Anaxomics maps have been presented in the cover page of the November issue of Nature Chemical Biology

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Mechanism of Action and Predictive Regulatory Studies

FDA and EMEA are emphasizing the importance of understanding the molecular and physiological basis of therapies by using new tools of Predictive Medicine. Anaxomics unique MoA models are comprehensive and predictive.

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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.

Anaxomics view or REAL Mechanism of Action of Drugs

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