The second webinar in the 2016/2017 Pre-Accelerator Programme was on how to build an evidence base for achieving regulatory approval and convincing investors.
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?
For more detailed information on the topic please read our medium.com blog: https://medium.com/@TERMISEUBPC/termis-pap-session…
You can also watch the recording of the webinar through: http://termisbpc.org/pap/session-2/