Workshop - Days 1, 2 & 3: An Introduction to NONMEM & PDx-Pop + New & Advanced Features of NONMEM 7.4 (All Courses)
The objective of these courses is to introduce the basic concepts of population pharmacokinetics (PK)/ pharmacodynamics (PD) and NONMEM analysis, and to introduce advanced concepts of population pharmacokinetics in NONMEM.
Deadline for registration is September 4, 2019. Contact ICON’s Lisa Wilhelm-Lear at Lisa.Wilhelm@iconplc.com for more information and to register.
Workshop - Days 1 & 2: An Introduction to NONMEM & PDx-Pop - Sept. 10 & 11, 2019 (Select Courses)
The objective of this course is to introduce the basic concepts of population pharmacokinetics (PK)/ pharmacodynamics (PD) and NONMEM analysis. The course is targeted to individuals interested in learning to solve population pharmacokinetic problems, and we have prepared the course in a general manner as to include a wide background of participants. The course will demonstrate how NONMEM, using the graphical user interface software PDx-Pop, can be used to solve practical population PK/PD problems, using a hands-on format with specific examples. This allows participants to work through the problems with the instructor, to develop a thorough understanding of the software and to establish confidence in applying the software to population pharmacokinetic problems.
Attendees will be instructed on the basic theory of mixed effects analysis, receive hands-on instruction of creating PK and PD models in NONMEM, learn to manage projects using PDx-POP, a graphical user interface software specifically designed for NONMEM, develop covariate models, and implement various graphical and statistical methods for validating models using PDx-POP's supplementary statistical and graphical tools. After attending this course, the participate will understand the fundamentals of population analysis; be able to run NONMEM with PDx-Pop; know how to apply some of the methods used to perform population analysis; know how to explore, develop, and evaluate population models; know how to estimate the mean pharmacokinetic (PK) and/or pharmacodynamic (PD) parameters in a population of patients; and be able to investigate and identify fixed effect sources of variability (covariates) which influence the PK and PD of a drug.
This two-day course and the workshop's third day course, the Advanced course, are part of one series. Interested parties may register for the first two days (this course), the third day (Advanced course), or a combination of all three courses.
Presenters
Robert J. Bauer, PhD.
Robert Bauer holds a PhD. in Pharmacology. He heads the Pharmacometrics R&D department at ICON in Gaithersburg, MD, where he and his group maintain the population analysis software NONMEM®, incorporating leading edge algorithms in pharmacometrics. Dr. Bauer’s focus is on developing and implementing mathematical and statistical algorithms for biomedical problems.
Brian M. Sadler, PhD.
Brian Sadler, Ph.D., Senior Scientific Director, Pharmacokinetics, Pharmacodynamics, Modeling and Simulation, joined ICON in 2010 and brings 37 years of relevant experience from the perspectives of his previous positions as a PKDM scientist at RTI International, a project pharmacokineticist at GlaxoSmithKline, an instructor and domain expert at a Pharsight, and as the principal and owner of his own pharmacometric consulting company. Dr. Sadler earned his Ph.D. in Pharmacology and B.A. in Biology from the University of Missouri - Columbia.
Indrajit Das, PhD
Indrajit Das holds a PhD. in Physics. He is Scientist I in Pharmacometrics R&D department at ICON Plc, Gaithersburg, MD., where he develops and maintains the population analysis software NONMEM®’s Graphical User Interface and post-processing tool PDx-Pop, incorporating leading edge algorithms using Java, Perl and R. Dr. Das’s focus is on developing and implementing Object Oriented Programming principles and practices such that PDx-Pop seamlessly works with NONMEM.
Fees
- Industry - $1600
- Academia - $1400
- Student - $1200
A discount of 15% is available to groups of 3 or more participants from the same organization.
Registration
Deadline for registration is September 4, 2019. Contact ICON’s Lisa Wilhelm-Lear at Lisa.Wilhelm@iconplc.com for more information and to register.
Workshop - Day 3: New & Advanced Features of NONMEM 7.4 - Sept. 12, 2019 (Select Courses)
The objective of this course is to introduce advanced concepts of population pharmacokinetics in NONMEM. The course is targeted to individuals interested in solving population PK/PD problems using the new stochastic methods. The course is for those who are familiar with classic NONMEM methods (first order (FO)/first order conditional estimation (FOCE)/Laplace), and are familiar with constructing control stream files. Most of the course is instructional, with several hands-on examples for attendee participation. A thorough discussion of stochastic approximation expectation maximization (SAEM), Importance sampling (IMP), and Markov chain Monte Carlo Bayesian analysis (BAYES) will be presented, along with hands-on exercises.
After attending this course, the participant will know how to use advanced stochastic methods for analyzing population PK/PD data; structure the models into a MU-referencing format that will greatly increase the efficiency of the analyses; apply prior information from previous analyses to the present data; create population mixture models; create models for categorical data; use new abbreviated code features for easier modeling of inter-occasion variability; model additional mixed effects levels for grouping individuals, such as inter-clinical site variability; use the new DO loop feature in abbreviated code, such as for handling multiple bolus doses in transit compartment models that use the analytical absorption function.
Additional topics covered are: parallel computing and dynamic memory allocation for efficient memory usage; symbolic referencing to thetas, etas, and sigmas; Monte Carlo search algorithms to improve FOCE estimation; built-in individual weighted residuals; bootstrap tools for simulation; and greater control in average eta shrinkage calculations.
This course and the Beginners/Intermediate course are part of one series. Interested parties may register for the first two days, (Beginners/Intermediate course), the third day (this course), or all three days of workshop courses if desired.
Presenters
Robert J. Bauer, PhD.
Robert Bauer holds a PhD. in Pharmacology. He heads the Pharmacometrics R&D department at ICON Plc, Gaithersburg, MD, where he and his group maintain the population analysis software NONMEM®, incorporating leading edge algorithms in pharmacometrics. Dr. Bauer’s focus is on developing and implementing mathematical and statistical algorithms for biomedical problems.
Brian M. Sadler, PhD.
Brian Sadler, Ph.D., Senior Scientific Director, Pharmacokinetics, Pharmacodynamics, Modeling and Simulation, joined ICON in 2010 and brings 37 years of relevant experience from the perspectives of his previous positions as a PKDM scientist at RTI International, a project pharmacokineticist at GlaxoSmithKline, an instructor and domain expert at a Pharsight, and as the principal and owner of his own pharmacometric consulting company. Dr. Sadler earned his Ph.D. in Pharmacology and B.A. in Biology from the University of Missouri - Columbia.
Indrajit Das, PhD
Indrajit Das, PhD. Indrajit Das holds a PhD. in Physics. He is Scientist I in Pharmacometrics R&D department at ICON Plc, Gaithersburg, MD., where he develops and maintains the population analysis software NONMEM®’s Graphical User Interface and post-processing tool PDx-Pop, incorporating leading edge algorithms using Java, Perl and R. Dr. Das’s focus is on developing and implementing Object Oriented Programming principles and practices such that PDx-Pop seamlessly works with NONMEM.
Fees
- Industry - $800/per day
- Academia - $700/per day
- Student - $600/per day
A discount of 15% is available to groups of 3 or more participants from the same organization.
Registration
Deadline for registration is September 4, 2019. Contact ICON’s Lisa Wilhelm-Lear at Lisa.Wilhelm@iconplc.com for more information and to register.