New H2020 project on ATMPs. Asphalion is the regulatory partner of the ARDAT project

The ARDAT Consortium, led by Pfizer (ARDAT Project Lead: Dr Gregory LaRosa) and the University of Sheffield (ARDAT Coordinator: Professor Mimoun Azzouz) and supported by Europe’s Innovative Medicines Initiative (IMI), aims to help standardize and accelerate the development of Advanced Therapy Medicinal Products (ATMPs), allowing potentially transformative treatments to reach patients sooner. 

This 5-year European consortium brings together the leading expertise of 34 academic, non-profit and private organizations including Asphalion, which will provide continuous regulatory support to all partners during the life of the project and co-lead the regulatory work package 5.

The consortium aims to:

• Develop standardized models for predicting ATMP immunogenicity in humans.
• Build understanding of ATMP drug metabolism within a host.
• Identify adaptive immune responses that could affect ATMP safety, efficacy and persistence.
• Engage regulators to help support filings that address standardized regulatory, safety and efficacy concerns.

The field of ATMP research, which includes gene and cell therapies, is expected to grow exponentially in the coming years with potentially up to 10-20 new drug applications submitted per year to the FDA by 2025. The ARDAT consortium will aim to bring together researchers from public and private organizations to help fill the knowledge gaps in how these therapies could potentially work, and to develop appropriate standards to aid researchers, developers and regulators in accelerating effective and safe gene and cell therapies to benefit patients. 

Asphalion is proud and excited to participate in the consortium and looks forward to a challenging and fruitful collaboration with all partners.