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Products are filtered by different dates, depending on the combination of live and on-demand components that they contain, and on whether any live components are over or not.
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  • UPCOMING LIVE!
    Contains 1 Component(s) Includes a Live Web Event on 07/16/2025 at 12:00 PM (EDT)

    The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.

    The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.  

    Phyllis Chan

    Pharmacometrician in Clinical Pharmacology Modeling & Simulation Group

    Genentech

    Phyllis is a pharmacometrician in the Clinical Pharmacology Modeling & Simulation group at Genentech in South San Francisco. Before joining Genentech in 2017, Phyllis worked at Bristol-Myers Squibb, obtained her PhD in Pharmaceutical Sciences from Auburn University and was a postdoctoral fellow at University of Southern California's Biomedical Simulations Resource (BMSR).  More recently, Phyllis received an MPH from Imperial College London.  She specializes in population PK, exposure-response, tumor growth inhibition-overall survival, and model-based meta-analysis.

  • UPCOMING LIVE!
    Contains 1 Component(s) Includes a Live Web Event on 06/24/2025 at 10:00 AM (EDT)

    Great data visualization is more than just charts—it’s about effective communication. This session explores principles of design that make data clear, efficient, and beautiful, ensuring your audience grasps key insights at a glance. Learn how to craft visualizations that not only look good but also enhance understanding and tell a compelling story with your data.

    Great data visualization is more than just charts—it’s about effective communication. This session explores principles of design that make data clear, efficient, and beautiful, ensuring your audience grasps key insights at a glance. Learn how to craft visualizations that not only look good but also enhance understanding and tell a compelling story with your data.

    Dr. Cédric Scherer

    Dr. Cédric Scherer (he/him) is a computational ecologist turned independent data visualization professional. Combining research expertise with a passion for data and design, he helps organizations, research teams, and businesses communicate insights through engaging visualizations, reports, and presentations. Specializing in bespoke, code-driven designs—from clear and effective to artistic and unconventional—Cédric has created visualizations across various disciplines and regularly teaches data visualization principles, R, and ggplot2.

  • UPCOMING LIVE!
    Contains 1 Component(s) Includes a Live Web Event on 06/18/2025 at 12:00 PM (EDT)

    The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.

    The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.  

    Rong Chen

    Research Scientist

    Certara

    Rong is a research scientist at Certara USA Inc’s Data Sciences Division Phoenix NLME group. His responsibility involves maintaining, improving, and developing the existing and new computational and statistical algorithms for Phoenix NLME software. Rong got his nuclear physics PhD at Arizona State University in 2020. The PhD focused on large-scale quantum Monte Carlo simulations. Prior to join Certara in 2023, Rong was a postdoctoral research fellow at Children’s Hospital Los Angeles where he developed high performance parametric and nonparametric algorithms for population pharmacokinetics/pharmacodynamics (PK/PD) modeling.

  • On-Demand
    Contains 1 Component(s) Recorded On: 05/23/2025

    Non-linear mixed effects modeling and simulation (NLME M& S) is evaluated to be used for standardization with longitudinal data. Non-linear mixed effects modeling (NLME) is a particular implementation of standardization that conditions on individual parameters – the random effects of the mixed effects model. The present work is motivated by the fact that in pharmacometrics NLME M& S is routinely used to analyze clinical trials and to predict and compare hypothetical outcomes of the same patient population under different treatment regimens. Such a comparison is a causal question sometimes referred to as causal prediction. Nonetheless, NLME M& S is rarely positioned as a method for causal prediction. As example a simulated clinical trial is used that assumes treatment confounder feedback in which early outcomes can cause deviations from the planned treatment schedule and are correlated with the final outcome. Being interested in the outcome for the planned treatment schedule, we evaluate possibilities to correct for the confounding using NLME M& S based on latent conditional exchangeability or implementations of other causal inference g-methods based on sequential conditional exchangeability (inverse probability weighting (IPW), standardization or g-estimation). All the methods can correct for the confounding, as long as assumptions required for identification of the estimand hold, including in particular, positivity, no unobserved confounding, and correct specification of the models used for the analyses.

    Non-linear mixed effects modeling and simulation (NLME M& S) is evaluated to be used for standardization with longitudinal data. Non-linear mixed effects modeling (NLME) is a particular implementation of standardization that conditions on individual parameters – the random effects of the mixed effects model. The present work is motivated by the fact that in pharmacometrics NLME M& S is routinely used to analyze clinical trials and to predict and compare hypothetical outcomes of the same patient population under different treatment regimens. Such a comparison is a causal question sometimes referred to as causal prediction. Nonetheless, NLME M& S is rarely positioned as a method for causal prediction. As example a simulated clinical trial is used that assumes treatment confounder feedback in which early outcomes can cause deviations from the planned treatment schedule and are correlated with the final outcome. Being interested in the outcome for the planned treatment schedule, we evaluate possibilities to correct for the confounding using NLME M& S based on latent conditional exchangeability or implementations of other causal inference g-methods based on sequential conditional exchangeability (inverse probability weighting (IPW), standardization or g-estimation). All the methods can correct for the confounding, as long as assumptions required for identification of the estimand hold, including in particular, positivity, no unobserved confounding, and correct specification of the models used for the analyses.

