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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.
