Dynamic Dosing in Onco

While dose modification occurs in many therapeutic areas, it is a nearly universal feature in oncology.  Flexibility under the protocol is granted to modify dose amounts, frequency, or even pause dosing altogether with the intent of allowing a patient to remain on therapy, particularly when alternatives are scarce. These deviances of actual versus nominal dosing present unique challenges to analyses.  When a patient progresses, was it because the drug was ineffective or because dose intensity fell short?  Can we leverage exposure response and toxicity mitigation strategies employed by the clinicians to recommend best practices to future clinicians and patients?

Presented at ACCP Annual Meeting 2025. This work showcases the OptiDose method in mrgsolve, enabling efficient and systematic optimization of dosing regimens with respect to both efficacy and safety considerations. By optimizing across multiple clinical endpoints and patient preferences, these model-informed strategies can guide patient-centered dosing decisions in oncology.

Presented at the PGRN 2025 Scientific Meeting, held in collaboration with ClinPGx, September 10–12, 2025 at the University of Montana in Missoula, where together leaders in pharmacogenomics and clinical pharmacology came together to advance the science and practice of precision medicine.

Pharmacogenetics (PGx) provides critical insights into how genetic variability influences drug metabolism, disposition, and response. This presentation highlights how when incorporated into population PK models, PGx information can:

• Identify subgroups with distinct pharmacokinetic profiles
• Improve predictions of individual dose–response relationships
• Support precision dosing strategies that optimize efficacy while minimizing toxicity

Integrating PGx into quantitative modeling is a powerful step toward making personalized medicine a clinical reality.

Parkinson’s disease remains a complex and poorly understood condition, with critical gaps in our knowledge of disease progression, heterogeneity, and mechanisms of action for existing therapies. To address these challenges, we are launching a collaborative, patient-led effort to develop a QSP model for PD—incorporating real-world patient experiences, clinical insights, and crowdsourced literature review within a secure digital research environment. This initiative aims to accelerate the development of more precise, mechanism-informed therapeutic strategies for the PD community.

This study presents a validated whole-body PBPK model characterizing drug-drug interactions (DDIs) involving posaconazole, a broad-spectrum antifungal, in individuals with normal weight and obesity. Findings highlight a prolonged half-life and irreversible CYP3A4 inhibition in patients with BMI ≥35 kg/m², underscoring the increased risk of DDIs even after discontinuation. The model supports optimized dosing and risk assessment for co-administered CYP3A4-sensitive drugs.

This work illustrates how integrated population PK modeling of antibody-conjugated payload and free payload analytes for an ADC can inform development strategies for targeted therapies—particularly in complex oncology settings.

Presented at ASCPT Annual Meeting 2025. The virtual population-based lymphoma QSP model enabled systematic exploration of alternate drug combinations, dosing schemes, clinical covariates and resultant effect on anti-tumor activity in silico. The results of the LOTIS-7 study (NCT04970901), a platform study evaluating loncastuximab tesirine in combination with glofitamab, will soon be available to assess the accuracy of the model predictions.

Presented at ASCPT 2025 Annual Meeting. Neural networks can be integrated with traditional pharmacometric models using several free open-source programming languages. Both Julia and R environments are suitable platforms, but there are tradeoffs regarding development speed, built-in capabilities, and documentation. DCM simplifies the covariate modeling process and uncovers complex, non-linear relationships in computationally efficient workflows.

A companion poster to the ASCPT print copy, this visual presentation emphasizes the simulation approach used to evaluate individualized dosing strategies and their economic implications. Results underscore the importance of reducing discontinuation rates to enhance value.

This poster presents a modeling framework linking target product profile characteristics to cost-effectiveness outcomes in early drug development for atopic dermatitis. It highlights how persistence of therapy, more than efficacy metrics, may improve cost utility of new treatments.

This study uses pharmacometric and pharmacoeconomic modeling to explore the cost effectiveness of individualized dosing for a hypothetical new atopic dermatitis drug compared to dupilumab. Simulation scenarios tested the impact of treatment discontinuation rates, efficacy variability, and pricing on cost utility outcomes.

This work tackles a central challenge in oncology drug development: predicting  benefit-risk for dosing regimens that have not yet been studied. Semi-mechanistic modeling can be used for this purpose, but model validation is complicated by the presence of safety-driven dose modifications—such as delays and reductions—commonly observed in real-world settings.

Co-developed with CSL Behring, this research introduces a high-resolution model that simulates hepatocyte turnover,  episomal retention and coagulation factor IX (FIX) expression  in virtual patients treated with Etranacogene Dezaparvovec ( HEMGENIX).  The model captured clinical variability before recent clinical readouts were available, and projects FIX expression durability  over two decades.

This piece explores the evolving role of AI across the drug development continuum—from explainable ML models to immune digital twins. The article reinforces that scientific rigor and innovation go hand in hand. AI tools are accelerating time to insight, helping teams make smarter, faster, and more ethical decisions in complex therapeutic areas.

This paper contributes to the oncology MIDD field by using robust exposure-response modeling to identify the optimal dosing regimen for HER3-DXd in EGFR-mutated NSCLC. Analyzing data from over 700 patients across four studies, it demonstrates that 5.6 mg/kg Q3W offers a favorable balance of efficacy and safety. The analysis incorporates patient covariates and compares fixed and up-titration regimens, supporting data-driven selection. These methods align closely with the goals of Project Optimus, emphasizing the importance of modeling and simulation in selecting doses that are both effective and tolerable, rather than defaulting to the maximum tolerated dose.

While the application of MIDD has grown, there have been no clear examples across programs to demonstrate its value at the portfolio level. This manuscript offers a methodology and examples to demonstrate MIDD value in terms of time and cost savings.

Presented at the ENAR 2025 Spring Meeting. Monitoring vaccine effectiveness (VE) against emerging variants is critical, but traditional methods can take substantial time to implement. This presentations includes an approach that leverages dynamic case-control sampling to provide timely VE estimates–helping public health officials make more informed decisions.

Presented at the Indiana CTSI Pharmacometrics Modeling and Simulation Symposium 2025. Dr. Tim Waterhouse explores the complexities of modeling an antibody-drug conjugate (ADC) for targeted cancer treatment, covering pharmacokinetics models with multiple clearance pathways and exposure-response models in a Bayesian framework.

Presented at the Boston Society Gene and Cell Therapy Conference 2025. The development landscape for cell therapies is rapidly evolving, driven by scientific advancements and increasing competitive pressures. Modeling and simulation technologies are playing a critical role in navigating this dynamic environment.

Explore real-world applications of LLM-driven multi-agentic workflows in clinical pharmacology, pharmacometrics, and translational sciences. These semi-autonomous AI systems are designed to streamline decision-making, optimize workflows, and ultimately accelerate the development of safe and effective medicines for patients in need. 

DZIF-10c (BI 767551) is a SARS-CoV-2-neutralizing recombinant monoclonal antibody designed for both systemic and respiratory tract exposure via intravenous infusion and inhalation. A semi-mechanistic population pharmacokinetic model integrated preclinical and clinical data using allometric scaling to characterize lung and systemic exposure profiles. Simulations showed that inhalation offers effective lung exposure at lower doses, while combining inhalation with intravenous therapy achieves sustained levels in both lungs and systemic circulation, optimizing treatment outcomes.

Presented at ACoP 2024. The Bone Health QSP model was extended by incorporating XLH disease mechanisms and burosumab impact on serum phosphate and other biomarkers using clinical data from adult and pediatric patients with XLH. The model reproduced clinically observed changes in pharmacodynamic markers in both adult and pediatric patients with XLH; normalization of serum phosphate with burosumab treatment was successfully replicated, facilitating a better understanding of burosumab dosing in patients with XLH going forward. The model could potentially be used to optimize treatment in the clinical setting.

Presented at ACoP 2024. Efavirenz is metabolized primarily by CYP2B6, to form 8-OH EFV, and also by CYP2A6, to form 7-OH EFV. Upon chronic administration, efavirenz induces both CYP2B6 and CYP2A6, leading to autoinduction of its metabolism. A population pharmacokinetic model was constructed to quantify the impact of CYP2B6 phenotype on efavirenz autoinduction and subsequent exposure.

Presented at ACoP 2024. The poster introduces a framework for developing physiologically based pharmacokinetic (PBPK) models that incorporate partial differential equations (PDEs) to account for spatial drug distribution, using open-source Julia tools. This approach simplifies the integration of spatial components into PBPK models, demonstrated through a case study on naphthalene diffusion, and is applicable to various pharmacometric models requiring spatial considerations, such as topical, inhaled, and antitumor therapies.

Presented at ACoP 2024. This poster describes additions to mrgsolve to facilitate adaptive dosing simulations. A case study is also presented where these tools were utilized to evaluate dose adjustment guidance for valemetostat in patients with non-Hodgkin lymphoma.

Presented at ACoP 2024. This poster describes the scientific project management role in MIDD and it’s benefits over a traditional project management approach.

Presented at ACoP 2024. A proof-of-concept was conducted using deep reinforcement learning to optimize vancomycin dosing based on predicted PK profiles. The reinforcement learner was able to produce dose recommendations that (on average) exceeded the standard-of-care recommended dose, and future opportunities for using reinforcement learning within pharmacometrics are vast with a large potential for impact through personalized dosing.

Presented at ACoP 2024. This poster described a QSP model that predicted the efficacy of loncastuximab tesirine (an antibody-drug conjugate) and mosunetuzumab/ glofitamab (T cell engagers) combination therapy, following the protocol of ongoing LOTIS-7 clinical trial. The model predicted keeping patients on combination therapy for longer but reduced the loncastuximab tesirine per treatment cycle would yield more tumor volume reduction.

Presented at ACoP 2024. Early drug development decision making, such as the definition and assessment of target product profile characteristics, rarely includes pharmacoeconomic (PE) considerations. The disciplines of phamacometrics (PM) and PE are closely aligned and intersect at the goal of a quantitative understanding of the system. Connection of these two disciplines is a logical extension of typical PM objectives and should lead to a more complete and accurate understanding of the probability of success for new therapeutics.

Presented at ACoP 2024. SHAP analyis, an interpretable ML technique, was applied to PopPK models with two examples: saturable PK and causal dependence in covariates. This analysis yieled insights beyond forest plots and clairified differences in different types of forest plots typically presented.

Presented at ACoP 2024. A longitudinal joint model of modified mayo scores and dropout for patients with ulcerative colitis receiving etrasimod was developed in two Phase 3 studies. This poster presents the development of the model in a Bayesian framework, illustrating the ability of the model to adequately describe changes in efficacy scores in the presence of a spike in dropout at the end of a maintenance phase.

Presented at ACoP 2024. The poster presents a framework for pharmacometric and quantitative systems pharmacology (QSP) model composition using open-source Julia tools. This framework allows for seamless integration and reuse of independent model components, facilitating the creation of complex models from simpler ones, and demonstrating applications in drug interactions, viral dynamics, and bispecific antibody modeling.

Presented at ACoP 2024. A Gompertz distribution is implemented in Stan and brms to enable cure rate survival modeling. The Gompertz brms family can be used to model exposure-response data in a Bayesian framework where a proportion of the population never experiences the event of interest.

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.

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.

