ASPHALION is proud to be a partner in the ARDAT consortium, led by Pfizer and the University of Sheffield, and supported by Europe’s Innovative Medicines Initiative (IMI), which is jointly funded by the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The ARDAT consortium aims to help standardise and accelerate development of ATMPs, allowing potentially transformative treatments to reach patients sooner.
As part of its ongoing work in the ARDAT consortium, ASPHALION has contributed to a Regulatory Perspective published in the April 2022 issue of “Cell and Gene Therapy Insights”, which summarises the current global regulatory landscape for biodistribution and shedding assessment of rAAV-based gene therapies and provides recommendations on future directions
The article includes a summary of current regulatory expectations for biodistribution and shedding, and describes the ongoing work of the ARDAT consortium to construct a database for the collation of biodistribution and shedding data and its use to inform recommendations for data standards and minimum requirements for reporting and publishing biodistribution and shedding studies.
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