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Episode 24 webinar slide featuring James Yates, David Fairman, and Scott Summerfield discussing brain penetration concepts for biologics.

Capabilities

Cardiovascular and Metabolic Diseases Animal Models

Recorded: December 2024

This webinar discussed the brain penetration of molecules where (1) the rate of passage into the brain is comparable to the associated clearance processes, (2) key aspects of their bioanalysis, and also (3) the importance of complementary pharmacological measurements.

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Agenda:

Introduction on CNS Distribution, Clearance Processes
- Importance of integrating CNS drug concentration measurements and dose prediction ?
- Dealing with molecules characterized by low BBB penetration?
  - Bioanalytical considerations?
  - Understanding measurement variability and interpretation of results ?
Key Points for Macromolecules and Biologics
- Key mechanisms driving lower brain permeation ?
- Examples and case studies?
Panel Discussion
- Balancing the focus on the fundamental pillars

Meet our Speakers

Moderated by:

Scott Summerfield – Senior Director Pharmaceutical Metabolism at Pharmaron

Speakers

James Yates – Scientific Director at GSK

James Yates is Scientific Director at GSK and leads the nonclinical PKPD modelling team in DMPK, Preclinical Sciencs. He has a background in mathematics and engineering (University of Warwick, UK) and has 20 ?years’ experience in drug discovery and development, particularly in oncology. He has published 90 papers on translational PKPD. He has a particular interest in the application of mathematical modelling for translation from nonclinical to patients and between patient populations.

David Fairman – Executive Director, Clinical Pharmacology Modelling and Simulation (CPMS) at GSK?

Dave is currently CPMS Translational head and is accountable for oversight and guidance of early phase clinical pharmacology studies. His background is in translational pharmacology with a specialisation in biologics including TMDD modelling and assay selection best practise. ?Previously experience includes time with the Clinical Pharmacology and Drug Metabolism and Pharmacokinetics department at MedImmune. His portfolio included preclinical and clinical biologics projects spanning the Oncology and Cardiovascular Therapy Areas with a focus on diabetes. Immediately prior to this position he led the Allergy & Respiratory preclinical modelling team at Pfizer and was responsible for the delivery of multiple small molecule candidates for evaluation in human clinical studies.