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.
It's important to understand that vaccines are a diverse class of product types and unlike small molecule drugs, they're complex macromolecules. They may be as simple as a peptide but mostly they are as complex as whole organisms. They can be multivalent, which means that they can contain immunogens from more than one strain or serotype or even from more than one organism, for example, the diphtheria tetanus and acellular pertussis vaccine. Regulators expect to receive two types of information about preclinical development of medicinal products, regardless of whether their drugs are biological products. And there are studies that support the safety of the product, upon which they can make assessments of risk. These are generally referred to as toxicology studies. And the other are studies that support the proof of concept or mode of action of the product. And this is what they base their decisions about the potential for benefit would be. And these are generally referred to as pharmacology studies which reflects the original intent of toxicology and pharmacology studies to the application of chemical drugs. It's also important for an international audience to be aware that there is a trilateral agreement between the U.S. , the European Union, and Japan. And many other countries follow this international conference on harmonization. And the preclinical studies or non-clinical studies, which I'll explain in a moment, are covered by the ICH topics of safety or 'S' topics. Vaccines unfortunately are not well covered by the ICH. However if you have a biotechnological vaccine then there is the S6 document that could apply. However there are other national and international guidances or guidelines on preclinical aspects that are relevant to vaccines and I'll describe those. It's also important to understand preclinical versus non-clinical. In fact historically, these types of studies were expected to be performed prior to moving into the clinic. But now many studies are actually undertaken simultaneously with clinical studies. And therefore it was decided along the time of the ICH process to use the term non-clinical instead. However that's somewhat of an undescriptive title. And so in fact these terms really are synonymous. And what it all means is really the laboratory analyses and the animal studies that are intended to support regulatory decision-making about clinical development, and ultimately about registration or as we call it in the U.S. , licensure of vaccines.