Webinar Registration

Webinar: Clinical Pharmacology Considerations and Modeling of CAR-T Cell Therapies Using Monolix®

Chimeric antigen receptor T-cell (CAR-T) therapies have revolutionized the treatment of hematologic malignancies, delivering durable responses in patients with relapsed and refractory cancers. However, the unique pharmacological behavior of these living drugs poses significant challenges for clinical pharmacology and model-informed drug development.

This webinar offers a comprehensive overview of the unique kinetics and pharmacodynamic characteristics of CAR-T therapies, including multiphasic kinetics, clinical pharmacology considerations, modeling strategies, exposure-response complexities, and the evolving landscape of CAR-T design. Through the lens of model-informed drug development, the presenters will explore how Monolix, a powerful nonlinear mixed-effects modeling platform, can be used to characterize CAR-T kinetics and pharmacodynamics.

Attendees will also see a practical case study on modeling Tisagenlecleucel, covering model development, data integration, and interpretation of results to inform clinical decision-making.

This webinar is ideal for clinical pharmacologists, modelers, translational scientists, and regulatory professionals seeking to deepen their approach to CAR-T development through quantitative modeling.

Thursday, January 22, 2026
8:00 am - 9:00 am PST

Speakers

Mitali Gaurav, Pharm.D.

Assistant Director, Pharmacometrics
Simulations Plus

Dr. Gaurav joined Simulations Plus in October 2019 as a pharmacometrician after completing her post-doctoral fellowship in Pharmacometrics from Union University, Jackson, TN. Her area of interests are oncology and infectious diseases along with clinical pharmacology and clinical trials. She has presented posters in various conferences and authored two publications. She is a member of various pharmacometric communities. She obtained her PharmD degree from Manipal University, India.

Nancy Lin, Pharm.D.

Pharmacometrician I
Simulations Plus

Nancy Lin joined Simulations Plus in October 2023 as a pharmacometrician. She holds a Pharm.D. and a Master’s degree in Pharmacometrics in Personalized Pharmacotherapy from the University at Buffalo. Her master’s research investigated the Population Pharmacokinetics and Pharmacodynamics of Carfilzomib in Adult Patients with Relapsed/Refractory Diffuse Large B Cell Lymphoma.

Before joining Simulations Plus, she completed pharmacy residency training and had two years of experience working as a clinical pharmacist in medical oncology and stem-cell transplant. She also completed a summer internship at the Clinical Pharmacology division at large pharma. She has robust training in quantitative clinical pharmacology, PK/PD modeling, and pharmacometrics, capable in leveraging mathematical and statistical models to optimize drug development and dosing design in pharmaceutical research. She is proficient in software such as NONMEM, Monolix, and R for nonlinear mixed effect modeling and simulation. Nancy is also known for strong interpersonal skills and her capability to communicate science in a cross-functional group.

Pauline Traynard, Ph.D.

Applications Manager
Simulations Plus

Dr. Pauline Traynard joined Simulations Plus in 2017 as Applications Manager. She has a multidisciplinary background focusing on computational and systems biology. After a double engineering degree specializing in computational biology from Ecole Polytechnique and MINES ParisTech (Paris, France) obtained in 2012, she applied different mathematical formalisms to model biological rhythms as part of her PhD studies at INRIA and IBENS Paris, and prostate cancer as a postdoctoral fellow in Institut Curie.

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