Presented at ACoP 2024. The aim was to provide a simple, reproducible, and traceable method for generating parameter tables in R for NONMEM. models. Attainedvia a new package (pmparams): a stable and easy-to-use tool intended to integrate with, and extend the functionality of, existing packages in the Metrum Research Group Ecosystem (MeRGE)

Presented at ACCP Annual Meeting 2024, this poster highlights novel research on innovative combination therapies for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). Our study focuses on a physiologically-based pharmacokinetic (PBPK) and quantitative systems pharmacology (QSP) model for Loncastuximab Tesirine in combination with Mosunetuzumab or Glofitama.

Presented at ACCP Annual Meeting 2024, this poster highlights a combination QSP model for Loncastuximab Tesirine and Epcoritamab in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), predicting potential anti-tumor synergies in proposed clinical trials.

The developed models characterized E–R relationships and covariate effects for efficacy and safety endpoints. The efficacious and safe exposure range was established and supported the clinical dose of 200 mg. The utility of logistic regressions in a Bayesian framework with spike and slab priors, in which all the covariate effects were included and simultaneously estimated, was demonstrated.

This study characterizes the population pharmacokinetics (PK) of vedolizumab in adults undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) for graft-versus-host disease (GvHD) prophylaxis. The analysis identified body weight and albumin levels as significant predictors of vedolizumab clearance, though the covariates studied had no clinically meaningful effect on its overall PK. The findings offer important insights into dosing strategies for vedolizumab in this patient population.

The paper details a collaborative initiative funded by the FDA, where the Critical Path Institute and partners created didactic e-learning materials on model-informed drug development (MIDD) for non-modeling audiences. The curriculum, enriched with case studies from multinational pharmaceutical companies, includes 13 hours of training videos and is currently being beta-tested by FDA reviewers. Future plans involve expanding the content, offering 1:1 mentorship sessions, and providing broader access to the learning management system to support global stakeholders and the evolving MIDD community.

Presented at PAGE 2024 – Hands-on Workshop. MeRGE is a suite of freely-available, open-source tools for scalable, reproducible pharmacometric workflows. MeRGE consists of individual but interconnected R packages that support scalability and reproducibility during: project setup, data assembly, data exploration, model development, execution, and evaluation, simulation, and reporting.

Presented at PAGE 2024. The bbr.bayes package reduces much of the friction associated with a Bayesian pharmacometrics analysis in NONMEM® and promotes good practice applications. 

Presented at PAGE 2024. This model, developed by Boehringer Ingelheim in collaboration with Metrum Research Group, provides insights into potential anemia risks and informs monitoring strategies for patients with cognitive impairment associated with schizophrenia.

Presented at the Graybill Conference 2024. Dr. Jim Rogers from MetrumRG as he demonstrates the application of causal selection diagrams as a statistical consulting tool for Bayesian prior elicitation. Bayesian dynamic borrowing is an increasingly important methodology in pediatric extrapolation, and its successful application requires quantitative scientists who can bridge the gap between qualitative notions of “similarity” and formal statistical notions of “exchangeability.”

Presented at the 37th New England Statistics Symposium (NESS).Dr. Jim Rogers from MetrumRG as he illustrates the use of causal inference frameworks for evaluating pediatric extrapolation plans.

Covariate analysis is typically performed, and results are reported, based on the purpose of the analysis and the anticipated audience. Failure to use a standard for reporting parameters has made it difficult to find common features of models and use covariate analysis in a consistent way in order to discover new knowledge. This article aims to provide a useful basis for analysts to choose the most appropriate approach for their specific sets of circumstances.

Presented at AACR Annual Meeting 2024. QSP model simulations were used to predict anti-tumor efficacy and guide dosing of the antibody-drug conjugate Loncastuximab tesirine combined with T cell-dependent bispecific antibodies, Mosunetuzumab or Glofitamab for the treatment of B-cell malignancies.

Presented at ASCPT Annual Meeting 2024. Discover the synergy between Machine Learning and classical approaches in covariate identification. Our scientist, Matthew Wiens, explored this vital topic at the pre-conference session ‘Empowering Clinical Pharmacologists and Translational Scientists Using Artificial Intelligence: Unlocking Potential with Cutting-Edge Use Cases.’

Presented at ASCPT Annual Meeting 2024. Garadacimab (anti-activated factor XII monoclonal antibody) demonstrated efficacy for the prevention of hereditary angioedema (HAE) attacks with a favorable safety profile in Phase 2, pivotal Phase 3 (VANGUARD), and Phase 3 open-label extension studies. In this exposure-response (ER) analysis, the efficacy of garadacimab and effect of covariates on attack rate (number of attacks/month) were assessed to support garadacimab dosing in patients with HAE.

Presented at ASCPT Annual Meeting 2024. Our model adequately characterized ibutilide PK and its QT interval lengthening effect. The higher Emax suggests more ibutilide induced QT lengthening in premenopausal women. The difference of Emax between group A and B reflects potential progesterone effect.

Presented at ASCPT Annual Meeting 2024. A population PK and turnover models were developed and show that the extent of efavirenz autoinduction and clearance is dependent on CYP2B6 genotype.

Engineered T cells, particularly CAR T cells, have revolutionized hematological cancer treatment. However, their complexity poses challenges. This research explores how mathematical models, utilizing clinical data, can elucidate relationships between product characteristics, patient physiology, and clinical outcomes, thereby facilitating the development of next-generation cell therapies.

Presented at the International Symposium on Biopharmaceutical Statistics, March 2024. From basic dose adjustments to more ambitious programs for personalized medicine, pharmacometrics has a long tradition of informing tailored treatment strategies. Many of the modeling strategies are well-precedented, but formal decision frameworks are needed to address the question: how much data is enough to support a decision?

Presented by Dr. Rena Byrne at the 13th Annual Indiana CTSI Disease and Therapeutic Response Modeling Symposium, February 2024.
View presentation recording.

Presented by Dr. Sam Callisto and Michael Heathman at the CTSI Disease and Therapeutic Response Modeling Symposium, February 2024.
View presentation recording.

This research delves into the significance of transitioning from intravenous (i.v.) to subcutaneous (s.c.) administration of biologics in enhancing patient convenience and treatment outcomes. It emphasizes the role of model-informed drug development (MIDD) in facilitating this transition, providing insights into crucial clinical pharmacology and regulatory considerations. Key aspects highlighted include comprehensive pharmacokinetic evaluations, exposure-response profiling, comparability studies, and safety assessments, with MIDD strategies aiding in expediting the shift to s.c. dosing, thereby improving patient adherence and clinical efficacy.

GPKPDviz is a Shiny application designed for real-time simulation, visualization, and assessment of PK/PD models. The app allows the generation of virtual populations, simulation of diverse dosing scenarios, and assessment of covariate and dosing regimen impacts on PK/PD endpoints. It supports loading actual population data from clinical trials and offers a streamlined workflow for efficient modeling.

Introduction to exposure-response (E-R) concepts. Presented at the 79th Annual Deming Conference on Applied Statistics.

Leveraging a sophisticated Bayesian framework and latent variable models, this research compared treatment effects against placebos, setting a new benchmark for assessing efficacy in SLE treatments. This novel MBMA not only benchmarks the efficacy of these compounds but also showcases the application of latent variable models in understanding chronic disease trajectories.

This study explores Lonca’s efficacy across varying CD19 expression levels, revealing its effectiveness in patients, regardless of low or undetectable CD19 levels by conventional methods. The study integrates quantitative systems pharmacology (QSP) modeling to predict treatment responses, indicating that CD19 expression alone may not predict Lonca’s effectiveness, however, response predictions are improved by considering CD19 surface density.

In this tutorial, the principles of Bayesian model development, assessment and prior selection are outlined. An example pharmacokinetic model is used to demonstrate the implementation of Bayesian modeling using the nonlinear mixed-effects modeling software NONMEM.

Exposure-response (E-R) modeling frequently relies on the use of exposure metrics that summarize drug concentrations over time. This research presents simulations to demonstrate that certain commonly used exposure metrics, including average concentration up to an event time, are likely to lead to causal confounding under the very conditions that motivate their use.

Many biostatisticians in pharma and biotech  have relatively little awareness of, let alone influence over, the heavily statistical “pharmacometric” reasoning that goes into CTD Section 2.7.2 of an FDA regulatory submission, the “Summary of Clinical Pharmacology Studies”.  This talk focuses on the value of increasing statistical influence in pharmacometrics and the path to get there.

Presented at ACoP14. Empagliflozin, effective for type 2 diabetes in adults and children, underwent Study 1218.91 to assess its safety and efficacy over 26 weeks (with potential extension to 52 weeks) in children and adolescents. Using pediatric data from this study, researchers re-evaluated empagliflozin’s models in a Bayesian framework. Results showed similar drug exposure between children and adults at a 10 mg dose. At week 26, pediatric patients displayed a slightly larger but variable decrease in A1c compared to adults. This Bayesian method allowed insights into empagliflozin’s effects in children, drawing from knowledge gained in adult studies.

Presented at ACoP14. This project is dedicated to integrating parameter uncertainty into pharmacometric simulations, which plays a crucial role in making informed decisions in drug development. Initially, the metrumrg package in R was instrumental for simulating both fixed and random effect parameters. However, this package has since been deprecated. Consequently, the primary objective was to create a new R package named simpar. This new package aimed to retain the essential functionalities of metrumrg while expanding its capabilities. The overarching goal was to significantly enhance the support for incorporating parameter uncertainty into pharmacometric simulations, thereby aiding more comprehensive and accurate decision-making processes in this field.

Presented at ACoP14. This study assessed linagliptin’s effectiveness and safety in children and adolescents with type 2 diabetes over 26 weeks, potentially extending to 52 weeks. The study re-evaluated models developed for adults and adolescents to understand linagliptin’s impact on pediatric patients’ HbA1c levels. Results indicated slightly higher and more varied linagliptin exposure in children compared to adults at a 5 mg dose. Although pediatric patients had a smaller and variable HbA1c reduction versus adults at week 26, the Bayesian approach helped characterize linagliptin’s effects in children based on limited data, borrowing insights from adult studies.

Presented at ACoP14. The DINAMO study assessed empagliflozin and linagliptin’s effectiveness and safety in treating type 2 diabetes in children. Using prior models based on adult data, the study predicted these medications’ effects in younger populations following FDA guidelines. Employing a Bayesian analysis with robust prior specifications, the study justified its approach by considering factors like weight, kidney function, age, race, and gender when extrapolating adult outcomes to pediatric populations.

Roller Coaster Talk presented at ACoP14. A workflow was introduced that integrates QSP modeling and machine learning in the form of UDEs. The workflow utilizes machine learning to learn missing parts in our knowledge of a QSP system while quantifying the uncertainty around the learned dynamics using Bayesian analysis.

Presented at ACoP14. The objective of this work is to integrate multiple PD clinical studies, harmonize the data, and deploy a user interface for rapid data interrogation and analysis subset generation.

Presented at ACoP14. Patritumab deruxtecan (HER3-DXd) is a human epidermal growth factor receptor (HER3)-targeting antibody-drug conjugate with a topoisomerase I inhibitor payload (DXd). The drug-to-antibody ratio is approximately 8. HER3-DXd is currently being investigated as an anticancer agent in several phase 1-3 clinical studies in breast cancer (BC) and nonsmall cell lung cancer ( NSCLC) patients.

Presented at ACoP14. DQSP framework successfully implemented a UDE that characterized the PK of remoxipride and its effect on PRL release from lactotrophs to plasma. The model also characterized the positive feedback effect of plasma PRL on lactotroph PRL stimulation using an ANN.

