Discover a groundbreaking webinar delving into the application of model informed drug development (MIDD) in oncology to support dose selection. The Food and Drug Administration’s (FDA) increased recommendations for oncology dose justification beyond maximum tolerated dose (MTD) have increased interest in quantitative methods and their application to oncology.
This webinar will review the updated recommendations and overview the platform of tools used for MIDD so that attendees can design their experimental path to ensure they gather appropriate and sufficient data to inform pharmacometrics modeling and increase the scientific justification of their dose selection for first-in human (FIH) to pivotal studies.
Join this webinar to gain insights into how to use model informed drug development in oncology to support dose selection in agreement with the FDA’s Project Optimus Goals.
Speaker
Angelean Hendrix, Senior Director, Quantitative Clinical Pharmacology, Amador BioScience
Angelean Hendrix has more than 10 years of Clinical and PreClinical drug development and management experience, with expertise in clinical pharmacology, pharmacometrics, systems pharmacology, translational medicine, and toxicology. She is a pharmacometric project leader for therapeutic areas including oncology, immunology, autoimmune, inflammatory, cardiovascular, gastrointestinal, optical, dermal, metabolic and rare diseases. Angelean is a bench to bedside MIDD strategic leader for small and large molecules, including polypeptides, siRNAs, bispecifics and mABs. She has cntributed to dozens of INDs, NDAs and BLAs with direct regulatory interactions with FDA, EMA and MHRA
Message PresenterWho Should Attend?
This webinar will appeal to professionals in the following fields:
- Clinical Pharmacologist
- Pharmacokinetics
- Medical Directors
- Translational/clinical oncology project team members
What You Will Learn
Attendees will gain insights into:
How to use model informed drug development in oncology to support dose selection in agreement with the FDA’s Project Optimus Goals.
Xtalks Partner
Amador Bioscience
Amador Bioscience is a science-driven translational & clinical research CRO with established sites in USA, China and Europe. As a leading partner for successful biopharmaceutical research and development, Amador Bioscience offers a comprehensive range of services, including translational sciences, clinical pharmacology, bioanalysis & biomarkers, regulatory strategy & submissions, and clinical research adhering to global standards. We excel in formulating and executing development strategies from pre-IND all the way to NDA/BLA/MAA submissions. Our scientific methodologies to select the right target, right patient & right dose, and our global adoption of rigorous quality standards, serve to substantially enhance the efficiency and success rate of novel drug development endeavors.
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