Author: NVGCT

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Launch of new guidebook for ATMP developers

FAST has collaborated with experts to create a renewed and expanded guidebook for developing Advanced Therapy Medicinal Products (ATMPs) in the Netherlands. Tailored to both academic and commercial developers, the guidebook delivers essential guidance on European and Dutch regulations and provides a roadmap to navigate the complex ATMP development process.

A guide to the ATMP landscape

The guidebook is the result of close collaboration with key partners, including the Dutch Medicines Evaluation Board (CBG), Hollandbio, DARE-NL, VIG, and input from over 25 experts. Building on the foundation of the VIG’s earlier guidebook, this updated and expanded edition integrates the latest insights, regulations, EMA processes, and advances in clinical research. With its practical tools and guidance, the handbook equips developers to handle complex procedures such as marketing authorization and reimbursement applications more effectively.

View the guidebook here

Patient-centered approach and collaboration

The guidebook underscores the value of early engagement with patient organizations and provides tools to facilitate this meaningful collaboration. It also emphasizes the importance of early engagement with stakeholders, such as the EMA, CBG, and the National Health Care Institute (ZIN). These collaborations contribute to faster patient access to ATMPs and long-term financial sustainability.

Structure of the guidebook
The guidebook is divided into three sections:

  • Part 1 covers key lessons and offers guidelines for patient involvement.
  • Part 2 provides background information and legal frameworks essential for ATMP development.
  • Part 3 offers a detailed overview of the entire ATMP development pathway, from preclinical research to practical implementation.

Support and advice

Finally, the guidebook includes an overview of available support and relevant legislation. Developers are encouraged to seek advice from experts and centres of expertise, such as FAST and DARE-NL, early in the development process to simplify the path to market and minimize obstacles.

This guidebook is a valuable resource for everyone active in the rapidly growing ATMP sector, aligning with FAST’s mission to accelerate the delivery of innovative therapies to patients. In the spring of 2025, FAST, together with its partners, will host a series of webinars to present case studies and provide deeper insights into various sections of the guidebook.

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Nieuwe signalering COGEM over de waarde van gentherapie

De COGEM heeft een nieuwe signalering gepubliceerd, waarin zij verkent hoeveel nieuwe gentherapieën in de pijplijn zitten, wat de kosten zijn, en de dilemma’s en keuzes die met de komst van deze therapieën gepaard gaan. Ook wordt ingegaan op de instrumenten die de overheid heeft om gentherapieën betaalbaar en beschikbaar te houden.

Lees het document hier.

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Project call COGEM: unintended germline modification in new gene therapies

The Netherlands Commission on Genetic Modification (COGEM) commissions third-party research to support its work. The following project is open for enrollment: Germline modification and new gene therapies; an exploration. This project is a collaboration with the Central Committee on Research Involving Human Subjects (CCMO), and aims to gain insight into the likelihood of unintended germline modification in new (non-viral) gene therapies to support risk analysis. Interested parties are invited to submit a project bid. More information can be read here.

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Vacancy: Technician Vector Analytics and Production @ MeiraGTx

Company

MeiraGTx Netherlands is an Amsterdam based biopharmaceutical company developing local gene therapy for different indications. The company specializes in the development of viral gene therapy vectors, in particular adeno-associated virus (AAV) based therapeutics. Several product candidates are in the discovery and development phase. In our programs, we collaborate with world leading scientists.

Position

MeiraGTx Netherlands is seeking a motivated technician to join our team. He/she will be involved in the execution of current and new projects and external collaborations, focusing on the generation of new AAV-based vectors targeting inflammatory disease. The aim of these projects is to develop new product candidates for clinical testing. In addition, the research should generate new intellectual property to protect the company’s future products. The technician’s main responsibility is to perform quality control on vectors produced by MeiraGTx Netherlands, using molecular and biochemical techniques, and setting up of new analytical assays to characterize vector batches. Furthermore, the technician will be involved in production and purification of research batches of vectors. The technician will have a unique opportunity to participate in multidisciplinary collaborative research at MeiraGTx.

Education and experience requirements

  • HLO level or equivalent in Lifesciences and at least 3 years of work experience
  • Experience in molecular biological and biochemical techniques, especially in qPCR and ELISA
  • Experience with ddPCR and preparing of samples for NGS sequencing is highly preferred
  • Experience with production and purification of viruses is preferred
  • Pro-active and accurate
  • Independent and problem-solving
  • Good documentation skills
  • Strong communication and social skills
  • Flexible, devoted and professional attitude
  • Proficient in English

MeiraGTx Netherlands offers the opportunity to work in an exciting and entrepreneurial environment. We allow you to grow within an organization that encourages talent, and that supports the development of its employees and fuels excellence. We are project focused and have built a culture with a high degree of personal empowerment. Our energetic and enthusiastic employees participate in and influence the long-term growth of MeiraGTx.

To apply, please send your full resume and motivation by e-mail to our Manager Operations Anouk Veneboer, e-mail: Anouk.Veneboer@meiragtx.com  / Address: Paalbergweg 2-4, 1105 AG  Amsterdam, The Netherlands. Phone: +31 682229139. For questions related to the position, please contact Mostafa Zahmatkesh (project lead vector productions and process development)  Mostafa.Zahmatkesh@meiragtx.com).