Thursday, May 17 - Saturday, May 19, 2018
Niagara Falls, NY
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.
Lectures will address primary determinants of antibody
pharmacokinetics (PK) and pharmacodynamics (PD), the design
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 review sessions.
Subjects that will be presented include:
Joseph P. Balthasar, PhD
Dr. Balthasar is 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 anticancer 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 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 also led the development of the ADAPT software for PK/PD modeling and analysis.
Donald E. Mager, PharmD, PhD
Donald Mager is 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 currently serves on the Clinical Pharmacology Advisory Committee to the FDA, and as an Associate or Consulting Editor at CPT:Pharmacometrics & Systems Pharmacology, J. of Pharmacology & Experimental Therapeutics, and Pharmacology, Research & Perspectives. 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 Assistant 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.
|Thursday, May 17||Friday, May 18
||Saturday, May 19|
Mathematical Modeling of Bimolecular Antibody-Antigen Interaction and ADC PKPD (Shah)
|9:00||Case Study: Target Mediated Drug Disposition (Mager)|
Physiologically-Based PK Modeling of Mab (Balthasar)
|9:45||Case Study: Antibody-Ligand Interaction and Disposition
Introduction to Antibody Pharmacokinetics (Balthasar)
|11:00||Break||10:15||Break||10:30||Case Study: Physiologically-Based Pharmacokinetic
Modeling for mAb (Balthasar)
Analytical Assays for Antibodies: Implications for PK/PD Analyses (Balthasar)
Review Module #2: Design & Analysis of a Preclinical Investigation of Antibody PK (Part 2, Balthasar)
|11:15||Case Study: PKPD for Antibody Drug Conjugates (Shah)|
Immunogenicity and Macromolecule PK/PD (Shah)
|12:00||Lunch||1:00||Application of PK/PD Theory to Guide the Discovery and Development of New Immunotherapies (Balthasar)||1:00||Modeling Bispecific mAb PKPD (Shah)|
|1:00||Use of PK/PD Studies to Support Comparability Assessments of Therapeutic Proteins (Balthasar)||2:00||Background: Modeling with ADAPT (D’Argenio)||1:45||Case Study: Denosumab PKPD (Mager)|
Interspecies Scaling of Antibody PK & PD (Balthasar)
Mathematical Modeling of Target-Mediated Disposition of Monoclonal Antibodies (Balthasar)
Review Module #3: Prediction of the Influence of Shed Antigen on the Distribution of Mab in Solid Tumors
|2:45||Estimation Principles & Challenges for Biologics (D’Argenio)|
Review Module #4 (Balthasar)
|3:30||Case Study: Non-depleting Anti-CD4 mAb (D’Argenio)|
Biologics and Drug-Drug Interactions (Balthasar)
||4:15||Discussion / Adjourn|
Review Module #1: Design & Analysis of a Preclinical Investigation of Antibody PK (Balthasar)
Individual fee: $2500. This includes course documentation, continental breakfasts, mid-session refreshments, lunches and opening dinner. Up to 5 graduate students may enroll at a fee of $1200 (registered MS and PhD). US Government rate: $1900 (FDA and NIH employees only).
Cancellations with a full refund may be made until March 13, 2018. No refund is possible on cancellations received after this date. Substitutions may be made at any time. Please inform course secretary of any substitutions.
The course will be held at:
The Conference and Event Center Niagara Falls
101 Old Falls Street
Niagara Falls, NY 14303, USA
Phone: (716) 278-2100
Fax: (716) 278-0008
The Conference Center is 28 minutes from the Buffalo Niagara International Airport.
Sheraton at the Falls
300 Third Street
Niagara Falls, NY 14303, USA
Phone: (716) 285-3361.
The price is $124/night single and double occupancy (add $10 per person for triple and quadruple occupancy).
Hotel deadline: April 16, 2018
Contact UB course secretary Suzette Mis at (716) 645-4831 or firstname.lastname@example.org if you need assistance.