Uniting experts at this CERSI-AT event to discuss the use of AI in ATMP development, from safety assessment to regulatory engagement and data sharing.
Artificial Intelligence (AI) and Machine Learning (ML) hold potential promise for transforming the development of Advanced Therapy Medicinal Products (ATMPs). A key challenge is determining how to apply these technologies in preclinical assessment while meeting rigorous scientific, ethical, and regulatory standards.
Hosted by the Cell and Gene Therapy Catapult on behalf of the Centre of Excellence in Regulatory Science and Innovation for Advanced Therapies (CERSI-AT), this symposium provides a collaborative forum for leaders from the pharmaceutical industry, academia, regulatory agencies, AI companies, data science, and toxicology to explore how Artificial Intelligence (AI) and Machine Learning (ML) might support the development and safety assessment of Advanced Therapy Medicinal Products (ATMPs). The event will foster open and collaborative dialogue in order to:
- Define the current landscape
- Examine regulatory perspectives and engagement strategies
- Discuss AI applications in preclinical assessment, with a particular attention on safety
- Highlight the importance of data sharing
- Discuss possible solutions that can accelerate the responsible and effective integration of AI and ML into non-clinical assessment for ATMPs