Non-clinical Testing of Vaccines
|Event Date/Time: Jun 04, 2007||End Date/Time: Jun 06, 2007|
The purpose of the meeting is to look at this data from a 21st century perspective and to get agreement on the most important issues for nonclinical development in our current understanding of vaccines. For many vaccines the final proof of action cannot be obtained in the clinical situation, unless large epidemiological studies are carried out. For these vaccines, the proof-of-concept has to rely therefore on animal experimentation (The Animal Rule).
Another important issue is the development of therapeutic vaccines, especially in cancer treatment. Again proof-of concept data is difficult to obtain and the classical humoral endpoint of the antibody titre is not sufficient as a secondary endpoint.
The meeting will discuss these items in depth and develop recommendations for industry and regulatory authorities.