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2-Day Workshop on Monoclonal Antibody Pharmacokinetics and Pharmacodynamics

May 11-12, 2017
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.

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Course Outline

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. 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:

  • 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
  • Common analytical assays for quantification of antibody in biological samples & implications for PK/PD investigations
  • Immunogenicity and Antibody PK/PD
  • Evaluation of biosimilarity of antibody drugs: Application of PK/PD for biosimilarity studies – opportunities and limitations
  • Interspecies Scaling of Antibody PK
  • 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 Direction

Joseph P. Balthasar, PhD
Dr. Balthasar is Professor of Pharmaceutical Sciences and Director of the Center for Protein Therapeutics. His research interests 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 (immune thrombocytopenia, myasthenia gravis). He serves as a consultant to the NIH and pharmaceutical industry.

Dhaval Shah, PhD
Dr. Shah, Assistant Professor of Pharmaceutical Sciences, will provide lectures relating to the impact of anti-drug antibodies on mAb pharmacokinetics, and he will discuss mechanistic modeling of the PKPD of antibody-drug conjugates.

Agenda

Thursday, May 11   Friday,
May 12
 
8:15-8:45 Continental Breakfast 8:30-9:00 Continental Breakfast
8:45-9:00 Introductions 9:00-10:00 Mathematical Modeling of Bimolecular Antibody-Antigen Interaction
9:00-11:00 Introduction to Antibody Pharmacokinetics   · Review of binding kinetics (Law of Mass Action, equilibrium vs. non-equilibrium binding)
  · Introduction to antibodies (isotypes, polyclonal vs. monoclonal, humanization, etc.)   · Mathematical modeling of antibody binding: Examples from antibodies used for immunotoxicotherapy
  · Mechanistic determinants of antibody absorption, distribution, and elimination (contrasting with determinants of small-molecule ADME) 10:00-11:00 Physiologically-Based PK Modeling of Mab
  · Comments on the mathematical modeling of antibody PK   · Review of PBPK models
  · Recent research relating to the role of FcR and mAb PK   · Application of PBPK models applied to Mab
11:00-11:15 Break   · Discussion of major features of PBPK models for Mab & discussion of associated physiology (convection, restriction coefficients, sites of catabolism, “two-pore formalism”, incorporation of specific binding, incorporation of FcRn)
11:15-11:40 Analytical Assays for Antibodies:  Implications for PK/PD Analyses 11:00-11:15 Break
  · Discussion of major types of analytical assays for monoclonal antibodies (ELISA, RIA, LC MS/MS, SPR, “direct” labeling) 11:15-12:00 Review Module #2: Design & Analysis of a Preclinical Investigation of Antibody PK (Part 2)
  · Examples / case-studies   · Development of mechanistic mathematical models
11:40-12:00 Immunogenicity and Macromolecule PK/PD 12:00-1:00 Lunch
  · Factors associated with immunogenicity 1:00-2:00 Application of PK/PD Theory to Guide the Discovery and Development of New Immunotherapies
  · Identification of host “anti-drug” antibodies 2:00-2:30 Review Module #3:  Prediction of the Influence of Shed Antigen on the Distribution of Mab in Solid Tumors
  · PK modeling   · Model development & simulations
12:00-1:00 Lunch 2:30-2:45 Break
1:00-1:30 Use of PK/PD Studies to Support Comparability Assessments of Therapeutic Proteins 2:45-4:00 Review Module #4
1:30-2:15 Interspecies Scaling of Antibody PK & PD   · Discussion questions and review
  · General review of interspecies scaling    
  · Considerations for scaling antibody pharmacokinetics    
  · Examples / case-studies    
2:15-3:30 Mathematical Modeling of Target-Mediated Disposition of Monoclonal Antibodies    
  · 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    
3:30-3:45 Break    
3:45 - 4:15 Biologics and Drug-Drug Interactions    
  · Mechanisms    
  ·  Examples / case-studies    
4:15-5:00 Review Module #1:  Design & Analysis of a Preclinical Investigation of Antibody PK    
  · Study objectives    
  · Consideration for study design    
  · Assay considerations    
  · Initial evaluation of data (Additional studies needed?)    
  · Initial characterization of ADME (NCA vs. modeling)    
  · Evaluation of NCA results    
6:00-7:30 Group Dinner    

Registration Information

Fee

The fee is $1,800. A US government employee rate of $1,200 and student rate of $800 is available for up to 3 participants of each type. The registration fee includes course documentation and handouts. Group dinner (Day 1), continental breakfasts, lunches and break-time refreshments during the course are included.

Cancellations

Cancellations with a full refund may be made until March 13, 2017. No refund is possible on cancellations received after this date. Substitutions may be made at any time.

Course Location

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.

Hotel Location

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 3, 2017

Questions?

Contact UB course secretary Suzette Mis at (716) 645-4831 or mis@buffalo.edu if you need assistance.

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