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<h3>What are tissue chips, and why are they important?</h3><p>Tissue chips are engineered microsystems that represent units of human organs — such as the lung, liver and heart — modeling both structure and function. The chips merge techniques from the computer industry with modern tissue engineering to combine miniature models of living organ tissues on a transparent microchip. Ranging in size from that of a quarter to a house key, the chips are lined by living cells and contain features designed to replicate the complex biological functions of specific organs. </p><p>Ultimately, this new technology aims to make drug development, especially toxicology and efficacy screening, more reliable, because the tissue chips may provide researchers with insights into predicting more accurately how effective potential drugs would be in humans. This could save money and resources because it would shorten the time it takes for a promising drug candidate to reach clinical trials. </p><h3>How might human tissue chips complement and improve upon existing research models?</h3><p>Approximately 30% of promising medications have failed in human clinical trials because they are determined to be toxic despite encouraging preclinical safety and toxicology studies in animal models. Tissue chips are a newer 3-D human cell-based approach, in contrast to a 2-D approach, that potentially can identify toxic therapeutic candidates in the development process. This may enable scientists to predict more accurately how effective a therapeutic candidate would be in clinical studies. </p><p>In addition, about 60% of new drugs fail to show effectiveness in treating human diseases due to poor prediction by current in vitro and in vivo models of adverse reactions to candidate compounds during clinical trials. Developing models for human diseases using tissue-on-chip technology may provide better tools for assessing the effectiveness of promising drugs. </p><h3>How will the program and initiatives be evaluated for success?</h3><p>NIH program staff, in coordination with experts from other government agencies and partners, including the IQ Consortium, the Center for the Advancement of Science in Space, pharmaceutical companies and other nonprofits, continue to work in close concert with research investigators to establish milestones and success criteria for these initiatives. For example, at the end of the first five-year program, the aim is to have a set of accurate and reliable cellular and organ microsystems representative of human physiology for the evaluation of drug efficacy and toxicity. These microsystems should be readily available and easily implemented by the broad research community and regulatory agencies.</p><p>Success measures for future initiatives will depend upon the respective initiative but will include aims such as using chips for disease modeling and efficacy testing and modeling human disease states in microgravity. Milestones and success criteria for these projects will be established with NIH program staff, with insight from the U.S. Food and Drug Administration (FDA) and industry partners. Ultimately, success will be adaptation and use of tissue chip technology across many areas of scientific research. </p><h3>Who will use the tissue chips once they are developed?</h3><p>The data and tools used to create the tissue chips will be published in scientific journals to make these resources available to the broader biomedical research community, in an effort to benefit the public. The initial primary users will be bench scientists from academia, the pharmaceutical industry and regulatory agencies.</p><h3>How will the Tissue Chip for Drug Screening program reduce the time and money needed to develop drugs for patients?</h3><p>A high proportion of drug candidates fail in the development process due to toxicity or lack of efficacy. Often, these toxic effects are not discovered until the drugs are tested in humans. By establishing new predictive models of drug toxicity, we anticipate that tissue chips could reduce the time and money needed to develop drugs by:</p><ul><li>Identifying classes of therapeutics that are likely to be effective or fail early in the drug development pipeline. Chips also will allow some tasks in therapeutic development to occur simultaneously, accelerating the process.</li><li>Determining which therapeutics can enter into clinical trials. Ultimately, if the devices are successful in predicting efficacy and safety, they could alter the way clinical trials are conducted. These devices likely are transformative, in that they have the potential to change paradigms of how we develop therapies, inform regulatory decision-making processes and shorten clinical trials.</li></ul><h3>What are the roles of the collaborators in this program?</h3><p>The government agencies and partners worked together to develop a collaborative program that builds upon each agency’s knowledge and resources.</p><p>The Defense Advanced Research Projects Agency (DARPA) is conducting a separate but parallel program. DARPA is funding two grants, one to the Wyss Institute at Harvard University and the other to the Massachusetts Institute of Technology, both of which also are NIH tissue chip grant recipients, to develop engineering platforms capable of integrating 10 or more organ systems.</p><p>The FDA is exploring how this new technology might be used to assess drug safety prior to approval for first-in-human studies.</p><p>The <a href="https://iqconsortium.org/">IQ Consortium</a> also has partnered with NCATS to contribute industry expertise to the Tissue Chip Consortium and help with the efforts to validate the technology, leading to future efforts for making the technology more widely available to the community.</p><h3>How much money is NIH contributing to this effort?</h3><p>NIH has committed up to $75 million over five years to date to its Tissue Chip for Drug Screening program. In fiscal year 2017, NIH awarded more than $20 million.</p><h3>How does this initiative support the NCATS mission?</h3><p>The Tissue Chip for Drug Screening program supports the mission of NCATS by fostering the development of innovative methods and technologies needed to accelerate the pace at which we develop new treatments for patients, demonstrate the usefulness of these technologies and disseminate that information to the broader research community.</p><h3>What effect would the tissue chips have on drug development efforts in the pharmaceutical and biotechnology sector?</h3><p>Improved drug safety testing is needed across the entire spectrum of drug development to accelerate the availability of new treatments for patients. Tissue chips would benefit basic and clinical researchers throughout the entire pharmaceutical and biotechnology sector.</p><h3>Will the tissue chip devices be made available commercially?</h3><p>The intellectual property developed under these grants will be covered under the Bayh-Dole Act. The NIH-funded grantee will determine how to further develop and commercialize any tissue chips resulting from the research conducted. Companies that have been formed to commercialize tissue chip technology include Emulate, CNBio and Nortis.</p>
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