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Fail Early, Fail Fast - And Increase Likelihood-of-Approval

What is this saying “Fail Early, Fail Fast” all about? Is there any merit to it and how is this changing the game for all pharmaceutical drug development companies? Here we will give our thoughts and opinions into how this really carries over to the real world and how it affects the industry.

Chart of the Week: Phase 3 LOA Vs Biomarker Coverage Percent

This week’s Chart of the Week demonstrates recent research on the correlation between the Biomarker Coverage Percent in a company's pipeline and the Company's Phase 3 Likelihood of Approval. This chart depicts how as a company increases their number of trials utilizing biomarkers, they will also ...

Chart of the Week: Phase 3 LOA Vs Precision Medicine Score

This week’s Chart of the Week attempts to communicate the correlation between a Company's Precision Medicine Score and the Company's Phase 3 Likelihood of Approval (LOA). This chart depicts how as a company increases their Precision Medicine Score, they will also see an increase in their likelihood ...

Biomarker Intelligence Management - Process (Part 2 of 5)

Three weeks ago we introduced the concept of the Biomarker Intelligence Maturity Model where we unveiled the 5 stage, 4 swim-lane model representing how companies improve biomarker intelligence management to win in drug and diagnostic development. This is the second installment of that series where ...

FDA Regulation to Support the Next Wave in Diagnostics

In February of last year the FDA hosted a two-day workshop focused on technical and regulatory considerations related to the use of next generation sequencing (NGS) diagnostics in clinical practice.  This was a very forward-thinking move on the part of FDA, as clinical NGS is advancing rapidly and ...

   

December

Webinar: 

Pharmacovigilance and Safety Biomarkers

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