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:
Efficacy:
few relevant animal models
high species specificity
unconventional PK/PD relationship
Safety:
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
Requirements:
• 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