Anatomic Pathology plays an important role in biomarker selection and companion diagnostics. This episode describes three key challenges in immuno-oncology development related to anatomic pathology. Some of the key issues organizations that support clinical trials I-O drug development face, particularly with companion diagnostics, involve ensuring the sample availability is adequate and appropriate for the different clinical trials, that the assay outcome is useful, and the results are relevant for the clinical trials. Many assays for the determination of PD-L1 status in most tumor types are based on immunohistochemistry, or IHC. Also, companion diagnostic strategies that are using multiple PD-L1 clones for related drugs in development are rapidly evolving.
Having adequate tissue samples is one of the most critical components; or “tissue is the issue.” It's also important that the sites that are sending samples have the ability to process samples in a timely manner, establishing that the fixation and other pre-analytical conditions that influence the outcome of the results are well evaluated. The podcast reviews our solutions that strive to make the whole process easier for patients and doctors alike.
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Central laboratories
Meeting the demands of today’s drug, device and diagnostics development environment requires a next generation service provider.
Genomics
We offer a range of genomic laboratory services to support drug discovery, precision medicine and clinical development. Our industry-leading team advances research by delivering scientific insights that help clients maximize the value of their data.
Discovery Sciences
Our labs bring expertise in protein production, antibody discovery, and immunogenicity to help you select the most promising candidates and reduce risk as you move toward IND-enabling studies.
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One of the world's largest and most respected bioanalytical and ADME laboratory networks. From our global locations, we serve many of the largest pharmaceutical, specialty pharmaceutical and biotechnology companies worldwide.
Specialty immunoassays
a CLIA-certified biomarker testing laboratory developing immunoassays used to quantify protein biomarkers in support of drug mechanism of action, pharmacodynamic, prognostic, and predictive clinical studies across all stages of drug discovery and development.
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