From Dosimetry to Dose Decisions How Clinical Pharmacology and Model-Informed Approaches Are Shaping TRT Development

Amandine joined Certara in 2020. She served as a Clinical pharmacologist in several pharmaceutical companies for 15 years. She has a proven track record in preclinical and clinical PK, clinical pharmacology with a special focus on oncology, drug development from early stages to Phase 3, and regulatory experience. Amandine graduated as a PharmD from Paris University, France and she also holds a Master’s degree in Pharmacokinetics.

Dr. Diane-Charlotte Imbs is an Associate Director in Clinical Pharmacology at Certara. She joined Certara in 2020 and has been supporting several projects (mAbs, radiopharmaceuticals, small molecules, ADC, fixed-dose combinations) from Phase I to Phase III in rare diseases, hematology, oncology, and post-marketing in cardiology. Before joining Certara, she spent 3 years at Ipsen as a clinical pharmacology project manager where she supported several Phase I projects in oncology (radiopharmaceuticals, small molecules). Diane-Charlotte is a pharmacist by training with a master’s degree in pharmacology and a PhD in Clinical Pharmacokinetics (University of Toulouse, France).

Joshuaine Grant is a Senior Director in Quantitative Systems Pharmacology at Certara with more than 25 years of experience integrating biophysics, disease biology, and quantitative modeling to advance drug development. She leads collaborative projects that use mechanistic and translational QSP modeling to inform key decisions from discovery through the clinic. Her broad experience across biologics and complex therapeutics has supported Certara’s growing leadership in radioligand and targeted radiotherapies.

Hunter Stephens, PhD, is an Associate Director in the Pharmacometrics group at Certara. He specializes in applying mathematical and computational models to understand the pharmacokinetics and pharmacodynamics of drugs, especially radiopharmaceuticals. He has a PhD in Medical Physics from Duke University. He also holds an MS in Physics from North Carolina State University and a BS in Mathematics from Tennessee Tech University. His work in TRT has focused on building semi-mechanistic population PK models to simulate and predict absorbed and biologically effective doses to inform dose-range finding and questions of safety and efficacy. In addition, he has extensive experience in radiation dosimetry from external and internal sources.

Mirjam is an expert in pharmacometrics and oncology drug development, serving as Head of Pharmacometrics USA – Division II at Certara Drug Development Solutions. With expertise spanning complex biologics, she supports exposure-response analysis, dose and study optimization, and regulatory strategy, with a special focus on radiotherapeutics and cell and gene therapies.