What will be the impact of these 3D systems on drug development, and will it help companies pick up the pace?
In a perfect world, making a safe and effective drug should be as easy as, well, baking a batch of chocolate chip cookies. In truth, of the millions of molecules tested and thousands produced, most fail to progress in preclinical or clinical settings.
It’s also costly. Drug development is a complicated, high-risk process that takes over 10–15 years with an average cost of over $1–2 billion for each new drug to be approved for clinical use. Nine out of 10 drug candidates that manage to reach human trails fail to be approved.
One key barrier is the translatability of the animal models used to determine if a compound is effective and safe enough to move into the clinic. Many times they fail to predict the human response because, let’s face it, their bodies and biological processes are not identical to humans. While animal studies are still highly valued and required by regulators before a drug can move into the clinic, alternative methods are being explored.
One compelling avenue that is coming into its own is the use of three-dimensional (3D) in vitro models such as organ-on-a-chip-platforms. Organ-on-a-chip technology allows researchers to replicate the function of tissues and organs, bridging the gap between animals and human systems. In drug development, it’s seen as an exciting in vitro alternative to assess not only the safety but efficacy of drugs.
Organ-on-a-chip technology, also referred to as tissue chips, contain engineered or natural miniature tissues derived from various organs that are grown inside miniaturized fluid channels molded into glass, silicon, or polymer. The hair-fine microchannels guide and manipulate minute volumes of solution to create the environments that recapitulate one or more tissue-specific functions. Though simpler than human organs or tissues, they are effective mimics of human physiology and disease.
“The basic premise of an organ-on-a-chip is to recreate the cellular micro-environment,” says Lorna Ewart, Chief Scientific Officer of Emulate, a Boston, MA life sciences company that has developed a range of validated organ-on-a-chip models. “If we do that correctly, the cells that we use find what we call a ‘home away from home’. In other words, their functionality is similar to what they would be doing if they were still inside the body.”
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