Blog Archives

05/22/2014

Biomarkers Enhance Astra Zeneca's Clinical Trial Successes

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Biomarker data from Astra Zeneca demonstrates that biomarkers enhance success in every aspect (safety, dosing, efficacy, patient selection) of every state of the drug development process.

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06/29/2013

Feasibility study: Improving Cryopreservation of PBMC for More Reliable Information From Clinical Trials

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Advanced automation of PBMC freezing (cryopreservation) and cell thawing improved the quantity and quality of PBMC yields and viability. through a partnership between ImmunoSite Technologies and MéCour.

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08/23/2011

Research Poster - Assay Standardization Saves Money

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The identification and application of correlates of immune response can enable significant time and money savings especially in clinical trial settings for vaccine and biologic R&D. To download, please fill in the form below:

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03/10/2011

How Useful are Cell Mediated Immunity Assays in Assessing Immune Response or Immunogenicity?

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How practical is it to run validated and standardized cellular assays to interrogate biomarker surrogate correlates of immunity in clinical trial settings? Can this be done with any level of confidence in the outcome? Can these assays be performed routinely?

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01/10/2011

Validation of Cell-Based Assays in the GLP Setting

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Readers gain an understanding of the details and the high level considerations of assay qualification for difficult cell-based assays. The level of optimization described for cell-based assays lends itself to biomarker assay automation which can be used for biomarker qualification and validation studies to the satisfaction of the FDA, EMEA, and other regulatory agencies.
Cell-based assay platforms covered are flow cytometry, intracellular cytokine ICS, immunophenotyping, elispot, IHC, cylex, neutralization bioassays, and endpoint assays.

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