Advanced Therapy Medicinal Product Development
The development of innovative therapy products is essential for future progress in therapy and diagnosis. These advanced therapy medicinal products (ATMPs), which include vaccine candidates and gene therapy products, are developed through translational research and can have a major impact on public health, fulfilling the hopes and thirst for innovation of patients, clinicians, and health policy officers.
At the Institut Pasteur, the Clinical Research Department (PIRC) is the dedicated body specialized in implementing the early stages of development of these ATMPs. The PIRC offers its expertise, skills, and know-how to scientists for the development of ATMPs designed to prevent infectious or neurodegenerative diseases or to treat cancers, and for their transition from fundamental research to first human administration.
In the development of these experimental ATMPs, several aspects are taken into consideration and regularly reviewed prior to testing on humans (the preclinical phase):
- the scientific proof of concept;
- the technology transfer that will enable the experimental product to be produced in large enough quantities;
- the harmlessness and safety of each experimental product;
- the quality of each experimental product;
and also when administered to humans (the clinical phase):
- response to the experimental product;
- the efficacy of the experimental product.
The PIRC also plays an important role for its scientific, regulatory and industry partners in innovation development by highlighting the essential issues that need to be considered when developing ATMPs and by requesting scientific advice from the relevant health authorities.
The PIRC builds on its own expertise by working alongside leading clinical, regulatory and industry experts.