Senior Director of CPMS (Clinical Pharmacology, Modeling and Simulation) Parexel International
Key Points: - Explain the critical role of a CRO in designing studies and analyzing the data to facilitate development of much needed therapies, particularly cell & gene and other therapies for rare diseases. - Navigate through different modeling & simulation approaches to answer regulatory /industry questions about the right drug given to the right patient(s), at the right dose, at the right time. - Case studies — how Parexel’s CPMS successfully contributed to clinical pharmacology packages, marketing applications NDA/ BLA for patient with unmet medical needs and/or special population.
At Parexel, we aspire to have a pursuit of excellence with insatiable hunger to make a positive difference in patient's lives. Research and development (R&D) allow new therapies like cell and gene therapies to reach patients faster, reduce development costs, and improve insights and decision making. Innovations in clinical pharmacology, modeling & simulation (CPMS) fuel the opportunity to transform drug development holistically - more so for rare diseases – faster/better tailored treatments to patient needs, and smarter, exploring scenarios untested in clinical trials. This scientific session aims at exploring Parexel CPMS experience in supporting drug development by designing PKPD objectives, analyzing, modeling and /or predicting the safety, efficacy, and drug response variability and interpreting clinical data. Physiologically-based pharmacokinetic modeling (PBPK) with its mechanistic nature can prospectively predict various PK scenarios like food effect, DDIs liability and exposure in special population e.g. pediatrics, hepatic or renally impaired patients.
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