Systems Pharmacology

Dosing regimen optimisation for oseltamivir in immunocompromised paediatric patients with influenza: Extrapolation of efficacy

Jordie EB, Gibiansky L, Knab T, Lemenuel-Diot A, Ravva P, Zwanziger E, Jolivet S, Bhardwaj R, Hernández-Sánchez J, Nasmyth-Miller C, Sturm S. Br J Clin Pharmacol. 2021;1-13. doi:10.1111/bcp.15059

Brexpiprazole Pharmacokinetics in CYP2D6 Poor Metabolizers: Using Physiologically Based Pharmacokinetic Modeling to Optimize Time to Effective Concentrations

Elmokadem A, Bruno CD, Housand C, Jordie EB, Chow CR, Lesko LJ, Greenblatt DJ.  J Exp Pharmacol.  2021; 1– 10. doi:10.1002/jcph.1946

CPT: Pharmacometrics & Systems Pharmacology – Inception, Maturation, and Future Vision.

Rowland Yeo K, Hennig S, Krishnaswami S, Strydom N, Ayyar VS, French J, Sinha V, Sobie E, Zhao P, Friberg LE, Mentré F.
CPT Pharmacometrics Syst Pharmacol. 2021 Jul;10(7):649-657. doi: 10.1002/psp4.12680.

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.

A Semi-physiological Population Pharmacokinetic Model Developed Using Clinical Dose Escalation and Dose Confirmation Data for an Oral Fixed-Dose Combination of CDA Inhibitor Cedazuridine with Decitabine (ASTX727) in Subjects with Myelodysplastic Syndromes

Eric Burroughs Jordie, Ahmed Elmokadem, Mohammad Azab, and Aram Oganesian

Presented by Eric Jordie at American Conference on Pharmacometrics 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-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.

Systems Pharmacology: A day in the life

Riggs MM. Slides presented at AAPS Forum to Connect Predictive Modelers in Boston, MA. 6 May 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

A perspective on the state of pharmacometrics and systems pharmacology integration

Trame MN, Riggs MM, Biliouris K, Marathe D, Mettetal J, Post TM, Rizk ML, Visser SAG, Musante CJ.  CPT Pharmacometrics Syst Pharmacol. doi:10.1002/psp4.12313. 21 August 2018.

Systems pharmacology model development to provide physiologically based interpretation and drug development decision support in osteoporosis and other bone mineral-related diseases

Riggs, M.  Presented at Pharmacology 2016, annual meeting of the British Pharmacological Society, London, December 2016.

Comparing the performance of four open-source methods for multiple parameter estimation in a systems pharmacology model

Eudy RJ, Riggs MM, Baron K.  Presented at the Sanofi–MSISB Mount Sinai Systems Pharmacology Symposium, June 2016.

Simulation from ODE-based population PK/PD and systems pharmacology models in R with mrgsolve

Baron KT and Gastonguay MR.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA; October 2015.

Linking a mechanistic model of bone mineral density to a time-to-event model of fracture

Eudy RF, Gillespie WR, Riggs MM, Gastonguay MR.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA; October 2015.

Modeling & simulation: Filling the knowledge gap in rare diseases. Return on Investment on the Utilization of Systems Pharmacology and pharmacometrics in drug development for rare diseases: challenges and opportunities

Gastonguay MR and Godfrey CJ.  American College of Clinical Pharmacology (ACCP) Workshop, September 26, 2015.

Connecting the dots: Linking osteocyte activity and therapeutic modulation of sclerostin by extending a multiscale systems model

Eudy RJ, Gastonguay MR, Baron KT, and Riggs MM.  CPT: Pharmacometrics & Systems Pharmacology. 2015;4(9):527-536. doi:10.1002/psp4.12013.

Sclerostin-mediated osteocyte control in bone remodeling: Extension of a multiscale systems model to consider new therapies for osteoporosis

Eudy RJ, Gastonguay MR, Baron KT, Riggs MM.  Presented at the Annual Meeting of the Population Group in Europe (PAGE), Hersonnisos, Greece; June 2015.

FDA advisory meeting clinical pharmacology review utilizes a quantitative systems pharmacology (QSP) model: A watershed moment?

Peterson MC and Riggs MM.  CPT: Pharmacometrics & Systems Pharmacology, 2015 Mar; 4(3).

Extensions of a multiscale systems pharmacology model of bone mineral balance and its regulation of bone health

Riggs MM. Presented at Sunrise Session: Integration of Systems Modeling in Clinical Development: Successes, Challenges, and Future Outlook at the American American Society for Clinical Pharmacology and Therapeutics Annual Meeting, 2013.

Systems pharmacology model development to provide physiologically-based interpretation and drug development decision support in osteoporosis and other bone-related diseases

Riggs M.  Presented at the Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, 2013.

An evaluation of calcilytic effects on parathyroid hormone and bone mineral density response using a physiologically-based, multiscale systems pharmacology model

Kyle T. Baron, Matthew M. Riggs, Ryoko Sawamura, Takako Shimizu, Fumihiko Okada, Jin Zhou, Takahiro Shibayama, Mendel Jansen. Presented at the American Society of Bone and Mineral Research (ASBMR), October, 2013.

Predicting nonlinear changes in bone mineral density over time using a multiscale systems pharmacology model

Peterson MC and Riggs MM. CPT Pharmacometrics Syst Pharmacol. 2012 Nov; 1(11): e14. Published online 2012 Nov 14. doi: 10.1038/psp.2012.15

Integrated pharmacometrics and systems pharmacology model-based analyses to guide GnRH receptor modulator development for management of endometriosis

Riggs MM, Bennetts M, van der Graaf PH, and Martin SW.  CPT Pharmacometrics Syst Pharmacol. 2012 Oct; 1(10): e11. Published online 2012 Oct 17. doi: 10.1038/psp.2012.10

Qualification of a physiologically-based model for predicted bone marker and bone mineral density changes associated with denosumab treatment

Riggs MM, Baron KT, Plan EL, Gastonguay MR. Presented at American Society of Bone Mineral Research (ASBMR) Annual Meeting, Minneapolis, MN; October 14, 2012 (Abstract SU0363).

Bayesian joint modeling of bone mineral density and repeated time-to-fracture event for multiscale bone systems model extension

Plan EL, Baron KT, Gastonguay MR, French JL, Gillespie WR, and Riggs MM. Presented at the 21st Annual Meeting of the Population Approach Group Europe (PAGE), Venice, Italy, 2012, Abstract 2592.

Systematic extension of a physiologic model of bone and calcium homeostasis

Riggs MM. . Presented at the AAPS Biotechnology Conference, San Diego, CA; May 22, 2012.

Multiscale physiology-based modeling of mineral bone disorder in patients with impaired kidney function

Riggs MM, Peterson MC, Gastonguay MR. The Journal of Clinical Pharmacology. 52(1 Suppl):45S-53S. January 2012. doi:10.1177/0091270011412967

 

Applying a multiscale physiologic system model to evaluate bone-related disease and therapeutic responses

Riggs MM. Presented at First Indiana Clinical and Translational Sciences Institute (CTSI) Symposium on Disease and Therapeutic Response Modeling. Indiana University – Purdue University Indianapolis; Indianapolis, IN; 13 November 2011.