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Peer review of efficacy and safety studies using glass slides or digital (Patholytix enabled) to achieve highest quality study data
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Provide expert input to responses to regulatory questions concerning pathology findings and technical due diligence on nonclinical data
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Project pathologist role-providing continuity and application of project knowledge through discovery into development
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Primary microscopic examination, interpretation and reporting of slides or whole slide images of efficacy and safety studies
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Strategic input on investigative approaches and mitigation plan for potential safety liabilities identified from target safety reviews to late stage development
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Expert input to AI algorithm development, validation and implementation in pathology workflow
Choose us for our:
- Experience in successfully addressing nonclinical questions at all key project milestones from regulatory authorities
- Recent experience with biopharm, cell therapy, oligonucleotide, small molecule and other modalities across a wide range of therapy areas
- Demonstrated ability to clearly communicate expert advice on the significance of pathology findings within project teams, governance committees and senior leadership
- Deep expertise gained at senior director level in pharma (AstraZeneca and GSK) helps clients obtain accurate pathology data and interpretation which act as a foundation for subsequent project planning