Thursday, August 21, 2008

FasterCures' Ten to Watch Mid-Year Review

by Greg Simon, President, FasterCures

FasterCures started the year with its Ten to Watch in 2008. Before summer's end, we wanted to share some of our insights on the ten things we've been watching (other than the Olympics) and how they are faring.

1. Return on philanthropy. This fall, FasterCures will preview its Philanthropy Advisory Service, which will help philanthropists decide where their contributions will have the greatest Return on Philanthropy – the greatest impact in finding new cures. The Gates and Robert Wood Johnson Foundations are supporting this effort to create an information marketplace to improve the efficiency and productivity of both the philanthropic investor and the nonprofit disease research organizations that depend on such support. Watch this space for updates.

2. The FDA. It hasn’t been a great year for FDA. In the first half of 2008 alone, the agency had to deal with contaminated heparin from China, salmonella-tainted jalapenos from Mexico, and a Supreme Court decision that has made it a shield protecting medical device manufacturers from lawsuits by patients. The silver lining is that all this bad news is focusing attention on the agency’s critical importance and woeful lack of resources. FDA chief Andy von Eschenbach even broke ranks with the Administration and confessed that the agency needs a larger budget than requested to do its job. But it needs more than that, starting with Congressional leadership that supports it constructively rather than attacking and denigrating it. A key step would be to fund the Reagan-Udall Foundation, and realize FDA’s Critical Path initiative.

3. Research: Lost in translation. The call for more translational research is now coming from a wider range of stakeholders, including interesting messengers such as Katie Couric. In a recent interview about the September 5, 2008 Stand Up To Cancer fundraising effort on “Larry King Live,” Couric said that its focus will be supporting research that has practical applications and patient-relevant outcomes. She noted that the funding will be"...focusing on cutting edge cancer research, which will hopefully inform people about how close we are to new therapies and new approaches and how…scientists need additional funding so these can go from the lab to the clinic and hopefully, eventually, save a lot of lives.”

4. Science 2.0. On June 3rd, members of FasterCures’ TRAIN network of disease research foundations spent some time with two innovators in the use of online platforms for scientific collaboration. June Kinoshita, Executive Editor of Alzheimer Research Forum, a pioneering e-community for Alzheimer’s researchers, is currently working on an ambitious project called Semantic Web Applications in Neuromedicine (SWAN), which will create a common semantic framework to allow researchers to more quickly and seamlessly integrate and combine data from diverse sources rather than just exchange documents. Jeff Shrager, Chief Technology Officer of CollabRx, demonstrated its product – a “virtual biotech,” a Web-based collaborative research platform that would enable funding organizations and research teams to manage, track, and prioritize their operations as well as to share data, knowledge, resources, and services. CollabRx is also working with Science Commons on its Health Commons initiative, which envisions a virtual marketplace or ecosystem where participants share data, knowledge, materials and services to accelerate research.

5. Crowd-sourcing innovation. FasterCures is seeking to benefit from the “wisdom of the crowd” by posting an “ideation challenge” on InnoCentive’s Web site this fall, as one of the company’s first “Public Policy and Citizens in Action” challenges seeking solutions to important issues facing society. The New York Times reported in July how this approach is “catching on…as would-be innovators can sign up online to compete for prizes for feats as diverse as landing on the Moon and inventing artificial meat....” Keep an eye out for more details – maybe you’ll have some ideas to offer and potentially win the prize!

6. Prize philanthropy. Top-down prizes are getting a lot of attention this year, not only by the press but by politicians. A panel appointed by the National Research Council recommended that the National Science Foundation offer prizes of $200,000 to $2 million in various areas of science to encourage innovation. Two weeks ago, The Wall Street Journal challenged political and business leaders to outline how they’d spend $10 billion in four years to address global problems. Newt Gingrich proposed the development and diffusion of new technologies by using large, tax-free prizes, arguing that prizes would be a useful experiment in large-scale breakthroughs.

7. Biomarkers Consortium. The Biomarkers Consortium public-private partnership has taken the interesting step of identifying “High Impact Biomarkers Opportunities.” Rather than be, essentially, investigator-driven and wait for participants (industry, academia, foundations) to walk in the door with good ideas, the Foundation for the NIH has chosen to develop this more strategic and prescriptive path, laying out projects that it believes “will have the greatest and most proximal impact on future diagnosis and treatment of patients and drug development.” We will continue to watch with interest to see if this effort proves to be an effective way of addressing the “first-mover disadvantage” in biomarker research and validation – i.e., the first mover spends all money and its competitors get the advantage of the biomarker.

8. Comparative effectiveness. The healthcare reform drumbeat is getting louder -- and much of the call for change is focused on the need for more cost effective and efficient approaches to our nation’s healthcare woes. Despite the buzz around comparative effectiveness, it’s important to note that both presidential nominees recognize that this issue is more complex than it may appear. In response to a question on the issue posed by the “Your Candidates - Your Health” program (of which FasterCures is a sponsor), Sen. McCain said we need “to ensure that [this] does not stifle the spirit of innovation,” and Sen. Obama cautions that the “decision on which treatment to use should be made by patients and doctors, not government or insurance companies.”

9. Electronic health records (EHRs). As the federal government muddles through its continuing effort to figure out what its role in the development of the “healthcare information superhighway” should be, there are at least small signs that it might be waking up to the importance of factoring research uses of EHRs into their plans. FasterCures recently joined a panel of research leaders that called on the group charged with creating the successor to the American Health Information Community to expand its scope and mesh data standards for medical research with its work on standards for e-health records. The group said it would consider how best to do that. Meanwhile, the FDA has launched its Sentinel initiative to better monitor medical product safety, a massive effort that will involve using existing electronic health records for post-marketing surveillance of approved drugs.

10. Clinical trials: Something’s gotta give. The discovery enterprise is calling for revolutionary change in how we conduct clinical trials. The NIH is studying how to accelerate and improve the conduct of clinical trials at its own Clinical Center, which could provide useful information and models to other trial sponsors. The Pioneer Portfolio of the Robert Wood Johnson Foundation (which supports FasterCures’ Philanthropy Advisory Service project) has made its largest grant to build ARCHeS, a Web-based interface and delivery system that will allow far more health and policy decision-makers to use the Archimedes simulation model – a sophisticated database that some believe could be used to radically streamline the design and simulation of clinical trials. This is definitely an area worthy of focused attention by the next President.

1 comment:

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