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Up at 5AM: The 5AM Solutions Blog

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Map of Biomedicine: Premarket Approval for Diagnostic Products

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In the last few Map of Biomedicine blog posts I’ve talked about several different ways that diagnostic products can get to market. Laboratory-developed Tests (LDTs) and tests that get 510(k) approval (for tests that are similar to existing tests) are two ways.

Skin Cancer - Tales from Two Hemispheres


Experts around the globe agree that most skin cancers are preventable. They disagree, however, on what skin cancer prevention looks like.

Long Commute? Update Your Software.

5AMers think about software a lot.

5AMers think about software. A lot.

Practicing Our Craft - Developing Great Software

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The clock shows a minute past noon. The stragglers of a steady stream of 5AMers finish sneaking in the conference room door and quickly take their seats. Someone dims the lights while another finishes pulling the shades. A hush comes over the room. “Everybody ready?” Nods answer. A mouse cursor clicks the play button. The frozen bespectacled figure on the projector screen comes to life. In a stern voice, he declares, “Integrated tests are a scam – a self-replicating virus that invades your projects! It threatens to destroy your codebase, to destroy your sanity, to destroy your life.” Another 5AM Tech Talk begins…

FDA: "Get More Men in Breast Cancer Trials"


This year, 2000 men in the U.S. will be diagnosed with breast cancer. Fewer than 500 of them will die from the disease. In general, men's chances of developing the disease are about 100 time less that of women's. Comparatively, about 200,000 women will receive a breast cancer diagnosis.

EMR Data + Clinical Trials = 21st Century Cures


The U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on Health held a hearing entitled "21st Century Cures: Modernizing Clinical Trials" last week.

Map of Biomedicine: Getting Diagnostic Products to Market


In my last post, I talked about the laboratory-developed tests (LDT), or “home brews.” LDTs are run in individual labs whose operations are regulated under Clinical Laboratory Improvement Amendments (CLIA). The home brews, however, are essentially unregulated, except in the sense that physicians and hospitals won’t recommend tests that aren’t good for their patients.

Taking Pharma to Where the Patients Are

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According to Murray Aitken, Executive Director of the IMS Institute for Healthcare Informatics “Social media is where the patients are.” 

Sky Lab: Is the Future of Life Sciences Research in the Cloud?

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The Wall Street Journal reported on an in interesting development in life sciences research. Silicon Valley has begun sprouting cloud-based laboratories that could lower one of the highest barriers to entry for researchers: the cost of setting up a lab.

Open to the Public: Making Health Data Mainstream

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It isn’t exactly a problem; but it is a thing. 

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