Biomedical engineering company Draper has announced a partnership with Pfizer. The goal of the collaboration is to use Draper’s Microphysiological Systems (MPS) technology to streamline the preclinical phase of testing new medications. The technology is colloquially known as “organ-on-a-chip.”
By using biomedical engineering, Draper aspires to improve the quality of new medications and provide better data in a more cost-effective manner, accelerating the research process for new treatments (e.g., drugs, devices, cell therapy). By combining in vitro and in vivo testing, the technology can eliminate some of the hurdles of preclinical testing and help to predict clinical outcomes. It can also measure function more quickly, accurately and cheaply than in traditional models.
Dean Mastrojohn, Pfizer spokesperson, said, “Scientists from Draper and Pfizer will work together to create unique versions of Draper’s technology. The initial aim is to improve preclinical safety testing and create more effective disease models.”
Joseph Charest, program manager and head of Draper’s Human Organ Systems initiative, said, “The goal is to have all models run on [our] PREDICT-96 platform technology, with adaptations for form, fit and function as needed. In addition, several specific tissue types will be developed on the platform, along with disease state models of those tissues. The models will build on Draper’s past experience in liver, gastrointestinal and vascular tissues.”
David O’Dowd, associate director of Biomedical Solutions at Draper, said, “The technology needs to go in a direction where the models have enough complexity to be predictive of the human state, yet can be scaled for throughput and standardized for repeatability and reproducibility. We haven’t seen any offerings that have covered all these bases on the market.”
Jos Joore, managing director of Mimetas, another organ-on-a-chip company that has partnered with several pharmaceutical companies, including Pfizer and Roche, said, “Obviously we’re competing in a way, but this is a rapidly growing market with lots of space for everybody. I think it’s very good to see these types of collaborations. We can team up with pharma to make custom-made models that serve a very specific purpose. I think it’s important that organ-on-a-chip really connects with pharma to codevelop models. Close collaborations with pharma are crucial to bring the technology forward. Organ-on-a-chip is nothing more than technology unless you combine it with the right biology.”
Another company working with this technology is Emulate, which has partnerships with pharmaceutical companies including Merck and Johnson & Johnson. Geraldine A. Hamilton, Ph.D., president and chief scientific officer of Emulate, said, “There has been an accelerated pace of progress with organ-on-chips technology in the past year or so, as this technology gains support and becomes accepted into the mainstream of drug development. Collaborations with pharmaceutical partners helps to address priority challenges that drug developers have identified in the R&D process for new medicines.”
If successful, the use of this technology could dramatically affect the clinical trial process. Only those drugs proven to be effective and safe in human tissues would be moved along to phase I testing in human beings. Eliminating false negatives from animal models would improve safety and cut costs.
Charest is optimistic. He said, “The goal is to better predict clinical trials. The MPS … will allow [us] to gauge the impact of a drug or disease on a population. Conditions of a specific patient cohort, both environmental and genetic, can be included and simulated on the platform. In this way, the technology can simulate a clinical trial in the lab and predict an outcome before any patients are dosed with the drug and before significant amounts of investment are made into manufacturing animal and human trials.”
However, Mastrojohn said that it is premature to start planning for the future of the trial industry at this point. He said, “Pfizer hopes to use the technology in preclinical research efforts. It is too early to speculate on how it could be used effectively in clinical trials.”
The idea behind the organ-on-a-chip technology is to create a three-dimensional tissue model with which to test compounds, replacing Petri dish cell cultures. Tiny tissue samples, grown in channels or wells, are able to recreate the complex functions of the target organ’s cells. To enhance the applicability to human testing, the tissue models exist in a microfluid environment that represents the conditions in the human body. This recreation of the organ’s natural environment should help researchers narrow down the drugs that are most likely to succeed in clinical trials. As Joore said about phenotypic testing, “You’re at the right end of biology; you’re at the end where the drug shows an effect or doesn’t show an effect.” In Draper’s PREDICT96 system, the wells in which the tissues grow are equipped with sensors that are able to collect data in real time.
There are many potential uses for this technology. Joore of Mimetas noted, “We are looking at organ-on-a-chip as an add-on technology to clinical trials, that is, actually more in the area of phenotypic testing. We are currently implementing, in a number of academic hospitals in the U.S. and Europe, organ-on-a-chip technology as a sideline of the trial … helping to stratify patients into potential responders and low responders in an in vitro situation, which is an immense help for medical doctors to prescribe drugs, but also to drug developers to carve out the right patient population.”
Somewhere between 10% and 19% of candidate drugs complete human clinical trials successfully, and companies must make back the costs of the failed drugs. A single drug can cost over 2 billion dollars to test, and the research and studies involved can take years, with pharmaceutical companies spending 75% of their budget on drugs that never make it to market.
“I think the most common example is cancer trials,” said Joore, “where you have all these targeted new drugs that are very interesting and very cool medical technology, but it’s very difficult to match the right patient with the right drug. This results in many failed trials, and drugs that enter the market and are only effective in sub-5% of patients. I think the key is to find a good bridge between the disease and the specific drug.”
The partnership between Pfizer and Draper is another step along the road to improving the efficiency of the drug development industry. Noted Hamilton, “Collaborations bring together world-leading expertise that contributes to new system functionality and accelerates putting organ-on-chips technology in the hands of researchers, so that any researcher can use organ-on-chips technology to predict human response to diseases, medicines, chemicals and foods with precision, high throughput and reliability.”
This article was reprinted from Volume 21, Issue 01, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »