ACoP7-Workshop: Industrialization and Knowledge Management of Pharmacometric Analyses

ACoP7 Meeting, October 23rd Sunday, 08:00-17:00, Hyatt Regency, Bellevue, WA, US

Workshop Description

Pharmacometric analyses have become an integral part of drug development and the decision making process across the pharmaceutical industry.

Even though, many of the pharmacometric analyses are fairly similar in nature, there is a large heterogeneity in the planning and conduct of these analyses on the level of individual modelers. The outcome of the current approach to modeling and simulation in Pharmacometrics is that even fairly standard analyses are very time and resource consuming, often placing the pharmacometric analysis results on the critical path, potentially leading to the inability to support a go/no go, a phase III dose selection, other investment decisions, or causing potential delays to regulatory filings.

Heterogeneity of approaches is not only observable in the conduct of pharmacometric activities, but also in the way ongoing and finalized activities and associated material (models, code, outputs, documentation, etc.) are stored. In many organizations it would be very difficult to find all required information about an ongoing modeling project if the modeler in charge would leave the company or not be available for some time and the project would need to be taken over by someone else, requiring considerable re-work.

Industrialization and knowledge management approaches have the potential to reduce regulatory risks, leverage excellence, create a platform for improved quality, consistency, compliance, improve turn-around time of pharmacometric deliverables, and reduce costs.

This workshop is designed to provide an introduction to the vision behind industrialization and knowledge management approaches in Pharmacometrics. Relevant examples will be discussed and demonstrated. All examples, code, models, scripts will be provided along with all slides to allow the interested participant to re-use examples for own purposes. Examples will both be R and MATLAB based and use both NONMEM and MONOLIX as a parameter estimation tool at the back-end. No expertise in NONMEM or MONOLIX is required to follow this workshop or for execution and understanding of the provided examples. Experience with R and/or MATLAB is beneficial.

 

Presenters

Nidal Nidal Al-Huniti, PhD. Senior Director, Quantitative Clinical Pharmacology AstraZeneca, 35 Gatehouse DR, Waltham, MA 02451
Wenping Wang, PhD. Executive Director, Pharmacometrics, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936-1080, USA
H2 Henning Schmidt, PhD. IntiQuan CEO; Engineer by training with a long background in modeling of a wide range of general linear and non-linear systems (automotive & process industry, biological, physiological and pharmacological systems), using both modeling and simulation results as a basis for impactful quantitative support of decision making in large and small, early and late phase projects. Developer of the Systems Biology Toolbox for MATLAB, a standard tool in the area of Systems Biology and Systems Pharmacology modeling.

 

Program

October 23rd Sunday
Time Topic Presenter
7:00-8:00 Continental Breakfast (Regency F&G Room) Open for all attendees
8:00-8:15 Opening remarks on vision of Industrialization and Knowledge management within Pharmacometrics Nidal Al-Huniti
8:15-9:15 Knowledge management of pharmacometric activities

  • Structure and organization of analysis projects (Reproducibility, Compliance, Review-friendliness, Flexibility & Simplicity)
  • Documentation of pharmacometric analysis activities (Institutional Memory)
  • “Modeling datasets: Bottleneck and information grave”: Improving time to dataset specification, preparation, checking, and analysis through the use of a General Dataset Format
Henning Schmidt
9:15-9:30 Break
9:30-12:00 Application of industrialization approaches and relevant examples in MATLAB, NONMEM, and MONOLIX

  • General introduction to IQM Tools – a freely available and open source MATLAB package, providing functionality for seamless transition from systems biology, systems pharmacology to pharmacometric modeling and simulation approaches, data analysis, and reporting
  • Examples for efficient conduct of typical modeling and simulation activities
    • Basic pharmacometrics: interface to NONMEM & MONOLIX, model diagnostics, VPC, bootstrap, covariate search, simulations
    • Pharmacometric popPK workflows
    • Clinical Trial Simulation
    • Systems pharmacology models: representation, simulation, parameter estimation
    • Automatic report generation

All example code, scripts, models, data, software, and slides will be shared with the participants. In case a participant would like to have a hands-on experience during the workshop, an installation of MATLAB and MONOLIX or NONMEM is needed. Each participant will obtain a copy of IQReport and a licence key valid for 6 months.

Henning Schmidt
12:00-13:00 Break
13:00-15:00 Industrialization of Pharmacometric Analyses and Reporting using R. Hands-on Example.

All example code, scripts, models, data and slides will be shared with the participants. In case a participant would like to have a hands-on experience during the workshop, an installation of R is needed.

Nidal Al-Huniti
15:00-15:15 Break
15:15-16:45 PMXStan and nlmixr: open-source PKPD modeling tools on R Wenping Wang
16:45-17:00 Concluding Remarks Nidal, Wenping, Henning

 

Registration

Workshop location: The workshop will be held at the Hyatt Regency, Bellevue, WA, US, which is the venue for the ACoP7 meeting.

Workshop fee: Regular fee 600 USD. This includes workshop material, coffee breaks, and lunch. Students/Academia/Government/Non-profit employees may enroll at a fee of 300 USD.

Registration: This is a pre-meeting workshop that requires registering for the ACoP 2016 meeting. Please register ASAP in view of the limited course capacity.

Contact: Henning Schmidt, IntiQuan GmbH, Oetlingerstrasse 161, 4057 Basel, Switzerland; Phone: +41 76 603 28 06; Email: henning.schmidt@intiquan.com.