Insights
General
Sin categoría
2025.02.20
From research to patients: Building a solid strategy in advanced therapy development
Bringing an advanced therapy from research to patients requires far more than scientific innovation. Early planning, regulatory strategy, preclinical development and product characterisation all play a critical role in building a successful development pathway.
General
Sin categoría
2025.02.19
European collaboration and the future of Advanced Therapies
European collaboration plays a key role in Advanced Therapy development, bringing together research centres, hospitals, companies and regulatory experts to help transform innovation into future clinical applications.
General
Podcast
2025.02.18
Implementing Regulation (EU) 2024/1689
Laying down harmonised rules on artificial intelligence (AI) Guidance to Medical Device Manufacturers
General
Sin categoría
2025.02.17
Celyvir: A two-decade journey in advanced cancer therapy
From preclinical research to clinical studies, the story of Celyvir highlights the scientific, regulatory and operational challenges involved in advancing innovative therapies towards patient application.
Sin categoría
2025.02.15
Why preclinical research matters before clinical translation
Preclinical research lays the foundation for successful advanced therapy development. From product classification and safety studies to regulatory planning, early decisions can have a significant impact on the future progression of an ATMP.
Sin categoría
2025.02.10
Navigating the regulatory landscape for Advanced Therapies
As advanced therapies continue to evolve, developers must navigate increasingly complex regulatory requirements. Early planning and regulatory guidance can help support more efficient development pathways.