chapter  12
24 Pages

Partnerships in Biomarker Research

Discovery of biomarkers* and the evaluation of their reliability for assessing

candidate therapies is a multifaceted process that integrates many disciplines,

technologies, strategies, and resources. Successful use of biomarkers in the

development of therapies for HIV/AIDS, cancer, cardiovascular disease, and

degenerative bone disease has heightened interest for their use in research. The

potential use of biomarkers as surrogate endpoints† in clinical trials has also been

recognized. Recently, efforts have been made to coordinate and streamline

biomarker research through collaborations and partnerships among a variety of

biomedical research and development (R&D) organizations, including

academic biomedical research institutions, commercial R&D organizations

(pharmaceutical and biotechnology companies), federal government biomedical

research and regulatory agencies, and voluntary, not-for-profit health advocacy

foundations. The rationale for encouraging partnerships in biomarker research

includes the complex and rapidly changing clinical research environment,

the high level of complexity of the diseases investigated, a substantial increase in

the number of candidate therapies to be evaluated, finite fiscal resources to

support rising costs of therapeutic R&D, and the lack of high-precision clinical

technologies to assess novel therapies in clinical trials.