Anaxomics' TPMS technology enables the re-analysis of clinical and preclinical data with the aim of extracting novel conclusions relating to amedicinal product on a molecular basis.
During the preclinical and clinical stages of the drug development large amounts of data are generated that usually are underexploited from a scientific point of view.
Anaxomics, by means of Systems Biology and Knowledge Discovery in Databases –KDD-(Bielekova B, Front Neurol. 2014), strategies studies the mechanism of action of the drug in the patients. Based on the available information of each patient captured in the Case Report Form it is possible to emulate in silico a part of the molecular effect of the drug for each patient. By using this information it is possible to unveil mechanistic justifications for clinical observations in terms of safety or efficacy and/or to identify new indications. While conventional approaches typically relies on the statistical assessment of clinical observations, Anaxomics' TPMS analyses clinical trial results in the context of human physiology. In fact, there is lot of information in clinical trial databases masked to classical statistical analysis that can be unveiled by using a molecular-based analysis. As an example, by using a systems biology analysis it is possible to understand why an unexpected adverse drug reaction appears even when it does not appear with statistically significance, or, in a more general setting, it is possible to analyse how the molecular effect produced by the tested drug is affected by other co-treatments.
By using this approach it is possible to perform the following services:
- Obtain mechanistic explanations for clinical observations
- Determine cohorts of patients on a mechanistic basis
- Identify co-treatments and other factors that could impact on efficacy/safety
- Find biomarkers associated with cohorts of patients
- Identify new potential indications of the compound
- Support medical and/or scientific writing
These relevant findings are intended to constitute the basis for new publications that can highlight the values of the compound to the scientific and medical community.