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Combining Bedside and Clinical Research Data to Inform Disease Progression and Outcomes

Baysient’s Founder and Chief Science Officer, Diane Mould, Ph.D., speaks in the 2025-26 Pediatric Clinical Pharmacology Lecture Series hosted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

This lecture covers the concept of understanding the difference between markers of disease severity and disease progression and relating disease progression to drug exposure, with a focus on pediatric IBD. It focuses on aspects of the PK of monoclonals used to treat IBD because the PK of MAbs is reflective of the response and disease activity. It looks at the concept of dashboard-guided dosing and monitoring individual PK as a metric of reducing disease activity, with the hope that this translates to slowing or halting disease progression.

Learning Objectives:

✔ Demonstrate the concept of disease progression versus disease activity.

✔ Review the pharmacology of biologic agents and some of the issues associated with dosing metrics as applied to pediatric patients.

✔ Recognize and understand the relationship between PK and PD commonly seen with biologic agents used to treat inflammatory disease.

✔ Understand the concept of using Bayesian adaptive dosing and monitoring of individual PK parameters as a metric of disease activity for biologics.

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