The Hamner Institutes for Health Sciences launched a partnership designed to advance a systems biology approach to the study of toxicity testing in pre-competitive research phases.

Hamner said the partnership will develop human cell-based assays that map and model key cell signaling pathways in order to evaluate dose response, using toxicity pathway case studies with the goal of speeding implementation of recommendations from the National Research Council report “Toxicity Testing in the 21st Century: A Vision and a Strategy.”

Once validated with prototype chemicals, the assays should enable toxicity testing and risk assessments based solely on in vitro test results, without progressing to toxicity studies in intact animals. According to Hamner, the in vitro results will speed testing of both compounds already on the market and new compounds coming into use. A synopsis of the first prototype pathways serving as examples of the systems biology approach to toxicity testing appears in a report reviewing The Hamner’s “Toxicity Testing in the 21st Century: Toxicity Pathways and Network Biology” program, available at

Research outcomes will dovetail with other efforts now under way, including the Tox-21 Consortium, a collaborative research effort between NIIH, FDA, and the Environmental Protection Agency. The project also leverages an NIH-funded consortium effort to map estrogenic pathways in human breast cancer cells, led by Thomas Hartung, M.D., Ph.D., director of the Center for Alternatives to Animal Testing at Johns Hopkins University.

Partners sponsoring the research include Agilent Technologies, Illumina, Dow Chemical, Dow Corning, ExxonMobil, Unilever, and CropLife America, while the Long-Range Research Initiative of the American Chemistry Council supported earlier stages.

“These joint contributions will accelerate our work and enable a more thorough biologically relevant assessment of chemical safety,” says Melvin Andersen, Ph.D., project director at The Hamner. “Initiative partners from the chemical industry bring experience in applications of toxicity research results in a regulatory context, an understanding of regulation in both the United States and the European Union, and knowledge of relevant human exposure patterns for their products. Our academic and nonprofit partners provide laboratory facilities, computational models, animal test capabilities, and a trained and talented research workforce.”

Added Darlene J. S. Solomon, Ph.D., senior vp and chief technology officer at Agilent Technologies: “We are pleased to help demonstrate the feasibility of this toxicity pathway-based approach to assess risks to human health. We welcome collaboration with additional federal agencies and industry partners to accelerate the development of new technologies and tools to facilitate next-generation research, and with academic thought leaders to discover new approaches that ensure scientific and technical rigor.”

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