Across many segments of the biomedical research enterprise and the health care delivery sectors, the impact of biomarkers has been transforming in many ways: from business and economics to policy and planning of disease management. The pace of basic discovery research progress has been profound worldwide, with the intertwining of innovative technologies and knowledge providing extensive and comprehensive lists of biological factors now known to play integral roles in disease pathways. These discoveries have had a vast impact on pharmaceutical and biotechnology industries, with tremendous growth in investment in biomarker research reaching into the laboratory technology and services sector. These investments have spawned new biomedical industry sectors, boosted the roles of contract research organizations, supported vast new biomarker discovery programs in large corporate organizations, and prompted the emergence of information management in research. Similarly, growth in the academic research programs supporting biomarker research has greatly expanded training capacity, bench and clinical research capacity, and infrastructure, while fueling the growth of intellectual property.

Biomarkers in Drug Development: A Handbook of Practice, Application, and Strategy, Edited by Michael R. Bleavins, Claudio Carini, Malle Jurima-Romet, and Ramin Rahbari Copyright © 2010 John Wiley & Sons, Inc.

By many reports, private-sector applications of biomarkers in toxicity and early efficacy trials have been fruitful in developing decision-making priorities that are introducing greater efficiency in early to midstage medical product development. Despite the heavy emphasis in private and publicly funded research, the reach of the impact of biomarkers into clinical practice interventions at present is challenging to quantify. The costs of development remain high for many drugs, and the numbers of new chemical entities reaching the marketplace have continued to remain relatively low compared to prior years and expectations following robust research expansion of the 1980s and 1990s. Industry concerns about the sustainability of research and development programs have grown in the backdrop of the clinical challenges that are attendant on biomarker applications in clinical trials. Understanding of the clinical implications of disease markers as a consequence of relatively slow evidence development has taken much longer to discern than many had predicted. There have been many challenges in establishing a translational research infrastructure that serves to verify and validate the clinical value of biomarkers as disease endpoints and their value as independent measures of health conditions. The lack of the equivalent of the clinical trial infrastructure for bio-marker validation and diagnostics has slowed progress compared to therapeutic and device development. Evidence development processes and evaluations have only now begun to emerge for biomarkers, and wide adoption of them in clinical practice measures has not yet matured. For some, the enthusiasm and economic balance sheets have not been squared, as the clinical measure indices that had been hoped for have been viewed as moderately successful by some and by others as bottlenecks in the pipelines of therapeutic and diagnostic development.

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