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Clinical Safety Profiling
Download our Anaxomics offers a solution based in Systems Biology and Protein Network Analysis, for evaluating and predicting Safety and Efficacy aspects of drugs (both in discovery, in early clinical phases, or already launched drugs).
- The solution will allow the client to:
Analyze their own pipeline for early identification of the safests compounds, or the ones that may give rise to potential future safety issues.- Increase the value of their pipeline for out-licensing, by ensuring that molecules are safe.
- Convince investors of the safety of their molecules, thus helping to raise investments.
- Select which products to in-license.
- Predict and solve drug-related safety issues by:
- Providing explanations about the mechanism of action.
- Identify potential problems, and recommend directed pre-clinical testing, or directed monitoring in early clinical phases.
- Assisting in discussions with Regulatory Authorities.
- FDA and EMEA require Predictive Safety for IND / IMPD:
European Innovative Medicines Initiative - Predictivity of Safety Evaluation (Pillar I).
- Predictivity of Efficacy Evaluation (Pillar II).
- Knowledge Management (Pillar III).
- "Innovative and powerful data exploitation tools, from the molecular to the systems biology level and from the organ to the living organism level".
In Anaxomics we provide hand-curated Safety Databases that encompass all the published relationships between targets, proteins, effectors, and the corresponding Adverse Events or Safety Issues, according to MedDRA classification.
SAFETY TARGETS (Sample)
At Anaxomics we develop our own Effect or / Safety database to ensure that all the potential safety issues of your drug are correctly mapped.
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SAFETY ANALYSIS : TOPOLOGICAL (Sample)
Normalized Risk of known adverse events of your drug, according to topological analysis of the map.
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SAFETY ANALYSIS : CLASS RANK (Sample)
Normalized Rank of "Your Drug", against other drug representatives in the same class, for a given AE.
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Besides, after the systems biology analysis, we provide the following complementary analyses:
- 1. Prior to FIH studies = Translational Safety
Preclinical toxicology suggests specific issues or known class effect(s) - 2. Agent fails to achieve target tolerability profile (Phase 1 or 2)
- Unanticipated adverse event(s) or more severe events than anticipated
- Class effect or non-class effect?
- Molecular basis of adverse event(s)
- - On-target or Off-target ?
- Will it kill the agent?
- - Structural motifs: rational selection of backup agents
- Reformulation strategy?
Please, contact us here to request more information.
