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靶向放射治疗的临床药理学和模型引导的药物开发启示

网络研讨会

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.
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演讲嘉宾
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
Applied BioMath 副总裁兼科学事务全球负责人,Certara
在共同创办Applied BioMath公司之前,Joshua 是勃林格殷格翰制药公司免疫学和炎症部系统生物学小组的首席科学家。他的工作是利用基于物理学的模型:转化体外和体内数据、评估靶点可行性、了解药物作用机制并预测人体剂量。这项工作的最终目标是通过对药物药理学和疾病病理生理学的深入定量研究,减少药物开发后期的损耗。Joshua 在麻省理工学院获得生物工程博士学位,在那里他从事系统生物学的实验设计工作,研究重点是识别可以用于估算未知参数并揭示信号转导网络复杂机制的可操作性实验。在此之前,Joshua 在 Avaki开发了一个可扩展性极强的软件平台,以支持生命科学和工程领域的高性能计算和企业信息集成。
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.

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