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Dr Nihal Engin Vrana, PROTiP Medical, and Dr Mercedes Dragovits, Immodgel, discussed building an evidence base for advanced therapeutics in this webinar.
To provide a strong evidence base for an advanced therapeutic a following must be performed:

  • The proof of concept must be demonstrated both in vitro and in vivo.
  • The safety of each component in the therapeutic must be tested (risk assessment, possible side effects, stability).

Efficacy and ideal parameters of each component must be tested.

  • Fundamental research must be performed to understand the underlying science of the proposed mechanism of the therapeutic.
  • A systematic review of scientific literature should be performed.
  • Meta-analyses must be carried out: What kind of proof does your experimental work provide in light of the analysis of the aggregate results in the relevant field? Randomised control trials have to be performed: What is the clinical and pre-clinical scenario for your product/idea? What are the measures to prevent bias?