Abstract
On 11 June 2024, a multistakeholder workshop was organised by the Regulatory Science Network Netherlands (RSNN) special interest group (SIG) Advanced Therapies and Centre for Future Affordable Sustainable Therapy Development (FAST). The aim of the meeting was to investigate the need for a national ATMP network in the Netherlands, including objectives, activities, relevant stakeholders, and governance. This hypothetical network was given the working title ‘ATMP-NL’.
Participants of the multistakeholder workshop expressed a clear need for a national ATMP network. Such a network should facilitate sustainable patient access to ATMPs by addressing fragmentation of the Dutch ATMP field, specifically through 1) maintaining an overview of existing initiatives and information, 2) acting as a knowledge-exchange platform that connects stakeholders, and 3) facilitating collaboration on specific topics. Importantly, alignment with existing ATMP-related initiatives in the Netherlands should be carefully considered to avoid overlap and ambiguity of roles and responsibilities. In addition, a national network should represent the Dutch ATMP field internationally and facilitate international collaboration with, for example, similar initiatives outside the Netherlands. Participants stressed the importance of having all stakeholders involved in such a network, establishing trust between stakeholders, and creating a safe environment to share knowledge and experience.
Based on the learnings from the workshop, the following recommendations concerning the establishment of a national ATMP network (i.e., an ‘ATMP-NL’) were formulated:
•Create a working group with a broad stakeholder representation, at least in line with the representation during the workshop, to establish the mission, vision, and governance of the network. These discussions should consider the learnings described in this report, to avoid duplication of efforts. Importantly, the working group should also include representatives of the existing ATMP-related initiatives including, but not necessarily limited to, DARE-NL; the National Growth Fund initiatives Biotech Booster, Oncode Accelerator, and RegMed XB; the Patient Platform Gene and Cell Therapy; and the RSNN SIG Advanced Therapies. A neutral party in the Dutch life sciences landscape should lead this effort (e.g., FAST).
•Create an agenda for the network based on input from the Dutch ATMP field.
•Involve EATRIS and funders such as the Association of Collaborating Health Foundations (‘Vereniging Samenwerkende Gezondheidsfondsen’ [SGF]), Health~Holland, NWO, the Netherlands Enterprise Agency (RVO), and ZonMw, to highlight opportunities for funding that can further strengthen the Dutch ATMP field.
•Launch the Dutch ATMP network at a national multistakeholder meeting that is focused on getting to know all network partners and stakeholders.
•Liaise with related international initiatives to seek collaboration and avoid duplication of efforts. Examples of such international initiatives are ATMP Engage (United Kingdom), ATMP Sweden, at.las (Belgium), Cell and Gene Therapy Catapult (United Kingdom), EuroGCT (Europe-wide), JOIN4ATMP. Alignment is essential given the broader European and international context of ATMP development, regulation, and use, including important developments such as the revision of the European pharmaceutical legislation and the new regulations on health technology assessment (HTA) and substances of human origin (SoHO).
Participants of the multistakeholder workshop expressed a clear need for a national ATMP network. Such a network should facilitate sustainable patient access to ATMPs by addressing fragmentation of the Dutch ATMP field, specifically through 1) maintaining an overview of existing initiatives and information, 2) acting as a knowledge-exchange platform that connects stakeholders, and 3) facilitating collaboration on specific topics. Importantly, alignment with existing ATMP-related initiatives in the Netherlands should be carefully considered to avoid overlap and ambiguity of roles and responsibilities. In addition, a national network should represent the Dutch ATMP field internationally and facilitate international collaboration with, for example, similar initiatives outside the Netherlands. Participants stressed the importance of having all stakeholders involved in such a network, establishing trust between stakeholders, and creating a safe environment to share knowledge and experience.
Based on the learnings from the workshop, the following recommendations concerning the establishment of a national ATMP network (i.e., an ‘ATMP-NL’) were formulated:
•Create a working group with a broad stakeholder representation, at least in line with the representation during the workshop, to establish the mission, vision, and governance of the network. These discussions should consider the learnings described in this report, to avoid duplication of efforts. Importantly, the working group should also include representatives of the existing ATMP-related initiatives including, but not necessarily limited to, DARE-NL; the National Growth Fund initiatives Biotech Booster, Oncode Accelerator, and RegMed XB; the Patient Platform Gene and Cell Therapy; and the RSNN SIG Advanced Therapies. A neutral party in the Dutch life sciences landscape should lead this effort (e.g., FAST).
•Create an agenda for the network based on input from the Dutch ATMP field.
•Involve EATRIS and funders such as the Association of Collaborating Health Foundations (‘Vereniging Samenwerkende Gezondheidsfondsen’ [SGF]), Health~Holland, NWO, the Netherlands Enterprise Agency (RVO), and ZonMw, to highlight opportunities for funding that can further strengthen the Dutch ATMP field.
•Launch the Dutch ATMP network at a national multistakeholder meeting that is focused on getting to know all network partners and stakeholders.
•Liaise with related international initiatives to seek collaboration and avoid duplication of efforts. Examples of such international initiatives are ATMP Engage (United Kingdom), ATMP Sweden, at.las (Belgium), Cell and Gene Therapy Catapult (United Kingdom), EuroGCT (Europe-wide), JOIN4ATMP. Alignment is essential given the broader European and international context of ATMP development, regulation, and use, including important developments such as the revision of the European pharmaceutical legislation and the new regulations on health technology assessment (HTA) and substances of human origin (SoHO).
| Original language | English |
|---|---|
| Place of Publication | Utrecht |
| Publisher | Utrecht University |
| Number of pages | 14 |
| ISBN (Electronic) | 978-90-393-7811-3 |
| DOIs | |
| Publication status | Published - 2024 |
Keywords
- Advanced therapy medicinal products
- ATMPs
- Advanced therapies
- Cell therapy
- Gene therapy
- Tissue-engineered products
- Drug development
- Regulatory Science Network Netherlands
- Centre for Future Affordable Sustainable Therapy Development