Advanced Therapy Medicinal Products (ATMPs) promise to transform patient care and revolutionize health care. However, developers often face significant challenges in getting these innovative therapies to patients. Common questions include:

• How can you meaningfully engage patients in your ATMP research?
• What does it take to effectively design and conduct clinical trials?
• How do you navigate the complex web of ATMP laws and regulations?

To address these challenges, FAST is hosting a case-based webinar series on ATMPs in March 2025. FAST invites developers and innovators to participate in this webinar series featuring case studies and insights from experts, offering practical answers and guidance to help move your ATMP journey forward.

Each session begins with a real-world case study showing challenges and solutions in ATMP development. This is followed by interactive Q&A with experts, covering each of the chapters in the FAST ATMP manual. The webinars will be in English.

Webinar Schedule:

March 11, 2025 (4:00-5:00 p.m.):

Case: LentiCure, Pim Pijnappel & Dirk van Asseldonk

Meet the experts  – break-out sessions:

• Patient participation by Mariette Driessens (VSOP)
• Classification of ATMPs by Patrick Celis (CAT)
• Product development by Marcel Hoefnagel (CBG)

March 18, 2025 (4:00-5:00 pm): 

Case: iSTOP-CP: intranasal Stem cells to Treat Perinatal brain injury and combat Cerebral Palsy by Manon Benders and Cora Nijboer of UMCU

Meet the experts  – break-out sessions:

• Regulation and legislation by Ineke Jonger (Eagle Pharma Consult)
• Non-clinical development by Jolanda Liefhebber & Trudy Straetemans (UMC Utrecht)
• Clinical development by Joop van Gerven (CCMO)

March 25, 2025 (4:00-5:00 pm): 

Case: Libmeldy by Andreas Schuil of Orchard Therapeutics

Meet the experts  – break-out sessions:

• Market authorisation by Emmely de Vries (CBG)
• Hospital exemption by Koosje van Lessen Kloeke (Universiteit Leiden)
• Reimbursement by Renske ten Ham, Jurriaan Gort and Chris van Lieshout (UMC Utrecht)

This series combines real-world examples with insights from the FAST ATMP guidebook and provides guidance for addressing challenges in ATMP innovation.

Sign up for one or more webinars here or keep an eye on our website for more information!