When extraordinary advances are made in science, why does it take so long to translate them into treatments for the country's most pressing medical needs?
It's tempting to blame the pharmaceutical industry for being unproductive, regulators for being slow and academia for being resistant to change. In some cases, that criticism has been well deserved. But as the FDA opens up new regulatory pathways and drug pipelines are getting stronger, in part because of great advances in science in certain areas and better collaboration between industry and academia, it's time to come up with some new solutions for advancing medical innovation.
We tackled this issue at the Aspen Ideas Festival. The Aspen Institute's Elliot Gerson moderated a group that included two physicians, Kenneth Davis, president and CEO of The Mount Sinai Medical Center and Tony Coles, chairman and CEO of the biopharm company Onyx; FDA Commissioner Margaret Hamburg and me to discuss how we can reduce the time it takes to discover new drugs and get them to patients .
Our panel agreed that science has never been more exciting but we're not seeing new discoveries and insights translate into real world products at the rate we'd like, particularly in certain therapeutic areas. Key to future improvements is a strong, aligned biomedical ecosystem. But how do we get there? I would propose three, practical proposals:
1. Incentivize pre-competitive research
Let's create a national priority around an area of medical need that is difficult for any one entity to tackle alone, such as Alzheimer's, and agree to share all of our early data and work together to find new treatments. The FDA, which already has visibility of what every company is doing, including making the same mistakes, could develop policy to move that information out of its current silos and provide incentives for those who are willing to share their studies. Complicated diseases such as Alzheimer's are going to require treatments that can be given before the disease advances and that could mean years of long-term studies. By pooling pre-competitive research we could do for Alzheimer's' what the Framingham study did for cardiovascular disease.
2. Incentivize antibiotics discovery and development
This is an area of science that has been deserted by most of the players in the pharma industry. New antibiotics, almost by definition, are going to have their use restricted in order to avoid resistance, and that means that even though there is a strong societal need for these drugs, the traditional funding model for them is dead. We need to encourage and develop more public-private partnerships to re-stimulate interest in antibiotics research and create realistic ways of paying for it.
3. Incentivize innovation by extending market exclusivity
Despite advances in some areas of science that allow us to develop medicines more quickly, it can still take 10, 15 or even 20 years, which means by the time new medicines are approved, only a very short period of exclusivity remains; sometimes it's as little as five years. We need to extend the market exclusivity for medicines to reward the time, energy and resources that have gone into those innovations and provide companies with the motivation to do more.
As panelist Ken Davis put it, in order to have a robust biomedical ecosystem we have to align public policy with the public good. If we are going to continue to be at the forefront of research and innovation, we must prioritize the science we want to do that is in the public's best interest and provide reasonable incentives to speed innovation and make these important treatments available for patients.
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