Since the initiation of DARE-NL infrastructure, two PhD candidates have conducted research on regulatory science and health technology assessment (HTA) of ATMPs within WP6. During this DARE-NL workshop, Christine van Hattum and Jurriaan Gort will present their ongoing work on these topics.

Subsequently the recommendations in the report from the Centre for Future Affordable Sustainable Therapy Development (FAST) Regulatory Science Network Netherlands (RSNN) Special interest group (SIG) Advanced Therapies workshop in June 2024 will be discussed. The aim of the workshop was to investigate the need for a national ATMP network in the Netherlands (i.e., an ATMP-NL). In the meeting the objectives, activities, relevant stakeholders, and governance for such a network were discussed. The full report of the workshop is available here.

A need for a national ATMP platform (ATMP-NL) was strongly expressed, but how do we turn this into a practical, actionable initiative? First a summary of the workshop report will be presented by Lourens Bloem (Utrecht University, DARE-NL WP6). Next, Mike Broeders-Gleitz (FAST) will present how FAST intends to further shape and organize an ATMP-NL. This is followed by an interactive discussion with the audience.

ATMP-NL is best built in collaboration with the field, for the benefit of the field. Be part of defining how by ensuring that defined priorities lead to concrete outcomes and working towards a clear roadmap.

This workshop is open for DARE-NL members and partners who signed a CDA with DARE-NL.

Agenda

09.30 – 10.00   Welcome with coffee/tea
10.00 – 10.30   Update DARE-NL PhD research Regulatory Sciences – Christine van Hattem
10.30 – 11.00   Update DARE-NL PhD research Health Technology Assessment (HTA) – Jurriaan Gort
11.00 – 11.15   Break
11.15 – 11.35   Presentation of FAST/RSNN-SIG ATMP workshops on ATMP-NL – Lourens Bloem
11.35 – 11.55  Approach by FAST to shape ATMP-NL – Mike Broeders
11.55 – 12.30  Plenary discussion: Concrete next steps and commitments
12.30 – 13.15  Lunch

Physical attendance is preferred, but the meeting will be hybrid for those unable to attend in person.