Session 3: A 3-Day Workshop on Monoclonal Antibody Pharmacokinetics and Pharmacodynamics (Virtual)

Lectures will address primary determinants of antibody pharmacokinetics (PK) and pharmacodynamics (PD), the design and implementation of pre-clinical investigations of antibody PK/PD, and state-of-the-art mathematical models to characterize and predict antibody PK and PD. Case studies, featuring use of the ADAPT program, will include application of models for antibody-ligand binding and disposition, target-mediated disposition, and physiologically-based pharmacokinetic modeling. Special emphasis is placed on discussion of the role of FcRn on the absorption, distribution, and elimination of antibodies, on the mathematical modeling of target-mediated antibody disposition, and on physiologically-based modeling of antibody pharmacokinetics. The workshop content is provided as a combination of formal lectures and informal discussion/review sessions.

Subjects that will be presented include:

• Determinants of antibody pharmacokinetics and pharmacodynamics: mechanisms of antibody elimination, the role of convection in the kinetics of antibody distribution, the role of FcRn in antibody absorption, distribution, and elimination
• Interspecies Scaling of Antibody PK: considerations and examples involving the use of allometric methods to scale protein pharmacokinetics from pre-clinical models to humans
• Drug-drug interactions: mechanistic considerations and examples for drug-drug interactions involving monoclonal antibodies, including consideration of antibodies as perpetrators and as victims of DDI
• Target-Mediated Antibody Disposition: modeling, implications for interspecies scaling, implications for First-in-Human studies
• Modeling of bimolecular antibody-ligand interaction
• Physiologically-based pharmacokinetic modeling: Incorporation of FcRn-mediated antibody transport in PBPK models, incorporation of target-mediated disposition, use of PBPK and preclinical data to predict antibody disposition in humans

Joseph P. Balthasar, PhD
Joseph P. Balthasar, PhD, is the David and Jane Endowed Chair for Drug Discovery and Development, Professor of Pharmaceutical Sciences at the University at Buffalo, State University of New York, and Director of the Center for Protein Therapeutics. His PK/PD modeling interests and capabilities include the development and preclinical evaluation of anti-toxin immunotherapies, the development and preclinical evaluation of anti-cancer immunotherapies (including immunoconjugate immunotherapies), and the development and preclinical evaluation of novel immunotherapies for humoral autoimmune conditions.

David Z. D'Argenio, PhD
David Z. D'Argenio, PhD, is Professor of Biomedical Engineering at the University of Southern California (USC) and holder of the Chonette Chair of Biomedical Technology. He is a Fellow of the American Institute for Engineering in Medicine and Biology, American Association of Pharmaceutical Sciences, International Society of Pharmacometrics, and a past member of the FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. Since 1985 he has served as co-director of the Biomedical and Simulations Resource (BMSR) at USC, which develops, applies and disseminates advanced modeling methods for studying biological systems, where he has led the development of the ADAPT software for PK/PD modeling and analysis.

Donald E. Mager, PharmD, PhD
Donald E. Mager, PharmD, PhD is Chair and Professor of Pharmaceutical Sciences at the University at Buffalo, State University of New York. He was also a Visiting Professor at the University Paris Descartes (Jan. 2007-2013). He has served on the Pharmaceutical Sciences and Clinical Pharmacology Advisory Committee to the FDA and is a Past President of both the International Society of Pharmacometrics and the American College of Clinical Pharmacology. His research involves identifying molecular and physiological factors that control the pharmacological properties of drugs, with a focus on anti-cancer and immunomodulatory agents.

Dhaval K. Shah, PhD
Dhaval K. Shah, PhD, is Associate Professor of Pharmaceutical Sciences at the University at Buffalo, State University of New York. His research focuses on understanding the determinants for the ADME of protein therapeutics. He is involved in the development of a platform PBPK model for biologics that can characterize and predict the pharmacokinetics of diverse protein therapeutics in several preclinical species and human. Dr. Shah also directs the discovery, development and clinical translation of novel protein therapeutics like antibody-drug conjugates and bi-specific molecules in his laboratory. His research is supported by NIH & pharmaceutical industry.

The course will be held via Zoom, including live lectures and Q&A discussions. All participants will be requested to attend via computer with camera and microphone switched on for interactive discussion sessions.

Computers equipped with Internet access, functional cameras and microphones.

Individual fee: $2,800. This includes electronic course documentation. Up to 5 graduate students may enroll at a fee of $1,400 (registered MS and PhD).

Mastercard, Visa, American Express, and Discover card payments will be accepted. 

Cancellations with a full refund may be made until March 17, 2025. No refund is possible on cancellations received after this date. Substitutions may be made at any time.  

Contact UB course secretary Suzette Mis at (716) 645-4834 or mis@buffalo.edu if you need assistance.