Leadership Opportunities in the Emerging Field of Translational Science: Forging a Path for Biomarkers from Academic Discovery to Clinical Laboratory Use

Translational science is focused on improving human health by bringing scientific discoveries from the academic research laboratory (bench) into clinical practice (bedside). In September 2004, the National Institutes of Health established a roadmap for medical research to overcome major hurdles of moving technologies from bench to bedside. Since then there have been great successes in the areas of therapeutics, medical devices and community interventions. However, translation of biomarkers from discovery to the clinical laboratory has remained sluggish. Rapid translation calls for a more defined path from academic discovery to clinical use. Leadership opportunities in academia and industry abound as this path is forged in the clinical diagnostic arena. Rapid translation of laboratory diagnostics is vital to patient care. Clinical laboratory diagnostics are primary tools used by clinicians to make decisions impacting patient care. Proteomic and genomic discoveries in the academic arena are vast yet rarely move into clinical validation and transfer to industry due to intellectual property disputes, scarce funding resources for validation, method development expertise and lack of communication between academia and industry. The objective of this paper is to define the barriers that exist for a biomarker along the path to a widely adopted assay in the clinical laboratory, offer solutions and define potential leadership opportunities in this emerging field. Barriers to translation of biomarkers from discovery to clinical use continue to persist. There may be limited communication between academic researchers and clinical laboratory leaders. Methods used to discover useful biomarkers may not be suitable for clinical laboratory high-volume testing. Often, development, method and clinical validation of the biomarker are necessary before an industry partner is interested in investing in the high-risk/high-return discovery as a potential clinical diagnostic assay. It has been challenging to secure funding for prospective clinical validation of diagnostic assays in the academic setting. Additionally, there is a gap in training and personnel at the academic level to take a biomarker beyond the discovery phase. The expertise to develop methods utilized in clinical laboratories lies in the hands of industry research and development experts cautious to invest in early method development of a 3 biomarker without evidence of its performance in the target population. Thus, many biomarkers never make it out of the discovery phase. A review of current literature reveals great opportunities exist for collaboration between clinical laboratories, academic researchers and industry leaders to move biomarkers rapidly from bench to bedside. During review of the literature and my own experience translating biomarkers for clinical use, it was discovered that no curriculum exist academia to train future scientists for method development on platforms suitable for clinical laboratory use. Just as communication has improved between basic science researchers and clinicians to facilitate translation of therapeutics into practice, so must the clinical laboratory, diagnostic industry and academia collaborate to form a clear path to translate biomarkers into useful clinical tools. Barriers and solutions to translation of biomarkers are discussed and recommendations provided for forging a clear path for biomarkers using the existing NIH Clinical and Translational Science infrastructure across college campuses in the United States as well as the Early Detection Research Network and the Biomarker Consortium resources. By rapidly delivering efficacious and effective diagnostic tools to clinicians, the implications for public health are many. Sensitive diagnostic laboratory assays may prevent costly treatment and extend quality life years. Screening assays may reduce the incidence of disease and allow effective interventions. Prognostic assays may assist patients and clinicians in making decisions about costly and high-risk interventions.Master of Public Healt