The University of Sheffield and Pfizer have today (23 November 2020) launched a new consortium which aims to standardize and accelerate the development of Advanced Therapy Medicinal Products (ATMPs), allowing potentially transformative treatments 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.
Led by ARDAT Coordinator, Professor Mimoun Azzouz from 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 which includes gene and cell therapies.
The field of ATMP research is expected to grow exponentially in the coming years, with potentially up to 10-20 new drug applications submitted per year 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 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.
This is a significant development expected to change the landscape of research, innovation and regulatory activities for cell and gene therapies.
We are very excited to bring together world-leading experts to accelerate delivery of advanced therapies to patients suffering from rare diseases."
Professor Mimoun Azzouz, Chair of Translational Neuroscience and Director of Research and Innovation at the University of Sheffield's Institute for Translational Neuroscience (SITraN) and ARDAT Coordinator
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; and engage regulators to help support filings that address standardized regulatory, safety and efficacy concerns.
"While still an emerging field, ATMP research has largely been fragmented and siloed within organisations with little opportunity to share best practices and information," said Dr Greg LaRosa, Head of Scientific Research, Rare Disease Research Unit at Pfizer.
"As gene and cell therapies research grows and more potential ATMPs move 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 data and regulatory expertise."