MONITORING THE CELLULAR COMPONENTS OF THE IMMUNE SYSTEM DURING CLINICAL TRIALS: A TRANSLATIONAL MEDICINE APPROACH - Flow Cytometry in Drug Discovery and Development - page 184

MONITORING THE CELLULAR
COMPONENTS OF THE IMMUNE
SYSTEM DURING CLINICAL TRIALS:
A TRANSLATIONAL MEDICINE
APPROACH
V IRGINIA L ITWIN AND J AMES A NDAHAZY
9.1 TRANSLATIONAL MEDICINE IN DRUG DEVELOPMENT
Historically, research scientists, clinical scientists, and pharmaceutical scientists
operated in isolation, rarely exchanging information. However, the emergence of
the translational medicine approach has facilitated a bidirectional flow of information
from “bench to bedside.” The importance of this paradigm shift is highlighted in the
NIH Roadmap for Clinical and Translational Science that describes a pathway to
shepherd biomedical discoveries into clinical application and advance both basic and
clinical research (Figure 9.1) [1, 2]. Moreover, translational research is emerging as a
field in its own right [3].
The translational medicine approach is now routinely applied in the drug devel-
opment process in order to improve the success rate of lead compounds as safe and
efficacious treatments [4]. The major stages of the drug development process are
target identification, target validation, pharmaceutical formulation, toxicity evalua-
tion, and clinical development (Figure 9.2). During the early stages of drug devel-
opment (target identification and validation), pharmaceutical scientists utilize
information generated by research scientists defining the molecular pathways and
mechanistic origins of diseases. In the later stages of drug development (toxicity
evaluation and clinical development), pharmaceutical scientists utilize information