Session 2: Building an Evidence Base (Webinar)
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?
Dr. Nihal Engin Vrana
VP of Scientific Affairs
PROTiP Medical, France
Dr. Mercedes Dragovits
Project Manager and Coordinator
- Committee for Advanced Therapies (CAT): http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000126.jsp&mid=WC0b01ac05800292a5
- Enterprise Europe Network: http://een.ec.europa.eu/
We would like to thank our sponsors, PROTiP Medical & Immodgel.