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To treat severe and rare diseases, medicines based on genes, cells or tissues, so called “Advanced Therapy Medicinal Products” (ATMPs) are increasingly used. ATMP development is specifically challenging because of complex manufacturing processes, clinical trial design and regulatory requirements. In order to provide support with regard to this problem, the Platform Humanized Model Systems and Cell Engineering invited to a workshop at the BIH on December 9, 2019.

The three invited speakers offered insights into their work with ATMPs, the resulting difficulties and subsequently, participants worked in small groups on specific strategies to overcome these challenges. Dr. Gabriele Dallmann presented her expertise in developing an IMPD for ATMPs, Dr. Markus Hofmann talked about risk management in ATMP development and Shaun Stapleton, PhD, talked about his experiences in preparing meetings with the regulatory authority FDA.

Additionally, the participants from BIH, Charité and MDC were able to share their experiences and specific occurring difficulties in ATMP development with each other and the invited speakers as well as devise possible solutions for these issues.

The workshop was fully booked and evaluated very favorably by the participants.