By Ana Lucia Jardim Evans
In a not too distant future, we will know what is wrong with our body just by spitting on your Blackberry – this was the vision shared at the World Healthcare Conference in Dubai in 2010 by Steve Burrill, CEO of the San Francisco based Burrill & Co.
Today, doctors mostly react to patients’ symptoms. Tomorrow, they will preemptively treat the right disease. Personalized Healthcare is a vision shared by many. David Ewing Duncan, journalist and bestselling author, recently released a Personalized Healthcare Manifesto funded by the Kauffman Foundation, which gathered views from science, business, government, patients, law, and the media.
The Manifesto’s plan for a new direction for health care emphasizes “prediction, prevention, individualized care and healthy wellness to ensure that the best medicines make it to the marketplace and optimize patient care”. Duncan warns that the path is not without obstacles. Among those are a lack of tools to interpret overwhelming amounts of data, a code system skewed to meet payers’ needs, and the need for fundamental shifts in patients’ behavior.
It would then appear that what stands between us and this innovation bounty is simply our ability to make good use of it.
What once may have worked, doesn’t anymore
However, a more disturbing viewpoint is that the current R&D model won’t meet our great expectations.
In a thorough analysis of the past 60 years of drug development published by Nature Reviews, Bernard Munos shows that the NME output in the US has remained astonishingly flat, unreactive to the various attempts to boost it, such as mergers and acquisitions, cost cutting and sophisticated portfolio management.
He goes further to show that just a few companies are actually contributing. Only 6% of the 4300 industry players today have ever registered an NME since 1950. And a mere 12% have even been around that long. Among these companies, Merck, Lilly and Roche are the most productive, but their output is still below the average 2-3 NMEs/year that would meet the current aggressive growth goals.
FDA Regulation: Contributing to innovation or a conflict of interest?
The only peak in NME output found in this analysis was in 1996, when the Prescription Drug User Fee Act (PDUFA) came into force and the FDA cleared a backlog of filings.
Interestingly, the PDUFA is up for renewal in 2012. A survey by PwC released late last year shows that only 24% of companies believe that the FDA is using these fees as intended towards reviewing submissions. On the other hand, 70% of individuals believe that it is a conflict of interest for industry to pay the FDA to review filings.
Nevertheless, the survey indicates that the majority of individuals think that the FDA is the best in the world at reviewing and approving drugs. Munos also believes that a demanding regulatory agency may contribute to innovation: it forces companies to be more selective about the drugs they launch, increasing the probability of success in other markets.
An Open New World
What does the R&D business model need to look like to deliver the future?
If you watch the TV series Mad Men, you should know by now that the secret to a great idea is to think long and hard about it, and then go do something else.
The Life Sciences industry has been “thinking long and hard” for the past 60 years. If it continues on this path, net income is estimated to decrease by 20-30% in 2012-2015, remaining 15% lower in the longer-term. A rather dismal vision for Personalised Healthcare.
The way out, according to Munos, is open-book collaboration. Large Pharma needs to carve areas that are truly free from corporate pressures, and give them the mandate to pursue disruptive innovation. They should tap into collaborative networks of knowledge shared by smaller companies, academia and other industries, and start “doing something else” by looking at disease areas heretofore ignored.
To explore this topic further:
- Steve Burrill at the World Healthcare Conference Middle East in 2010 , available on YouTube
- Lessons from 60 years of pharmaceutical innovation, by Bernard Munos- Nature Reviews, Volume 8, December 2009
- Personalized Health Manifesto by David Ewing Duncan, available online
- As Battle Readies, Industry, Public Question User Fees- The Burrill Report podcast on December 6, 2010, available online
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