community download

Presentation: Challenges in non-clinical testing of innovative immunotherapies /therapeutic vaccines

Dr Emmanuelle Cornali, Head of Business Development, Aurigon Life Sciences joined us at the World Vaccine Congress Lyon 2012 to discuss the challenges for non-clinical assessment for therapeutic vaccines, which include:


few relevant animal models
high species specificity
unconventional PK/PD relationship

difficult modelling of patient population (pediatric, cancer patients)
relevance/predictivity of animal data
no legal definition

-> no specific regulatory non-clinical guidance available
-> use of product or indication related existing guidelines

Scope for assessment:

new vaccine and/or new adjuvant
new combinations of licensed antigen(s)
new formulations or delivery system

• evidence of efficacy and safety prior to clinical trials
• evaluation of a risk/benefit ratio

Download the full presentation on the “Challenges in non-clinical testing of innovative immunotherapies /therapeutic vaccines” to find out more about the following:

Non-clinical strategy: supported by science, framed by regulations, but which regulation?
Species & animal model and design selection: power and limitation for translation into the clinic
Specific concerns for advanced therapy products

Some quick details

Email Address:*
First name:*
Last name:*
Job Title:*

Remember my details Information

Remember my details
We place a 'cookie' on your computer so next time you visit us you don't need to fill in all these details

Privacy statement »
Manage your email preferences »

Unfortunately the document is not available at this current time, however if you leave your details we'll get it to you as soon as we can.

Please fill in all the information requested. It is very important you enter this information correctly so we can contact you with the document.