Over the past 20 years, annual spending on biopharma R & D has almost tripled to more than $50 billion. At the same time, in spite of these huge sums in investment, the average number of drugs beings approved has decreased, and more than 150 drugs have either failed in late-stage clinical trials or have been withdrawn from the market. Today, less than half of drugs that enter Phase 3 – the final clinical trial phase before a drug is marketed – are successful.
Late-stage failures put patients at risk and add to drug development costs. In fact, it’s estimated that if we were able to resolve these issues before Phase 3, we could save around $1 billion per drug failure.
The major challenge is that preclinical studies to test the safety and efficacy of new drugs use laboratory animals and traditional 2D cell culture, where cells are grown individually in a flat layer. Neither of these methods are completely accurate reflections of how a drug will react in a human.
Let’s take the liver as an example. Liver metabolism differs greatly between animals and humans, so animal testing does not accurately reflect how a human might react to a particular drug. As for 2D cell culture, human liver cells stop producing normal liver enzymes and proteins when they are dissociated and grown in a Petri dish. On top of that, 2D cell culture does not have the same range of cells and cell-to-cell interaction that naturally occur in tissue, which again limits its effectiveness.
When we co-founded Organovo in 2007, we were excited about the possibility of 3D bioprinting technology to address these problems. By using cells to create tissues that mimic the human body’s biological process – including cell-to-cell interactions, which is essential to understanding how a cell behaves – the technology has the potential to improve drug development and medical research.
How does bioprinting work? The first step involves identifying the main architectural and compositional elements of the tissue – basically its make-up. This is then used to create a template that the bioprinter can use to generate the same tissue. To do so, the bioprinter uses “bio-ink”, made up of cells from any source, which it deposits in precise layers. The end result? Compared to traditional methods, functional living human tissue can provide better predictive value of what occurs in the human body when a drug is given or during disease progression.
The possibility that we might be able to bioprint human organs, such as kidneys, liver and hearts, is also very exciting. At Organovo, we think that this will one day be a reality. But it will take time to solve the bioengineering problem as well as to get approval for therapeutic use. Bioprinting smaller functional units of organs, such as tissue patches or grafts, that can have a huge impact on patients is something that we are working towards for the near future.
This year has been an important milestone, as the technology behind bioprinting has reached commercial scale. Our next goal is that by 2020, the technology will be in wide use by pharmaceutical companies to significantly improve the safety and efficacy of drugs reaching patients.
Bioprinting is a revolutionary technology. In the short term, it has the potential to make the drug development process safer and more effective. For the long term, the ability to bioprint tissues and organs on demand will create nearly endless possibilities for improving medical research and practice.
Author: Keith Murphy is the CEO of Organovo, a World Economic Forum Technology Pioneer
Image: Cross-section of bioprinted human liver tissue. ORGANOVO