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Biological Assay Development & Validation

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Event Information

Benchmarking the Critical Quality Control Assay
April 14 - 16, 2009 · Renaissance Washington D.C. Hotel · Washington, DC

Document Title

Event Overview

Event Overview

We recently polled past attendees of Biological Assay Development & Validation and asked them how the information they learned at this conference has helped them in their workplace. This is what we heard back:

  • 92% told us it has helped their organization save time
  • 65% told us it has helped their organization save money
  • 82% told us it has helped their organization streamline processes
  • 79% told us it has helped their organization speed up validation efforts
  • 89% told us it has helped their organization move products through the clinic more efficiently
Keynote Presentation

Bioassay [R]Evolution
A General Overview of Bioassays and the Progress Made in Utilization of Bioassays in Drug Development Today
Meena Subramanyam, Ph.D., Senior Director, Clinical Science & Technology, Biogen Idec

Program highlights include:
  • Regulators’ Perspective on Technical Requirements for Biological Assays
  • USP Bioassay Chapter Updates – Validation and Design
  • Strategies for Establishing Platforms for Bioassays
  • Case Studies for Bioassay Development and Optimization
  • Bioassays for Product Characterizations
  • Neutralizing Antibody Assays
  • Bioassays for Biosimilars
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.

Hear the Following Practical Pointers to Accelerate your Bioassay Projects:

  • Streamlined statistical approaches to validating complex bioassays
  • Characterizing products using your bioassays
  • Platform approaches for developing assays for multiple products

Plus! Pre-Conference Workshop
Biological Assay Validation
Statistical and Practical Approaches to Validation: ICH, USP <1033> and Beyond!

  • Historical Perspective: Validation Yesterday, Today and Tomorrow
  • Differentiating between Assays and Tailoring your Validation to Assay Use
  • Establishing Validation Acceptance Criteria
  • USP Chapter <1033> Update
  • Statistical Tools for Validation and Assay Maintenance
  • Practical Hands-On Recommendations for Real Life Validations

IBC's 18th International Bioassay meeting has it all. We cover only bioassays, and we cover them very comprehensively! Get the tools you need to quickly and efficiently develop critical biological assays needed for successful product development. This is the only conference with no hidden agenda, and no single point of view being pushed. It is a technical conference which allows you to discuss and share information in a collegial environment. Here you will discover many practical approaches that can be applied to your assays. Plate layouts, new cell cultivation techniques, statistical tools for validation and assay development, use of platform approaches are just some of the new topics you will hear at this year’s conference.

Stay up-to-date with the most recent trends. Find out about bioassays and how they are used to determine product potency, characterize clinical products, monitor clinical samples for unwanted neutralizing antibodies and even provide clinical efficacy endpoints. The conference is perfect for you whether you are experienced or new to the bioassay field.

» Register today to take advantage of early discounts, and use the generous team discount to allow more members of your lab group to attend.

Attendee Testimonials

"Each time I attend this conference, I broaden my understanding of the challenges and solutions in this industry." - L. McNeill

"The best and most directly applicable information for our industry presented by industry leaders and newcomers alike. A most valuable resource." - R. Lowe

"An interesting and entertaining interface between biologists and statisticians. I would have loved to have all this information six months ago, and I greatly appreciate having it now." - M. Woodrow

"The information presented was illuminating, entertaining and informative so that even a statistician with almost no biological background could understand it." - R. Eyben

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