Garret FitzGerald, MD, chair of the Department of Pharmacology and Director of the Institute for Translational Medicine & Therapeutics, Perelman School of Medicine at the University of Pennsylvania, has long said the current drug-development system in the United States is in need of change, “representing an unsustainable model.” He suggests a new model for sustainability, inspired by the not-for-profit sector.
The present approach to drug development is unsustainable - roughly the same number of drugs have been approved by the Food and Drug Administration each year since 1950 while the estimated cost, mostly because of the failure to bring new medicines all the way to market - has exploded. Many groups – most recently the President’s Council of Advisors on Science and Technology (PCAST) have mulled over the problem and issued reports. The last recommendation of the one from PCAST, in which I was involved, suggests setting up a working group to re-examine incentives that might foster more efficient drug development.
Personally, I have been really impressed by what has been achieved in the not-for-profit sector, where outfits like Medicines for Malaria Venturehave used a pot of money to provide incentives for collaboration of excellent groups scattered across the world from biotech, academia, and pharma, in ways that have accelerated the development of novel treatments for diseases of neglected populations in a very cost efficient manner. How can we export this public-private model to the for-profit sector?
Altruism and the perception that no money is to be made in developing drugs for certain diseases have prompted the players in groups like MMV to share their intellectual property (IP) and accelerate drug development for such diseases as tuberculosis, Chagas’ disease, and malaria.
However, both academia and industry often have unrealistic expectations around IP, which serves as a drag on the process in the for-profit world. Short of rewriting IP laws, is there a way to shake up this system?
Intellectual property in drug development is focused on the composition of matter – the chemicals from which new medicines are made - which very rarely becomes an approved drug. In a recent policy forum in Science, I propose a way in which we might model the challenges of bringing such “matter” to market.
I suggest prospectively modeling a therapeutic challenge - to allocate rewards according to where we see the biggest scientific obstacles along the path from chemical matter to an approved drug. This model could then be iteratively revised to reflect reality as one traversed the developmental process – a feature of the intellectual property deal that all collaborators would buy into from the start.
We model all sorts of steps in drug discovery and development. I think it is the time to start modeling how we allocate monetary rewards for developing drugs to encourage the best people to collaborate – irrespective of their sector or geography – and rise to the challenge of reinvigorating this process.