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The University of Sheffield and Pfizer have today (23 November 2020) established a new consortium which aims to standardize and accelerate the growth of Advanced Therapy Medicinal Products (ATMPs), allowing potentially transformative remedies to reach patients sooner.
The new, five-year consortium, Accelerating Research and Innovation for Advanced Therapies (ARDAT), is supported by the Innovative Medicines Initiative (IMI) and brings together the leading expertise of 34 academic, nonprofit and private organizations from across Europe and the US.
Directed by ARDAT Coordinator, Professor Mimoun Azzouz in the University of Sheffield, and ARDAT Project Lead, Dr Gregory LaRosa from Pfizer, the new consortium will pioneer a $25.5 million project to accelerate the development of ATMPs Including cell and gene therapies.
The sphere of ATMP study is expected to grow exponentially in the next few years, with possibly up to 10-20 new drug applications submitted annually to the FDA (US Food and Drug Administration) by 2025.
The ARDAT consortium will aim to bring together researchers from public and private organisations to help fill the knowledge gaps in how these treatments could potentially work, and to develop appropriate standards to aid researchers, developers and regulators in hastening safe and effective gene and cell therapies to benefit patients.
The consortium aims to develop standardized models for predicting ATMP immunogenicity in humans; construct comprehension of ATMP drug metabolism within a host; identify adaptive immune responses that could influence ATMP security, efficacy and persistence; and engage regulators to help support filings that tackle standardized regulatory, safety and efficiency concerns.
“While still an emerging field, ATMP research has largely been fragmented and siloed within organisations with very little chance to discuss best practices and data,” said Dr Greg LaRosa, Head of Scientific Research, Rare Disease Research Unit at Pfizer.
“As cell and gene therapies research grows and more potential ATMPs go into later-stage clinical trials, it is in the interest of the industry and of patients to further our collective understanding of their mechanisms by sharing information and regulatory expertise.”
University of Sheffield
