Sidebar: Improving the Clinical Relevance of Early-Stage Research & Development
Given that one of the greatest drains on pharma return in investment is the exorbitant cost of clinical failure, it is imperative to ensure that in vitro and preclinical in vivo data is as predictive as possible of the clinical outcome. According to officials at Caliper Life Sciences, the company first recognized the critical nature of the “in vitro to in vivo bridge” in 2005 and subsequently developed it as the basis of its business model.
An abundance of recent technological developments, such as next-generation sequencing, genomic/proteomic biomarker discovery, companion diagnostics, and in vivo imaging with new modalities have strengthened this bridge, thereby facilitating more clinically relevant drug development, according to Caliper scientists.
Caliper has focused on the development of tools that specifically address key points across the in vitro to in vivo bridge, including genomics, proteomics, molecular profiling, and in vivo molecular imaging.
For example, Caliper’s IVIS® imaging system allows one to visualize the biological effect of a compound within a live animal, in real time, in a longitudinal manner, without the need to sacrifice the animal to obtain data.
“Not only does this reduce cost in terms of animal usage and labor (such as histology workload), but it provides real-time in vivo information that is more predictive of the compound’s activity in humans,” notes Mark Roskey, Ph.D., senior vp of biology R&D.
“With Caliper-engineered mouse and rat models for IVIS imaging across all the major disease indications, this platform is of broad utility to the pharmaceutical industry, and has been strategically used by many large companies to generate data for FDA regulatory approval of small molecule drugs, including Sutent® and Cubicin®” (developed by Pfizer and Cubist Pharmaceutials, respectively).
Going forward, Caliper intends to augment the in vitro to in vivo bridge by addressing molecular diagnostics, specifically by using Caliper tools to identify and measure biomarkers and to select key candidates for our new plastic chip assay format for evaluation as companion diagnostics, concomitant with the drug.
“By using a holistic approach and integrating data from multiple independent sources, we envisage creating a drug profile that will be more predictive of the drug candidate’s performance at the clinical stage and beyond,” adds Dr. Roskey.