Presented at ACoP14. ER analyses showed that the 5.6 mg/kg Q3W regimen offers a positive benefit-risk profile with clinically meaningful efficacy and overall manageable and tolerable safety profile. The analyses results support the selection of 5.6 mg/kg Q3W as the recommended dose for further clinical development of HER3-DXd monotherapy.

Presented at ACoP14. The differentiation of mammalian hematopoietic stem cells (HSCs) is complex and multiscale, providing an opportunity for mathematical modeling and simulation to aid in mechanistic understanding, and ultimately, to inform drug development efforts. Historically, HSC mathematical models were focused on the development of a subset of cells, but mathematical models encompassing the overall cellular system’s complexity are rarely available. Here, an integrated quantitative systems pharmacology (QSP) model that characterizes multi-organ HSC differentiation was developed by integrating literature models and adding novel features.

Presented at ACoP14. The American Statistical Association (ASA) comprises regional chapters and specialized sections, including the Biopharmaceutical Section (BIOP), established in 1981. BIOP focuses on applying statistics to drug development, biologics, devices, and related technologies in humans and animals. Initially created to connect ISoP and ASA, SxP employs innovative statistical methods to address similar inquiries, despite using distinct terminologies and assumptions in modeling. This poster offers insight into BIOP’s history, objectives, organization, and avenues for involvement or contacting its members.

Presented at ACoP14. Deep compartment models (DCMs) are a proposed alternative to traditional nonlinear mixed effect (NLME) pharmacometrics approaches [1]. DCM uses neural networks to represent estimated pharmacokinetic parameters which can then be used in either closed-form or ordinary differential equation (ODE)-based representations of pharmacokinetic models

Presented at ACoP14. Analysis of the QSP model found that the internalization rate of the target receptors may be an important, yet often underestimated, factor for understanding bsAb efficacy in vitro. Simulations of the model indicated that high rates of receptor turnover can increase model predictions of efficacy, particularly at higher antibody concentrations.

Oral presentation for ACoP14 Abstract Quality Award winner. The Hierarchical Deep Compartment Modeling (HDCM) framework introduced in this abstract was developed using open-source tools in the Julia Programming Language and integrated Bayesian inference to quantify the uncertainty around the model parameters. It provides a convenient, readily accessible HDCM framework to the pharmacometrics community interested in applying deep learning to hierarchical compartmental models.

ACoP14 pre-meeting workshop. Highlights include exploring Julia as an open source alternative for QSP support of model-informed drug development, gaining insights into IO QSP modeling for antibody drug conjugate (ADCs) and bispecific mAb (bsAb) therapies to drive your own implementations of Project Optimus, and accessing open source Julia versions of two pivotal IO models and parameterizations.

Presented at ACoP14. Here, we introduce a pair of packages PMParameterized.jl which simplifies specification of parameters and initial conditions for Ordinary Differential Equation models, and PMSimulator.jl which enables complex dosing, inputs and events. Together these packages result in stateful, reproducible models and simulation for a quantitative systems pharmacology and pharmacometrics workflow in the Julia language.

When tailored for specific questions, QSP models enhance our grasp of clinical observations, guiding research with informed decisions, especially when they incorporate mechanistic insights. These models facilitate the integration of theory and data to test our understanding and explore the root causes of events. By offering quantifiable insights into the interactions within physiology, disease, and pharmacology, QSP models steer further research, impacting study design and biomarker selection. The presentation will encompass case studies on monoclonal antibody (mAb) development in bone health (osteoporosis), infectious disease (SARS-CoV-2), and oncology (relapsed/refractory diffuse large B-cell lymphoma).

A novel QSP framework integrating PBPK modeling with tumor dynamics was developed using literature and in-house data. By employing a virtual population reflecting patients treated with Lonca, it is possible to evaluate indication, clinical population selection, influence of clinical study covariates, disease phenotypes, and CD19 expression levels on clinical responses

This poster highlights the use of population pharmacokinetic and exposure-response models with regularized regression using spike and slab priors to optimize dosing for specific patient subpopulations, particularly focusing on the context of valemetostat treatment for Adult T-cell Leukemia / Lymphoma (ATTLL) and Non-Hodgkin’s lymphoma (NHL).

Antibody-drug conjugates (ADCs) are promising anti-cancer drugs but often cause toxicities in clinical use. This poster presents a new model that predicts toxicities of ADCs, including liver and lung effects for drugs like T-DM1 and T-Dxd, and high hepatotoxicity in CM.

As Julia usage continues to grow within regulated biomedical environments, it is vital to ensure analyses are traceable and reproducible. Conducting analyses in an open-science manner is also critical to expand the adoption of Julia and to facilitate the infrastructure growth of Julia as an accessible ecosystem. A step-by-step model-building example of a classic monoclonal antibody-drug conjugate PBPK/tumor dynamics system illustrates how to develop such a reproducible open-science framework.

Demonstrates a Bayesian analysis workflow in Julia for an ODE-based model using PBPK modeling as an illustrative example.

The demand for pharmacometricians has outpaced academic supply, with increasing investments in on-the-job training. Despite growth in academic programs, the expanding scope of pharmacometrics and emerging fields like machine learning pose challenges. Leading experts from diverse sectors offer recommendations for effectively training future pharmacometricians, ensuring their ability to navigate this evolving discipline.

The objective of this study was to quantitatively characterize the relationship between serum free IgE and pulmonary function (as measured by forced expiratory volume in 1 s [FEV1]) in pediatrics using a population-based pharmacodynamic model.

The current analysis aimed to characterize exposure-response relationships of TV exposure on the incidence, severity, and longitudinal time course of grade ≥2 ocular adverse events (AEs).

DINAMO showed that an empagliflozin dosing regimen provided clinically and statistically meaningful reductions in HbA1c in youth with T2D. Bayesian Borrowing analysis confirmed evidence for clinically meaningful efficacy of empagliflozin

The present work is to establish feasibility of using a joint tumor growth dynamic model (TGDOS) to extrapolate OS and generate a synthetic control arm from historical data by propensity score modeling.

The aim of this study was to quantify identifiable sources of variability, including key pharmacogenetic variants in oxypurinol pharmacokinetics and their pharmacodynamic effect on serum urate (SU).

The goal of this simulation-estimation study was to investigate the extent to which PK and RUV model misspecification, errors in recording dosing and sampling times, and variability in drug content uniformity contribute to the estimated magnitude of RUV and PK parameter bias.

Stakeholders met to address persistent challenges facing development of therapeutics for polyarticular JIA (pJIA), which result in fewer approved therapies for children with pJIA than adults with rheumatoid arthritis (RA) and long lag times from adult RA approval to pediatric labeling.

Presented by Bill Gillespie at StanCon 2023, this workshop highlights how to leverage the R package bbr.bayes to create traceable and reproducible Bayesian modeling workflows. The current version of bbr.bayes supports Stan models using cmdstanr, and future releases will include support for Bayesian modeling with NONMEM.

Presented by Jim Rogers. This joint ASCPT + ISoP webinar explores the application of causal inference concepts in pharmacometrics. May 18, 2023

Shelly Wang presents a ProjectOptimus focused webinar focused on the use of MIDD in dose selection and optimization in oncology drug development. May 11, 2023.

Ana Ruiz-Garcia, Paul Baverel, Dean Bottino, Michael Dolton, Yan Feng, Ignacio González-García, Jaeyeon Kim, Seth Robey, Indrajeet Singh, David Turner, Shu-Pei Wu, Donghua Yin, Di Zhou, Hao Zhu, Peter Bonate. J Pharmacokinet Pharmacodyn. March, 4 2023

Tim Waterhouse. Presented at 12th Annual Indiana Clinical and Translational Sciences Institute (CTSI) Symposium on Disease and Therapeutic Response Modeling. February 23, 2023.

TV, a tissue factor-directed antibody-drug conjugate, is approved under accelerated approval in the US at a dose of 2.0 mg/kg every 21 days (Q3W) for adult patients (pts) with recurrent or metastatic cervical cancer (r/mCC) who have progressed on or after chemotherapy. Based on TV pharmacokinetics (PK) and exposure-response relationships, we hypothesized that a higher dose intensity and optimized key PK parameters can lead to improvement in efficacy. Here, we report a pharmacometric approach to continuously optimize the TV dosing schedule in non-cervical solid tumors.

Sam Callisto, Tim Waterhouse. Presented at 12th Annual Indiana Clinical and Translational Sciences Institute (CTSI) Symposium on Disease and Therapeutic Response Modeling. February 23, 2023.

This study aimed to combine modeling techniques from psychometric research (e.g., item response theory) and pharmacometrics (e.g., hierarchical models) to describe the multivariate longitudinal disease progression for patients with mild-to-moderate Alzheimer’s disease.

Ana-Marija Grisic, Karthik Venkatakrishnan, Jonathan French, Akash Khandelwal. CPT Pharmacometrics Syst Pharmacol.  December, 20 2022. doi:10.1002/psp4.12905

Rena Eudy-Byrne, Matthew Riggs, Amale Hawi, Thomas Sciascia, Shashank Rohatagi. Br J Clin Pharmacol. 2023.  doi:10.1111/bcp.15663

Ahmed Elmokadem, Yi Zhang, Timothy Knab, William R. Gillespie. CPT Pharmacometrics Syst Pharmacol.  January, 20 2023. doi:10.1002/psp4.12926

Sonoko Kawakatsu. Virtual presentation for Children’s Hospital of Philadelphia and Cincinnati’s Children’s Hospital. 13 December 2022.

Masato Fukae, Kyle Baron, James Rogers, Ramon Garcia, Masaya Tachibana, John Mondick, Takako Shimizu. Poster presented at 2022 American Conference on Pharmacometrics (ACoP13). 30 October – November 2 2022. Poster M-026

Nadia Terranova, Jonathan French, Haiqing Dai, Matthew Wiens, Akash Khandelwal, Ana Ruiz-Garcia, Juliane Manitz, Anja von Heydebreck, Mary Ruisi, Kevin Chin, Pascal Girard, Karthik Venkatakrishnan. CPT Pharmacometrics Syst Pharmacol. 2022;11(3):333-347.

Masato Fukae, Kyle Baron, Masaya Tachibana, John Mondick, Takako Shimizu. Poster presented at 2022 American Conference on Pharmacometrics (ACoP13). 30 October – November 2 2022. Poster M-030

Simon Dagenais, Marc Gastonguay, Abie Ekangaki. Hot topic presented at 2022 AAPS PharmSci360. 17 October 2022.

