Cashing in on Biomarkers, Targeted Therapies,
And Precision Medicine
Biomarkers Will Drive Approvals: Are You Prepared?
Pennside Partners has a staff of well qualified professionals who are prepared to answer the many questions regarding the development of biomarkers by competing companies with targeted therapies seeking to cash in on “Precision Medicine”.
Adding to the complexity of drug development, biomarkers play an increasingly important role especially in defining the utility of new targeted therapies. Competing companies have teamed up with diagnostics companies to explore biomarkers as early as the preclinical testing phase. Fully understanding the utility of a biomarker is now critical in assessing the threat posed by a competitor that has a precisely targeted therapy.
Key Approved Therapeutics with FDA Mandated Companion Diagnostic Tests
Biomarkers are now a routine part of drug development.
How are competitors using them to better position their drugs?
Over the past 12 years virtually every presentation we have attended about “targeted therapy” has concluded with the statement that “we must identify which patients benefit from this new drug”.
For many targeted therapies, the inability to identify the beneficiaries has directly led to the failure of the Ph III trials. The regulatory authorities strongly encourage drug sponsors to have a companion diagnostic test, which is predictive of the likelihood of treatment benefit, and thus qualifies patients for the use of expensive therapies. Companies are now acting on this recommendation.
Biomarker & Companion Diagnostics: A Primer
Click below to learn more, including:
- The importance of diagnostic tests in predicting treatment benefits
- Personalized medicine and the role of predictive vs. prognostic markers
- Biomarker sensitivity and specificity and test result accuracy
- Determining the true utility of biomarker evaluation and analysis
As part of Pennside’s biomarker analysis service, we can help you wade through the clutter of putative biomarkers in development for targeted therapy and come to an understanding of where the real threats may lie.
Recognizing the strategies behind biomarker development and how competitors are successfully using them to gain faster drug approvals will help you meet competitive challenges in time to do something about them. Make no mistake, companies can use companion diagnostics as an important differentiator and use them to build barriers to market entry for others.