FDA and other regulatory agencies continue to scrutinize immunogenicity for large molecules. It is critical for biotechnology firms to stay up to date with the latest immunogenicity strategies and technology, receive clarification on emerging regulatory guidances and white papers, and understand immunogenicity operational basics. This training course is a must-attend to gain the necessary knowledge to overcome your immunogenicity challenges.

Section I of the training course addresses how to develop an overall approach to immunogenicity. e section begins with an introduction to what immunogenicity is and just as important, what it isn’t. Participants receive a brief review on the basic causes of immunogenicity and why molecules can produce an immunogenic response. Learn how to develop strategic plans for your pre-clinical and clinical trials, data handling and analysis and your overall immunogenicity program.

Section II covers the operational considerations that must be addressed on a day to day basis including methods for choosing assay platforms and technologies, assay validation, and assay development. Learn how to overcome challenges associated with outsourcing assays, neutralizing antibody assays and use technology to help address the drug interference problem.

Section IIIof the training course covers post-approval immunogenicity issues as well as regulatory challenges. Participants learn how to interface appropriately with manufacturing teams and decide when and what immunogenicity testing is required post-approval. Further explore risk and risk-based strategies and determine what the FDA would like to see in regards to assay sensitivity, etc. There will be an in-depth review of the EMEA’s latest immunogenicity guidance which was just released in April 2008.

Throughout the two-day training course, case studies and white papers will be analyzed to help ensure that learning transfers to on the job improvement. Don’t miss your chance to attend this hands-on, interactive training course where you will learn from distinguished industry experts in an intimate, professional environment.

After attending this training course, you return to your jobs, confident in your ability to:

• Understand why your product may elicit an unwanted immunogenic response
• Design a risk-based immunogenicity surveillance program
• Decide how and when to obtain samples for antibody assessment
• Implement preclinical and clinical immunogenicity prevention plans
• Validate immunogenicity assays
• Choose the appropriate assay platform for your product
• Determine assay cut points
• Overcome assay outsourcing challenges
• Use technology to better address the drug interference problem
• Review current regulatory documents
• Interface successfully with manufacturing teams and perform the correct immunogenicity tests post-approval

Register today by calling 800-647-7600 to reserve your place. We offer group rates and other discounts to encourage collaborative participation. For questions about the program, please contact Kathryn Paulson at 646-723-8013 or kpaulson@worldrg.com.

For more information or to register, please contact the World Research Group toll free by phone at 1-800-647-7600 or via e-mail at info@worldrg.com.