Learning Lab | MIDD Strategies for Preclinical and Clinical Translation – A Collaboration Between Clinical Pharmacologists and Modeling Disciplines brought to you by Certara
Learning Labs have limited capacity and rooms will fill up quickly! Arrive early to ensure you can secure your spot.
Translation from preclinical to clinical development has evolved from empirical allometric scaling in the 1990s to more contemporary modeling-based approaches leveraging advancement in our understanding of pharmacokinetics, physiology and disease as well as a variety of in vitro assays and translational biomarkers. Simultaneously, emerging biotechnologies are introducing novel and complex molecules into clinical development, which may require different approaches for preclinical to clinical translation. Certara provides an integrated framework to support the translation from preclinical research to early clinical development, enabling quantitative decision-making. The framework includes a broad range of modeling approaches—such as physiologically-based pharmacokinetic (PBPK), quantitative systems pharmacology (QSP), empirical PK/PD modeling and model-based meta-analysis (MBMA)—as well as clinical pharmacology stewardship to help identify the appropriate approaches based on their deep scientific and development expertise in nonclinical-to-clinical study design, data interpretation, and dose/regimen selection.
In this Lunch-and-Learn, we will present case studies highlighting the application of model-informed translational strategies that have enabled robust decision-making and optimized first-in-human and proof-of-concept studies. Furthermore, the model-informed translational strategies could reduce and even replace the needs for animal studies.
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This event is sponsored by an ASCPT Partner organization. The content of the session is provided for informational purposes only and does not constitute or imply ASCPT's endorsement, recommendation, or approval of a specific institution, service, employer, or content.