James Rogers, Hugo Maas, Alejandro Perez Pitarch. CPT Pharmacometrics Syst Pharmacol.  November, 16 2022. doi:10.1002/psp4.12894

Kosalaram Goteti, Jonathan French, Ramon Garcia, Ying Li, Florence Casset-Semanaz, Aida Aydemir, Robert Townsend, Cristina Vazquez Mateo, Matthew Studham, Oliver Guenther, Amy Kao, Marc Gastonguay, Pascal Girard, Lisa Benincosa, Karthik Venkatakrishnan. CPT Pharmacometrics Syst Pharmacol.  November, 9 2022. doi:10.1002/psp4.12888

Katherine Kay, Justin Goodwin, Hanna Ehrlich, Joyce Ou, Tracey Freeman, Kaicheng Wang, Fangyong Li, Martina Wade, Jonathan French, Liusheng Huang, Francesca Aweeka, Norah Mwebaza, Richard Kajubi, Matthew Riggs, Ana Ruiz-Garcia, Sunil Parikh. Clin Pharmacol Ther. Published online October 19, 2022. doi:10.1002/cpt.2768

Kosalaram Goteti, Ramon Garcia, William Gillespie, Jonathan French, Lena Klopp-Schulze, Ying Li, Cristina Vazquez Mateo, Sanjeev Roy, Oliver Guenther, Lisa Benincosa, Karthik Venkatakrishnan. Poster presented at 2022 American Conference on Pharmacometrics (ACoP13). 30 October – November 2 2022. Poster T-075

Katherine Kay, Justin Goodwin, Hanna Ehrlich, Joyce Ou, Tracy Freeman, Kaicheng Wang, Fangyong Li, Martina Wade, Jonathan French, Liusheng Huang, Francesca T. Aweeka, Norah Mwebaza, Richard Kajubi, Matthew Riggs, Ana Ruiz-Garcia, Sunil Parikh. Poster presented at American Society of Tropical Medicine and Hygiene (ASTMH). October 30 – November 3, 2022. Poster #1434.

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.

Kosalaram Goteti, Jonathan French, Ramon Garcia, Ying Li, Florence Casset-Semanaz, Aida Aydemir, Robert Townsend, Cristina Vazquez Mateo, Matthew Studham, Oliver Gunther, Amy Kao, Marc Gastonguay, Pascal Girard, Lisa Benincosa, Karthik Venkatakrishnan. Poster presented at 12th American Conference on Pharmacometrics (ACoP), November 2021. Poster PIB-011.

Ahmed Elmokadem, Yi Zhang, Tim Knab, Eric Jordie, William R. Gillespie. Poster presented at 2022 American Conference on Pharmacometrics (ACoP13). 30 October – November 2 2022. Poster W-074

Rena Byrne, Rahul Ballal, Ana Ruiz-Garcia. Poster presented at 2022 American Conference on Pharmacometrics (ACoP13). 30 October – November 2 2022. Poster T-016

James A. Rogers, Hugo Maas, Alejandro Peréz. Poster presented at 2022 American Conference on Pharmacometrics (ACoP13). 30 October – November 2 2022. Poster T-022

Katherine Kay, Kyle Baron, Seth Green, Samuel Callisto, Curtis Johnston, Kyle Barrett, Devin Pastoor, Jim Rogers, Ana Ruiz-Garcia, Tim Waterhouse, Matthew Wiens, Matthew Riggs. Poster presented at 2022 American Conference on Pharmacometrics (ACoP13). 30 October – November 2 2022. Poster M-062

Matthew Wiens, Kyle Barrett, Amir-Hadi Maghzi, Jonathan French, Himanshu Naik, Jackson Burton. Poster presented at 2022 American Conference on Pharmacometrics (ACoP13). 30 October – November 2 2022. Poster M-055

Matthew Wiens, Amir-Hadi Maghzi, Naveen Mangal, Kumar Kandadi Muralidharan, Francois Gaudreault, Jackson Burton, Jonathan French, Himanshu Naik. Poster presented at 2022 American Conference on Pharmacometrics (ACoP13). 30 October – November 2 2022. Poster M-053

Jonathan French. Presented at Bayes 2022. 12 – 14 October 2022.

Seth Green. Presented at R/Medicine 2022. 26 August 2022.

Jeffrey S. Barrett, Megan Cala Pane, Timothy Knab, William Roddy, Jack Beusmans, Eric Jordie, Kanwaljit Singh, Jonathan Michael Davis, Klaus Romero, Michael Padula, Bernard Thebaud, Mark Turner. Front. Pharmacol. 2022 October 12. doi: 10.3389/fphar.2022.988974

Katherine Kay, Justin Goodwin, Hanna Ehrlich, Joyce Ou, Tracey Freeman, Kaicheng Wang, Fangyong Li, Martina Wade, Jonathan French, Liusheng Huang, Francesca Aweeka, Norah Mwebaza, Richard Kajubi, Matthew Riggs, Ana Ruiz-Garcia, Sunil Parikh. Clin Pharmacol Ther. Published online October 19, 2022. doi:10.1111/cpt.2768

Mariacristina Castelli, Katsumi Suzuki, Brittney Starling, Kanan Balakrishnan, Suzanne Meeves, Marina Komaroff, Janelle Lennie, John T. Mondick, Stephen V. Faraone.
Presented at the American Society of Clinical Psychopharmacology Annual Meeting, May 31–June 3, 2022, in Scottsdale, AZ. Poster #W2

Matthew Riggs. Presented at the University of Buffalo QSP Symposium 2022. 28 July 2022

QSP to Link Learn:Confirm with Expand:Understand in Model-Informed Drug Development

Charles C. Margossian, Yi Zhang, William R. Gillespie. Flexible and efficient Bayesian pharmacometrics modeling using Stan and Torsten, Part I. CPT Pharmacometrics Syst Pharmacol. 2022 May 15. doi: 10.1002/psp4.12812. Epub ahead of print. PMID: 35570331.

Yana Vorontsova, David M. Haas, Kathleen Flannery, Andrea R. Masters, Larissa L. Silva, Rebecca C. Pierson, Brittany Yeley, Graham Hogg, David Guise, Michael Heathman, Sara K. Quinney. Clin Transl Sci. 2022; 00: 1- 9. doi:10.1111/cts.13306

Janelle L. Lennie, John T. Mondick, Marc R. Gastonguay. PLoS One. 2022 Apr 28;17(4):e0247286. doi: 10.1371/journal.pone.0247286.

Kevin J. Downes, Austyn Grim, Laura Shanley, Ronald C. Rubenstein, Athena F. Zuppa, Marc R. Gastonguay. Antimicrob Agents Chemother. 2022;66(5):e0237721.

Neutralizing monoclonal antibodies (mAb) have emerged as promising therapeutics for COVID-19, with research efforts accelerated through open-access in silico models. Innovative approaches, including a physiologically-based pharmacokinetic (PBPK) model and a longitudinal SARS-CoV-2 viral dynamic model, facilitated the selection of optimal mAb candidate and therapeutic dose. By utilizing these models, the first-in-human trial of bamlanivimab (NCT04411628) initiated with a conservative dose of 700 mg, aiming to achieve maximum therapeutic effect while ensuring safety and tolerability.

Matthew Riggs. Presented at the third World Conference on Pharmacometrics (WCoP) virtual hybrid meeting. 31 March 2022, South Africa and online. See video here for the first half of this presentation covering “Compare and Contrast” presented by Stacey Tannenbaum, Ph.D.

WCoP2022-Riggs-CompareCollide

Samuel P. Callisto, Christopher M. Barkley, Mark Fiecas, Richard Brundage, Angela K. Birnbaum, Susan E. Marino. Poster presented at 2022 WCOP. March 29 – April 1 2022. Poster 35.

Akash Khandelwal, Ana-Marija Grisic, Jonathan French, Karthik Venkatakrishnan. Clin Pharmacol Ther. Published online March 14, 2022. doi:10.1002/cpt.2564

Pohl O, Baron K, Riggs M, French J, Garcia R, Gotteland JP. Br J Clin Pharmacol. 2021; 1– 13. doi:10.1111/bcp.15171

Seth C. Hopkins, Sean D. Wilson, Ajay Ogirala, Gabriel Stellman, Snezana M. Milanovic, Steven T. Szabo, James A. Rogers, Chris J. Edgar, Kenneth S. Koblan. Poster presented at 2021 American College of Neuropsychopharmacology. 5-8 December 2021.

William R. Gillespie. The Lewis B. Sheiner Lecturer Award slides presented at International Society of Pharmacometrics. November 2021.

Yi Zhang and William R. Gillespie. Poster presented at 2021 American Conference on Pharmacometrics (ACoP12) virtual meeting. 8-12 November 2021. Poster PIIIB-028

Matthew Wiens, Amir-Hadi Maghzi, Naveen Mangal, Kumar Kandadi Muralidharan, Himanshu Naik, Jonathan French, Francois Gaudreault. Poster presented at 2021 American Conference on Pharmacometrics (ACoP12) virtual meeting. 8-13 November 2021. Poster PIIIB-009.

Yin O, Zahir H, French J, Polhamus D, Wang X, Van de Sande M, Tap WD, Gelderblom H, Wagner AJ, Healey JH, Greenberg J, Shuster D, Stacchiotti S. CPT: Pharmacometrics & Systems Pharmacology. 2021; 10: 1422– 1432. doi:10.1002/psp4.12712

Alliance for Maternal and Newborn Health Improvement (AMANHI) Gestational Age Study Group, & Alliance for Maternal and Newborn Health Improvement (AMANHI) GA Study Group. BMJ Global Health. 2021;6(9):e005688. https://doi.org/10.1136/bmjgh-2021-005688

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.

Tim Knab, Ahmed Elmokadem, Emmanuel Chigutsa, Eric Jordie, Matthew Riggs, Patricia Brown-Augsburger, Christopher Wiethoff, Ajay Nirula, Jenny Y Chien, Lisa O’Brien.  Poster presented at Population Approach Group Europe Annual Meeting; 2-3 and 6-7 September 2021.  Poster I-64.

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.

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

Jackson K, Chua L, Velez de Mendizabal N, Pitou C, Rodriguez Capriles C, Paller AS, Lansang P, Seyger M, Papp K, IXORA-PEDS study group. Br J Clin Pharmacol. 2021; 1– 13. doi:10.1111/bcp.15034

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

Galluppi GR, Polhamus DG, Fisher JM, Hopkins SC, Koblan KS. CPT Pharmacometrics Syst Pharmacol. Published online July 22, 2021. doi:10.1002/psp4.12692

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.

John T. Mondick and Curtis K. Johnston.  Webinar presented for American Society for Clinical Pharmacology and Therapeutics (ASCPT).  June 22, 2021.

Eudy-Byrne R, Zane N, Adeniyi-Jones SC, Gastonguay MR, Ruiz-Garcia A, Kushal G, Kraft WK. Clin Transl Sci. 2021;14:2171-2183. doi:10.1111/cts.13074

French J, Mentré, F. CPT Pharmacometrics Syst. Pharmacol. 2021;10: 273-274. doi:10.1002/psp4.12625

Chen J, Ruiz-Garcia A, James LP, et al. Clin Pharmacol Ther. 2021;110(5):1273-1281. doi:10.1002/cpt.2228

Seminar presented by Marc R. Gastonguay, Ph.D., at the FDA’s Model Informed Drug Development (MIDD) Education Series, April 26, 2021 (virtual).

Leohr J, Heathman M, Kjellsson MC. Diabetes Obes Metab. 2021 Apr;23(4):1001-1010. doi: 10.1111/dom.14306.

Johnston CK, Eudy-Byrne RJ, Elmokadem A, Nock V, Marquard J, Soleymanlou N, Riggs MM, Liesenfeld K-H. Pharmaceutics. 2021; 13(4):485. https://doi.org/10.3390/pharmaceutics13040485

Marc Gastonguay, Jing Liu, Jean Lachaine, Anna G. Kondic, and Daniel Polhamus.  Presented at the American Society for Clinical Pharmacology (ASCPT) annual meeting, March 15, 2021.

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

Okamoto H, Dirks NL, Rosario M, Hori T, Hibi T. Intest Res. 2021;19(1):95-105. doi:10.5217/ir.2019.09167.

