A biomarker is a measurable biological characteristic that can help assess disease or healthy states or responses to therapeutic or environmental factors. Hence, biomarkers are vastly diverse and include physiological and molecular parameters. Developing suitable biomarkers can help discover disease mechanisms, direct clinical trials, monitor therapeutic effects, and guide regulatory and developmental decisions. Hence, having a partner with expertise in all these elements is always better in complex processes such as drug development. Biomarker discovery and testing services are one such expert that can help accelerate drug discovery and development projects.
Accelerating drug development projects through biomarker testing services
Biomarkers are critical for the success of a drug discovery and development project. They facilitate the quicker development of effective and safe therapeutics, making the entire development process seamless. Data suggests that around 20% of drugs approved between 2014 and 2018 belonged to personalized medicine. Moreover, 65% of FDA and EMA drug approval had at least one biomarker incorporated in the study. These data show that biomarker acceptance will grow in the coming future. Though factors such as regulatory landscape, recent scientific advances, and characteristics of a biomarker study govern the acceptance of a biomarker, it is evident that biomarker development is a vital aspect of drug development endeavors. The following section dives deep into ways biomarker discovery services help accelerate drug development projects.
- Biomarker testing services can help identify the most potential drug compounds and significantly reduce the time and costs involved in drug development projects.
- Biomarker tests are used routinely in diagnostics and drug R&D projects. They can guide research at every step of a project, ranging from identifying animal models to selecting suitable subjects for clinical trials.
- Multiplex biomarker assays have demonstrated their clinical utility in studying underlying mechanisms of complex diseases. This understanding can help better predict drug-drug interactions and unwanted adverse reactions.
- Testing labs are most experienced in biomarker assay development and validation. A partner lab with expertise in biomarker method validation is always critical for the approval of a drug product.
- Being exposed to such a wide range of drug development projects, biomarker discovery and testing services have the expertise to guide and facilitate crucial regulatory decisions.
- Biomarker services can employ tests to reduce the number of patients enrolled in clinical trials. Further, they stratify patients through biomarker tests and reduce the chances of drug failure due to safety and efficacy issues.
- Today biomarkers are used as surrogate endpoints. From March-May 2016, 27% of drugs approved by the FDA had at least one surrogate marker for primary endpoints. Hence, biomarker testing services can employ suitable biomarker assays and help achieve accurate analysis of drug products.
- Biomarkers are beneficial in providing early benefit-risk profiles and thus entrust confidence for its approval by regulatory agencies.
- Biomarker services help clearly define the target population and correspondingly reduce the risks of unwanted adverse effects. This advantage eventually reduces the drug project spending and has an overall positive impact on subsequent projects.
Thus, biomarker discovery and testing services can potentially improve the safety and efficacy of drug products, develop sustainable timelines and reduce the overall drug developmental costs.