Biomarkers drug development

Type of Biomarkers Drug Development Disease Management... 

Biomarkers in Clinical Drug Development, edited by John Bloom... 

Greater clarity on the most appropriate applications of pharmacogenetic and pharmacogenomic biomarkers in drug development is needed to advance the field. 

Lesko, L.J. and Atkinson, A.J., Jr., Biomarkers and surrogate endpoints — Use in drug development and regulatory decision making criteria, validation, strategies, Ann. Rev. Pharmacol. Toxicol, 41, 347-366, 2001. 

Key words Reverse phase protein microarrays, RPMA, Drug development, Drug discovery, Biomarkers,... 

Fig. 2. Dynamic steps in the drug development cycle. As explained in the text, multiple strategies can be used for initial drug target discovery, and at various steps in validating the drug target, mechanisms of action, or defining biomarkers of response, new drug targets can emerge.

A final caveat in the RPAIA field that limits biomarker discovery as well as other uses in drug development is the somewhat limited panel of antibodies that have been validated to date for the platform. Many antibodies that work on western blots have the potential to work with RPMAs as well, because in both platforms proteins are in a denatured state. However, because the molecular weight of analytes detected by RPMA cannot be known, it is imperative to demonstrate the specificity of antibodies, usually measured by the absence of nonspecific reactive bands on western blots developed under similar blocking conditions. A second requirement for antibody validation is proof of principle that an antibody detects quantitative changes in the expected target on an... 

Vangala, S. and Tonelli, A. (2007) Biomarkers, metabonomics, and drug development can inborn errors of... 

The patients included in a developmental study of a pharmacogenomic biomarker to be used in drug development should be appropriate to enable identification of patients who are most likely to benefit from the new drug in a pivotal study. For example, suppose... 

Key Words Toxieogenomics microarray gene expression profile genetic signature drug development biomarker drug resistance... 

Finally, in the third section, readers will find four chapters that address the role of pharmacogenomics in drug development in oncology, including an industry perspective on this subject, as well as statistical aspects related to the discovery of pharmacogenomic biomarkers during drug development. 

Marrer, E. and Dieterle, F. (2007) Promises of biomarkers in drug development a reality check. Chem. Biol. Drug Des., 69, 381-394. 

REID E, HILL H M and Wilson ID (1998), Drug development assay approaches, including molecular imprinting and biomarkers — SP 226. London, Royal Society of Chemistry. 

---