EDUCATING LEADERS IN PHARMACY AND PHARMACEUTICAL SCIENCES SINCE 1886
Session 3: A 3-Day Workshop on Monoclonal Antibody Pharmacokinetics and Pharmacodynamics (Virtual)
May 18 - 20, 2026
This workshop has been designed to provide a detailed discussion of issues relevant to the pharmacokinetic/pharmacodynamic (PK/PD) modeling of antibody drugs, and to provide a series of “hands-on” case studies describing the development and application of mathematical models to simulate and characterize antibody PK/PD.
Registration is closed
Registration opens late January 2026
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Workshop Overview
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 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
Course Instructors
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 is CEO of ePD and past-president of ISoP and ACCP and has served as Visiting Professor at the Université Paris Descartes and on the Advisory Committee on Clinical Pharmacology to the FDA. He also serves as an Associate Editor at Pharmaceutical Research. His research involves identifying molecular factors that control the pharmacological properties of drugs, with particular interest in anti-cancer therapy and immunomodulatory pharmacotherapy.
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 and pharmaceutical industry.
Agenda
All times listed are Eastern Standard Time (EST)
| Time | Event |
|---|---|
| 8:45 – 9:00 a.m. | Introductions |
| 9:00 – 11:00 a.m. | Introduction to Antibody Pharmacokinetics 1 (Balthasar) |
| · Introduction to antibodies (isotypes, polyclonal vs. monoclonal, humanization, etc.) | |
| · Mechanistic determinants of antibody absorption, distribution, and elimination (contrasting with determinants of small-molecule ADME) | |
| · Comments on the mathematical modeling of antibody PK | |
| · Recent research relating to the role of FcR and mAb PK | |
| 11:00 – 11:15 a.m. | Break |
| 11:15 a.m. – 12:15 p.m. | Mathematical Modeling of Target-Mediated Disposition of Monoclonal Antibodies (Balthasar) |
| · Introduction to TMD of mAb with examples | |
| · Review of mathematical models that have been applied to characterize mAb TMD | |
| · Comparison of model performance; discussion of implications for predicting mAb PK/PD | |
| 12:15 – 1:00 p.m. | Immunogenicity and Macromolecule PK/PD (Shah) |
| · Factors associated with immunogenicity | |
| · Identification of host “anti-drug” antibodies | |
| · PK modeling | |
| 1:00 – 1:15 p.m. | Break |
| 1:15 – 2:00 p.m. | Interspecies Scaling of Antibody PK (Balthasar) |
| · General review of interspecies scaling | |
| · Considerations for scaling antibody pharmacokinetics | |
| · Examples / case-studies | |
| 2:00 – 2:30 p.m. | Biologics and Drug-Drug Interactions (Balthasar) |
| · Mechanisms | |
| · Examples / case-studies | |
| 2:30 p.m. | Adjourn, Day 1 |
All times listed are Eastern Standard Time (EST)
| Time | Event |
|---|---|
| 9:00 – 9:45 a.m. | Mathematical Modeling of Bimolecular Antibody-Antigen Interaction (Balthasar) |
| · Review of binding kinetics (Law of Mass Action, equilibrium vs. non-equilibrium binding) | |
| · Mathematical modeling of antibody binding: Examples from antibodies used for immunotoxicotherapy | |
| · Inverse targeting for ADCs | |
| 9:45 - 10:30 a.m. | Mathematical Modeling of Antibody-Drug Conjugate PK/PD (Shah) |
| · Considerations for mAb, payload, conjugate disposition and dynamics | |
| · Examples of mechanistic modeling of ADC PK/PD | |
| 10:30 - 11:15 a.m. | Physiologically-Based PK Modeling of mAb (Balthasar) |
| · Review of PBPK models | |
| · Application of PBPK models applied to mAb | |
| · Discussion of major features of PBPK models for mAb and discussion of associated physiology (convection, restriction coefficients, sites of catabolism, “two-pore formalism,” incorporation of specific binding, incorporation of FcRn) | |
| 11:15 - 11:30 a.m. | Break |
| 11:30 a.m. - 12:00 p.m. | Review Module #1: Concerns for Preclinical Evaluation of mAb PK (Balthasar) |
| · Discussion based on literature example | |
| 12:00 – 12:45 p.m. | Review Module #2: DEQ systems for mAb PK models (Balthasar) |
| · Development of mechanistic mathematical models | |
| 12:45 – 1:00 p.m. | Break |
| 1:00 – 2:00 p.m. | Application of PK/PD Theory to Guide the Discovery and Development of New Immunotherapies (Balthasar) |
| 2:00 – 2:30 p.m. | Review Module #3 (Balthasar) |
| · Discussion questions and review | |
| 2:30 p.m. | Adjourn, Day 2 |
All times listed are Eastern Standard Time (EST)
| Time | Event |
|---|---|
| 9:00 – 9:45 a.m. | Introduction: Computer Modeling PKPD (D’Argenio) |
| 9:45 – 10:15 a.m. | Case Study 1: Antibody-Ligand Interaction and Disposition (Balthasar) |
| 10:15 – 11:00 a.m. | Case Study 2: Target Mediated Drug Disposition (Mager) |
| 11:00 – 11:15 a.m. | Break |
| 11:15 a.m. – 12:00 p.m. | Case Study 3: PKPD for Antibody Drug Conjugates (Shah) |
| 12:00 – 12:45 p.m. | Case Study 4: Modeling Bispecific mAb PKPD (Shah) |
| 12:45 – 1:00 p.m. | Break |
| 1:00 – 1:45 p.m. | Case Study 5: Denosumab PKPD (Mager) |
| 1:45 – 2:30 p.m. | Estimation Principles and Challenges for Biologics (D’Argenio) |
| 2:30 – 3:15 p.m. | Case Study 6: Non-depleting Anti-CD4 mAb (D’Argenio) |
| 3:15 p.m. | Adjourn, Day 3 |
Registration Information
Virtual Platform
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.
Requirements
Computers equipped with Internet access, functional cameras and microphones.
Fee
Individual fee: $2,800. Up to 5 graduate students may enroll at a fee of $1,400 (registered MS and PhD).
Registration
Online registration will begin January 26, 2026. The course is limited to the capacity of 40 participants. Confirmation email of registration will be returned upon successful registration and payment.
Payment
Mastercard, Visa, American Express, and Discover card payments will be accepted.
Cancellations
Cancellations with a full refund may be made until March 16, 2026. No refund is possible on cancellations received after this date. Substitutions may be made at any time.
Questions?
Contact UB course secretary Suzette Mis at (716) 645-4834 or mis@buffalo.edu if you need assistance.