reasons for and against the development of biosimilars within the USA, generic manufacturers, originators and payers have differing views as to how this should come about. Visiongain is delighted to host the 4th Annual Biosimilars conference in Philadelphia this November. This 3-day event will provide you with practical insights into the scientific developments and regulatory challenges that will influence the success of biosimilars/follow-on biologics market. Enabling you with a platform to discuss the issues effecting the market, such as product selection and payer acceptance in a broader industry context. Consideration will be given to the evaluation of unwanted immunogenicity of follow-on biologicals, from preclinical development, through clinical trials, and into the post-registration period to minimise the risks associated with immunogenicity in recipients of therapeutic products. This meeting has received excellent feedback in previous years and this years programme will be no exception.

Key Speakers:
Linda R. Horton, Partner, Hogan & Hartson
Dr Rustom Mody, Director & Head Strategic Research, R&D and Quality, Intas Biopharmaceuticals
Elona Baum, Director, Policy and Management Operations, Regulatory/Quality/Compliance, Genentech
Lore Unt, Counsel for Intellectual Property, Federal Trade Commission (FTC)
Tom Saylor, Chief Executive Officer, Arecor
Diane Edquist Dorman, Vice President for Public Policy, National Organization for Rare Disorders (NORD)
Marc Martens, Senior Associate, Bird & Bird
Dr Arnon Chait, President and CEO, Analiza
James Harris, Chief Effective Officer, Healthcare Economics
Dr Antony C Tridico, Partner, Biotechnology/Pharmaceutical Practice Group, Finnegan Henderson
Arnold I. Friede, Counsel, McDermott Will & Emery
Robin Howard, Director, SimonKucher & Partners
Cecil Nick, Vice President Biotechnology, Parexel
Dr Jacco Keja, Managing Director and Practice Leader, Quintiles Global Consulting Services
Dr Helmut Brunar, VP Research & Business Development, Kwizda Pharma
Jim Furniss, Director, Market Access Solutions, Bridgehead International
Ronald A Rader, President / Author: Biopharmaceutical, Products in the U.S. and European Markets, Biotechnology Information Institute
Professor Adrian Towse, Director, Office of Health Economics

Reasons to register today:
Identify the trends that will shape future market development of follow-on biologics
Explore the current market and regulatory environment for biosimilars in Europe and the relevance to US legislation
Examine the emerging market landscape for biosimilars in India and China
Understand interchangeability/substitutibility policies
Discuss unwanted immunogenicity issues for biosimilars
Analyse the market impact of biosimilars from the Payers perception
Examine the pre-marketing hurdles and post-marketing challenges faced by biosimilar/follow-on biologics developers:
Utilise new and established analytical tools for demonstrating comparability Assess how is the landscape evolving for biosimilar medicines

Who should attend?
Branded Biotechnology & Generic Pharmaceutical Companies, Drug Regulators, Healthcare Agencies, Government Departments, Contract Research/Biomanufacturing Organisations, Regulatory Affairs, Pharmacovigilance

VPs, Directors, Heads, Managers of:
Legal Counsel
Intellectual Property
Regulatory Compliance
Pharmacovigilance
Drug Safety & Risk Management
Quality Affairs/ Quality Control
New Product Development
Process Science
Business Development
Business Operations
Scientific Affairs
Commercial Affairs
Marketing
Analytical Characterisation
Process Control and Analytical Technologies
Clinical Immunology
Biopharmaceuticals/ Biotherapeutics
Principal Scientist
Chief Scientific Officer

Weblink: www.visiongain.com