Translational Biomarkers

The focus on biomarkers in aiding drug development is evident from the emphasis most regulators place on them, due to their role in translational medicine. The FDA has a Biomarker Qualification Program for sponsors who are interested in developing biomarkers.

However, not all sponsors include  biomarkers  as a consideration early in the drug development process. To maximize biomarkers' benefits, focusing on them in preclinical studies is beneficial. This is the ideal time to determine which biomarkers can help establish efficacy and whether other biomarkers must be included to monitor safety as the drug progresses.

The bioanalysis of the  biomarkers  can present more complexity than measuring the drug, since they are often complex proteins and are present endogenously. Working with a bioanalytical team with experience designing fit-for-purpose assays is key. The Altasciences approach has the added benefit of bringing in toxicologists and clinical pharmacologists to develop a comprehensive  preclinical -to- clinical  approach to maximize the translation of the results.

View our  validated bioanalytical assay list  and  translational biomarker assays .

Looking to conduct a study? View this  list of biomarker assays  and  contact us  to discuss further.