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ADAPT Workshop on Biologics

May 13-14, 2017
Niagara Falls, NY

The ADAPT Workshop on Biologics will illustrate modeling methods and approaches used to describe the pharmacokinetics and pharmacodynamics of monoclonal antibody, as well as other biologics. This workshop is intended for both basic and clinical researchers, as well as drug development scientists who are actively involved with the application of modeling, simulation and data analysis methods to problems involving drug kinetics and drug response. Participants are expected to have experience with PK/PD modeling methods and applications, but not necessarily applied to biologics.

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Workshop Overview

The workshop will include background lectures on mathematical, statistical, and computational aspects of pharmacokinetic/pharmacodynamic modeling, with an emphasis on the principles and applications of simulation and estimation methods. Case studies will focus on the application of the ADAPT software to modeling problems involving biologics, and will include hands-on computer work. The case studies will illustrate different PK modeling approaches (e.g., target mediated drug disposition, rapid binding, quasi-steady state, Michaelis Menten, PBPK) used for biologics, and will demonstrate the application of ADAPT’s simulation, estimation and sample schedule design tools for understanding the PK/PD of biologics. Laptop computers are required to participate in case studies. No special software is needed, and all ADAPT examples will be made available as stand-alone executable programs.

This workshop will give participants an in-depth exposure to modeling approaches and issues relevant to studying biologics, with a comprehensive hands-on  exposure to the use of the ADAPT software.  ADAPT is made freely available through the Biomedical Simulations Resource at the University of Southern California, which is supported by the Bioengineering Program of the National Institute for Biomedical Imaging and Bioengineering at the NIH (P41-EB001978).

Course Instructors

David Z. D'Argenio, PhD
David D'Argenio 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, a past member of the FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology, and a founding member of the International Society of Pharmacometrics. 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.

Joseph P. Balthasar, PhD
Joseph Balthasar is Professor of Pharmaceutical Sciences at the University at Buffalo, State University of New York, where he serves as the Director of the Center for Protein Therapeutics. His PK/PD modeling interests and expertise 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 is a consultant to the NIH and the pharmaceutical industry.

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. He is a Fellow of the ACCP and is President of the International Society of Pharmacometrics. His research involves identifying molecular and physiological factors that control the pharmacological properties of drugs, with a focus on anti-cancer and immunomodulatory agents.

Workshop Schedule

Saturday, May 13   Sunday, May 14
 
       
8:00 Continental Breakfast 8:00 Continental Breakfast
8:30 Introductions and Overview 8:30 Case Study: PD Model for Anti-Platelet Antibodies (NPD)
9:00 Background: Modeling with ADAPT 9:15 Case Study: Introduction to PBPK Modeling (SIM)
10:15 Break 10:15 Break
10:30 Case Study: Target Mediated Drug Disposition (SIM) 10:30 Case Study: PBPK Modeling of IgG (SIM)
11:15 Case Study: Rapid Binding and MM Models (SIM) 11:15 Case Study: PBPK of mAb-ligand interaction (SIM)
12:00 Lunch 12:00 Lunch
1:00 Background: Individual Estimation 1:00 Case Study: Interferon β PK/PD (SIM)
2:00 Case Study: Nondepleting Anti-CD4 mAb (ID) 2:00 Case Study: Denosumab PD in Multiple Myeloma (SIM)
3:00 Break 3:00 Break
3:15 Case Study: Rituximab Extravascular Absorp. (NPD) 3:15 Background: Population Modeling with ADAPT
4:15 Case Study: Antibody-Antigen Interactions (SIM) 4:30 Final Q&A and Discussion
5:00 Recap, Looking Forward, Adjourn 5:00 Adjourn

Registration Information

Fee

The fee is $600. A US government employee rate of $400 and student rate of $200 is available. The registration fee includes printed and electronic copies of all course materials. 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. Please inform course secretary of any substitutions.

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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