Training Seminar

2024年10月16日(三)  8:30 am - 5:30 pm | 2024年10月17日(四)  8:00 am - 12:00 pm

TS1: A Guide to Statistical Methods for Bioassay

This course introduces statistical ideas supporting bioassays (illustrated with relevant examples) and reviews properties of bioassays. The course covers how practical constraints in the laboratory create the ‘statistical design structure’ of assays. Adapting design of experiments (DOE) to bioassay development, validation, and monitoring involves using the assay design structure. Examples (mostly from cell-based bioassays; some using robotics) illustrate strategic approaches to early development, measuring assay capability, improving a bioassay, and doing validation. Strategic assay design considerations combine with good assay analysis methods to offer good assay monitoring with graphical and quantitative tools as part of a lifecycle approach.
David Lansky, PhD, President, Precision Bioassay, Inc.

TOPICS TO BE COVERED INCLUDE:

  • Statistical concepts
  • Biological Assay: fundamentals, types, properties, and similarity
  • Intro to ‘Classical’ Design of Experiments: factorials, response surface designs, blocking
  • Using DOE with bioassays
  • Bioassay analysis: addressing violations of assumptions, modeling, why mixed models, similarity
  • Considerations when setting product specifications
  • Setting assay and sample acceptance limits in bioassays
  • Modular assay designs ease development, robustness, qualification, and validation
  • Qualification and validation design and analysis
  • Assay monitoring
  • Managing changes in assays
  • Assay transfers

WHO SHOULD ATTEND:

Those who are involved with the design, development, analysis, validation, monitoring, transfer, and updating of biological assays will benefit from this course. This includes bench scientists, assay managers, those responsible for planning and analyzing bioassay validation experiments, statisticians who are new to bioassay, as well as managers who have responsibility for bioassay development and validation. The course focuses on key concepts, properties of bioassays, and enough details to understand how medical needs drive product specifications, which drive the requirements for assay capabilities. We will not focus on formulae or calculations. We will discuss the strengths and weaknesses of various big picture approaches to bioassay development and validation.

INSTRUCTOR BIOGRAPHIES:

David Lansky, PhD, President, Precision Bioassay, Inc.

David has been practicing statistics on bioassays (and other non-clinical applications in Pharma) for 35 years. This includes Searle/Monsanto/Pharmacia (10 years) and as the owner of Precision Bioassay, Inc. (since 2002). Most of his bioassay experience involves helping teams improve and validate cell-based bioassays. His experience includes some early (late 1990’s) success as part of a team that used lab automation for a series of cell-based bioassays. He has been and is still an active participant in the work to revise the USP bioassay chapters. His education includes a year of Electrical and Computer Engineering (University of Michigan), a BS in Botany (San Francisco State), an MS in Entomology (Cornell) and finally both an MS and Ph.D. in Biometry (both Cornell).

* 活动内容有可能不事先告知作更动及调整。

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