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An industry leader’s perspective on the complexity of scientific data

Drug Target Review

Data-driven discovery As with many early-stage biotech companies, Five Alarm Bio is highly data-driven, producing vast amounts of experimental data through cell-based assays and phenotypic screening. She founded Pellis Care Ltd and in 2022 joined Five Alarm Bio Ltd as CEO.

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Applying ICH Q14 in Pharmaceuticals Part 1: The Application of Analytical Target Profile in Analytical Method Development

The Premier Consulting Blog

Technology Selection Description of which technology was selected (HPLC, SDS-PAGE, cell-based assay, ELISA, etc.) and a rationale for selecting it (could be based on development studies, prior knowledge, literature, etc.). ICH Harmonised Guideline. Analytical Procedure Development Q14. ICH Harmonised Guideline.

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Exploring alternatives to animal testing in drug discovery

Drug Target Review

allowing researchers to use “certain alternatives to animal testing, including cell-based assays and computer models, to obtain an exemption from the FDA to investigate the safety and effectiveness of a drug.” A new research paper, co-authored by PETA Science Consortium International e.V., Annals of Internal Medicine.

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ASLAN Pharmaceuticals to Develop ASLAN003 as Next Generation DHODH Inhibitor in Autoimmune Conditions

The Pharma Data

ASLAN003 is a highly selective and potent inhibitor of human DHODH (IC 50 = 35 nM) and has been shown to be more than 30 times more potent at inhibiting the DHODH enzyme in cell free and cell-based assays than the first generation inhibitor teriflunomide. In 2019, ASLAN completed a Phase 2 study testing ASLAN003 in AML.

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Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

Cell-based assays , while more complex to develop and use, offer another option for characterizing product activity at a slightly higher level, allowing sponsors to measure the further downstream effects of products (e.g., morphological cell changes or alterations in protein production or expression).

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Machine learning’s growing importance in researching cells

Drug Target Review

Ultimately, multi-omics represents an opportunity to generate high-fidelity, richly informative datasets that are often internally orthogonal. At Beckman Coulter Life Sciences , he supports the applications development team in NGS, cell-based assays, and proteomics workflows. So why doesn’t everyone do it?

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