    Christian Bartels

    Senior Director

    Novartis

    Christian Bartels studied molecular biology at the Biocentre in Basel to focus then on data analysis, modeling and simulation. After some notable contributions to proteomics, protein structure determination, peptide folding and drug design, he specialized into pharmacometrics. Since 2009, Christian works in the pharmacometrics modeling and simulation group from Novartis supporting compounds across the portfolio.

    Manuela Zimmermann

    Principal Pharmacometrician

    Novartis

    Manuela Zimmermann is a Principal Pharmacometrician at Novartis, supporting the clinical development of new compounds primarily in the oncology therapeutic area. Before joining the Pharmacometrics Department, she worked on type-I error controlled exploratory variable selection as part of the Advanced Methodology and Data Science group at Novartis. Manuela holds a Ph.D in Biophysics and Biophysical Chemistry from the University of Cambridge. Her thesis focused on developing quantitative methods to investigate stochastic phenomena linked to Alzheimer’s disease.

  • On-Demand
    Contains 1 Component(s) Recorded On: 05/21/2025

    The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.

    The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.  

    Yuezhe Li

    Research Scientist II

    Metrum Research Group

    Yuezhe Li is a Research Scientist II at Metrum Research Group. Since joining Metrum Research Group in 2021, her work has focused on developing quantitative systems pharmacology (QSP) models to support preclinical and clinical development of antibody drug conjugates (ADCs), bispecific T cell engagers, and gene therapies. Yuezhe earned her Ph.D. in Biomedical Science from the University of Connecticut. Other fields of experiences include systems biology, machine learning, and mathematical modeling.

  • On-Demand
    Contains 1 Component(s) Recorded On: 05/19/2025

    This event aimed to define minimum evaluation criteria for QSP virtual populations used in regulatory submissions, establishing clear credibility assessment guidelines that will shape the future of QSP modeling.

    This event aimed to define minimum evaluation criteria for QSP virtual populations used in regulatory submissions, establishing clear credibility assessment guidelines that will shape the future of QSP modeling.

    Featured Presentations

    The workshop features an impressive lineup of speakers sharing real-world experiences with VPOPs in regulatory submissions:

    • Steve Chang: "Virtual Population Assessment Landscape: Where are we thus far?"
    • Rohit Rao, Pfizer: "Learn-Predict-Confirm: Development and Qualification of QSP Virtual Populations for COVID-19 Therapeutics"
    • Mengdi Tao, Sanofi: "Credibility of QSP Virtual Populations in Rare Disease Drug Development"
    • Yili Qian, BMS: "Developing Virtual Populations for QSP Models: A Workflow Illustrated by an Immune Checkpoint Inhibitor Case Study"

    Discussion Leaders

    • Lourdes Cucurull-Sanchez: Best Practices from Experience
    • Jingqi Gong & Monica Susilo: Digital Twins and Future Directions

  • On-Demand
    Contains 1 Component(s) Recorded On: 05/13/2025

    An important skill for quantitative scientists within the pharmaceutical industry is the need effectively communicate complex technical information. This is especially challenging when the audience includes high-level stakeholders such as senior managers and regulatory representatives who may not have a deep technical understanding but must rely on modeling and simulation analyses to drive decision making. In this webinar, important points to consider will be discussed that can help attendees develop and deliver successful presentations that are tailored to meet the needs of the target audience and their objectives.

    An important skill for quantitative scientists within the pharmaceutical industry is the need effectively communicate complex technical information.  This is especially challenging when the audience includes high-level stakeholders such as senior managers and regulatory representatives who may not have a deep technical understanding but must rely on modeling and simulation analyses to drive decision making.  In this webinar, important points to consider will be discussed that can help attendees develop and deliver successful presentations that are tailored to meet the needs of the target audience and their objectives. 

    Ginny Schmith

    Virginia (Ginny) Schmith has 35+ years of experience in clinical pharmacology and pharmacometrics providing strategy across all phases of drug development and numerous therapeutic areas: anesthesia, cardiovascular, pulmonary, gastrointestinal, central nervous system, dermatology, cancer, inflammation, antibiotics, antivirals, and rare diseases, and has actively contributed to the approval of 15+ drugs. She worked for GSK (and predecessor companies) for 26 years and then went into consulting at Nuventra Pharma Sciences for almost 7 years. Currently, she continues to consult with small companies within her own company (Schmith PK/PD Consulting LLC) and as part of the Syntegrity Quantitative Clinical Pharmacology Collaborative.

    Ginny’s focus is on the strategy for using quantitative clinical pharmacology approaches to answer drug development questions, even when there is incomplete data, and communicating (written and orally) this information to regulatory agencies and management within small biotechnology companies.

