CONTEXT:  An interview article with a UK based company looking to bring “natural” psilocybin medicines to market through RWE studies and dodge the usual RCT regulatory routes.  One to watch if they succeed.

IMPACT:  Medium

READ TIME:  2 mins

Quality Level Mean [1 – 10]:  6

1. “We have had so many technical advancements such as fMRI scanning which allows us to look at the brain in a new way, yet it’s only now, with psychedelics we’re using this newfound knowledge to develop medicines for psychological medicines such as mental health treatments.” 

2. “The company is using real-world evidence studies to help patients suffering from a range of mental-health challenges gain access to MDMA, psilocybin, psilocin and other psychedelics.” 

3. “MBJ: Albert Labs is the first psychedelic drug developer leveraging real-world evidence (RWE) Studies to accelerate patient access to psychedelic-assisted therapy in hospital settings across the UK and Europe that address niche mental health indications with urgent and high unmet needs.” 

4. “Because patients suffering from the niche mental health indications such as cancer-related distress have an urgent and unmet need, Albert Labs needs to employ an accelerated pathway in order to provide approved treatment solutions quickly and effectively.” 

5. “RWE studies are sanctioned in the UK and Europe and will be the means that allow us to get our proprietary natural psilocybin medicine approved and to patients quickly.” 

Source URL: https://www.outsourcing-pharma.com/Article/2021/05/13/Drug-developer-uses-RWE-to-research-psychedelic-therapies