Preclinical safety evaluation of biopharmaceuticals: science-based approach of facilitating clinical trials

Published on July 30, 2009   46 min

A selection of talks on Clinical Practice

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Preclinical Safety Evaluation of Biopharmaceuticals. A Science-Based Approach to Facilitating Clinical Trials. Joy Cavagnaro, President, Access BIO, Boyce, Virginia.
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This presentation will outline the goals of preclinical safety evaluation, highlight the differences between pharmaceuticals and biopharmaceuticals based upon a consideration of product attributes, discuss what was considered, at the time, a new approach to preclinical safety evaluation, distinguishing principles versus practices, and establishing the why for case by case. I'll also outline the key considerations of study design, including species and animal model selection and the use of surrogate molecules, as well as establishing dose response. I will discuss the impact of the immune response and provide an overview of the relevance of icities, including general toxicity, immunogenicity, genetic toxicity, reproductive and developmental toxicity, as well as carcinogenicity, and highlight specific considerations based upon selected product classes. I'll also provide some insights as to how best to select the first-in-human dose, as well as discussing an opportunity for realizing safer medicines.
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The goals of preclinical safety evaluation include optimization of lead candidate selection, allowing for an early introduction of new compounds into clinical trials by recommending initial starting dose and dose escalation scheme in humans, identifying potential target organ or organs of toxicity, and identifying appropriate parameters to monitor in the clinic for any delayed effects. And to look for reversibility, if there are effects, and to identify at-risk populations. The goals also include ensuring an uninterrupted clinical development, as well as providing data in time for decision making throughout the various phases of clinical trials, including Phase 1, 2, and 3 clinical trials, and ultimately, for product labeling.

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