Covid-19 vaccine-maker BioNTech to acquire former rival CureVac

Both German companies have continued mRNA programs on so-called cancer vaccines.

Belgium’s university-industry collaboration model could accelerate EU's advanced therapeutics

Despite its significant potential, Europe trails North America and the Asian Pacific in Advanced Therapy Medic

Collaboration can unlock the potential of gene therapies in Europe

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EU needs to step up to unleash gene therapies potential, stakeholders say

While gene therapies have the potential to transform the approach to rare diseases and improve the quality of

EU Medicines Agency (@EMA_News)

Are you an academic sponsor 🎓 or a non-profit organisation developing advanced therapy medicines? Are you seeking regulatory support? 💊💉 Join EMA’s pilot for European academic and non-profit developers of advanced therapy medicinal products (#ATMPs). #research

EU Medicines Agency (@EMA_News)

📢 We are launching a pilot to provide enhanced regulatory support for selected advanced therapy medicinal products 💊💉 (#ATMPs) that address unmet clinical needs and are developed by academic sponsors 🎓 and non-profit organisations in 🇪🇺. #research

Advanced Non-animal Models in Biomedical Research

Advanced therapy medicinal products (ATMPs) are innovative therapies expected to reshape our approach towards several pathologies, particularly those that do not respond adequately to conventional treatments. ATMPs are based on gene therapy, somatic-cell therapy, engineered tissues and combinations of those. Immunogenicity testing is an important step in the development of these therapies since it aims to predict an adverse immune response of a patient prior to receiving a particular treatment. Fundamental biological differences between the immune system of different species frequently limit the human applicability of immunogenicity testing results carried out using animal models. The JRC’s EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) therefore carried out a study to review the state-of-the-art of advanced non-animal models in use for immunogenicity testing in ATMPs. The majority of the 88 models that were identified were based on in vitro techniques with a limited amount of in silico methods, and most of these focused on the investigation of cell therapy products. This review highlights a pressing need for the development and acceptance of more sophisticated and innovative non-animal approaches in this field which will pave the way for the broader use of ATMPs in the clinic.

EMA and EATRIS Present: Scientific advice for advanced therapy medicinal products (ATMPs): what and when to ask - EATRIS