Institute for International Research

Who Should Attend This meeting is specially designed for scientists, analysts, assay statisticians, and managers who work with biological assays during development or routine product release. Regulatory and quality assurance professionals who deal with submitting or overseeing complex assays will also gain much needed insight to successfully deal with biological assays. Conference Co-Chairpersons Laureen Little Ph.D., Principal Consultant, Quality Services Sally Seaver, Ph.D., President, Seaver Associates LLC Keynote Presentation Potency Assays in Development and Lot-Release: An Insider Perspective HÈlËne Gazzano-Santoro, Ph.D., Associate Director, Quality Bioanalytical Development, Genentech, Inc. Pre-Conference Workshop Working Session: Practical Approaches to Establishing Parallelism for Your Potency Assay

IBC's 16th annual Bioassay Conference is the must attend meeting to learn about developing, qualifying, validating and maintaining the all-important biological assay. Come and discover the newest techniques for streamlining development and validation using easy-to-understand statistical approaches. Hear how other assay developers are accelerating their development plans and meeting aggressive timelines. Learn about use of the newest technology and regulatory trends to help you develop the right assay, at the right time in the quickest possible way. By attending this conference, you will catapult your assay development efforts into a higher and more successful arena.

This is the only forum that focuses solely on biological assays. Take advantage of this unique opportunity to discuss "nitty gritty" practical approaches with your colleagues and explore best practices that can be applied right away to your assays.

Highlights Include:

• Keynote address - bird's eye view of role potency assays during product development
• Trials and tribulations of developing cell-based assays
  • Case studies about developing ADCC assays
  • Approaches to utilize alternate testing strategies
  • Developing difficult apoptosis potency assays
  • Case study on neutralizing antibody assays
• Potency assays involving immunogenicity - case studies
• Maintaining assays for the long run - what to monitor and how to establish limits
• Using DOE to speed up validation - two case studies
• Streamlined approaches to validating animal assays
• Parallelism - practical approaches during development
• USP <111> update
• Dose-response model development