Advanced Therapy Medicinal Products
ATMPs (Advanced Therapy Medicinal Products), which include cell and gene therapy products, have tremendous therapeutic promise for the treatment of critical disorders. Their development, on the other hand, is complicated. The ATMP Think Tank will debate and share insights on effectively identifying and addressing possible hurdles that businesses face when they transition from academic research to commercialization.
Tissue Engineerd Products
Addressing ATMP development challenges
1. Round Table Discussions
Starting with and from the Leiden Biosciences Park, the Think Tank will serve as a platform for open discussion and cooperation between researchers, entrepreneurs, patients, health economists, regulatory experts, and market access specialists. We will also explore new challenges including, clinical development, regulatory affairs, and market access strategies.
ATMP Think Tank will organize from 6 roundtables a year focused on:
- Addressing challenges in research proposals
- Advocating securement of (EU) funding
- Overcoming regulatory hurdles
- Signaling issues concerning development incentives, regulations, and access to ATMPs.
We will also share the practical examples of constraints in adopting ATMP in health systems and the insights gained during the round tables as articles to maximize its benefit to the EU ATMP community.
2. Sharing ATMP Insights
Besides sharing the insights from the Think Tank’s meetings, feel free to contact us for ad hoc advise. We welcome discussion and see how we can contribute to particular requests to increase the chances of successful ATMP development. For example:
- To develop a proposal for the development of new treatments
- Identifying challenges in development roadmaps
- Validation of research protocols for new treatments
- Overcoming regulatory hurdles on the way to approval
- Defining market access strategies for a specific product
3. Advocating EU Collaboration
Finally, the Think Tank aims to enhance collaboration with established networks and consortia and build new partnerships throughout the EU.
Our kick-off at the LBSP
Working together with the Leiden BioScience Park Tech Talks, we kicked off the ATMP Think Tank.
The Think Tank means to be simultaneously inclusive and a well-balanced reflection of stakeholders from the development chain including:
- biopharmaceutical company representatives
- contract research / development organization
- patient representatives
- researchers & leading academics
- Health-Economics specialists
- Regulatory and Clinical experts
An integrated approach that takes all aspects into account is the solution.
ATMP ThinkTank Management
The Think Tank is coordinated by ISHEO Development (Leiden), a specialist firm that focuses on health technology assessment, health economics, and market access. The initiative will be promoted through the Leiden Bioscience Park.
We commit ourselves to organize the meeting, engage panelists, prepare background documents, moderating the panel, and writing reports to be published online. Shortly, to facilitate new proposals to ignite the development of and patient access to advanced therapies.