Proposed new technology could bring safe and effective new drugs to market sooner
BOSTON, Mass. — Researchers from the Wyss Institute for Biologically Inspired Engineering at Harvard University today announced that they have been awarded more than $3 million in funding from the National Institutes of Health and the U.S. Food and Drug Administration to develop a "Heart-Lung Micromachine" that will accelerate drug safety and efficacy testing.
The Wyss Institute project is one of four award winners selected as part of an unprecedented effort by the NIH and FDA to work together on the critical public health issue of advancing regulatory science. Regulatory science involves the development and use of the scientific knowledge, tools, standards, and approaches necessary to assess medical product safety, efficacy, quality, potency, and performance.
"These projects show the potential breadth of opportunity that comes from advancing regulatory science. The results are likely to have broad application to researchers across scientific disciplines and will result in better-informed regulatory decision-making and faster drug development and approval processes," said Commissioner of Food and Drugs Margaret A. Hamburg, M.D.
The Heart-Lung Micromachine will be based on novel Wyss Institute technology that combines microfabrication techniques from the computer industry with modern tissue engineering techniques, human cells, and a vacuum pump to replicate the complex physiological functions and mechanical microenvironment of a breathing lung and beating heart.
These capabilities will enable the microdevice to provide accurate and immediate measures of the efficacy and safety of inhaled drugs, nanotherapeutics, and other medical products on integrated lung and heart function–all at a fraction of the time and cost involved in traditional animal testing methods. Such methods can take years to complete and often cost as much as $2 million for a single drug compound.
The research will be led by Wyss Institute Founding Director, Donald E. Ingber, M.D., Ph.D., and Wyss core faculty member Kevin Kit Parker, Ph.D.
"We’re very grateful for the confidence that the NIH and FDA have shown in us by funding this important work," said Ingber. "Their support affirms our belief that this engineered organ combination has tremendous potential to make a difference in people’s lives by enabling faster access to safe and effective new medical treatments."
The micromachine will build on recent groundbreaking work by Ingber and Parker in developing the technology for building tiny, complex, three-dimensional models of human organs. These "organs on chips" mimic the complicated mechanical, cellular, and biochemical functions of specific organs, such as the lung. The proposed heart-lung device will mark a new milestone by combining two different organ systems within a single microsystem for the first time.
The Wyss Institute is working on other organ models as well, such as a kidney-on-a-chip that produces urine and an intestine-on-a-chip that exhibits peristalsis. An artificial spleen-on-a-chip is also being developed, as well as a sepsis therapeutic device, a blood infection diagnostic, and even bone marrow and cancer models.