Prior knowledge is fundamental for the progression of science and critical for efficient product development and informed regulatory assessments of product safety and quality. In this session, a variety of case studies will be presented touching on aspects of modeling, extrapolation, analysis of structured and unstructured datasets and the application to product development and the assessment of regulatory submissions. The panel will discuss successful applications of prior knowledge and explore the challenges and areas for improvement.

Session Speakers:

How to Incorporate Prior Knowledge: What Are Bayesian Statistics and Why Non-Statisticians Should Be Interested
Christopher Thompson, AstraZeneca

Predictive Stability for Biologics Using Kinetic Modeling

Michael Dillon, Merck & Co., Inc.

Leveraging Prior Knowledge for Efficient mRNA Vaccine Drug Product Development
Bob Walters, Pfizer, Inc.

Additional Panelists:

Jayda Siggers, Health Canada

Jason Warfel, Bristol-Myers Squibb Company

Charles Morgan

Appearances

Parallel Session 6A - Prior Knowledge to Support Clinical and Marketing Applications

Session Chairs

Speakers