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A 3-Day Introductory Workshop in Population PK Data Analysis

A Hands-on Course Using NONMEM®

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.

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Workshop Synopsis

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.

Learning Objectives

Following the workshop, the participant should be able to:

  1. Understand the conceptual basis and rationale for the population approach to data analysis, its benefits and advantages, including where and when population methods may be optimally applied during drug development
  2. Write, execute, and de-bug basic NONMEM® control streams for structural PK models
  3. Outline the requirements and understand the format for basic NONMEM® datasets
  4. Understand the importance of exploratory data analysis (EDA) and the interpretation of standard goodness-of-fit diagnostic plots
  5. Perform covariate analyses to evaluate determinants of variability by understanding, identifying, and coding basic functional forms for covariate-parameter relationships
  6. Understand the basis for model selection strategies and discriminate between candidate models on the basis of both quantitative and qualitative factors
  7. Understand and interpret NONMEM® output, including error messages, and have insight into potential model refinement issues

Course Instruction

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).

Agenda

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
10:20-10:40 Break 10:20-10:40 Break 10:20-10:40 Break
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    

Registration Details

Workshop Fee

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

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

Computer Requirements

Laptop computers required to fully participate in hands-on exercises. Minimum configuration required: Google Chrome with Flash 9+ plugins.

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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