    Dr. Schmith has been an Adjunct Professor at UNC-CH Eshelman School of Pharmacy since 1989 and recently become a Courtesy Clinical Professor at the University of Florida School of Pharmacy. Ginny has published 50 peer-reviewed articles and reviews in international scientific journals in addition to over 80 published abstracts related to clinical pharmacology and pharmacometrics; she has authored 6 patents; and is an active member of the American Society of Clinical Pharmacology (since 1989), the International Society of Pharmacometrics, and a fellow of the American College of Clinical Pharmacology. 

  • On-Demand
    Contains 1 Component(s) Recorded On: 04/16/2025

    The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.

    The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.  

    Nadia Noormohamed

    Clinical Pharmacologist

    GSK

    Nadia is a clinical pharmacologist currently working in the CPMS group at GSK within Vaccines and Infectious Disease. For the past 3 years, she has worked on MIDD approaches in the HBV space, with a focus on PKPD modeling. She has also contributed to internal and external initiatives in the areas of organ impairment and QT prolongation. Nadia had initially trained as a pharmacist and graduated with a PharmD from Massachusetts College of Pharmacy. Research experience while in pharmacy school motivated her to pursue a postdoc in pharmacometrics as part of a combined program with Merck and Rutgers University. After her postdoc and prior to joining GSK in her current role, she continued with Merck in the Pharmacometrics group and gained hands-on experience in various therapeutic areas. Outside of work, Nadia enjoys reading, powerlifting, and perusing different neighborhoods in Philadelphia.

  • On-Demand
    Contains 1 Component(s) Recorded On: 03/31/2025

    We consider nonlinear mixed effects models including high-dimensional covariates to model individual parameters variability. The objective is to identify relevant covariates and estimate model parameters. We combine a penalized LASSO-type estimator with an eBIC model choice criterion to select the covariates of interest. Then we estimate the parameters by maximum likelihood in the reduced model. We calculate the LASSO-type penalized estimator by a weighted proximal gradient descent algorithm with an Adagrad-type adaptive step. This choice allows us in particular to consider models that do not necessarily belong to the curved exponential family. We illustrate the performance of the method in a nonlinear mixed-effects logistic growth model.

    We consider nonlinear mixed effects models including high-dimensional covariates to model individual parameters variability. The objective is to identify relevant covariates and estimate model parameters. We combine a penalized LASSO-type estimator with an eBIC model choice criterion to select the covariates of interest. Then we estimate the parameters by maximum likelihood in the reduced model. We calculate the LASSO-type penalized estimator by a weighted proximal gradient descent algorithm with an Adagrad-type adaptive step. This choice allows us in particular to consider models that do not necessarily belong to the curved exponential family. We illustrate the performance of the method in a nonlinear mixed-effects logistic growth model.

    Estelle Kuhn

    Researcher in Statistics

    INRAE - University Paris Saclay

    Estelle Kuhn, Senior Researcher in Statistics, at INRAE-University Paris Saclay I am senior researcher in statistics at INRAE-University Paris Saclay in the Dynenvie team at the Applied Mathematics and Computer Science from Genome to Environment lab (MaIAGE). My current research topics concern inference and variable selection in high-dimension setting in latent variable models such as mixed and joint models. I am also interested in hybrid models combining mechanistic and statistical models. I develop stochastic optimization algorithms such as expectation maximization and gradient descent adapted to different contexts. I apply these methodologies in strong collaboration with colleagues at interfaces, particularly in plant breeding and animal genetics.

  • On-Demand
    Contains 1 Component(s) Recorded On: 03/26/2025

    The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.

    The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.  

    Mayu Osawa

    Director in Pharmacometrics

    Bristol Myers Squibb

    Mayu Osawa has over a decade of experience in the pharmaceutical industry at Bristol Myers Squibb, where she serves as a Director in Pharmacometrics. She has extensive experience in both early and late development programs, leading modeling work across therapeutic areas including oncology, immunology, and hematology to support drug development decisions, dose selection, and health authority submissions. She obtained her Ph.D. in biostatistics from Kitasato University.

    Géraldine Cellière

    VP Applications Clinical Pharmacology & Pharmacometrics Solutions

    Simulations Plus

    Dr Géraldine Cellière is a multidisciplinary scientist with a background in statistics and modeling. She holds an engineering degree from Ecole Polytechnique (Paris, France) and a Master in computational biology from ETH Zürich (Switzerland). After an experience as assistant project manager at SoBios, she did a PhD in systems biology and multi-scale modeling at INRIA Paris and received her doctoral degree in 2016. Géraldine then joined Lixoft (now part of Simulations Plus) as VP Application. There, she leads the team in charge of all pre- and post-sales activities (demonstrations, trainings, technical support), research activities (improvement and development of new methods, application to case studies, publications), as well as the MonolixSuite development (product specification and testing).