Patients expect approved drugs that work, are safe and
are "right" for them.
Biomarkers can help drug development focus
more on defined subgroups of patients, thereby
potentially increasing treatment efficacy and safety. Biomarker-enabled R&D is maturing into a new discipline that is
addressing these goals with more precision. However, the science is outpacing widespread
acceptance. The path toward acceptance
by regulators and the medical community is through discovery and consistent validation of genomic, proteomic, in vitro and
imaging
biomarkers. Further collaborative efforts and powerful technology approaches can increase public confidence.In the imaging field, biomarkers are increasingly being used
non-invasively to assess patients'' localized disease progression and
response to drug candidates. Biomarkers can help determine whether the
drug reaches the target, whether it affects biological activity and, if
it does, whether that effect leads to the desired clinical outcome.