With the wide availability of increasingly large research and clinical datasets, as well as with rapid advances in computation, comes the need and the opportunity to use this data in a more quantitative and correlative way. The field of Precision (or Personalized) Medicine aims to do exactly that, namely to inform healthcare decisions on a patient-by-patient basis that take into account a large spectrum of patient-specific quantitative and qualitative data. According to the FDA, biomarkers will play an increasingly important role towards this goal, but also towards the goal of discovering better therapeutics, even before they reach patients.
But what is a biomarker? There are plenty of definitions out there but, broadly defined, a biomarker is a measurement-derived quantity that is indicative of a biological process. Each time you go to the doctor’s office the nurse will typically measure some biomarkers such as your temperature, your blood pressure and oxygenation, resting heart rate and your weight. If these biomarkers are out of a known normal range, they might indicate that there is something wrong such as an infection, heart problems or poor fitness. A lipid panel that shows LDL and HDL cholesterol levels is another example of biomarker that might have a prognostic value of the risk of developing heart disease. Check out FDA’s biomarker resources here.
Aside from managing patient health, biomarkers play an important role in drug development and evaluation prior to reaching patients, both at the clinical and the preclinical stage. At Preclinical I&T we use a variety of safety, diagnostic and pharmacodynamic/efficacy biomarkers for each therapeutic technology we evaluate. Check out the table below for examples of common biomarkers used:
| Biomarker | Type |
| left ventricular ejection fraction (LVEF) | diagnostic/PD |
| PET standardized uptake value (SUV) | diagnostic/PD |
| weight | safety |
| blood glucose levels | diagnostic/PD |
| tumor volume | diagnostic/PD |
| cytokine levels | safety |
| blood count | safety |
| enzyme levels | safety |