fda regulation Archives

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

Oct 31, 2016 | Biomarkers, News

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...

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

Oct 24, 2016 | News

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...

Biomarker Intelligence Management – Process (Part 2 of 5)

Oct 17, 2016 | Biomarkers, News

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...

FDA Regulation to Support the Next Wave in Diagnostics

Jul 12, 2016 | News

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...