"Expertise in optimizing
non-clinical safety assessments required for successful product development."

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

Special pathology assessment
    • 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

 

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