Dear NMusers:
ICON Development Solutions is presenting a 4-day workshop which will be hosted
in Howard County, Maryland, September 10-13.
First two days are beginner/intermediate NONMEM / PDxPoP workshops, and the
third day is for Monte Carlo Expectation/Maximization and full Bayesian
analyses.
Day 4 will be a workshop on Modeling Biologics with Target-Mediated Disposition
(TMDD) presented by Leonid and Ekaterina Gibiansky of QuantPharm LLC.
The link below currently contains registration details for Days 1-3.
http://www.iconplc.com/news-events/events/workshops/
Day 4 has not yet been added but if interested please contact Lisa Wilhelm for
assistance. Below is a brief overview of what to expect.
Title: A 1-day workshop on Modeling Biologics with Target-Mediated Disposition
The workshop is intended for PK scientists with or without prior population PK
modeling experience. It provides an overview of the PK of biologics, introduces
target-mediated drug disposition (TMDD) modeling concepts, and discusses some
applications of TMDD modeling to drug development of biologics. NONMEM codes,
inputs and outputs for TMDD modeling are provided to the participants.
Workshop summary:
The 1-day workshop is intended for PK scientists with or without prior
experience in population PK modeling of therapeutic proteins. It will provide
an overview of the PK of biologics, introduce target-mediated drug disposition
(TMDD) modeling concepts, and discuss some applications of TMDD modeling to
drug development of biologics. We will start with the detailed introduction of
the TMDD system. Equations that describe the TMDD process will be introduced
and implicit and explicit assumptions of these equations will be reviewed.
Characteristic features of the TMDD system will be demonstrated on the
simulated examples. Data that are typically available for the analysis and
assay properties will be reviewed. It will be demonstrated why TMDD models are
often overparameterized and poorly identifiable. The hierarchy of TMDD
approximations (rapid binding, quasi-steady-state, irreversible binding, and
Michaelis-Menten) will be derived and discussed. Extensions of the TMDD
equations to more general systems, including antibody-drug conjugates will be
demonstrated. Experience-based recommendations for modeling of TMDD systems
will be discussed and demonstrated on case studies. Nonmem control streams that
implement TMDD equations and its approximations will be provided. Biological
considerations for choice of TMDD approximations will be introduced. We will
review allometric scaling for FIH exposure predictions, covariates that may
influence PK properties of biologics, and possible drug-drug interactions.
Methods for detection, evaluation and modeling of immunogenicity will be
discussed. Use of different Nonmem estimation methods and parallelization for
TMDD models will be reviewed.
You may register for the Beginners course (days 1 & 2), the Advanced course
(day 3) or all three. The TMDD lecture can also be registered for in
conjunction with the NONMEM courses or separately.
Cost: Industry - $800 USD/day
Academia - $600 USD/day
Lisa R. Wilhelm
Customer Service Representative
ICON Development Solutions
Internal Tel: 7210 3060
External Tel: (410) 696-3060
Fax: (215) 789-9549
Email: [email protected]<mailto:[email protected]>
Web: http://www.iconplc.com/
[Description: cid:[email protected]]