Uechi L, Jalali M, Wilbur JD, French JL, Jumbe NL, Meaney MJ, Gluckman PD, Karnani N, Sakhanenko NA, Galas DJ; GUSTO study group. PLoS One. 2020 Dec 3;15(12):e0242684. doi: 10.1371/journal.pone.0242684.

Hastings, IM, Hardy, D, Kay, K, Sharma, R. Evol Appl. 2020; 13: 2723– 2739.

Kay K, Goodwin J, Mwebaza N, Ruiz A, Ehrlich H, Ou J, Freeman T, Wade M, Huang L, Wang K, Li F, Aweeka FT, Riggs M, Kajubi R, Parikh S.  Presented at the annual meeting of the American Society of Tropical Medicine and Hygiene, October 16-18, 2020.

Kang J, Eudy-Byrne RJ, Mondick J, Knebel W, Jayadeva G, Liesenfeld KH. Br J Clin Pharmacol. 2020 Nov;86(11):2274-2285. doi: 10.1111/bcp.14330.

Presentation by Marc R. Gastonguay, Ph.D., at the Otago Pharmacometrics International Seminar Series on November 10, 2020.

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.

Yi Zhang, William R. Gillespie, Ben Bales, Aki Vehtari.  Poster presented at 2020 American Conference on Pharmacometrics (ACoP11) virtual meeting. 11 November 2020.

Ramon I. Garcia, Seth Robey, Pavan Vaddady, Lokesh Jain, Jonathan L French.  Poster presented at 2020 American Conference on Pharmacometrics (ACoP11) virtual meeting. 12 November 2020.

Presentation by Jonathan L. French, Sc.D. at 2020 American Conference on Pharmacometrics (ACoP11) virtual meeting. 11 November 2020.

Presentation by Marc Gastonguay, Ph.D. at 2020 American Conference on Pharmacometrics (ACoP11) virtual meeting. 11 November 2020.

Presentation by Marc Gastonguay, Ph.D., at the 2020 Virtual Annual Meeting of the American College of Clinical Pharmacology (ACCP) during the symposium: Innovative Approaches in the Use of Exposure-Response in Therapeutic Proteins to Support Pediatric Extrapolation. 23 September 2020.

Utsey, Kiersten, Madeleine S. Gastonguay, Sean Russell, Reed Freling, Matthew M. Riggs, and Ahmed Elmokadem. 2020. Drug Metabolism and Disposition: The Biological Fate of Chemicals, July. https://doi.org/10.1124/dmd.120.090498.

Troy S, Wasilewski M, Beusmans J, Godfrey CJ.  Clin Pharmacol Ther. 2020 Jun;107(6):1394-1404. doi: 10.1002/cpt.1752. Epub 2020 Feb 25. PMID: 31868225; PMCID: PMC7325319.

Patel, Chirag, Sanjay Goel, Manish R. Patel, Lakshmi Rangachari, Jayson D. Wilbur, Yaping Shou, Karthik Venkatakrishnan, and A. Craig Lockhart. Clinical Pharmacology in Drug Development, June 2020.

A.C. Lee, K.E. Semrau, B. Wylie, A.H. Baqui, B. Kirkwood, A.A. Manu, F. Jehan, M. Nisar, S. Sazawal, U. Dhingra, D.H. Hamer, J.D. Wilbur, S. Yoshida, R. Bahl.  Simplified Models to Assess Gestational Age in Low-Middle Income Countries: Findings from the Multi-site AMANHI Study.  Pediatric Academic Societies Meeting, May 2, 2020. E-PAS2020:1555.6

Lennie, J.L., Mondick, J.T. & Gastonguay, M.R. Latent process model of the 6-minute walk test in Duchenne muscular dystrophy. J Pharmacokinet Pharmacodyn (2020).

Krishnaswami, S., Austin, D., Della Pasqua, O., Gastonguay, M.R., Gobburu, J., van der Graaf, P.H., Ouellet, D., Tannenbaum, S. and Visser, S.A. (2020), MID3: Mission Impossible or Model‐Informed Drug Discovery and Development? Point‐Counterpoint Discussions on Key Challenges. Clin. Pharmacol. Ther. Accepted Author Manuscript. doi:10.1002/cpt.1788

Perkins BA, Soleymanlou N, Rosenstock J, Skyler JS, Laffel LM, Liesenfeld KH, Neubacher D, Riggs MM, Johnston CK, Eudy-Byrne RJ, Elmokadem A, George JT, Marquard J, Nock V.  Diabetes, Obesity & Metabolism, 2019 Dec 19. Available from: https://doi.org/10.1111/dom.13945.

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

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

Chia-Chi Lin, Jun Guo, William D. Tap, Andrew J. Wagner, Silvia Stacchiotti, Jih-Hsiang Lee, Xiaoning Wang, Jia Kang, Hamim Zahir, Shun-ichi Sasaki, Ophelia Yin

Poster presented at the 2019 Connective Tissue Oncology Society annual meeting in Toyko, Japan. 14 Nov 2019

Presented by Jonathan French, Sc.D., at the American Conference on Pharmacometrics (ACoP10) during the tutorial: The Role of Pharmacometrics in Advancing Quantitative Benefit-Risk Assessments for Drug Review and Approval. 24 Oct 2019

Kiersten Utsey, Madeleine S Gastonguay, Sean Russell, Reed Freling, Matthew M Riggs, Ahmed Elmokadem

Poster presented at 2019 American Conference on Pharmacometrics (ACoP10) in Orlando, FL. 22 October 2019.

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.

Ophelia Yin, Jonathan French, Daniel Polhamus, Hamim Zahir, Michiel van de Sande, William D. Tap, Hans Gelderblom, Andrew J. Wagner, Jon Greenberg, Dale Shuster, Silvia Stacchiotti

Poster presented at 2019 American Conference on Pharmacometrics (ACoP10) in Orlando, FL. 23 October 2019.

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

Presented by Eric Jordie at American Conference on Pharmacometrics 2019.

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

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

Presentation by Kyle Baron, PharmD, Ph.D., at the American Conference of Pharmacometrics in October 2019. Poster can be found here.
Authors: Kyle Baron, Oliver Pohl, Matthew Riggs, Jonathan French, Jean-Pierre Gotteland, Ramon Garcia

Poster presented at the American Conference of Pharmacometrics in October 2019. Accompanying slides can be found here.
Authors: Kyle Baron, Oliver Pohl, Matthew Riggs, Jonathan French, Jean-Pierre Gotteland, Ramon Garcia

Ophelia Yin, Jia Kang, William Knebel, Hamim Zahir, Michiel van de Sande, William D. Tap, Hans Gelderblom, Silvia Stacchiotti, Jon Greenberg, Dale Shuster, Andrew J. Wagner

Poster presented at 2019 American Conference on Pharmacometrics (ACoP10) in Orlando, FL. 21 October 2019.

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

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.

Presented by Marc Gastonguay, Ph.D. at the DIA Pediatric Drug Development Workshop on October 28, 2019. Event details on the DIA website.

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

Presented by Marc Gastonguay, Ph.D. at Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA) on October 2, 2019. Event details on the FDA website.

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

Presentation by Katherine Kay Ph.D at R/Medicine. Boston, MA. 14 September 2019.

Pastoor, Devin. Presentation at R/Pharma. Cambridge, MA. 22 Aug 2019.

Gastonguay, Madeleine. Presentation at R/Pharma. Cambridge, MA. 23 Aug 2019.

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

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

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.

Zhang Y,  Gillespie W. Poster presented at 2019 Population Approach Group in Europe (PAGE). Stockholm, Sweden. 13 June 2019. Abstract IV-29.

Johnston C, Riggs MM, Marquard J, Soleymanlou N, Nock V, Liesenfeld, K. Poster presented at 2019 Population Approach Group in Europe (PAGE). Stockholm, Sweden. 13 June 2019. Abstract IV-66.

Eudy-Byrne R, Elmokadem A, Riggs MM, Johnston C, Marquard J, Soleymanlou N, Nock V, Liesenfeld K. Poster presented at 2019 Population Approach Group in Europe (PAGE). Stockholm, Sweden. 13 June 2019. Abstract III-02.

Perkins BA, Soleymanlou N, Rosenstock J, Skyler JS, Laffel LM, Liesenfeld K, Neubacher D, Riggs MM, Johnston CK, Eudy-Byrne RJ, Elmokadem A, George JT, Marquard J, Nock V. Poster presented at American Diabetes Association (ADA) 79th Scientific Sessions 2019. San Francisco, CA. 7-11 June 2019. Abstract 1198-P.

Lu D, Li C, Riggs M, Polhamus D, French J, Agarwal P, Chen S-C, Vadhavkar S, Patre M, Strasak A, Quartino A, Jin JY, Girish S. Cancer Chemother Pharmacol [Internet]. 2019 May 17. doi: 10.1007/s00280-019-03852-z.

Riggs MM. Slides presented at AAPS Forum to Connect Predictive Modelers in Boston, MA. 6 May 2019.

Rogers JA. CPT Pharmacometrics Syst Pharmacol [Internet]. 2019 Feb 14; Available from: http://dx.doi.org/10.1002/psp4.12395

Osterman MT, Rosario M, Lasch K, Barocas M, Wilbur JD, Dirks NL, Gastonguay MR. Aliment Pharmacol Ther. 49(4):408–18. February 2019.

Riggs MM, Cremers S. British Pharmacological Society. 85(6):1136–46. 28 January 2019. https://doi.org/10.1111/bcp.13881

Zuppa AF, Conrado DJ, Zane NR, Curley MAQ, Bradfield J, Hakonarson H, Gastonguay MS, Moorthy G, Prodell J, Gastonguay MR. Crit Care Med [Internet]. 21 Jan 2019. DOI: 10.1097/CCM.0000000000003638

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

Rogers JA. Presentation at 2018 American Conference on Pharmacometrics (ACoP9). San Diego, CA. 9 Oct 2018.

Riggs MM. Poster presented at 2018 American Conference on Pharmacometrics (ACoP9). San Diego, CA. 9 Oct 2018. Abstract #T-078.

Hajjar J. Poster presented at 2018 American Conference on Pharmacometrics (ACoP9). San Diego, CA. 9 Oct 2018. Abstract #T-011.

Riggs MM. Presentation at 2018 American Conference on Pharmacometrics (ACoP9). San Diego, CA. 9 Oct 2018.

Riggs MM. Presentation at 2018 American Conference on Pharmacometrics (ACoP9). San Diego, CA. 8 Oct 2018.

Elmokadem A. Poster presented at 2018 American Conference on Pharmacometrics (ACoP9). San Diego, CA. 9 Oct 2018. Abstract #M-003.

Hajjar J. Poster presented at 2018 Annual Meeting of the American College of Clinical Pharmacology. Bethesda, MD. 23 Sep 2018.

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

Elmokadem A. Lightning talk presented at International Society of Pharmacometrics New England 2018. Cambridge, MA. 12 Sep 2018.

Gastonguay MS. Presented at the R/Medicine 2018 Conference. New Haven, CT. 8 Sep 2018.

Zhang Y, Gillespie WR, Minjie Zhu. Poster presented at StanCon. Helsinki, Finland. 30 Aug 2018.

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.

Gastonguay MR. Lightning Talk presented at the 1st annual R/Pharma conference. Boston, MA. 16 August 2018.

Kang J. Lightning Talk presented at the 1st annual R/Pharma conference. Boston, MA. 16 August 2018.

Eudy-Byrne R. Lightning Talk presented at the 1st annual R/Pharma conference. Boston, MA. 15 August 2018.

