Up at 5AM: The 5AM Solutions Blog

Map of Biomedicine: Premarket Approval for Diagnostic Products

Posted on Thu, Jul 31, 2014 @ 12:00 PM

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.

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Tags: map of biomedicine, diagnostic test development, 510(K), LDT, PMA, Premarket Approval

Skin Cancer - Tales from Two Hemispheres

Posted on Tue, Jul 29, 2014 @ 03:38 PM

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

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Tags: cancer, personalized medicine

Long Commute? Update Your Software.

Posted on Thu, Jul 24, 2014 @ 02:45 PM

5AMers think about software. A lot.

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Tags: software development, 5AM, Working at 5AM, Life at 5AM, software

Practicing Our Craft - Developing Great Software

Posted on Tue, Jul 22, 2014 @ 12:30 PM

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…

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Tags: Working at 5AM, software development, 5AM, Life at 5AM

FDA: "Get More Men in Breast Cancer Trials"

Posted on Thu, Jul 17, 2014 @ 03:35 PM

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.

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Tags: cancer awareness, clinical trials, diagnostics, BRCA

EMR Data + Clinical Trials = 21st Century Cures

Posted on Tue, Jul 15, 2014 @ 02:31 PM

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.

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Tags: EHR, electronic health records, electronic medical records, EMR, clinical trials, Big Data

Map of Biomedicine: Getting Diagnostic Products to Market

Posted on Thu, Jul 10, 2014 @ 12:00 PM

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.

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Tags: map of biomedicine, diagnostic test development, 510(K), LDT, PMA

Taking Pharma to Where the Patients Are

Posted on Tue, Jul 08, 2014 @ 11:00 AM

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

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Tags: FDA, social media, pharma

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

Posted on Thu, Jul 03, 2014 @ 10:00 AM

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.

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Tags: life sciences, business of science, research

Open to the Public: Making Health Data Mainstream

Posted on Tue, Jul 01, 2014 @ 02:26 PM

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

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Tags: public health data, Big Data, Data Science, data

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