Up at 5AM: The 5AM Solutions Blog

Newly Approved Lung Cancer Drug Inhibits Immune Checkpoint

Posted on Fri, Mar 13, 2015 @ 03:00 PM

A couple of weeks ago, we blogged about the strides being made to combat melanomas by releasing the brakes on the immune system. Last week, the FDA approved Bristol-Myers Squibb's Opdivo (nivolumab), an immunotherapy drug that has had dramatic results in lengthening the lives of patients with some late-stage melanomas.

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Tags: cancer, clinical trials, immunotherapy, drugs

The Comeback Kids: Old Drugs, New Uses

Posted on Tue, Mar 03, 2015 @ 03:00 PM

Drug development is a long, expensive process with a very high failure rate. In a 2011 commentary in the journal Science Translational Medicine, NIH director Francis Collins described it like this:

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Tags: clinical trials, drug development, drugs

Clinical Trial for Ebola Drug Canceled, But That's Not Terrible News

Posted on Thu, Feb 05, 2015 @ 03:49 PM

There is some good news in West Africa, as cases of Ebola are on the decline,  even in Liberia, Sierra Leone, and Guinea, the continent's hardest hit areas.

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Tags: clinical trials, vaccines, ebola

CIRM Wants to Turn Stem Cells Into Cures - Faster!

Posted on Tue, Dec 16, 2014 @ 03:00 PM

The California Institute for Regenerative Medicine (CIRM), has completely overhauled its process for funding projects to develop stem cell-based treatments and therapies. Beginning  January 1, CIRM, which is California's voter-supported, grant- and loan-making agency funding stem cell research, will launch CIRM 2.0 which will shorten the time from application to funding from nearly two years to 120 days. 

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Tags: clinical trials, stem cells

Clinical Trials: Finding Goldilocks to Cure Rare Diseases

Posted on Tue, Dec 09, 2014 @ 03:00 PM

One of the challenges in drug development is enrolling participants in clinical trials that meet very specific criteria. The reason for this is sound: make the trial too broad and researchers risk missing meaningful data about a potential therapy's efficacy.

However, there is a tension between mitigating that risk and the need to reach as many people with horribly debilitating -- and often life-threatening -- illnesses as possible with a life-altering miracle.  Often multiple trials have to be conducted that test lots of different scenarios, and each one needs participants whose conditions, like the porridge and the bed in the fairy tale, are "just right."

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Tags: clinical trials, rare diseases, drug development

Big Data and the (Near) Future of Genomics

Posted on Tue, Nov 11, 2014 @ 03:00 PM

At ASHG 2014, I had the pleasure of listening to the talks of Ajay Royyuru from IBM’s Computational Biology Center, and David Glazer from Google, during the ‘Separating Signal from Noise’ symposium.

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Tags: clinical trials, Big Data, Genomics

Some Thoughts on Jonas Salk, Vaccines, and Ebola

Posted on Thu, Oct 30, 2014 @ 03:00 PM

"Don't want little Johnny or Betty to develop a crippling disease with the potential for lifelong paralysis? Then sign here and be a pioneer in improving global health!"

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Tags: clinical trials, vaccines, ebola

Ebola is Scarier than War: Drugs Fastracked for Clinical Trials

Posted on Tue, Sep 30, 2014 @ 03:30 PM

With the death toll topping 3000 in West Africa, health agencies around the world are working to speed the development of treatments and vaccines against Ebola. According to the UN Security Council, the epidemic is "...a threat to international peace and security." Normally, taking medical treatments and vaccines from laboratories to patients is a lengthy process that can go on for years. Ebola is different. 

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Tags: clinical trials, vaccines, ebola

Ebola Vaccine in Clinical Trials

Posted on Tue, Sep 09, 2014 @ 03:30 PM

Twenty human subjects became participants in clinical trials for an Ebola vaccine. Almost 2300 people have died from the disease since January 2014 when an outbreak of the disease began and spread through western Africa. In an animal study, four crab eating macaques showed immunity to lethal doses of the virus when they were inoculated with a vaccine.

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Tags: clinical trials, map of biomedicine, ebola

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


Diagnostic Tests on the Map of Biomedicine


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