iBET participates in ARDAT – Accelerating Research and Innovation for Advanced Therapies project which aims to standardize and accelerate the development of Advanced Therapy Medicinal Products (ATMPs). This project is supported by Europe’s Innovative Medicines Initiative (IMI) with €25.5 million.
ATMPs have unprecedented potential to significantly improve patients’ life quality. ATMP research is growing exponentially, it is expected that up to 10 to 20 new drug applications submitted per year to the FDA by 2025 are ATMPs. As an emerging field, ATMP knowledge is still fragmented and siloed within organizations with little opportunity to share best practices and information, ARDAT project aims to break these silos and streamline ATMP development.
Specifically, ARDAT consortium aims to fill the knowledge gap in ATMP research and how these therapies could potentially work by:
- developing appropriate standardized models for predicting ATMP immunogenicity in humans
- building understanding of ATMP drug metabolism within a host
- identifying adaptive immune responses that could affect ATMP safety, efficacy and persistence and
- engaging regulators to help support filings that address standardized regulatory, safety and efficacy concerns.
iBET collaborates in ARDAT by evaluating the immune response and toxicity of gene therapy vectors, using 3D cell models of human neurological tissue.
ARDAT is a 5-year precompetitive consortium, led by Pfizer and University of Sheffield, UK.