The future legal and regulatory pathway for follow-on biologic (FOB) products will be as complex as are protein products themselves. Questions range from how to 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. As approval from the US legislature becomes a reality, innovator and FOB companies will prepare for the future by taking a proactive, not reactive, approach to ensure success. This is the event to attend to find out what you need to know to position your company for success in a postapproval FOB world.
IBC’s sixth annual “Global Follow-On Biologics” conference will assess the science and safety of FOBs through an in-depth analysis of the questions posed above. Learn about likely challenges and strategies to help guarantee that your organization is poised for success and ready to maximize forthcoming opportunities. You will hear from scientific, legal, and financial experts, along with innovator and FOB industry leaders who will provide the latest analysis of immunogenicity and comparability concerns surrounding FOBs. You’ll also receive invaluable insight into regulatory guidelines and intellectual property protection, along with current and future business opportunities.
Speakers will address what some consider the most important aspect of the postapproval FOB world: How will patients be affected? Will more have access to protein-based drugs that treat diseases and improve quality of life?
Mark I. Bowditch, patent attorney with Sandoz International
Patrick Vink, senior vice president and global head of biologics for Mylan Pharmaceuticals, Inc.
Scott M. Wheelwright, president of Strategic Manufacturing Worldwide, Inc.
Gillian R. Woollett, chief scientist at Engel and Novitt, LLP
The sixth annual conference will provide insight from the US FDA as well as innovator and FOB companies to prepare attendees for the future marketplace of FOBs and provide strategies and tools to maximize this new industry.
Perspectives from the US FDA: “Product Quality Issues Surrounding Follow-On Biologics” by Barry Cherney, deputy director of the division of therapeutic proteins in the Office of Biotechnology Products (CDER, FDA); and “Immunogenicity of Biological Therapeutics Following Major Manufacturing Changes” by Susan Kirshner, acting associate chief of the laboratory of immunology in the Division of Therapeutic Proteins (CDER, FDA)
Back-to-Back Keynote Presentations: “The Follow-On Dilemma — A Global Perspective” by Robert Garnick, senior vice president of regulatory, quality, and compliance at Genentech, Inc.; and “The Follow-On Biologics Landscape — A Pioneer’s Perspective on the Future” by Joerg Windisch, head of global development in biopharmaceuticals at Sandoz InternationalHighlights
Special Session on Legislation of Follow-On Biologics around the World: Learn from international representatives who address some of the same practical scientific issues that the United States faces. Gillian R. Woollett (Engel and Novit, LLP) will analyze the biosimilars pathway already established in the European Union and provide an overview of the legislative opportunities that will benefit patients locally, nationally, and globally. Geoffrey Allan of Insmed Inc. will demonstrate best practices for creating a product specific development strategy for FOBs in the United States. Alex D. Kanarek of AK Consulting Services will guide you through an in-depth comparison of the European and North American approaches to FOB licensing. Jaime Uribe of Probiomed will discuss the intricacies of working with the Mexican senate and house of representatives and review the Mexican regulatory framework for the introduction of subsequent entry biologics (SEB). And Mary Alice Hefford of Health Canada will discuss Canadian guidance and the research Canada has undertaken to help address some practical scientific issues it have encountered.
Two Audience-Interactive Panel Discussions: “Preparing for Post-FOB Approval Legislative Guidelines” and “The Role of Service Providers and Suppliers in Follow-On Biologics Development”
This is the only event for a full scope of the likely future, from research and manufacturing needs all the way to market penetration and branding. Prepare for the future now so you don’t get left behind.