Pastoor D. Invited Talk presented at the 1st annual R/Pharma conference. Boston, MA. 15 August 2018.

Gillespie WR. Presented at Stan for Pharmacometrics. Paris, France. 24 July 2018.

Eudy-Byrne R. Presented at the 17th American Pediatrics Healthcare & Infectious Diseases Congress, Vancouver, Canada, 28 June 2018.

Meng Z, Rogers JA, Sidi J, Tang Q, Patel D, Gaudel-Dedieu N, and Delvart D. Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE) Montreux, Switzerland, May 2018. Abstract I-76.

Moore JN, Gastonguay MR, Ng CM, Adeniyi-Jones SC, Moody DE, Fang WB, Ehrlich ME, Kraft WK. Clin Pharmacol Ther. 103 (6) 1029-1037; June 2018

Vujkovic M, Bellamy SL, Zuppa AF, Gastonguay MR, Moorthy GS, Ratshaa B, Han X, Steenhoff AP, Mosepele M, Strom BL, Bisson GP, Aplenc R, Gross R. Pharmacogenomics J. doi: 10.1038/s41397-018-0028-2. Epub June 1, 2018.

Park SY, Xiao L, Wilbur JD, Staicu A, Jumbe NL. Computational Statistics and Data Analysis. 122:101-114. June 2018

Mondick J, Riggs M, Kaspers S, Soleymanlou N, Marquard J, Nock V. J Clin Pharmacol. 58 (5): 640-649; May 2018

Gillespie WR. Presented at the Midwest Biopharmaceutical Statistics Workshop (MBSW), Indianapolis, IN, May 2018.

Rosario M, French JL, Dirks NL, Sankoh S, Parikh A, Yang H, Danese S, Colombel JF, Smyth M, Sandborn WJ, Feagan BG, Reinisch W, Sands BE, Sans M, Fox I. J Crohns Colitis 12 (4): 510. 2018 Mar 28.

Troy S, Wasilewski M, Godfrey CJ. Poster presented at the 14th Annual WORLDSymposium. San Diego, CA. 5-9 February 2018.

Li C, Wang B, Chen SC, Wada R, Lu D, Wang X, Polhamus D, French J, Vadhavkar S, Strasak A, Smitt M, Joshi A, Samant M, Quartino A, Jin J, Girish S. Cancer Chemotherapy and Pharmacology 80 (6): 1079–90. December 2017.

Eudy-Byrne RJ, Gillespie W, Riggs MM. Gastonguay MR. J Pharmacokinet Pharmacodyn (2017).  First online 28 Oct 2017. https://doi.org/10.1007/s10928-017-9551-z

Zhu R, Zheng Y, Dirks NL, Vadhavkar S, Jin JY, Peng K, Holweg CTJ, Olsson J, Matthews JG, Putnam WS. Pulmonary Pharmacology & Therapeutics 46: 88–98. October 2017.

Ocampo-Pelland AS, French JL.  Presented at the 8th American Conference on Pharmacometrics (ACoP), Fort Lauderdale, FL, October 2017.

Gastonguay MR. Presented at the 8th American Conference on Pharmacometrics (ACoP), Fort Lauderdale, FL, October 2017.

Margossian C and Gillespie WR.  Presented at the 8th American Conference on Pharmacometrics (ACoP), Fort Lauderdale, FL, October 2017.

Gastonguay MR. Presented at the 8th American Conference on Pharmacometrics (ACoP), Fort Lauderdale, FL, October 2017.

Gastonguay MR.  The International Society of Pharmacometrics Lewis B. Sheiner Award Lecture presented at the 8th American Conference on Pharmacometrics (ACoP), Fort Lauderdale, FL, October 15, 2017.

Chen S-C, Quartino A, Polhamus D, Riggs M, French J, Wang X, Vadhavkar S, Smitt M, Hoersch S, Strasak A, Jin JY, Girish S, and Li C. Br J Clin Pharmacol, 2017 Jul 21.

Lu D, Gillespie WR, Girish S, Agarwal P, Li C, Hirata J, Chu YW, Kagedal M, Leon L, Maiya V, Jin JY. CPT: Pharmacometrics & Systems Pharmacology 6 (6): 401–8. June 2017.

Tortorici MA, Rogers JA, Vit O, Bexon M, Sandhaus R A, Burdon J, Chorostowska-Wynimko J, Thompson P, Stocks J, McElvaney NG, Chapman KR, and Edelman JM. Br J Clin Pharmacol, June 2017.  doi: 10.1111/bcp.13358.

Pierre V, Johnston C, Ferslew B, Brouwer K, Gonzalez D.  CPT: Pharmacometrics & Systems Pharmacology. 2017;6(5):331-339. doi:10.1002/psp4.12185.

Park SY, Xia L, Wilbur J, Staicu AM, Jumbe NL.  Paper presented at: Eastern North American Region (ENAR) Spring Meeting of the International Biometric Society, March 2017, Washington, DC.

Riccobene TA, Khariton T, Knebel W, Das S, Li J, Jandourek A, Carrothers TJ, Bradley JS.  The Journal of Clinical Pharmacology, March 2017; 57: 345–355. doi: 10.1002/jcph.809

Wilbur JD, Gupta M, Passey C, Roy A.  Poster presented at Eastern North American Region (ENAR) Spring Meeting of the International Biometric Society, March 2017, Washington, DC; Abstract 57d.

Moore JN, Gastonguay M, Adeniyi-Jones S, Moodey DE, Kraft WK.  Poster presented at: American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting, March 2017, Washington, DC; Abstract PII-099.

Zomorodi K, Dumas T, Berry S, Johnston C, and Eller M. Blood, Dec 2016, 128 (22) 1631

Chen SC, Quartino AL, Polhamus D, Riggs MM, French JL, Wang X, Vadhavkar S, Smitt M, Hoersch S, Strasak A, Chernyukhin N, Jin JY, Girish S, Li C.  Abstract in Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Cancer Res 2017;77(4 Suppl):Abstract P4-21-26.

Nagy CF, Mondick J, Serbina N, Casey LS, Carpenter SE, French J, Guttendorf R.  Clinical And Translational Science, 2016 Dec; 10: 12–19.

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

Polamus D, Rogers JA, Paul R, Kshirsagar S, Sahasranaman S, Jin JY, Quartino AL.  Presented at the 9th Annual Clinical Trials on Alzheimer’s Disease (CTAD), December 2016.

Ocampo-Pelland AS, Gastonguay MR, Riggs MM.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Margossian CC and Gillespie WR.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Gillespie WR. Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Gillespie WR.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

French JL.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Yamamoto BJ, Shadiack AM, Carpenter S, Sanford D, Henning LN, O’Connor E, Gonzales N, Mondick J, French J, Stark GV, Fisher AC, Casey LS, Serbina NV. Antimicrob Agents Chemother 60:5787–5795. doi:10.1128/AAC.00972-16

Gastonguay MR, Lasch K, Barocas M, Rosario M, Wilbur JD, Dirks NL, Osterman MT.  Presented at the American College of Gastroenterology Annual Meeting, October, 2016.

Hajjar J, French JL, Gastonguay MR.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Melhem M, Polhamus D, Lau T, Chen P, Narayanan A, Clements JD, Gibbs J, Seegan G.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Lu D, Li C, Polhamus D, French JL, Riggs MM, Agarwal P, Chen SC, Wang X, Smitt M, Patre M, Strasak A, ChernyukhinN , Quartino AL, Jin JY, Girish S.  Presented at the 7th American Conference on Pharmacometrics (ACoP), Bellevue, WA; October 2016.

Riccobene TA, Pushkin R, Jandourek A, Knebel W, Khariton T.  Antimicrob Agents Chemother. 2016 Sep 23;60(10):5849-57.

Gillespie WR and Margossian CC.  Presented at Stan for Pharmacometrics Day, Paris 22 Sep 2016.

Eudy-Byrne RJ, Gillespie WR, Riggs MM, Gastonguay MR.  Poster presented at: American Society for Bone and Mineral Research Annual Meeting; September 2016.

Baron KT, Macha S, Broedl UC, Nock V, Retlich S, Riggs M.  Diabetes Ther. 2016 Sep;7(3):455-71.

Polhamus D.  Presented at The Joint Statistical Meetings (JSM), August, 2016.

Park SY, Xia L, Wilbur J, and Staicu, AM.  Presented at The Joint Statistical Meetings (JSM), August 2016, Chicago, IL; Abstract 319197.

Polhamus D, French J, Chen SC, Wang B, Li C, Lu D, Girish S, Jin J, Quartino A.  Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE), Lisboa, June 2016.

Chen SC, Riggs MM, Nueesch E, Strasak A, French J, Jin J, Girish S, Li C.  Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE), Lisboa, June 2016.

French JL, Racine A, van Buuren S, Haggstrom J.  Presented at the Annual Meeting for the Population Approach Group in Europe (PAGE), Lisboa, June 2016.

Hajjar J, Fisher J, Gastonguay MR.  Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE), Lisboa, June 2016.

Wilbur JD, Gupta M, Passey C, Roy A.  Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE), Lisboa, June 2016.

Wilbur JD, Ohuma E, Xiao L, Mouksassi S, Hafen R.  Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE), Lisboa, June 2016.

Gastonguay MR.  Presented at the Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics: FDA – U Maryland CERSI Cosponsored Workshop.  FDA. June 1, 2016.

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

Su F, Gastonguay MR, Nicolson SC, DiLiberto M, Ocampo-Pelland A, Zuppa AF. Anesth Analg. 2016 May;122(5):1556-66.

French JL.  Presented at Trends and Innovation in Clinical Trial Statistics Conference, Durham, NC; May 2016.

Flockhart D, Bies RR, Gastonguay MR, Schwartz SL.  Br J Clin Pharmacol. 2016 May;81(5):804-6.

Ocampo-Pelland AS, Gastonguay MR, French JF, Riggs MM.  J Pharmacokinet Pharmacodyn. 2016 Apr;43(2):191-206.

Mondick J, Riggs M, Sasaki T, Sarashina A, Broedl UC, Retlich S. Diabetes Obes Metab. 2016 Mar;18(3):241-8.

Rogers JA, Tortorici MA, Viti O, Brexon M, Sandhaus RA, Burdon J, Piitulainen E, Seersholm N, Stocks J, McElvaney NG, Chapman KR, Edelman JM.  Presented at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting, San Diego, CA, March 2016.

Strand V, Ahadieh S, French J, Geier J, Krishnaswami S, Menon S, Checchio T, Tensfeldt TG, Hoffman E, Riese R, Boy M, Gómez-Reino JJ.  Arthritis Res Ther. 2015 Dec 15;17:362.

Pradhan RS, Gastonguay MR, Gao X, Monteleone JPR, Lathia CD, Fisher J, Godfrey C, Dirks NL, Melian A, Thompson DD.  Poster presented at ASBMR 2015 American Society for Bone and Mineral Research’s Annual Meeting. 9-12 October 2015.

Conrado DJ, Hather GJ, Chen D, Denney WS. Facilitating Cardiovascular Safety Exposure-Response Modeling in Early-Phase Clinical Studies with the cardioModel Package for R.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA, October 2015

Lalovic B, Rogers JA, French J, Flack M. PK-PD Analysis of PASI with Data at Boundary: BI 655066, an Anti-IL-23A mAb for the Treatment of Psoriasis.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA, October 2015

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

Polhamus D, French J, Chen S-C, Wang B, Li C, Lu D, Girish S, Jin J, Quartino A.  Presented at the 6th American Conference on Pharmacometrics, Arlington, VA; October 2015.

