Services
Develop strategy to address toxicity issues
- Fully characterize toxicity issue based on all species evaluated
- Assess available information on toxicity based on extensive experience and literature review
- Provide advice on the probability that the issue can be satisfactorily addressed within time and resource constraints
- Provide advice on approaches to address toxicity issue
- Interpret results from studies utilized to understand the toxicity
Benefit: The development of an appropriate strategy to address animal toxicity may allow successful development of molecules that might otherwise be stopped
Develop strategy to address clinical and regulatory concerns
- Evaluate clinical and regulatory concerns based on animal toxicity
- Propose approaches to understand animal toxicity and predict human relevance
- Interpret results from any special evaluations or studies related to animal toxicity
- Interact with company clinicians, company advisory panels or regulatory agencies to provide a scientific assessment regarding human safety
Benefit: Aggressive attention to clinical and regulatory concerns based on animal toxicity can reduce drug development delays and failures
Review toxicology documents
- Assure that documents are clear, concise, complete, and scientifically accurate
- Assure that documents fully utilize available information from animal studies and the literature
- Review toxicology sections of INDs, NDAs and position papers in response to regulatory questions related to toxicity
Benefit: Complete, well-written regulatory documents can avoid delays in drug development related to multiple interactions with regulatory agencies on a single point
Design GLP studies
- Assure optimal dose and species selection
- Anticipate potential toxicity based on known data and enhance efficiency of resource utilization to optimize evaluation of the toxicity
Benefit: Optimal study design will expedite toxicity evaluation and reduce the need for repeat studies
Evaluate and interpret toxicity findings
- Provide an integrated assessment of in life, anatomic and clinical pathology findings to fully characterize the toxicity
- Identify known animal toxicities that have little or no human relevance
- Evaluate comparison of animal to human exposure to determine relevance of the animal toxicity to humans
- Prepare written assessment for use in internal company decision making process or submission to regulatory agencies
Benefit: Provides a scientific basis for assessing the relevance of the animal toxicity to potential successful development of a drug
Assessment of special pathology
- Histologic review and interpretation of specific carcinogenicity questions
- Histologic review and interpretation of liver injury
Benefit: An accurate, detailed characterization of tissue effects enhances decision-making concerning human relevance.
Due diligence reviews for in-licensing
- Evaluate the completeness of toxicology studies performed
- Assess toxicity study findings that may impact further development and regulatory acceptance
- Provide advice on potential additional work required to address toxicity findings
- Assess feasibility of successful continued development or regulatory filings
Benefit: Critical evaluation of available toxicology data reduces the possibility of delayed completion of development or registration