Rodney King died on Sunday, but his famous question lives on: “Can we all get along?” At BIO 2012, the proposition seems to be: “Can we all just collaborate?”
At a meeting hosted by The European Institute on Tuesday morning, Dr. Elias Zerhouni, Sanofi’s president of global research and development, said that biological complexity is a mandate for collaboration. In the 1970s, he said, the approach to disease and treatment was based on identifying a magic bullet. Science and biological systems were viewed as mechanistic; one intervention equals one result, which will work for everyone.
This approach “is no longer tenable…there is not a single institution, country, government or organization” able to solve the problem of biological complexity. And if you accept that, “you have to use open innovation,” said Zerhouni. “Innovation is a team sport, not something that can be done in isolation,” and this has been demonstrated, for example, by the “fundamental gap” or failure rate associated with predicting a drug’s efficacy or safety in humans based on its efficacy or safety in mouse models.
Zerhouni said that fundamental discovery is an individual endeavor, but after that, it takes a team. “What is broken right now is not process alone, it’s also fundamental gaps in our understanding of human disease.” Zerhouni’s proposal? “If I had one innovation to promote, it’s the ‘phase zero’ trial concept. In other words, bring together patient groups, scientists, academics, industrialists and so on, to do in the pre-competitive space what I call verifiable insight selection. When someone has an insight, how do they verify it, as early as possible, with creative methodologies, which are here, but which aren’t being used in humans,” said Zerhouni. “We have a huge lack of connectivity. What ails us in translation is the lack of participation of patients who are affected by chronic diseases in clinical trials.”
FDA’s Dr. Vicki Seyfert-Margolis, senior advisor for science and innovation, office of the chief scientist, said one of the things she hears in discussions with scientific reviewers at FDA is that, for many conditions, “the science isn’t there yet, the diseases aren’t well understood.” One of the reasons for this conundrum is that “we aren’t capitalizing on the knowledge we already have…FDA has a pre-market data asset. What can we do with it? What can reviewers offer to industry in terms of identifying gaps?” Seyfert-Margolis stressed the fact that she promotes collaboration between the pharmaceutical industry and FDA, and called for a clearly defined, national strategy for technology investment to address the many disconnects between patients, physicians, government, payers and other actors within the healthcare ecosystem.
Internally at FDA, Seyfert-Margolis has helped to develop and implement software – called “scientific enclaves” – for data sharing with other government agencies. A pilot program launched in September 2011 is being expanded this year to “communicate collaboratively within and outside the FDA,” including communication with the President’s Council of Advisors on Science and Technology (PCAST) and the CDC.
On intellectual property collaboration, Robert Wells, head, biotechnology unit, directorate science and technology at the Organization for Economic Cooperation and Development (OECD), said the traditional “own and protect” approach to IP needs to be changed to an “own and share” model, especially in the pre-clinical stages. He cited synthetic biology as an example of a field that has “come of age with online social networks” and collaboration online, and the David H. Koch Institute for Integrative Cancer Research as an example of collaboration, where biologists and engineers sit on the bench together.
On the merits of preventative collaboration, Sanofi CEO Chris Viehbacher cited the Asheville Project in the US, “where if you can actually intervene on things like type 2 diabetes and get people to goal, you can drop the cost of a person with type 2 diabetes by 40%, and maintain that over five years.”
Collaboration may indeed be the solution to many of the problems industry faces, but as Zerhouni pointed out, rational decisions about investment, risk or health interventions at the individual level are often irrational in aggregate; consider the political debate around the budget in Washington DC, as an example. For collaboration to work, organizations and governments have to go all in from the beginning, together.