“I have been invited to speak at the European Medicine Agency’s workshop on MS this coming Thursday. I am representing the European Multiple Sclerosis Platform (EMSP), a European MSer lobby, on the staggered ‘two-step approach’ for treatments with ‘profound’ effect on immunity.Christoph Thalheim approached me to speak on behalf of MSers after my talk at the TIME MATTERS satellite presentation at the European Neurological Society meeting.”
The EMA has decided to provide an opportunity for the different stakeholders to come together and discuss the key scientific issues in the field of MS. The stated goal of the workshop is to make sure that in the revision of the MS guideline EMA can take into consideration the most up-to-date, state of the art scientific developments in MS, as well as the positions of the experts in the field on the main topics in the guideline, which are:
- New outcome measures in MS: possible better ways to assess disability that overcome limitations of the EDSS.
- New perception of disability – including cognition, fatigue, pain and other symptoms specifically related to MS.
- The staggered “two-step approach” for treatments with significant effect on immunity:
How to address safety concerns in new drugs with significant effect on immunity?
What data on safety should be presented at initial MAA?
- Changing MS population, definition of “insufficient treatment response”, and their impact on the benefit-risk assessment of new drugs.
- The need for placebo in controlled trials in multiple sclerosis and how to design them.
- Patient reported outcomes, biomarkers and novel methodologies, and their role in the development of new MS drugs.
“I could simply talk about my treatment philosophy, i.e. early effective treatment, but I am not sure this is what you would want me to do on your behalf. Another strategy is to imagine myself as someone with MS who is as an MS activist; what messages would I want to get across? I only have 20 minutes. Should I present my campaign to rebrand MS a preventable dementia? Should I focus on MSer rights and access to active monitoring? If you have any suggestions please let me know; I need your help.”
“May be I should present my MS clinic list from last week? It was full of patients with moderate to severe disability who are now in the secondary progressive phase of their disease. I also saw two new patients with PPMS; a couldn’t offer them any DMTs. What would the same clinic look like in 20 years time when the next generation of MSers have had access to early highly-effective therapies?”
“I have uploaded the EMA programme for you.”