Josie Hayes PhD’s Post

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Biomarker Dev Strategies for Therapeutics| Preclinical to Phase 2 | Bioinformatics | ex Revolution Medicines| ex Clinical Cytogeneticist | Bridging Bench to Bedside: Precision in Every Step

The Overlooked Simplicity in Biomarker Discovery I'm all for large omics studies and the utility they have in understanding the mechanism of action, especially in the preclinical setting. But, in the early stages of clinical trials, the heterogeneity (often multiple indications and disease stages) and high costs associated with biomarker mining challenge its budget effectiveness and statistical value. Many of the features in a comprehensive gene assay are not of appropriate prevalence in the population or have enough dynamic range to make it a robust biomarker. Historical successes, such as the identification of PSA for prostate cancer, exemplify the potential of targeted, hypothesis-driven research over complex methodologies. Embracing simplicity could lead to more scientifically and economically efficient discoveries, aligning closely with clinical utility and real-world applicability. #biomarkerdiscovery #biomarkers #clinicaltrials ---- Hi, I'm Josie, a strategic biomarker consultant. I provide advice to therapeutics companies on preclinical and clinical biomarker strategy. Follow me to hear more of this or schedule a call with me for a free intro chat.

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Josie Hayes PhD

Biomarker Dev Strategies for Therapeutics| Preclinical to Phase 2 | Bioinformatics | ex Revolution Medicines| ex Clinical Cytogeneticist | Bridging Bench to Bedside: Precision in Every Step

8mo

In some cases though, you may need a comprehensive assay to calculate the biomarker. TMB and MSI are an example.

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Wesley Sukdao

CEO @ Proteotype | Dad | On a Mission

8mo

That’s us!

Marco Salvatore

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8mo

Thank you for the insightful post Josie Hayes PhD, PCCC. I agree, however it's important to note that the effectiveness of these methods depends on the specific disease and the type of biomarker being sought. Currently, there is significant progress in identifying blood-based biomarkers through sequencing techniques. As technology becomes more affordable, a dual approach combining traditional methods with these new blood-based biomarkers could be a promising strategy. What are your thoughts on this potential dual approach?

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