TS1: An Introduction to Strategic Bioassay Design, Development, Analysis, Validation, and Monitoring

Day 1: Wednesday, October 16, 2019 | 8:30 am – 5:50 pm
Day 2: Thursday, October 17 | 8:00 am – 12:00 pm

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

This course will build from an introduction to the statistical concepts needed for bioassays (all illustrated with useful and relevant examples) and some review of the properties of bioassays. These inform the choices we make in applying design of experiments (DOE) to bioassay development, validation, and monitoring. Examples (mostly from cell-based bioassays; some using robotics) will illustrate strategic ways to design bioassays to make it (relatively) easy to use DOE differently in early bioassay development, when measuring the capability of a bioassay, when improving an existing bioassay, and when doing validation. We will cover ways that these strategic assay design considerations, when combined with good assay analysis methods, also support good assay monitoring with graphical and quantitative tools as part of a lifecycle approach.

TOPICS TO BE COVERED:

• Statistical concepts
• Biological Assays
• Fundamental concepts
• Types of bioassays
• Similarity: what, why, and how
• Properties of bioassays
• Introduction to ‘Classical’ Design of Experiments
• Factorials: why and how
• Blocking and other designs
• Sequences of experiments
• Using DOE with bioassays
• Bioassay analysis
• Challenges: non-constant variance, non-normality, outliers
• Modeling methods: non-parametric, linear, nonlinear
• Mixed models: what, why, and how
• Similarity and Potency
• Considerations when setting product specifications
• Clinical experience
• Manufacturing experience
• Assay and process capability
• Setting assay and sample acceptance limits in bioassays
• Modular assay designs ease development, robustness, qualification and validation
• Strategies for using modular designs
• Qualification and validation design and analysis
• Assay monitoring
• Managing changes in assays
• Assay transfers
• Assay updates

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 senior and upper level managers who have responsibility for bioassay development and validation. The course focuses on key concepts, properties of bioassays, with enough details to understand how medical needs drive product specifications, which drive the requirements for assay capabilities, which gives us targets for assay development. 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 BIOGRAPHY:

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

David Lansky has been practicing statistics on bioassays (and other non-clinical applications in Pharma) for 30 years. This includes 10 years at Searle/Monsanto/Pharmacia and 16 years as the owner of Precision Bioassay, Inc. David 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).

TRAINING SEMINAR INFORMATION:

Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the training seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.

Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because Seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.