Vaccine preclinical studies 1

Published on December 31, 2015   41 min

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Other Talks in the Series: Vaccines

My name is Rebecca Sheets and this lecture has to do with the context of the preclinical studies that are intended to support moving from the research arena into clinical trials of vaccines.
Although other speakers in this series may be coming from a more academic or industry background, in fact my background is more from a regulatory perspective. And so this lecture will be presented in that context. However I also have to give the disclaimer that I am reflecting solely my own opinions and I am not speaking on behalf of the U.S. government. I will apologize though that although I know this is intended for an international audience I will be giving a bit of a U.S. centric lecture, so I apologize for that.
The outline of the presentation is to give you a little bit of introduction in context. And then to talk about the two types of studies that regulators need in order to make their risk benefit decisions about what should proceed into clinical trials. And those are safety studies and proof-of-concept studies.