Biomarkers are an important tool in identifying possible clinical events and who would most likely respond to treatment.
By Galina Bernstein, Ph.D., PRA Health Sciences; Jozsef Palatka, M.D., Syneos Health; Stephan Schmidt, B.Pharm., Ph.D., F.C.P., University of Florida
The number of new treatment options is growing in different therapeutic areas. The promises of these new drug candidates often hinge on optimal treatment selection for a given disease state. Facilitating this decision-making process requires integrating available information including patient and disease characteristics, biomarker data, and the drug’s mechanism. This hinders a direct translation of previously developed biomarkers to emerging treatments with a different mechanism of action. Single biomarkers rarely provide a complete picture of a drug’s efficacy and safety profile, which is governed by a dynamic interplay between drug, biological system, and disease. Panels of biomarkers are now increasingly used to characterize a patient’s response to drug treatment. This requires prospective design of clinical studies, optimized sampling regimens, and analysis strategies of biomarker data to fully leverage the plethora of information. The process may be streamlined by sharing data between similar therapeutic programs to inform individualized treatment regimens.