A pipeline meeting is a session where the MEB engages with a company to discuss new innovations and plans in the area of drug development for the upcoming period. The primary focus is on the general aspects of the company's product portfolio.
Next Meeting: Wednesday, November 5, 2025.
Topic: Regulatory development of psychedelics - therapeutic targets and new indications
Psychedelics are known for recreational use as well as experimental treatments for various mental health conditions. There is a need for evidence-based, regulated medical treatments, but regulatory development of psychedelics faces a unique set of challenges due to their pharmacology, historical stigma, safety concerns, and therapeutic delivery model.
This theme focusses on the development of psychedelics in several psychiatric or neurologic disorders and this pipeline-day aims at discussions on:
- How to evaluate market need, unmet burden, and regulatory feasibility
- Challenges during development
- Potential use of biomarkers
- Individual variability and personalized dosing
- Development of low-dose psychedelics, without the psychedelic effect.
- Safety and long-term monitoring
Applicants can apply for this pipeline meeting to present products in their pipeline related to this theme and elaborate on the challenges they face and how they wish or have addressed them.
CCMO will participate during this pipeline meeting.
Applicants are informed that no scientific advice will be provided during pipeline meetings and the discussion will focus on new innovative developments and challenges in the portfolio of the applicant.
Registration deadline: Friday, August 29, 2025.
After the registration deadline, the MEB will select three companies from the submissions. The selected companies will be informed via email about their scheduled pipeline meeting. Companies that are not selected will receive a rejection notice via email. Notifications can be expected on Tuesday, September 9, 2025.
If a pharmaceutical company is selected to participate in a specific pipeline meeting, we ask the company to provide a briefing document to help the MEB participants prepare for the meeting. This briefing document should be submitted no later than Friday, October 3, 2025.