"Heart-Lung Micromachine" for drug safety testing receives funding

$3.3 million grant from NIH-FDA could bring safe and effective new drugs to market sooner

Harvard bioengineers 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 research will be led by Donald E. Ingber, Founding Director of the Wyss Institute; Professor of Bioengineering at the Harvard School of Engineering and Applied Sciences (SEAS); Judah Folkman Professor of Vascular Biology, Harvard Medical School and Children's Hospital Boston; and Kit Parker, Associate Professor of Biomedical Engineering at SEAS and a core member of the Wyss Institute.

The project is one of four 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 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.

"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.