((Photo above: Corey Dow-Hygelund, Chris Kraybill, Seth Taylor, John Audette & Adam Carroll of Amplion Research)
New Report from Bend-based Amplion, BIO and BioMedTracker examined ~10,000 clinical trials to make groundbreaking conclusion regarding biomarkers.
Amplion (inventors of BiomarkerBase), Biomedtracker and BIO announces the publication of the largest study of clinical drug development success rates ever. The report examines ~10,000 clinical programs by therapeutic area as well as three unique categories: rare diseases, chronic high prevalence diseases, and programs utilizing selection biomarkers.
The results show dramatic differences between disease groups and modalities to be presented during the “The State of the Innovation Industry” session at BIO International in San Francisco on June 6.
“The dramatic increase in Likelihood of Approval (LOA) when utilizing biomarkers from 1 in 10 to 1 in 4 is really the big takeaway in this report,” said Dave Thomas, senior director of industry research for BIO. “Combining Amplion’s BiomarkerBase with BioMedTracker’s clinical transition records enabled us, for the first time, to quantify the benefit of using selection biomarkers in drug development. In combination with the rare disease section of the report, these results appear to be revealing the overall strength in targeting well-defined, homogenous patient populations.”
This study was possible due to the clinical program monitoring and data entry by Informa’s Biomedtracker service. “BIO has long partnered with BioMedTracker to analyze clinical development successes and failures”, said Michael Hay, Head of Intelligence Products at Informa. “Now by partnering with Amplion we have been able to analyze the effects of biomarkers in clinical trial success and show in detail the substantial positive effect a good biomarker strategy can have on successful development outcomes.”
Having real data to tie LOA to use of biomarkers will influence the advancement of precision medicine. “Tripling your LOA through the use of selection biomarkers is not only impressive, but it makes a clear statement about where the future of drug development is headed”, said John Audette, Founder and President of Amplion. “As the use of patient selection biomarkers increases, and drug developers realize higher clinical success, this will also expedite the identification and validation of companion diagnostics, another transformative component of the precision medicine landscape.”
Amplion will talk about the biomarker data that contributed to the report findings during their upcoming webinar, “Triple your clinical trial success rate with biomarkers”, on June 21.
Amplion is a biomarker intelligence company, and its flagship product BiomarkerBase, along with consulting services and free reports, deliver insights that inform key strategic decisions for drug and diagnostic test developers. Since 2012 Amplion has helped large and small companies alike make the best use of biomarkers in advancing precision therapeutics and next generation diagnostics.
About Biotechnology Innovation Organization (BIO)
BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations.
BioMedTracker, a subscription-based product of Informa, tracks the clinical development and regulatory history of investigational drugs to assess its LOA by the FDA.