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Home / Resources / Webinar / Clinical Pharmacology & Model-Informed Drug Development Insights for Targeted Radiation Therapies

Clinical Pharmacology & Model-Informed Drug Development Insights for Targeted Radiation Therapies

Live webinar
Date
Mon, June 24th 2024
Time
11am ET

Targeted radiation therapies (TRT) deliver cytotoxic radiation selectively to tumors. In recent years, oncology drug developers have increased their interest in this therapeutic class. However, the regulatory landscape is still evolving. In addition, clinical pharmacology concepts have not yet been optimally applied to this modality.  

This webinar will illustrate how clinical pharmacology considerations and model-informed drug development (MIDD) concepts could help streamline therapeutic index-focused discovery and drug development for TRTs. By attending this webinar, you will learn how to craft strategies that comply with the FDA’s Project Optimus initiative to optimize oncology drug dosing. 

Figure 1. Radiation delivery methods for Therapeutic Radioligands. From Sgouros, G., Bodei, L., McDevitt, M.R. et al. Radiopharmaceutical therapy in cancer: clinical advances and challenges. Nat Rev Drug Discov 19, 589–608 (2020).  

What non-clinical and clinical development insights will you learn? 

  • Clinical pharmacology regulatory landscape and overview of the current requirements in terms of dose optimization of TRT 
  • How MIDD can help solve major questions and streamline TRT development: 
  • How quantitative systems pharmacology (QSP) modeling can translate molecular features to predict key drug properties such as on and off-target biodistribution and therapeutic index 
  • How pharmacometrics can utilize radiological/nuclear medicine imaging to predict biodistribution and the absorbed doses per organ and tumor 
  • How predicted organ and tumor exposures can inform clinical safety and efficacy outcomes to guide dose optimization from discovery to registration 

Who should attend? 

Are you a clinical pharmacologist, pharmacometrician, discovery scientist, clinical lead, or regulatory representative involved in developing TRTs? Are you interested in learning more about how clinical pharmacology and MIDD can optimize TRT development? If yes, you’ll find this webinar valuable! 

Why should TRT drug developers attend this free virtual event? 

  • Expert Insights: Gain knowledge from experts in clinical pharmacology, pharmacometrics, and QSP to optimize TRT development following Project Optimus guidance 
  • Interactive Q&A: Get your questions answered during our live Q&A session. 
  • Valuable Takeaways: Leave the webinar with actionable strategies to implement in your complex biologics projects. 
Register Now

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Speakers
Amandine
Amandine Manon, PharmD
Senior Director, Clinical Pharmacology and Translational Medicine

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.

Diane Charlotte
Diane-Charlotte Imbs, Pharm.D. Ph.D.
Associate Director, Clinical Pharmacology
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).
Apgar 8×10
Joshua Apgar, PhD
VP, Global Head of ABM Scientific Affairs
Before co-founding Applied BioMath, Josh was a Principal Scientist in the Systems Biology Group of the Department of Immunology and Inflammation at Boehringer Ingelheim Pharmaceuticals. His work leveraged physics-based models to: translate in vitro and in vivo data, assess target feasibility, understand drug mechanism of action, and predict human doses. The ultimate goal of this work was to reduce late stage attrition in drug development through a deep and quantitative interrogation of drug pharmacology and disease pathophysiology. Josh received his PhD from MIT in Biological Engineering where he worked on experiment design for Systems Biology, focusing on the identification of tractable experiments that could allow for the estimation of unknown parameters and reveal complex mechanisms in signal transduction networks. Before that Josh worked at Avaki to develop a highly scalable software platform to support High Performance Computing, and Enterprise Information Integration in the Life Sciences, and Engineering.
Hunter Stephens
Hunter Stephens, PhD
Associate Scientist
Hunter Stephens, PhD, is an Associate Scientist 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.