The Centre for Future Affordable Sustainable Therapy Development (FAST), in collaboration with key partners and over 25 experts, has launched a comprehensive handbook for Advanced Therapy Medicinal Product (ATMP) developers. The resource provides guidance on navigating the complex European and Dutch regulatory landscapes, offering tools to streamline the journey from preclinical development to market access.
The handbook, an updated and expanded version of a previous guide by VIG, reflects the latest insights into legislation, EMA processes, and clinical research developments. It is designed for academic and commercial developers alike, offering practical tools and a detailed roadmap to successfully tackle key steps, including marketing authorisation and reimbursement applications.
Structured into three key parts, the handbook covers:
- Part 1: Key lessons and guidance on patient engagement.
- Part 2: Essential legal and regulatory information for developers.
- Part 3: A step-by-step overview of the ATMP development journey, from preclinical work to clinical integration.
A unique feature of this resource is its emphasis on early collaboration with patient organisations and stakeholders, such as the EMA, CBG, and Zorginstituut Nederland (ZIN). This approach is vital for expediting patient access and ensuring sustainable financing for ATMPs. The guide also highlights support options from centres of expertise like FAST and DARE-NL, encouraging developers to seek advice early to overcome potential challenges.
Mike Broeders, Advisor at FAST, commented the following: “This guidebook provides a compass for navigating the complex European and Dutch ATMP landscape. It offers both academic and commercial developers clear practical insights on patient involvement, regulatory guidelines, and a comprehensive roadmap through the ATMP lifecycle. We hope it will help accelerate the journey of innovative therapies from bench to bedside, ensuring patients benefit sooner.”
Saco de Visser, Scientific Director at FAST and EATRIS Governor of the Netherlands added:”Access to ATMPs is critical for patients, as these innovative therapies offer transformative potential for conditions that current treatments cannot adequately address. However, the complex regulatory pathways and specific requirements can hinder timely, affordable and sustainable access. It is essential that we bridge these gaps, ensuring clarity for developers and fostering a healthcare system where patients can benefit from these groundbreaking advancements.”
Upcoming Webinar Series
In spring 2025, FAST will host a webinar series with stakeholders, offering detailed case studies and insights into the handbook’s content.
Learn More
- Read more about the handbook launch here: FAST News
- Access the handbook directly: FAST ATMP Handbook PDF
This initiative underscores the commitment of FAST and its collaborators to equip ATMP developers with the knowledge and tools they need, ultimately bringing innovative therapies to patients more efficiently and effectively.
