Today Sophia Kolbe attended the RegMed Forum in Berlin, where discussions focused on the critical challenges of process development, GMP readiness, and clinical translation of Advanced Therapy Medicinal Products (ATMPs). With Europe catching up in early-phase ATMP clinical trials, it is essential to strengthen the collaboration between academia, CMOs, and industry to accelerate development and adoption.
The day began with Petra Reinke’s keynote on the challenges of translating cell and gene therapies from academic research to the clinic.
The breakout sessions on clinical trials, education, and manufacturing provided valuable insights into key bottlenecks, followed by an engaging panel discussion on overcoming GMP facility bottlenecks for ATMP development.
Some key takeaways:
- GMP remains a major hurdle – early integration of quality and scalability is essential.
- Connecting research with industry is essential – academic innovation must align with commercial viability.
- Lessons from translation efforts – real-world case studies highlighted what could have eased the process.
It was great to connect with the German Cell & Gene Therapy community exploring solutions that will drive ATMPs forward.
Thank you to the Berlin Institute of Health, HealthCapital Berlin-Brandenburg, German Stem Cell Network (GSCN), and all organising partners for facilitating this event.
