Mechanism of Action and Predictive Regulatory Studies
In connection with regulatory requirements of EMEA and the FDA, Anaxomics provides ways to improve the consistency, transparency and communication of benefit-risk assessments. Basically, we write the corresponding chapters in the IND / IMPD submissions regarding Predictive Medicine and Mechanism of Action understanding.
Moreover, a recent trend to press biopharma to completely elucidate the MoA of drugs requires the resolution of complex biological network systems. At Anaxomics, we believe that the actual mechanism of action of drugs with multiple targets can only be explained by using complex biological network and systems biology approaches.
Besides, a number of new regulatory requirements make the effort in understanding the MoA really interesting:
- Regulatory Submissions
- Paediatric Studies, where a paediatrica application of a new drug can be discussed based on mechanism of action
- Possibility to enter directly in Phase II studies with combination therapies skipping the initial studies with individual drugs, provided that a sound mechanistic rationale is provided.