Institute for International Research

As approval from U.S. Legislature for Follow-On Biologics becomes a reality, innovator and FOB companies will prepare for the future by taking a proactive, not reactive, approach to ensure success.

IBC's 6th Annual Global Follow-On Biologics conference will assess the science and safety of Follow-On Biologics through an in-depth analysis of questions ranging from How can you be certain of the similarity, safety, and efficacy of follow-on products? to What will be the key drivers for success in the future marketplace for Follow-on Biologics? and many more. Learn about likely challenges and strategies to help guarantee that your organization is poised for success and ready to maximize the forthcoming opportunities of Follow-On Biologics.

In the News FDA blocks imports from two Follow-on Biologics from India Keynote Presentations The Follow-On Dilemma - A Global Perspective Robert Garnick, Ph.D., Senior Vice President, Regulatory, Quality and Compliance, Genentech, Inc. The Follow-on Biologics Landscape: A Pioneer's Perspective on the Future Joerg Windisch, Ph.D., Head of Global Development Biopharmaceuticals, Sandoz International FDA Presentations Immunogenicity of Biological Therapeutics Following Major Manufacturing Changes Susan Kirshner, Ph.D., Acting Associate Chief, Laboratory of Immunology, Division of Therapeutic Proteins, CDER, FDA Product Quality Issues Surrounding Follow-On Biologics Barry Cherney, Ph.D., Deputy Director, Division of Therapeutic Proteins, Office of Biotechnology Products, CDER, FDA Featured Presentation Patient Perspective on FOB and the Need for Affordable Treatments Anna Schwamlein Howard, Senior Legislative Representative, Federal Affairs, Health Issues, AARP Diane Dorman, Vice President for Public Policy, National Organization for Rare Disorders

This is the event to attend to find out what you need to know to position your company for success in a post-FOB approval world.

You will hear from scientific, legal and financial experts, along with innovator and FOB industry leaders who will provide the latest analysis of the immunogenicity and comparability concerns surrounding Follow-On Biologics. Attendees will also receive invaluable insight into regulatory guidelines, I.P. protection, along with current and future business opportunities.

Speakers will also address what some consider to be the most important aspect of the post-FOB approval world: How will patients be affected? Will more people have access to protein-based drugs that will treat diseases and improve quality of life?

Prepare Yourself for the Post FOB Approval World.

By attending IBC's 6th Annual Global Follow-On Biologics conference you will:

• Learn how FOB companies are implementing effective and economically sound methods for the development, manufacturing, and approval of Follow-On Biologics.
• Hear how first to market companies like Pfizer and Genentech will to continue to innovate and compete in the future FOB marketplace.
• Interact with FDA representatives and present them with your questions and concerns regarding FOB's.
• Gain information from FOB companies from around the world that have already achieved or attempted legal and regulatory approval.
• Discover how slight changes in next generation products could dramatically extend market exclusivity.

Interactive Panel Discussions

Preparing for Post-FOB Approval Legislative Guidelines
Moderator: Mark I. Bowditch, Patent Attorney, Sandoz International
Panelists:
Emily Shacter, Ph.D., Chief, Laboratory of Biochemistry, Division of Therapeutic Proteins, Office of Biotechnology Products, OPS, CDER, FDA
Mary Alice Hefford, Ph.D., Research Scientist, Centre for Biologics Research, Biologics and Genetic Therapies Directorate, Health Canada
Geoffrey Allan, Ph.D., President and CEO, Insmed Incorporated
Gillian R. Woollett, MA, D.Phil., Chief Scientist, Engel & Novitt, LLP

The Role of Service Providers and Suppliers in Follow-On Biologics Development
Sponsored by Invitrogen
Moderator: Trent Carrier, Ph.D., Director of BioProcess Services, Invitrogen Corporation
Panelists:
Roger Lias, Ph.D., President, Eden Biodesign
Jerold Martin, Senior Vice President, Scientific Affairs, Pall Life Sciences
Additional panelists to be announced

Post-Conference Reports from Last Year's Event Prepared by Global Insight

» Follow-On Biologics: The Evolution in the FDA's Thinking (135KB PDF)

» Health Canada Advances Biosimilars Approval Legislation (81KB PDF)

View an Outline of the Cost Budget for Follow-On Biologics from the US Senate
» Biologics Price Competition and Innovation Act of 2007 (61KB PDF)