Discovery Stage Assistance

Discovery or exploratory toxicology and has been shown to provide key early safety information that is important in distinguishing key characteristics of potential lead molecules.  Designed to reduce the failures of potential candidate drugs in early clinical development due to potential toxicology issues, discovery toxicology provides essential information when more than one potential lead compound is identified by early pharmacology studies.  Having early toxicology input in discovery projects can increase success in selecting the best compounds to move into full development and eliminate compounds with poor chances of successful development. Key information related target-related toxicity, off-target effects, and compound-chemistry related toxicity are all considered.  Expert review of the literature, in vitro, ex vivo, in silico and early non-GLP exploratory in vivo assessments will enable the selection of drug candidates with an acceptable safety profile and provide the opportunity to reduce attrition and increases the success of drug development.  Assays used as part of discovery toxicology can also provide insight into potential mechanisms of toxicity at the cellular, biochemical, and molecular level, and can aid in risk assessment.

The Weinberg Group’s experts understand regulators’ interest in biomarker and mechanistic data and the ability of these data to define the sensitivity of organs and cells to therapeutic agents.  We can assist with the design, evaluation, and optimization of investigative toxicity and exploratory/discovery studies for candidate therapeutics that are early in the drug discovery process.  In addition to a Sponsor’s own data, we utilize publicly available information to identify potentially supportive data.

The Weinberg Group can assist in establishing the relevance of in vitro and animal data to humans in support of the initiation of clinical testing.   Our expertise in typical early discovery assessments includes, but is not limited to:

  • In vitro and in vivo models for mechanism of action and efficacy assessments
  • CEREP/Kinase panels to flag off-target activities of compounds
  • Cell culture, tissue slice, 3D tissues models and Organs on a Chip
  • In vitro hERG and cardiovascular studies
  • In vivo cardiovascular, pulmonary, CNS, gastrointestinal, and renal assessments
  • In vitro metabolism and drug interaction studies
  • In vivo pharmacokinetic studies (various species and routes of administration)
  • QSAR assessments for genotoxic potential
  • In vitro and in vivo genotoxicity tests
The Weinberg Group has extensive experience helping our clients achieve successful interactions with the FDA.  To learn more about our services and how we can help you, contact us today.