I attended a great meeting yesterday: FierceBiotech Executive Breakfast. It was a great discussion with a very interesting panel. One discussion that intrigued me was the idea of turning the Phases of clinical trials on its head. Companies are starting to go to the FDA early, with Phase I clinical trial data – and not waiting 6-8 years but getting to market in about 3. There was a call for adaptive development: get 100 people, be first in class or a fast follower – and then run a traditional RCT later.
While this sounds great, many companies are reluctant to change. A comment made by Jose-Carlos Guitierrez-Ramos (Pfizer) resonantes with my experiences with clients:
” The bigger the organization, the more experience people have about what can go wrong.”
I think it’s safe to say that sometimes institutional knowledge can be a detriment and an inhibitor to innovation – not a generator of it.
At the end, I asked a question about the panel’s view on the role of patients and patient advocacy groups on the FDA’s slight change of heart and willingness to fast track applications. Some highlights of their responses include:
- We all need to be patient centric
- Patients need to have some skin in the game
- We have a challenge of having no groups in some disease areas and too many groups (with their own agendas and politics) in other disease areas
- We need to involve patients, for real, and not just for show – to say we have included a patient – we need to do it and mean it
All in all, it was a really nice way to start of my day!