FAQ About Tissue Chips
- What are tissue chips, and why are they important?
- How might human tissue chips complement and improve upon existing research models?
- How will the program be evaluated for success?
- Who will use the tissue chips once they are developed?
- How will the Tissue Chip Program reduce the time and money needed to develop drugs for patients?
- What are the roles of NIH, DARPA and FDA in this program?
- How much money is NIH contributing to this effort?
- How does this initiative support the NCATS mission?
- What effect would the tissue chips have on drug development efforts in the pharmaceutical and biotechnology sector?
- Will the tissue chip devices be made available commercially?
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 with combining miniature models of living organ tissues on a transparent microchip. Ranging in size from a quarter to a a house key, the chips are lined by living cells and contain features designed to replicate the complex biological functions of specific organs.
Ultimately, this new technology aims to make drug development and toxicology 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.
More than 30 percent of promising medications have failed in human clinical trials because they are determined to be toxic despite encouraging pre-clinical safety and toxicology studies in animal models. Tissue chips are a newer 3-D human cell-based approach, rather than a 2-D approach, that potentially can identify therapeutic candidates that are toxic in the development process. This may enable scientists to predict more accurately how effective a therapeutic candidate would be in clinical studies.
NIH program staff, in coordination with experts from the Defense Advanced Research Projects Agency (DARPA) and the U.S. Food and Drug Administration, worked in close concert with research investigators to establish milestones and success criteria for this initiative. For example, at the end of the 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.
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 qualified basic and clinical researchers, including those involved in therapy development.
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 they 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:
- Identifying classes of therapeutics that are likely to be effective or fail early in the drug development pipeline. It also will allow some tasks in therapeutic development to occur simultaneously, accelerating the process.
- Determining which therapeutics can enter into clinical trials. Ultimately, if the devices are successful in predicting efficacy and safety, it likely will alter the way clinical trials are conducted. These devices likely are transformative in this way in that it has the potential to change paradigms of how we develop therapies, inform regulatory decision-making process and shorten clinical trials.
The agencies worked together to develop a collaborative program that builds upon each agency’s knowledge and resources.
In July 2012, it issued 17 awards, 10 of which will support studies to develop 3-D cellular microsystems which represent a number of human organ systems. These bio-engineered devices will be functionally relevant and accurately reflect the complexity of the tissue of origin, including genomic diversity, disease complexity and pharmacological response. The additional seven awards will explore the potential of stem and progenitor cells to differentiate into multiple cell types that represent the cellular architecture within organ systems. These could act as a source of cells to populate tissue chips.
DARPA is conducting a separate but parallel program. It has awarded two grants, one to the Wyss Institute at Harvard University and the other to MIT, both of which also are NIH tissue chip grant recipients, to develop engineering platforms capable of integrating 10 or more organ systems.
The FDA will help explore how this new technology might be used to assess drug safety, prior to approval for first-in-human studies.
NIH has committed up to $70 million over five years to its Tissue Chip program. In fiscal year 2012, NCATS contributed about $9 million to these awards. In addition, the NIH Common Fund provided $4 million.
The tissue chip program supports the mission of NCATS by fostering the development of innovative methods and technologies needed to accelerate the pace in which we develop new treatments for patients.
What effect would the tissue chips have on drug development efforts in the pharmaceutical and biotechnology sector?
Improving 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.
The Intellectual Property (IP) 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.
Learn More About Tissue Chips
The Tissue Chip for Drug Screening initiative aims to develop 3-D tissue chips that researchers can use to predict the performance of a candidate drug, vaccine or biologic agent quickly and inexpensively. Learn more about this program.