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Advancements in hit identification for membrane protein drug discovery

Drug Target Review

Advancements in screening technologies for small-molecule drug discovery including cellular assays, computational screening, and biophysics-based methods enhanced by structural biology breakthroughs have improved screening hit rates and facilitated the identification of drug candidates for previously undruggable targets.

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Target-directed cancer: protein-ligand interactions  

Drug Target Review

The mission of the CCDD is to discover novel small-molecule therapeutics for the treatment of cancer and progress them to hypothesis testing phase 1 clinical trials. We support the drug discovery projects of the CCDD with assay development and screening, biophysics, structural biology and recombinant protein production.

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The hidden risks of over-reliance on healthy donor material

Drug Target Review

What are the risks of over-reliance on healthy donor material in early-stage research, and how can decision-makers ensure a balanced integration of diseased material to avoid potential gaps when transitioning to clinical trials? Healthy cells may also serve as a valuable control in experiments.

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Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

Prognostic biomarkers enable patient selection that would have a better clinical outcome irrespective of treatment. This enables patient selection, stratification and other adjustment in clinical trial design planning. biomarker negative) must also be supported by a sound rationale and clinical data.

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Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Agency IQ

In general, FDA determines the “effectiveness” of a product based on its ability to demonstrate clinical benefit: to prolong life, improve function, and/or improve the way a patient feels. In parallel, FOCR developed a white paper that provided an overview of the potential regulatory applications for ctDNA in oncology.

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Integrating Bioanalytical Automation, Biomarkers, Pharmacogenomics, & Cost-Effective Strategies

Conversations in Drug Development Trends

Biomarkers are indispensable tools in clinical trials, providing critical insights that enhance the efficiency and precision of drug development. Our biomarker testing capabilities, offered across BioA and Clinical Pharmacology Unit (CPU) sites, provide a comprehensive and tailored approach to biomarker analysis.