Wednesday, January 25, 2012

Who decided that “top 10” lists should have 10 things on them?

By Kristin Schneeman, Program Director, FasterCures

For five years now FasterCures has been producing its “Top 10” list of medical research trends to watch in the coming year. And every year we have to go through the painful process of deciding what to leave on the cutting room floor.

We relish the opportunity to tell people about some of the interesting trends, ideas, initiatives, events, and people that we think are worthy of attention in the 12 months ahead. But there is more that we’re thinking about, of course. The Top 10 list tends to be focused on things that we think are likely to be the subject of action or debate over the coming year, but there remain big, critical issues that span across years for all of us to focus on and work on together.

We’re concerned about the financial sustainability of the whole research enterprise. We’re hearing that venture capital is fleeing from life sciences, and those who are sticking around are investing in less risky opportunities. We’ll be fortunate if government funding remains flat – we’re not predicting any big increases in the current fiscal environment. So if more money isn’t likely to be pouring into the system anytime soon, what new sources of funding are out there, and what new financial models might be applied? Could constrained resources be an impetus for greater focus and efficiency in the research process?

The “business model” of university innovation is changing, and we’re working to understand the landscape of new approaches to commercializing university inventions: Who are the new partners? What are the new sources of capital? Do we have the human capital needed? What are the new intellectual property policies? When is the right time to license?

We’re interested in what appears to be an increasing openness on the part of big pharma to the need for new business models of their own, not just doing things better the same old way. They’re groping their way toward it – embracing more truly “open innovation,” more pre-competitive collaboration, new ways of interacting with academia, working more closely with patient groups – but the pressure is on to “evolve or die.”

Supporting and improving the FDA will continue to be a major focus for us. We’d like to see FDA be able to better leverage NIH’s research capacity to improve its ability to evaluate the new science coming down the pipeline. We’d like to see the Reagan-Udall Foundation established on firm footing so it can become the kind of resource that the Foundation for the NIH has become for the NIH. We’d like to see more patient-driven research foundations engaging in a conversation with FDA about patients’ needs and priorities. And we’ll be doing our best to ensure a productive public dialogue about the role and record of FDA; a “blame game” doesn’t serve any of us well.

As if our mission weren’t ambitious enough, we’re also considering how the states on either end of the medical R&D continuum – prevention/wellness and the delivery of care – fit in with our work to improve the system that discovers and develops treatments for disease. And we are considering what the impact of an increasingly global research enterprise, as well as global sources of capital, could have on the U.S. biomedical research system.

With so much work to be done, there is no time to waste!

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