- 07-10-2026
- MEB
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.
Planned meeting: Wednesday, October 7, 2026.
Topic: ATMPs
Development of Advanced Therapy Medicinal Products (ATMPs) involves major challenges including complex manufacturing, logistical difficulties, uncertain long-term efficacy and complex regulatory pathways.
Quality concerns of ATMPs will often influence the obtained clinical safety and efficacy results of the product. In order to get innovative ATMPs approved for patients and to increase approval success for ATMPs more insight in needed on the hurdles and opportunities in the area of ATMPs.
This theme focusses on the innovative development of ATMPs and the challenges faced by developers on the following aspects:
- Use of platform approach in the development of gene editing
- Development of biosimilars
- Development of peptides in specific therapeutic areas, such as obesity.
- Defining the ATMP, such as active substance, dose, indication and development of biosimilars
- Ensure consistency in the manufacturing process and reproducibility, in order to increase availability in Europe.
- Proving efficacy and building evidence, such as potency assay, dose finding and longterm uncertainty.
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.
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: Thursday, July 9, 2026.
After the registration deadline, the MEB will select a maximum of 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 around Tuesday, July 21, 2026.
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 Monday, September 14, 2026.