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

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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

Download the full presentation here >

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