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

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

Hajjar J, Fisher J, Gastonguay MR.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA; October 2015.

Bergsma T and Pivirotto S.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA, October 2015.

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

Eudy RJ, Riggs MM, Gastonguay MR. AAPS J. 2015 Sep;17(5):1280-4.

Knebel W, Corcoran M, Ermer J, Gastonguay MR.  Clinical Pharmacokinetics (2015) 54: 875. doi:10.1007/s40262-015-0245-7

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

Rosario M, Dirks NL, Gastonguay MR, Fasanmade AA, Wyant T, Parikh A, Sandborn WJ, Feagan BG, Reinisch W, Fox I.  Aliment Pharmacol Ther. 2015 Jul;42(2):188-202.

Mascarenhas MR, Mondick J, Barrett JS, Wilson M, Stallings VA, Schall JI.  The Journal of Clinical Pharmacology, 55: 854–865. doi:10.1002/jcph.484

Polhamus D, French J.  Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE), Hersonissos, Greece; June 2015.

Ocampo-Pellend AS, Gastonguay, French JL, Riggs MM. Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE), Hersonissos, Greece; June 2015.

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

Ferslew B, Johnston C, Tsakalozou E, Bridges A, Paine M, Jia W, Stewart P, Barritt A and Brouwer K. Clinical Pharmacology and Therapeutics, 97: 419–427. doi:10.1002/cpt.66

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

Knebel W, Rogers JA, Polhamus D, Ermer J, Gastonguay MR. Journal of Pharmacokinetics and Pharmacodynamics, Feb 2015, Volume 42, Issue 1, pp 45–65. doi:10.1007/s10928-014-9397-6

P. Ravva, M. R. Gastonguay, H. M. Faessel, T. C. Lee, and R. Niaura. Nicotine & Tobacco Research, Volume 17, Issue 1, 1 January 2015, Pages 106–113.

Marc Gastonguay. Presented at CERSI Workshop on the Use of Exposure Matching and Exposure Response for Extrapolation of Efficacy in Pediatric Drug Development. January 22, 2015.

Stricker PA, Gastonguay MR, Singh D, Fiadjoe JE, Sussman EM, Pruitt EY, Goebel TK, and Zuppa AF.  BJA: British Journal of Anaesthesia, 114(4), 689–699. http://doi.org/10.1093/bja/aeu459

Jin Y, Bies R, Gastonguay MR, Wang Y, Stockbridge N, Gobburu J, Madabushi R. J Pharmacokinet Pharmacodyn. 2014 Dec;41(6):693-704. doi: 10.1007/s10928-014-9394-9

Romero K, Sinha V, Allerheiligen S, Danhof M, Pinheiro J, Kruhlak N, Wang Y, Wang SJ, Sauer JM, Marier JF, Corrigan B, Rogers J, Lambers Heerspink HJ, Gumbo T, Vis P, Watkins P, Morrison T, Gillespie W, Gordon MF, Stephenson D, Hanna D, Pfister M, Lalonde R, Colatsky T. Journal of Pharmacokinetics and Pharmacodynamics, 2014 Dec;41(6):545-52. doi: 10.1007/s10928-014-9390-0.

Riggs MM, Seman LJ, Staab A, MacGregor TR, Gillespie W, Gastonguay MR, Woerle HJ, Macha S.  Br J Clin Pharmacol. 2014 Dec;78(6):1407-18. doi: 10.1111/bcp.12453.

Endres CJ, Salinger DH, Köck K, Gastonguay MR, Martin D, Klekotka P, Nirula A, and Gibbs MA. The Journal of Clinical Pharmacology, 54(11): 1230–1238, November 2014. doi:10.1002/jcph.334.

Ferslew BC, Johnston CK, Tsakalozou EF, Su MI, Xie GU, Jia WE, Brouwer KLR and Barritt AS. Presented at the American Association for the Study Of Liver Diseases Annual Meeting, Boston, MA, November 2014; Abstract 831.

Polhamus DG, Kang J, Rogers JA, and Gastonguay MR. Presented at the 7th Annual Clinical Trials on Alzheimer’s Disease (CTAD), November 2014.

Eudy RJ and Gastonguay MR. Presented at the 5th American Conference on Pharmacometrics (ACoP), Las Vegas, NV, October 2014.

Jonathan French. Presented at the 5th American Conference on Pharmacometrics (ACoP), Las Vegas, NV, October 2014.

Khariton T, Riccobene T, Knebel W, O’Neal T, Ghahramani P. Presented at the 5th American Conference on Pharmacometrics (ACoP), Las Vegas, NV, October 2014.

Bergsma T and Pivirotto S.  Presented at the 5th American Conference on Pharmacometrics (ACoP), Las Vegas, NV, October 2014.

W. Knebel, J. Ermer, J. Purkayastha, P. Martin, and M. R. Gastonguay.  The AAPS Journal. 2014;16(6):1237-1246. doi:10.1208/s12248-014-9645-0.

Quartino A, Polhamus D, Rogers JA, and Jin J. Presented at the Population Approach Group Europe (PAGE), Alicante, 2014. Abstract 3187.

Knebel W, Gastonguay M, Polhamus D, Hane JT. Presented at the Annual Meeting of the Population Analysis Group in Europe (PAGE), Alicante, Spain; June 2014; Abstract I-55.

J. S. Gewandter, R. H. Dworkin, D. C. Turk, M. P. McDermott, R. Baron, M. R. Gastonguay, I. Gilron, N. P. Katz, C. Mehta, S. N. Raja, S. Senn, C. Taylor, P. Cowan, P. Desjardins, R. Dimitrova, R. Dionne, J. T. Farrar, D. J. Hewitt, S. Iyengar, G. W. Jay, E. Kalso, R. D. Kerns, R. Leff, M. Leong, K. L. Petersen, B. M. Ravina, C. Rauschkolb, A. S. C. Rice, M. C. Rowbotham, C. Sampaio, S. H. Sindrup, J. W. Stauffer, I. Steigerwald, J. Stewart, J. Tobias, R.-D. Treede, M. Wallace, and R. E. White.  Pain. 2014 Sep;155(9):1683-95. doi: 10.1016/j.pain.2014.05.025. Epub 2014 May 24.

Hansson EK, Ma G, Amantea MA, French J, Milligan PA, Friberg LE, and Karlsson MO. CPT: Pharmacometrics & Systems Pharmacology. 2013;2(12):e85-. doi:10.1038/psp.2013.62.

Hansson EK, Amantea MA, Westwood P, Milligan PA, Houk BE, French J, Karlsson MO and Friberg LE. CPT: Pharmacometrics & Systems Pharmacology. 2013;2(11):e84-. doi:10.1038/psp.2013.61

Polhamus DG, Rogers JA, Gillespie WR, French J. Presented at the Alzheimer’s Association International Conference (AAIC),  2013.

Johnston CK, Ferslew BC, Barritt AS, Brouwer KL. Presented at the American Association of Pharmaceutical Scientists Annual Meeting, San Antonio, TX, November 2013.

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.

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

Olson S, Baron K, Riggs M, Bocher WO, Mensa FJ.  Journal of Hepatology, 58:S492–S493.

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.

Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S.  The Journal of Clinical Pharmacology. 2013 Oct;53(10):1028-38. doi:10.1002/jcph.147

Presented at the Annual Meeting of the Population Approach Group Europe (PAGE), Glasgow; June, 2013. Abstract A-06.

Stricker PA, Zuppa AF, Fiadjoe JE, Maxwell LG, Sussman EM, Pruitt EY, Goebel. TK, Gastonguay MR, Taylor JA, Bartlett SP, Schreiner MS.  Br J Anaesth. 2013 May;110(5):788-99. doi: 10.1093/bja/aes507

Bergsma T, Knebel W, Polhamus D, Hane JT, Gastonguay MR. Presented at the 4th American Conference on Pharmacometrics (ACoP), Ft. Lauderdale; May 2013.

French J. Presented at the 4th American Conference on Pharmacometrics (ACoP), Ft. Lauderdale; May 2013.

Gross JL, Rogers JA, Polhamus D, Gillespie W, Friedrich C, Gong Y, Monz BU, Patel A, Staab A, Retlich S. BMJ Open. 5 March 2013.

Bergsma TT, Knebel W, Fisher J, Gillespie WR, Riggs MM, Gibiansky L, Gastonguay MR. Comput Methods Programs Biomed. 2013 Jan;109(1):77-85.

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

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

Gross JL, Rogers JA, Polhamus D, Gillespie W, Patel S, Friedrich C, Gong Y, Monz B, Staab A, Retlich S.  American Diabetes Association 72nd Scientific Sessions, 2012.

Knebel W, Rao N, Uchimura T, Mori A, Fisher J, Gastonguay MR, and Chaikin P. The Journal of Clinical Pharmacology, 2012; 52: 1468–1481. doi:10.1177/0091270011420566.

Rogers JA, Polhamus D, Gillespie WR, Ito K, Romero K, Qiu R, Stephenson D, Gastonguay MR, Corrigan B. J Pharmacokinet Pharmacodyn. October 2012, Volume 39, Issue 5, pp 479-498.

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).

Knebel W, Rogers JA, Polhamus D, Youcha S, White C, Ermer J, and Gastonguay M. American Academy of Child and Adolescent Psychiatry, 59th Annual Meeting. 2012.

Abu Tarif M, Kaplita S, Berman RM, Coric V, Baron K.  Presented at the Alzheimer’s Association International Conference (AAIC), Vancouver, BC, July 2012.

Rogers J, Lockwood P, Polhamus D, Brault Y, Desmet A, Ito K, Romero K, Qiu R, Gillespie W, Corrigan B, Gastonguay M.  Presented at the Alzheimer’s Association International Conference (AAIC), Vancouver, BC, July 2012.

Bergsma TT and Smith MS. The R Journal; June 2012, Vol. 4 Issue 1, p60-63.

Jin Y, Bies R, Gastonguay MR, Stockbridge N, Gobburu J, Madabushi R.  J Pharmacokinet Pharmacodyn. 2012 Jun;39(3):283-94.

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.

Polhamus D, Rogers JA, Gillespie W, French J, and Gastonguay M.  Presented at the 21st Annual Meeting of the Population Approach Group Europe (PAGE), Venice, Italy, June 2012, Abstract 2580.

Rogers JA, Polhamus D, Gillespie W, Friedrich C, Staab A, and Retlich S. Presented at the 21st Annual Meeting of the Population Approach Group Europe (PAGE), Venice, Italy, June 2012, Abstract 2448.

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

Hane J and Kraut A.  Presented at BioIT World Conference and Expo, Boston, MA; April 23-25, 2012.

Riggs MM, Bergsma TT, Rogers JA, Gastonguay MR, Subramanian GM, Chen C, Devalaraja M, Corey AE, Sun H, Yu J, and Stein DS. The Journal of Clinical Pharmacology, 52: 475–486, April 2012. doi:10.1177/0091270011399576

Rogers JA, Polhamus D, Ito K, Qiu R, Gillespie W, Corrigan B. Presented at the 2012 American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting, National Harlbor, MD; March 2012.

D’Argenio DZ, Gastonguay MR, Brundage RC, Miller R, Tannenbaum SJ, Pfister M. J Pharmacokinet Pharmacodyn. 39(1):3. February 2012.

Davies K.  Bio-IT World, Feb 14, 2012.

