Archive for December, 2011

Digital Meets Health

December 14th, 2011
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Last week I attended the 3rd annual mHealth Summit in Washington, D.C. Organized by the Foundation for the National Institutes of Health (FNIH), this multi-track conference attracted some 3,600 attendees and included representatives from across the health innovation spectrum, including industry, investors, entrepreneurs, policy makers, standards, NGOs, mobile operators, wireless technology producers, healthcare systems, insurers, pharma, regulators, researchers, and a multitude of others with an interest in the burgeoning space of ‘mHealth.’
While the lexicon for mHealth (an amalgam of “mobile” and “health”) is diverse and overlapping, a natural theme emerges if we look at the genesis of the term. The PC and ever-smaller, more powerful computer microprocessors spawned the digital revolution. Recently, we’ve seen the mobile revolution taking hold, wherein digital tools and wireless technologies have converged to allow us to be connected consumers, patients, and professionals. Now we are seeing a digital health revolution, wherein mobile, and the connectivity it provides for us, is enabling a new paradigm for health. Moreover, this phenomenon is spreading throughout the entire life sciences and health care ecosystem, including all strategics. To characterize all of this as simply being a combination of mobile and health is not only ambiguous (the term “mobile” has often been used interchangeably to mean a cell phone or mobility), but is somewhat disingenuous to the fundamentals that are driving this paradigm shift. Of course, mHealth is a very catchy and accessible term – and proponents have steadily broadened its meaning – so it’s often easier to make a concession in many modes of communication rather than fight a good-natured but losing battle!
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Where is the Device Industry’s Seat at the “Network of Experts” Table?

December 8th, 2011
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Recent draft polices from the FDA’s Center for Devices and Radiological Health (CDRH) have created concern by industry members that they have been left out of the “network of experts,” a program to supplement the FDA’s existing expertise and to expedite the review process. Despite the fact that the FDA has more than 800 scientists, engineers and clinicians, the agency believes that it is impractical to expect CDRH staff to keep current with so many new and complex technologies surfacing.
The network of experts is designed to be a resource for CDRH, particularly to address questions on emerging and unfamiliar technologies. The outside organizations that are being considered by CDRH for inclusion in the network “…will include professional scientific and medical organizations and academic institutions.”  Even though we have not yet heard what organizations the FDA will use in a pilot program to assess their new process, a number of organizations are interested in participating in the program. Industry also would like a seat at the table.

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Applauding Cautious Optimism from a Big Pharma CEO

December 1st, 2011
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Recently journalists at WSJ and Xconomy interviewed John Lechleiter, Chairman, President & CEO, of Eli Lilly and Company. When I sat down to read Mr. Lechleiter’s interviews, I was prepared to get up from my desk several times to find something more interesting to do thinking the articles were to be somewhat mind-numbing. My expectations were not based on any preconceived notions about Mr. Lechleiter, but rather that I assumed the focus of the interviews would be lamenting the pharmaceutical industry’s problems. Instead I was encouraged by Lechleiter’s dedication and optimism.
It is increasingly easy to criticize big pharma: Fewer truly “new” drugs are developed. It is difficult to understand the economics behind the high costs of certain drugs. After being approved, some drugs go on to be proven ineffective or, sometimes, potentially dangerous.
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