Friday, 30 May 2014

FDA special session for patient representatives and advocates

On Sunday, I will be going to a special session organised by the FDA where they will talk about

- What’s New at FDA: Breakthrough Therapy and other Expedited Approval Pathways

- Expanded Access & Patient-Focused Drug Development        

- Opportunities & Challenges in Global Oncology Drug Development   

  So the main topic will be how to accelerate drug approval and how to ensure patients can access new drugs faster- and as we all know, this is something that would make all the difference for patients with cancers like Melanoma!

We'll be a group of European cancer advocates going, so these are problems we share with other cancers.

If you've got questions you would like me to ask, let me know!



  1. Patient-Focused Drug Development? ..I wished. Maybe is not the right place to say it but if you can, please suggest (again!) more focus on real research priorities. For example on overcoming melanoma resistance to Braf inhibitors. I do not feel that research is going enough on this. And this will be a real good thing to do for patients, but not loosing money in useless studies (e.g. comparing paclitaxel with dacarbazine etc.)

  2. Hi Violeta- this is now the regulatory perspective, not the science in the sense of lab work. They don't ask for the studies to be done….but apart from that, I totally agree!!!!