May 4-6, 2017
Niagara Falls, NY
This introductory population PK training workshop has been designed to provide the necessary information to successfully implement population pharmacokinetic methodology in a drug development program and to provide the foundation for understanding the basics of NONMEM coding and interpretation of NONMEM output.
The material is structured to impart both the theoretical and practical aspects of the population approach and is versatile so that participants with diverse backgrounds and areas of expertise may benefit. Examples of the use of population PK studies in drug development programs will be presented to provide specific details of various implementations and better illustrate essential aspects of population PK methods. Emphasis will be placed on compliance with the FDA’s Guidance for Industry on Population PK and the EMA’s Guideline on Reporting the Results of Population PK Analyses; participants will gain an appreciation for the essentials of accurate and sufficient data collection and learn how to proactively plan in order to maximize study effectiveness.
The workshop content is provided as a combination of formal lectures, review of data, code, and data analysis results, in addition to hands-on exercises. Participants will use their own laptop computers, with which they will be able to practice coding control streams, running various models, and evaluating the results. A thorough examination of an example dataset, from development of the structural and statistical models through covariate analysis will be covered. Overall, this workshop will provide the participants with a comprehensive understanding of the population PK approach to data analysis, its usefulness and added value in drug development, as well as when and where to employ population PK methods and sparse sampling within a given development program.
Following the workshop, the participant should be able to:
The workshop is organized and taught by experienced pharmacometricians from Cognigen Corporation, also affiliated with the University at Buffalo Department of Pharmaceutical Sciences. Cognigen Corporation, a wholly owned subsidiary of Simulations Plus, Inc., has been providing clinical pharmacology and pharmacometric consulting services, including population PK/PD modeling and simulation to the global pharmaceutical industry for over 20 years to generate and communicate the knowledge required for time-sensitive decision-making and regulatory review.
The course is organized and taught by Jill Fiedler-Kelly, co-author of Introduction to Population Pharmacokinetic / Pharmacodynamic Analysis with Nonlinear Mixed Effects Models (John Wiley & Sons Inc., 2014).
|Thursday, May 4||Friday, May 5||Saturday, May 6|
|08:00-08:35||Continental Breakfast||08:00-08:30||Continental Breakfast||08:00-08:30||Continental Breakfast|
|08:35-08:45||Welcome and Introduction to the Workshop||08:30-09:15||Discuss Control Stream and Dataset Exercise||08:30 -09:00||Forward Selection Exercise (cont’d)|
|08:45-09:45||The Population Approach in Drug Development||09:15-09:50||Exploratory Data Analysis||09:00-09:40||Data Review: Forward Selection Results and Multivariable Model Checking|
|09:45-10:20||Population Modeling Basics||09:50-10:20||Exercise: Introduction to KIWI||09:40-10:20||Exercise: Backward Elimination of Covariate Effects|
|10:40-11:50||NONMEM® Terminology||10:40-11:25||Running NONMEM® and Interpreting the Output||10:40-11:20||Backward Elimination Exercise (cont’d)|
|11:50-12:45||Estimation Methods in NONMEM®||11:25-11:35||Data Review: Introduction to the Example Dataset and Exploratory Data Analysis||11:20-12:00||Applications of Bayesian Parameter Estimation|
|12:45-01:45||Lunch||11:35-12:30||Exercise: Developing a Base Structural Model||12:00-01:00||Lunch|
|01:45-03:15||Brief Overview of the NONMEM® Program and Writing an NM-TRAN Control Stream
||12:30-01:30||Lunch||01:00-02:50||Diagnosing Errors, Model Checking, Model Refinement, and Model Evaluation Techniques|
|03:15-03:35||Break||01:30-02:00||Base Structural Model Exercise (cont’d)||02:50-03:00||Data Review: Backward Elim & Model Refinement|
|03:35-04:05||NM-TRAN Lecture (cont’d)||02:00-02:10||Data Review: Base Model||03:00-03:20||Break|
|04:05-05:20||NONMEM® Dataset Structure||02:10-02:45||Model Diagnostic Plots||03:20-03:40||Pharmacometric Analysis Planning and Population PK/PD Modeling and Simulation|
|05:20-05:30||Exercise: Writing Control Streams and Diagnosing Dataset Problems||02:45-03:05||Break||04:20-04:30||Wrap-up and Final Q&A|
|03:05-03:35||Model Selection and Covariate Evaluation – Part 1: The Covariate Assessment Process|
|03:35-04:25||Covariate Evaluation–Part 2: Functional Forms|
|04:25-04:40||Data Review: Introduction to Covariate Analysis and Coding Issues|
|04:40-05:30||Exercise: Forward Selection of Covariate Effects|
The fee is $2,500. A US government employee rate of $1,900 and student rate of $1,200 is available for up to three (3) participants of each type. The registration fee includes hard-copy course documentation, USB drive with code examples, and a copy of the textbook, Introduction to Population Pharmacokinetic/Pharmacodynamic Analysis with Nonlinear Mixed Effects Models by Owen and Fiedler-Kelly (John Wiley & Sons Inc., 2014).
Continental breakfasts, lunches and break-time refreshments during the course are included.
Cognigen Corporation will sponsor an evening excursion, including dinner, on Thursday, May 4.
Cancellations with a full refund may be made until March 13, 2017. No refunds will be given for cancellations received after this date. Substitutions may be made at any time
Laptop computers required to fully participate in hands-on exercises. Minimum configuration required: Google Chrome with Flash 9+ plugins.
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 3, 2017
Contact UB course secretary Suzette Mis at (716) 645-4831 or firstname.lastname@example.org if you need assistance.