Bill Malone wrote a great article for Clinical laboratory News (American Assoc for Clinical Chemistry) that goes straight to the heart of the folklore and myth surrounding the use of automation in laboratories. Check out “Blood, Sweat, and Robots.” Share this:
Recently, it was announced that the Food and Drug Administration has approved a breakthrough cancer medication from Bristol-Myers Squibb Co. that researchers have heralded as the first drug shown to prolong the lives of patients with advanced skin cancer. Share this:
It is of concern of all in pharma and biotech research fields that the number of vaccines and drugs that get to the market is very low compared to the number that enter phase I clinical trial testing. For this to change, among other improvements, new surrogate markers must be identified early on for the purpose of patient stratification, immune monitoring and/or therapeutic or prophylactic efficacy assessment.
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? Share this:
Tuesday, March 29, 2011 – Please join in with the topical discussions about the newest trends in clinical drug development, and learn strategies to avoid costly mistakes and improve efficiency. The focus of this BioFlorida SE Chapter-sponsored event is on advancing biomedical products through the clinical development process, and is being led by Planning Committee […]
Dr. Wade E. Bolton, president & CEO of ImmunoSite Technologies, moderated a special session on Cell Mediated Immunity (CMI) at the Phacilitate Vaccine Forum in Washington, DC, on Tuesday, January 25, 2011. Topics included: Do you want standardized assays to interrogate surrogate correlates of immunity? Do you need high-throughput, validated, and automated assays to measure immunogenicity? […]
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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