Open Science

Data Gaps, Model Mishaps: Quantifying the Impact of Missing Pharmacometrics Data on Pharmacodynamic Projections.

Presented at ACoP 2024. In this analysis aimed to evaluate the ability to estimate robust population PD parameters and a landmark endpoint in different scenarios. In the primary workflow different levels of missing PK data were tested. Additionally, varying degrees of of individual-level and residual variability were tested. Finally, scenarios with smaller populations were tested. In all scenarios, PD parameters and endpoints could be estimated with adequate accuracy and precision.

Accounting For Dose Modifications In Exposure-Response Analyses In Oncology: The Case Example Of Brigimadlin.

Presented at ACoP 2024. A Bayesian model of the probability of dose modification as a function of platelet and neutrophil counts was developed to characterize the dynamic and probabilistic nature of dose decisions. The dose modification model was successfully integrated into a dynamic simulation framework accounting for the impact of safety on dose.

A showcase of open-source tools for scalable, reproducible PMx workflows

Kyle Baron, Sam Callisto, Seth Green, Matthew Riggs. A showcase of open-source tools for scalable, reproducible PMx workflows. Pre Meeting Workshop presented at 2022 American Conference on Pharmacometrics (ACoP13). 30 October 2022.

Development and validation of open-source pharmacometrics software using an iterative software development life cycle methodology: the pmtables R package for submission-ready table generation

Kyle T. Baron, Devin Pastoor, Anna Nevison, Katherine Kay, Marc R. Gastonguay. Poster presented at Population Approach Group Europe Annual Meeting; 2-3 and 6-7 September 2021.  Poster III-02.

Torsten: Stan functions for pharmacometric applications – Improvements and new R interface workflow

Yi Zhang and William R. Gillespie.  Poster presented at Population Approach Group Europe Annual Meeting; 2-3 and 6-7 September 2021.  Poster I-61.

Theory, Empiricism, Certain Random Events, and a Vision for the Continued Growth of Pharmacometrics

Presentation by Marc Gastonguay for the ASCPT Sheiner-Beal Award during the American Society for Clinical Pharmacology (ASCPT) annual meeting, March 11, 2021.

Development and evaluation of a predictive model of hyperphosphatemia induced by inhibition of FGFR by extending an existing multiscale systems pharmacology

Matthew M. Riggs, Howard A. Ball, Kanji Komatsu, Akihiro Yamada.  Poster presented at 2020 American Conference on Pharmacometrics (ACoP11) virtual meeting. 10 November 2020.

Model code and supporting material is available here.

Toward Progress in Quantitative Translational Medicine: A Call to Action

Venkatakrishnan, Karthik, Songmao Zheng, Cynthia J. Musante, Jin Y. Jin, Matthew M. Riggs, Sriram Krishnaswami, and Sandra A. G. Visser. 2020. “Toward Progress in Quantitative Translational Medicine: A Call to Action.” Clinical Pharmacology and Therapeutics 107 (1): 85–88.  Available from: https://doi.org/10.1002/cpt.1687

Quantitative Systems Pharmacology and Physiologically Based Pharmacokinetic Modeling With mrgsolve: A Hands-On Tutorial

Elmokadem, A., Riggs, M. M. and Baron, K. T. (2019), Quantitative Systems Pharmacology and Physiologically‐Based Pharmacokinetic Modeling With mrgsolve: A Hands‐On Tutorial. CPT Pharmacometrics Syst. (2019) 8, 883–893.  Available from: https://doi.org/10.1002/psp4.12467

A completely open-source pharmacometrics tool set: Moving from vision to reality with R, mrgsolve and Stan/Torsten

Presentation by Marc Gastonguay, Ph.D. and William Gillespie, Ph.D., at 2019 American Conference on Pharmacometrics (ACoP10) in Orlando, FL during the tutorial: Pharmacometrics Goes Open-Source. 24 October 2019.

Considerations and Future Directions for the Development of Open-Source, Public License, Pharmacometric Software

Presentation by Marc Gastonguay, Ph.D. at 2019 American Conference on Pharmacometrics (ACoP10) in Orlando, FL. 21 October 2019.

Considerations for Assuring Quality Tools and a Proposal for Open Software Development Standards

Presentation by Marc Gastonguay, Ph.D. at 2019 American Conference on Pharmacometrics (ACoP10) in Orlando, FL. 20 October 2019.

Bridging Knowledge Gaps in PBPK through Open Science

Presented by Marc Gastonguay, Ph.D at Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision -Making Sponsored by the Office of Clinical Pharmacology OTS, CDER, U.S. Food and Drug Administration (FDA) on 18 November 2019. Event information here. Slides are here

Transparent, Open and Reproducible PBPK and QSP Modeling and Simulation Using an R-Based Framework

Presented by Ahmed Elmokadem, Ph.D at the 9th Annual CTSI Disease and Therapeutic Response Modeling and Simulation Symposium at Indiana University School of Medicine on November 12, 2019. Event details can be found here.

Open Systems Pharmacology Community—An Open Access, Open Source, Open Science Approach to Modeling and Simulation in Pharmaceutical Sciences

Lippert, J. , Burghaus, R. , Edginton, A. , Frechen, S. , Karlsson, M. , Kovar, A. , Lehr, T. , Milligan, P. , Nock, V. , Ramusovic, S. , Riggs, M. , Schaller, S. , Schlender, J. , Schmidt, S. , Sevestre, M. , Sjögren, E. , Solodenko, J. , Staab, A. and Teutonico, D. (2019), Open Systems Pharmacology Community—An Open Access, Open Source, Open Science Approach to Modeling and Simulation in Pharmaceutical Sciences. CPT Pharmacometrics Syst. Pharmacol, 2019, 8 (12): 878–882.  Available from: https://doi.org/10.1002/psp4.12473

 

 

Considerations and Future Directions for the Development of Open-Source, Public License, Pharmacometric Software

Presented by Marc Gastonguay, Ph.D. at ACCP Annual Meeting September 17, 2019.

Leveraging Multiple R Tools to Make Effective Pediatric Dosing Decisions

Fisher, Jeannine. Presentation at R/Pharma. Cambridge, MA. 22 Aug 2019.

Open-Source and Open-Science to Progress the Integration of Pharmacometrics and Systems Pharmacology

Riggs, Matthew. Presentation at ISoPNE iPSP event. Cambridge, MA. 26 Aug 2019.

Development of an open-source physiologically-based pharmacokinetic model to predict maternal-fetal exposures of CYP450-metabolized drugs

Gastonguay MS, Russell S, Freling R, Riggs M, Kay K, Utsey K, Elmokadem A.

Poster presented at 2019 American Society for Clinical Pharmacology & Therapeutics (ASCPT). Washington DC. 14 March 2019.

Poster presented at ISoP Regional QSP Day 2019. Princeton, NJ. 16 July 2019.

When learn/confirm leads to expand/understand: The expanding role of quantitative systems pharmacology in the betterment of therapeutics development

Riggs MM. Clin Pharmacol Ther. 98:394. 18 December 2018. doi: 10.1002/cpt.1287

Open and transparent pharmacometrics publication process

Gastonguay MR, Riggs MM. Lightning talk presented at International Society of Pharmacometrics New England 2018. Cambridge, MA. 12 Sep 2018.