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 Qualifcation 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 the benefits of biomarkers it is beneficial to focus on them in preclinical studies. 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 moves through development.
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 that has experience in 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 preclinical to clinical results.