It's a long, expensive, risky road to turn a scientific breakthrough into a treatment that can help patients. Fewer organizations are trying to tackle the challenges alone, says a new paper from MIT researchers published August 28 in the journal Science Translational Medicine.
An essential new way to move discoveries forward has emerged in the form of multi-stakeholder collaborations involving three or more different types of organizations, such as drug companies, government regulators and patient groups, write Magdalini Papadaki, a research associate, and Gigi Hirsch, a physician-entrepreneur and executive director of the MIT Center for Biomedical Innovation.
The authors are calling for a new "science of collaboration" to learn what works and doesn't work; to improve how leaders can design, manage and evaluate collaborations; and to help educate and train future leaders with the necessary organizational and managerial skills.
"Getting new, better, affordable drugs to the right patients faster involves a series of historically independent decisions made by different players or stakeholders," says Hirsch. The system is uncoordinated, takes too long, and costs too much. In some cases, the drug-such as new antibiotics for life-threatening resistant infections-may never become available.
"One of the interesting paradoxes of biomedical innovation is increasingly going to be that even though we have the scientific knowledge required to provide potentially better treatments for patients-or even to prevent disease in those who are at high risk-we may be unable to help patients benefit from them anytime soon," she says.
To help change this scenario, in the last decade, thousands of researchers, pharmaceutical and biotechnology companies, government regulators, payers, clinicians and patients have come together in more than 100 multi-stakeholder collaborations to solve some specific shared problem standing in the way of finding a cure or a better diagnostic approach.
"Multi-stakeholder collaborations provide the opportunity to create an environment that allows for new kinds of interactions among the players," Hirsch says. The largest multi-stakeholder effort, the European Union's Innovative Medicines Initiative (IMI) began in 2008 and has established more than 40 consortia with financial and in-kind investments totaling -2 billion. Some projects focus on specific health issues, such as Alzheimer's disease, chronic pain, diabetes and obesity. Others tackle bigger issues, such as drug and vaccine safety and the use of stem cells for drug discovery. The success has led to a proposal to extend the effort for 10 years and -3.5 billion. Last year, the U.S. President's Council of Advisors on Science and Technology (PCAST) recommended the U.S. form something similar.
"The prevalence of multi-stakeholder initiatives reflects a continued optimism about the value of this collaboration approach for addressing biomedical innovation bottlenecks," the authors write in the paper. "Although the need for collaboration is no longer in question, it is worth noting the importance of this development. A willingness to share proprietary data among industry competitors represents a dramatic shift in the culture of the historically highly competitive pharmaceutical industry."