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

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.

Gastonguay MR.  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.

Johnston CK, Tsuji BT.  Presented at the American College of Clinical Pharmacy (ACCP) Annual Meeting; October 2011; Pittsburgh, PA.

Zuppa AF, Nicolson SC, Barrett JS, Gastonguay MR.  J Pediatr. 159(3):414-419.e1-3. September 2011.

Gastonguay MR.  Presented at the 20th Annual Meeting of the Population Approach Group Europe (PAGE),  Athens, Greece,  June 2011. Abstract 2229.

Baron KT, Ravva P, Purohit V, Riggs MM, Gastonguay MR. 6th International Workshop on Clinical Pharmacology of Hepatitis Therapy, June 2011.

Gibbs JP, Emery MG, McCaffery I, Smith B, Gibbs MA, Akrami A, Rossi J, Paweletz K, Gastonguay MR, Bautista E, Wang M, Perfetti R, Daniels O.  J Clin Pharmacol. 51(6):830-41. June 2011.

Bergsma T. Presented at ACOP; April 2011; San Diego, CA.

Cirrincione-Dall G, Gastonguay MR, Knebel W, Bergsma T, Zhang AY, Patel D, Barrett JS, van Schaik R, Soldin OP, Soldin SJ, Nulmin I, Koren G, de Wildt SN. Presented at ACOP; April 2011; San Diego, CA.

Riggs MM. Presented at ACOP; April 2011; San Diego, CA.

Bergsma T, Fisher J, Gastonguay MR, Hane J, Knebel W, Riggs MM, Rogers JA. Presented at ACOP; April 2011; San Diego, CA.

Polhamus D, Baron KT, Purohit VS, Ravva P, Rogers JA, Gastonguay MR. Presented at ACOP; April 2011; San Diego, CA.

Baron K, Ravva P, Purohit V, Riggs MM, Gastonguay MR. Presented at ACOP; April 2011; San Diego, CA.

Rogers JA. Presented at ACOP; April 2011; San Diego, CA.

Riggs MM, Bennetts M, Martin SW, Van Der Graaf PH. Presented at ACOP; April 2011; San Diego, CA.

Feng Y, Gastonguay MR, Pollock BG, Frank E, Kepple GH, Bies RR.  Neuropsychiatr Dis Treat. 7:117-25. 16 March 2011.

Knebel W, Tammara B, Udata C, Comer G, Gastonguay MR, Meng X.  J Clin Pharmacol. 51(3):333-45. March 2011.

Rogers JA, Ito K, Gillespie WR, Corrigan BW, Gastonguay MR. Presented at the Fourth Annual Bayesian Biostatistics Conference, Houston, TX. 26–28 January 2011.

Rogers JA, Wilbur J, Cole S, Bernhardt PW, Bupp JL, Lennon MJ, Langholz N, Steiner CP. Statistics in Biopharmaceutical Research. 3(4):515-525. (2011)

Riggs MM, Gastonguay MR, Peterson MC. Presented at 2010 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting, New Orleans LA; 17 November 2010; Poster # W4403

Riggs MM.  2010 AAPS Clinical Pharmacology and Translational Research (CPTR) Open Forum; 16 November 2010.

Riggs MM, Gillespie WR, Gastonguay MR, Peterson MC. Presented at National Institute of General Medical Sciences Quantitative Systems Pharmacology Workshop II. Bethesda, MD; 9 September 2010.

Romero K, Corrigan B, Tornoe CW, Gobburu JV, Danhof M, Gillespie WR, Gastonguay MR, Meibohm B, Derendorf H. J Clin Pharmacol. 50(9 Suppl):9S-19S. September 2010.

Pfister M, Brundage RC, Gastonguay MR, Miller R, Tannenbaum SJ, D’Argenio DZ. J Clin Pharmacol. ;50(9 Suppl):158S. September 2010.

Brundage RC, Pfister M, D’Argenio DZ, Gastonguay MR, Miller R, Tannenbaum SJ. J Clin Pharmacol. 50(9 Suppl):7S-8S. September 2010.

Gastonguay MR, Gillespie WR, Bauer RJ. Presented at PAGE 2010. Berlin, Germany. 8–11 June 2010

Knebel W, Bergsma TT, Dagdigian C, Hane J, Gastonguay MR. Presented at PAGE 2010, 19th Meeting, Berlin, Germany, June 8–11, 2010.

Peterson MC and Riggs MM. Presented at American Association of Pharmaceutical Scientists National Biotechnology Conference, Update on Quantitative Systems and Disease Models for Biologics. Mini–Symposium. San Francisco, CA; May 2010.

Su F, Nicolson SC, Gastonguay MR, Barrett JS, Adamson PC, Kang DS, Godinez RI, Zuppa AF. Anesth Analg. 110(5):1383-92. May 2010.

Riggs MM. Presented at American Association of Pharmaceutical Scientists National Biotechnology Conference, Update on Quantitative Systems and Disease Models for Biologics. Mini–Symposium. San Francisco, CA; May 2010.

Rogers JA. Presented at 3rd Annual FDA/MTLI Medical Device and IVD Statistics Workshop. 28 April 2010.

Dirks N, Gastonguay MR, Gillespie WR, Knebel W, Riggs MM, Panetta JC, and Meibohm B. Presented at ASCPT 111th Annual Meeting, March 17-20, 2010.

Sweeney KR, Gastonguay MR, Benincosa L, Cronenberger CL, Glue P, Malhotra BK. Drug Discov Ther. 4(1):44-53. February 2010.

Ravva JP, Gastonguay MR, French JL, Tensfeldt TG, and Faessel HM. Clinical Pharmacology & Therapeutics. 87(3):336-44. January 2010.

Mondick JT, Johnson BM, Haberer LJ, Sale ME, Adamson PC, Coté CJ, Croop JM, Russo MW, Barrett JS, Hoke JF. Eur J Clin Pharmacol. 66(1):77-86. January 2010.

Peterson MC, Riggs MM. Bone. 46: 49-63. January 2010.

Gastonguay MR. Presented at ACOP 2009. 6 October 2009; Mashantucket, CT.

Gillespie WR, Rogers JA, Ito K, Gastonguay MR. Presented at ACOP 2009. October 4-7, 2009; Mashantucket, CT.

Gillespie B, Gastonguay MR. Presented at ACOP 2009. October 4-7, 2009; Mashantucket, CT.

Rogers JA, Riggs MM, Coffiner M, Gillespie WR, Burford R, Vanderbist F, De Niet S, Gastonguay MR. ACOP 2009. October 4–7, 2009; Mashantucket, CT.

Riggs MM, Peterson MC, Gastonguay MR. Presented at ACOP 2009. October 4-7, 2009; Mashantucket, CT.

Nicholas T, Knebel W, Gastonguay MR, Bednar MM, Billing B, Landen JW, Kupiec JW, Corrigan B, Laurencot R, Zhao Q. Poster presented at the ICAD 2009 Annual Meeting; July 11–16, 2009; Vienna, Austria.

Gillespie B, Rogers JA, Ito K, Gastonguay MR. ASCPT 110th Annual Meeting, March 18-21, 2009; Washington D.C.

Knebel W, Palmen M, Dowell JA, Gastonguay M. J Clin Pharmacol. 48(7):837-48. July 2008.

Fisher J, Gastonguay MR, Knebel W, Gibiansky L, Wire MB. Poster presented at the American Conference on Pharmacometrics. March 9-12 2008; Tucson, Arizona.

Riggs MM, Bergsma TT, Gillespie WR, Gastonguay MR, Sprenger KJ. Poster presented at the American Conference on Pharmacometrics. March 9-12 2008; Tucson, Arizona.

Gillespie WR, Gastonguay MR, Knebel W, Georgalis G. Poster presented at the American Conference on Pharmacometrics. March 9-12 2008; Tucson, Arizona.

Knebel W, Bergsma T, Fisher J, Georgalis G, Gibiansky L, Gillespie WR, Riggs MM, Gastonguay MR. Poster presented at the American Conference on Pharmacometrics. March 9-12 2008; Tucson, Arizona.

Gillespie WR, Gastonguay MR, Knebel W. Presented at the AAPS Annual Meeting; November 2007; San Diego, CA.

Knebel W, Rao N, Bergsma T, Gastonguay M, Mori A, Uchimura T, Allenby K, Dvorchik B, Sussman N, Chaikin P. Presented at ACCP; October 14-17, 2007; Denver, CO.

Rawa P, Faessel H, Gastonguay MR, Tensfeldt TG, Reeves K. Clin Pharmacol Ther. 81(S1) March 2007; Abstract PII-73: S72.

Faessel HM, Rawa P, Gastonguay MR, Rohrbacher KD, Tenfeldt TG. Clin Pharmacol Ther; 81(S1). March 2007; Abstract PI-26: S20-21.

Riggs M. FDA/Industry Statistics Workshop. 29 September 2006; Washington D.C.; Parallel Session 14: Case Studies in Modeling and Simulation, Abstract.

Agoram B, Heatherington AC, Gastonguay MR. AAPS Journal. 8(3), September 2006. doi: 10.1208/aapsj080364

Gastonguay MR, Gibiansky L. Presented at the ECPAG Conference. July 24-26, 2006; Rockville, MD; Workshop Poster Session, Abstract.

Mondick JT, Gibiansky L, Gastonguay MR, Veal GJ, Barrett JS. Presented at PAGE 2006. June 14-16, 2006; Brugge/Bruges, Belgium; Abstract 938.

Gibiansky L and MR Gastonguay. Presented at PAGE 2006. June 14-16, 2006; Brugge/Bruges, Belgium; Abstract 958.

Gibiansky E, Gibiansky L. Presented at PAGE 2006. June 14-16, 2006; Brugge/Bruges, Belgium; Abstract 959.

Gastonguay MR, Gibiansky L. Presented at the MUFPADA Annual Meeting. May 2-3, 2006; Ann Arbor, MI; Abstract.

A practical, iterative, “fit-for-purpose” approach to biomarker method development and validation is proposed, keeping in mind the intended use of the data and the attendant regulatory requirements associated with that use. Sample analysis within this context of fit-for-purpose method development and validation are well suited for successful biomarker implementation, allowing increased use of biomarkers in drug development.

Knebel B, Bergsma T, Gibiansky L, Hane JT, Gastonguay MR. Presented at PAGE Annual Meeting. June 16-17, 2005; Pamplona, Spain; Abstract 779.

Gastonguay MR, El-Tahtawy A. The AAPS Journal. 7(S2), June 2005. Abstract W5318.

Gastonguay MR, El-Tahtawy A. Clinical Pharmacology and Therapeutics. 77(2), P2-P2; February 5, 2005.

Gibiansky E, Gibiansky L, Enriquez J. Clinical Pharmacology and Therapeutics. 77(2), P48-P48; February 5, 2005.

Gastonguay MR, Venitz J, Steffen R, Hackman J. Clinical Pharmacology and Therapeutics. 77(2), P89-P89, February 5, 2005.

Gibiansky L. Presented at AAPS Annual Meeting: PPDM Poster-Podium Session, November 10, 2004; Baltimore, MD.

Gastonguay MR, Hane JT. The AAPS Journal. 6(S1) (2004); Abstract W4355.

Gastonguay MR. The AAPS Journal. 6(S1) (2004); Abstract W4354.

Gastonguay MR, Bies R. The AAPS Journal. 6(S1) (2004); Abstract W4353, 2004.