Denovo Biopharma

A Novel Strategy to Discover Clincal Biomarkers Retrospectively with Archived Samples

Many drugs unfortunately fail after expensive phase III studies have been completed, largely due to lack of efficacy or undesirable adverse effects. Our technology can enable drug developers to design new clinical trials in smaller and targeted patient population at lower cost than the previous studies.

A highly novel aspect of this technology is that plasma samples (Almost always retained for PK studies) can be used to identify novel genetic biomarkers by scanning the entire human genome and conducting a proprietary data analysis developed internally, which has not been possible in the past using other technologies. This process can be completed as rapidly as 90 days at an affordable cost that can generate attractive return on investment.

If no patient informed consent existed, we have developed a double blinded sample processing procedure to meet FDA guidance on further testing of leftover clinical samples.
We will support a partner throughout the development process up to approval and launch of the drug together with the companion diagnostic test.

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