Over the last few months, there has been a noticeable increase in the number of meetings, seminars, and conferences that include a session on—or are entirely devoted to—personalized medicine. The prospect of tailor-made medication is not a new one, but the prospective cost of such treatments has always been a barrier to growth in the area. Simply put, the return on compounds that only treat small populations cannot justify the investment.
The ever-increasing cost of the healthcare systems in the West may provide the impetus for this to change. In the US, President Barak Obama has put healthcare reform on everyone’s agenda. With life expectancy increasing and the cost of health care rising, he has made it clear that changes are needed. Although the cost of prescription drugs is only a small part of the total health care bill, there has been significant pressure on the pharma/biotech sector to reduce the cost of its products. Earlier this year the industry committed to contributing $80 billion towards reform over the next 10 years. With an economic imperative driving change, the pharmaceutical and biotechnology sectors are taking a closer look at personalized medicine.
In a world where patients take more responsibility for their own health, health care will look very different from the system we see today. The first stage of a shift from managing sickness to managing wellness is already underway. The endgame will be a move from doctors reacting to illness and fixing the problem (for all but the obvious acute and chronic illnesses), to patients spending more money on preventing illness and maintaining their health.
In this new world, a trip to the supermarket for the weekly groceries will incorporate several diagnostic checks run as soon as the store is entered. While the patient shops, the results will be reviewed, necessary prescriptions—whether for prevention or cure—written, and their electronic health record updated. If needed, the shopper/patient can be referred for secondary care. The point is that blood pressure, cholesterol and insulin levels, and other diagnostic markers can be tested and managed before problems arise. As more sophisticated diagnostics become available, increasingly complex testing and treatment regimes can be deployed.
This world is not very hard to imagine; we are already seeing in-store treatment rooms appearing and not just in traditional pharmacies and health care stores. If you think the leap to seeing this in supermarkets is far-fetched, then take a look at the indepdendent health care clinics at Wal-Mart stores www.walmart.com/clinics to see some of the conditions they can deal with. Wal-Mart (Bentonville, Ark.) is also investing significantly in the electronic health records market, working with Dell, Inc. (Austin, Tx.) to provide a cost-effective solution. The pharmaceutical industry is taking notice too; Johnson & Johnson (New Brunswick, NJ) was very close to establishing a wellness and disease-prevention business unit, but has now announced it will be folded into their consumer business. Anticipated revenues are $20 billion a year.
All of this should be good for the patients. A wellness-management approach detects conditions early, and hence the level of reversibility is high; the current, reactive model has lower reversibility. This approach also reduces the burden on the health care system that will, of course, still exist to manage sickness.
With the onset of an environment of prediction, preemption, and personalization the R&D process could fundamentally change. With drugs targeted toward specific populations, the importance of in silico modeling would increase and become more widely accepted. Programs will then run more quickly, and the FDA and other regulators would be able to approve drugs much earlier once a response in the target population has been proven. This would reduce the time needed for clinical development. Given dramatic reductions in the cost of development, this would no doubt be very acceptable to health care providers, allowing for cheaper drugs. The win for pharma/biotech is one of improved cash flow with revenues coming on stream far earlier than they do now. If patent protection rulings are static, then the negative effect on those revenues by generics or biosimilars is reduced because of prolonged exclusivity. It is fairly easy to see how everyone could be satisfied by this model.
For change to occur in a system there needs to be an incentive that provides the momentum to get the stakeholders to the new model. The recent economic challenges coupled with the drive to reform the health care system in the US have provided such an incentive. In terms of personalized medicine, the enabling technologies have been available for some time. Now other crucial factors have come together that could just see a major change in our approach to both how we manage our health and the R&D process.
About the Author
Andrew MacGarvey is the Commercial Director for Quanticate International and President of the US operation. Having spent three years working in both operational and commercial roles for Quanticate, Andrew has recently moved to Cambridge, MA to drive Quanticate’s expansion in the US whilst continuing to run the global sales effort for the company.