October 1, 2017 (Vol. 37, No. 17)

The right biomarker can make all the difference in a drug-development program, allowing a clinical trial to enroll a smaller patient population, lowering costs, and shortening timelines. As much as the right biomarker might be desired, it might not exist. It might need to be discovered and developed.

A biomarker is anything that can serve as an indicator of a biological process and/or a pharmacologic response to a therapeutic intervention. Any given biomarker, then, may be analyzed by any one of a varied collection of methodologies. Besides traditional methodologies, there are newer ones, such as flow cytometry, molecular genomics, clinical chemistry, immunohistochemistry, and anatomical pathology.

Because biomarkers may manifest themselves in so many ways, and because an appreciation of biomarker subtleties is needed to advance personalized medicine, biomarker discovery and development often requires a multifaceted approach.

PPD Laboratories is applying this multifaceted approach in its gene-therapy and rare-disease studies, which are demanding because they have extremely small patient populations. In these studies, the right biomarkers are essential. Also, each sample collected from each patient is precious and needs to be handled with care. These sample-handling needs are met by a specialized laboratory concierge services team.

The company’s bioanalytical, biomarker, and central labs have extensive capabilities in the biomarker space, which include screening assays, copy number assays, flow cytometry analysis such as PBMCs, cytokine analysis, and immunogenicity testing with and without gene-specific antibodies. These laboratories are closely integrated and often use a single sample for a multitude of different assays. This gives the laboratories the ability to produce CAP/CLIA biomarker data for inclusion or medical monitoring, as well as biomarker data for efficacy for primary or secondary endpoints in a GxP setting.

PPD Laboratories has research staff with significant regulatory and analytical experience that can help facilitate biomarker development. A variety of biomarkers can be explored at different phases of the drug development process. However, the development of biomarker assays is most efficient when it is performed in parallel with the development of the product. Collaboration between the bioanalytical, biomarker, and central labs and the laboratory concierge service can help support the simultaneous development of both the therapeutic product and biomarker, which in turn helps support the ongoing effort to bend the cost and time curve of drug development.

Katie Matys is associate director, lab operations, and Janine McKnight is senior manager, project management, PPD Laboratories.

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