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Emerging Safety Science: Workshop Summary
Quantitative, reproducible, robust, and high-throughput—These characteristics would make it possible to carry out informatics correlations with clinical data.
Highly standardized—Highly standardized assays would be well suited to database generation and archiving. Standardized screens would make it possible to perform multiple comparisons among test groups, as well as to make comparisons over time. This is a particularly important feature, one that is missing in current efforts to model human biology.
Based on human biology—As it is not possible to use human beings, the next best option is to use human primary cells.
Of broad interest to many people—Assays should cover a wide range of biology and a large number of mechanisms of toxicity, including various targets, pathways, and diseases.
Integrative—Integrative assays would attract the interest of scientists from multiple disciplines, including, for example, biologists, chemists, clinicians, and safety scientists.
Predictive—Assays should predict safety, toxicology, efficacy, and clinical indications.
Although no such ideal screens exist today, researchers should keep this vision in mind as they work to develop new screens. The value of a screen will depend in large part on how closely it approaches this ideal.
Elaborating on BioSeek’s own efforts to develop an ideal screen, Butcher described the long-term goal as developing in vitro models that can predict in vivo biology. By developing a database that connects drug biology to clinical responses, BioSeek’s BioMAP system, based on human cells, can be used to provide an early prediction of which drug candidates are most likely to be developed as safe and effective therapeutics.
Although BioMAP uses an artificial cell culture system, it is based on human cells placed in complex environments designed to reflect key aspects of the natural environments the cells would experience in the human body. Using information from the literature, the company’s scientists strive to create environments that mirror real situations in which multiple pathways are active at the same time—pathways similar to those believed to work together in different disease states. One cannot model in vitro biology by
This section is based on the presentation of Dr. Butcher.