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A Robust Workflow, Technical Approaches, and Software Tools for Application of QSP in Model-based Drug Development: ACoP6 Tutorial

Sponsored by ISoP QSP SIG; cosponsored by AAPS working group on QSP

(Video of each session listed is available at the links below)

1. Description of the session, including background and scientific importance.

Quantitative Systems Pharmacology (QSP) is seeing increasing adoption and efforts in pharmaceutical sciences and industry. In contrast to traditional pharmacokinetic- pharmacodynamic approaches, the biological scope required to capture the impact of complex systems-level behaviors frequently requires non-parsimonious models and consideration of numerous, diverse data sets. These novel aspects of QSP necessitate different technical workflows and approaches. Furthermore, one practical consideration for implementation is identification of software and tools to support QSP efforts. Critical considerations include: (i) the modeling capabilities of the software (e.g. size and types of models, ability to run large-scale simulations, intuitive user interface, etc.); (ii) software integration with existing IT environment and the cost of the software and technical support; (iii) existing user base and the cost of training; (iv) interoperability with other software tools including model export-import capabilities, availability of existing models

This session presents a robust workflow (illustrated below) that integrates approaches that have been successfully applied in QSP efforts to address many of the novel challenges these efforts face. Technical approaches for each of these stages are discussed. with individual presentations following, to highlight specific applications of these approaches in QSP. One of the aspects of this technical workflow, specifically consideration of software tools for implementation of the model, will then be discussed in additional short talks by representatives from multiple software organizations. Finally the session will conclude with a roundtable discussion on these subjects.

2. Learning objectives
a. Understand how a multi-step workflow in the application of QSP can address many of the technical challenges unique to systems modeling
b. Gain exposure to specific technical approaches that can be applied in each stage of the workflow and how these approaches have been applied in specific QSP-based research in industry and academia
c. Gain information to guide software evaluation and selection for QSP efforts
d. Learn how different software platforms address QSP models and challenges

3. Video Sessions

Dr. Saroja Ramanujan (Princ. Sci. PKPD, Genentech Inc) Introduction to session and workflow discussion (5 mins)

Dr. Kapil Gadkar (Sr. Scientist, PKPD, Genentech Inc): “A proposed workflow for robust development and application of QSP models” (25 mins)

Dr. Julio Saez-Rodriguez (Sys. Biomedicine Group Leader, Eur Bioinfo Inst) “Exploration of alternate model structures in QSP” (25 mins)

Dr. Stephan Schmidt (Asst. Prof. of Pharmaceutics, Univ of Fla): Analysis Methodologies in QSP” (25 mins)

d. Dr. Richard Allen (Princ. Sci, CVMED, Pfizer Inc): “Efficient Generation of virtual populations of CKD patients and application in Systems Pharmacology” (25 mins)

Co-chair intro to software discussion Dr. Sergey Ermakov, (5 mins)

Dr. Fulden Buyukozturk, Mathworks, and Dr. Christina Friedrich, Rosa, “Enabling and streamlining QSP workflows with SimBiology and MATLAB” (20 mins)

Dr. Michael Block, Bayer Technology Services, “Modeling platforms: How can they provide guidance for the drug development process” (20 mins)

Mr. Steven Chang, Immunetrics, “Slaying the hydras of QSP model development." (20 mins)

I could not find the links of each session.

Coming soon.
We are awaiting release forms from the authors