We support every stage of compound progression, from target identification/toxicological risk assessment, through lead-generation/optimisation, to life-cycle maintenance. Our extensive experience will help you design, run and interpret the studies necessary for your IND/IMPD submission and we will guide you through the associated FDA/EMA/PMDA interactive process.
Safety Liability/Toxicological Risk Assessment:
Slide Reading and Interpretation:
Our FRCPath-accredited and ACVP board-certified pathologists can conduct both the primary read and the peer review of the full range of investigative and regulatory efficacy and safety studies, including ecotoxicology protocols, gene manipulation and phenotyping projects and disease-model-based research. We can assist in the design, implementation and interpretation of each study, fortifying your research and maximising your drug-development programme.
Our pathologists have extensive experience and scientific publications in the field of ecotoxicology. We can provide slide read-outs for short and full-life-cycle endocrine disruption studies, including the interpretation of findings in the fathead minnow, the zebrafish and the Japanese medaka.
We can provide a comprehensive and image-documented characterisation of the full range of genetic knock-in/out models, used extensively within both academia and industry-based disease research.
We use both traditional pathology and contemporary technologies to characterise disease models and their reaction to drug. Objective structural analysis can then be employed to bolster the pharmacology/efficacy datasets of a given candidate.
Pathology Working Group:
In the event of an unexpected in vivo finding, our extensive pathology network can be utilised to provide a thorough evaluation of the lesion in question and an expert opinion/interpretation of the finding(s). Appropriate documentation can then be filed for regulatory submission.
We can provide a comprehensive analysis of your target in order to assess potential safety hazards and associated risk. This will allow for the identification and selection of key target tissues in subsequent studies.