Organs on a Stick: the growing potential of human organ systems
In contrast to costly and inefficient traditional animal and human pharma testing methods, the use of human organ systems is proving to be more accurate, reliable and cheaper way to get drugs to the market. Dr Ken Gabriel, president and CEO of R&D company Draper, explores the growing potential of the technology.
espite major advancements in drug development over the past several decades, the procedures to test and qualify drugs used by the pharmaceutical corporates and regulatory agencies are staggeringly inefficient. The number of new drugs approved to enter the market continues to decline. Meanwhile, the cost of developing those drugs is increasing, driving up their price for healthcare providers and patients.
It currently takes an average of 12 years for a drug to travel from preclinical research to the patient, at an average cost of $359m. It’s a widely recognised problem throughout the industry and is occasionally characterised by ‘Eroom’s Law’. This is a tongue-in-cheek reference to the famous ‘Moore’s Law’, an observation that the number of transistors on a chip doubles every 18 months, while the costs are halved.
Eroom’s Law observes that the number of new drugs approved per $1bn spent on research and development has halved roughly every nine years since 1950. Whilst we have made remarkable steps in improving drug capabilities, the efficiency of the market’s research and development model continues to worsen— the exact opposite of Moore’s Law.
Effective, efficient and cost-effective testing alternatives
The reasons for Eroom’s Law, and this continued decline in efficiency, are myriad. Pharma is one of the most regulated markets in the world, the industry is increasingly less risk tolerant and the quest for truly breakthrough drugs requires huge financial and talent resources.
But more so than any of these issues, I believe the fundamental problem is the research and development model, or more specifically, the current testing and qualification process. For all its technological advances, the drug market remains largely reliant on animal testing followed by human trials.
Put simply, animals aren’t a good indicator for human physiology. The anatomic, metabolic, and cellular differences are too great, and this limits predictability; resulting in many ineffective drugs advancing to later stages of human testing, only to fail. In fact, 88% of products that fail human trials pass the animal testing phase. This is a massive waste of time and resources and is a major contributor to Eroom’s Law.
We need to use more effective, efficient and less expensive testing alternatives. We need a fundamental change in testing and qualification of drugs.
Replicating live organs using technology
Using pioneering new human organ systems on a chip, we have that fundamental change. These systems on a chip are functional microchips that house living cells and are able to accurately replicate live human organs. We have successfully modelled liver, kidney, the vascular system and most recently cancerous tumours.
This approach is a genuine breakthrough for the drug industry, and a viable alternative to dated and ineffective testing methods. For several reasons, I believe we will see a greater number of research teams using this technology from 2019 onwards.
These microchips can be instrumented with sensors, are more accurate and can bypass the need for animal tests. The microchips can scale to greater sample numbers and diversity not feasible with animal testing or human trials. They can also be embedded with a specific disease, for example cancer or asthma, giving researchers a mini-laboratory setting in which they can test immune cells, drugs and reactions.
Finally, this technology is much more cost-effective. At present, more than $16bn is spent on preclinical trials annually, with $6bn worth failing due to efficacy or safety issues.
Addressing the ethical debate of human and animal trials
Not to be minimised is also the ethical dilemma of both animal and human trials.
Despite increased regulation, animal testing remains inhumane and exposes animals to food and sleep deprivation, poisoning, physical restraint and pain. Once through to the human stage of testing, some prospective drugs remain unsafe, with Thalidomide and Vioxx being two of the worst examples. The use of human organ systems on a chip negates any risk of pain or death in living test subjects.
By identifying ineffective drugs early in the discovery process, this microchip technology can enable pharmaceutical companies to focus their research funding on effective drugs earlier, growing their bottom line and getting treatments to those patients in need much faster.
Far from being a distant vision, this technology is working and in practice now, opening the door to reversing Eroom’s Law for the good of both patients and the market.
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