3D Printing: The Path to Cheaper, Faster Drug Approval
3D Bioprinted tissue may offer a better way of screening drugs before human trials. Pharmaceutical companies could use the tissue for preclinical testing and drug discovery research, enabling faster and lower cost clinical trials.
The current preclinical phase of drug development is markedly inefficient. A staggering 94% of drugs that pass animal tests fail during human clinical trials, 30% due to toxicity. Most toxic responses occur in the liver.
3D Bioprinted liver tissue could identify unsuccessful drugs sooner in the preclinical trial process, saving time and resources. The out of pocket costs to develop an approved drug are currently estimated to be almost $1.4 billion. Overall, 40% of R&D spending goes to drugs that fail in human trials. Toxicity related failures cost $6 billion per year. Preventing toxic drugs from reaching human trials could increase pharmaceutical margins, and/or lower drug prices for consumers.
Last year, Organovo [ONV] entered into a partnership with Johnson & Johnson [JNJ] commercializing a test for exVive3D™, its 3D bioprinted human liver tissue. Constructed with Autodesk’s [ADSK] 3D printing software and a proprietary printer, the exVive3D™ goes through Organovo labs for testing.
While test-tube drug screening is not new, in-vitro toxicity studies have relied primarily upon 2-D human liver tissue. Relative to 3-D, 2-D tissue cell cultures have a short shelf life and lack robust cell-to-cell interactions, both key to assessing the liver’s response. Initially, 3-D tissue will be an additional screen before drugs enter animal testing. Ultimately, 3-D tissue could supplant animal testing altogether. Perhaps more important, it also could lead to liver-tissue grafts made out of patient cells.
In a test with Roche [RHHBY] in 2014, the exVive3D™ correctly predicted toxicity levels of a known liver toxin. The milestone was meaningful because neither 2-D tissue tests nor rats have been able to predict the toxicity of the compound.
Organovo does face some competition, but boasts an 80% request-for-quotation (RFQ) conversion rate. Competitor Insphero has entered a partnership with Pfizer [PFE] to produce a competing product but, with a more uniform structure, the exVive3D™ mimics real liver tissue more accurately. Moreover, Insphero’s shelf life is only five weeks, compared to six for exVive3D™.
Since mid-2014, the National Institute of Health (NIH) and Emulate, Inc., among other groups, have been working on a competing technology, “organs on chips”. Combining human cells with microchips and sensors, “organs on chips” aim to measure tissue reactions to drugs, but have yet to be commercialized.
The 3D bioprinting market is another advancement in precision medicine, and is improving the health and wellbeing of many individuals. An 18-month old boy in Ann Arbor, Michigan, for example, received a 3-D printed trachea implant built from his own stem cells in under a week. The US Army is working on a process to repair wounds using 3D bioprinted skin.
Like most other 3D printing stocks, Organovo’s seems to have been left for dead. Ironically, its products might not only increase the productivity of pharmaceutical R&D budgets, but also save lives.