Assay Development & Validation

Biomarkers Can Enrich Patient Populations for Faster Enrollment, Potentially Increase Response Rates and Improve the Odds for Drug Approval.

Source: BIO, Amplion

Drug development timelines can be compressed resulting in reduced development cost and increased ROI. Companion Diagnostics can also enhance postlaunch competitive positioning and pricing strategies. A biomarker can add value to a drug program, but it also has the potential to introduce unwanted risks so it is important to closely manage the codevelopment process.

Biomarker Strategies and the Path to Commercializing Targeted Therapies

Biomarker discovery and maturation follows along a time continuum which is dependent on scientific evidence and the establishment of clinical utility.

In order for a biomarker to move forward into clinical trials, many companies reach a point in time when they need additional diagnostic expertise. Calling upon MolecularMD to become a trusted advisor results in a close collaboration that effectively manages risks, timelines and budgets. It is not uncommon for the clinical trial assay to change over the course of time and the diagnostic partner needs to closely manage these changes. Key considerations such as bridging strategies need to be put into place for contingency planning. Having a codevelopment partner who has experience with assay development, validation, bridging and regulatory interactions are critical to the success of the therapeutic program.