Food & drug safety risk assessment

Adverse event prediction and scientific risk assessment can be complex and costly challenges due to information silos, disparate and lack of sufficient and curated pre-clinical and clinical data. The Professional Services Group (PSG) specializes in helping organizations assess patient and customer safety risk through evidence based adverse event prediction and animal-human concordance via bespoke reporting solutions and curation of Elsevier data and 3rd party data.

Adverse event prediction

PSG helps researchers determine the likelihood of a preclinical toxicology event through molecular structure analysis and helps predict human toxicity based on the concordance of animal adverse events.

Our custom reports answer key research and development questions such as:

Adverse event prediction

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  • Which studies have been conducted for similar compounds and what were the findings?
  • What adverse events might occur based on molecular structure and class?

Animal-human concordance

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  • What are the most predictive preclinical species for understanding human toxicity for this compound?
  • What is the biomedical implication of an observation in an animal for human risk?

Professional services solutions

In the pursuit of addressing adverse event prediction and scientific risk assessment, PSG addresses problems related to information silos, disparate data sources, and gaps in pre-clinical and clinical data. These solutions include:

Translation of pre-clinical safety risk: Elsevier data assets such as PharmaPendium, in conjunction with customer data or other external sources, provide animal-human concordance analysis to evaluate the predictability of adverse events and potential clinical safety risk.

Adverse event prediction based on chemical structure: Machine learning models through which researchers can draw any molecular structure to predict risk associated with that structure or class—including odds, ratios, and probabilities.

Patient safety

Key outcomes

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Insights

Deeper understanding of drug safety impacts and implications to help prioritize list of compounds for synthesis and/or in vivo testing

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Assessment

Ability to determine potential drug-drug interactions and evaluate similar drugs to identify markers indicating adverse event risk

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Harm reduction

Reduced use of animal testing in pre-clinical trials and increased evidence to support regulatory advocacy changes


Scientific risk assessment

PSG helps customers analyze scientific literature to identify potential drug and patient safety signals and to determine risk factors for future litigation or post-market withdraw or relabeling.

Our custom reports answer key research questions such as:

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What is the overall risk of your drug program based on adverse event signals and the experience of similar post-market drugs?

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What is the potential risk of litigation based on drug failure?

Professional services solutions

PSG addresses challenges related to gaps in internal data; resources needed to integrate and analyze all available evidence; and a means to efficiently apply predictive analytics to understand probable risks. The team offers the following solutions related to pre- and post-market risk evaluation:

Text mining: Thorough identification of all possible safety risks in scientific literature.

Risk prediction: Development of a custom tool to identify patterns and score potential risk areas.

Risk evaluation: Detailed assessment to determine the potential of litigation.

Machine learning model: Determination of drug failure risk through analysis of similar compounds.

Innovative research

Key outcomes

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Predictive intelligence

Informed decision making, risk mitigation, and proper allocation of resources before an event occurs

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Vigilance

Calculation of litigation risk up to one year in advance of potential action

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Adverse events

Reduction of future adverse event risk through drug re-labeling and narrowing of applicable patient population