In 2011, the US Food and drug Administration (FDA) developed a strategic plan for
regulatory science that focuses on developing new tools, standards, and approaches to …

Unlike most medical treatments obtained from large-scale studies and designed as “one-
size-fits-all” approach, precision medicine is a modern concept of personalized treatment …

Personalized medicine, driven by advancements in pharmacology, is revolutionizing
healthcare by tailoring medical treatments to the unique characteristics of individual patients …

Biomarker-guided personalized therapies offer great promise to improve drug development
and improve patient care, but also pose difficult challenges in designing clinical trials for the …

The high costs incurred when drugs fail during clinical trials has prompted interest in
biomarkers as biological indicators for progress of disease, effect of therapeutic …

The refinement of disease taxonomy utilizing molecular phenotypes has led to significant
improvements in the precision of disease diagnosis and customization of treatment options …

There have been several major problems that have plagued biopharmaceutical
development since the end of the 1990s, but two in particular have reached the point where …

Drug development expenditures continue to escalate, in part reflecting inefficiencies in
current drug discovery paradigms. Traditional drug discovery has been dichotomous …

The introduction of targeted therapeutics into clinical practice has created major
opportunities for further development of the molecular diagnostics industry. Emerging …