My last post talked about off-label use of drugs, which is one way that patients can get access to drugs that are not officially approved for their condition. There’s another way this can happen, and it’s called compassionate use.Read More
Up at 5AM: The 5AM Solutions Blog
The last two Map of Biomedicine blog posts have introduced us to the clinical trial process. Clinical trials are the gold standard for determining whether a drug works, and are extremely important to make sure that drugs are only used in situations when they are known to help.Read More
In my last Map of Biomedicine blog post, I talked about the different phases of clinical trials and a little bit about how trials are structured. I mentioned that trial is really just an experiment designed to test a hypothesis. When you studied science in school you learned about the scientific method:Read More
Two new studies published in JAMA this week confirm that amyloid plaques on the brain predict future Alzheimer's Disease (AD). What's more, there is evidence that the plaques appear decades before patients experience the cognitive declines associated with AD. Researchers have long suspected that amyloid plaques precede the disease, but according to an article in the New York Times, this new research is "[t]he largest analysis to date of amyloid plaques in people’s brains [and it] confirms that the presence of the substance can help predict who will develop Alzheimer’s and determine who has the disease."Read More
Last week, the National Institute of Standards and Technology (NIST,) working through the Genome in a Bottle Consortium (GIABC) (a NIST-funded and initiated working group) pushed next generation sequencing (NGS) a little closer to being adopted into regular clinical practice. NIST/GIABC have released a standard for measuring the accuracy of genetic tests.Read More
The newest installments in the Map of Biomedicine blog posts take us down the routes that get drugs to patients, primarily in the United States. Of course, we are all patients at one time or other regardless of where we live. Without a doubt, the route to getting effective therapies from the lab to your local pharmacist is convoluted and expensive even if you live in a wealthy nation. If you don't, making the most effective treatments available to the people who need them most in middle- and low-income nations is more difficult.Read More
As I said in my last post, one of the key components of the Map of Biomedicine is how new treatments get developed. That’s one of the parts of the map that is highlighted, as shown below.Read More
It’s finally here: the Map of Biomedicine ebook!
Last year, 5AM’s Chief Science Officer Will FitzHugh started to make notes about the vast -- and expanding -- field for which we develop software: biomedicine. Originally, his purpose was keeping all of the players straight so that he and 5AM’s software development teams could have a big-picture view of the context that our clients work in, as well as details like the regulatory processes and technological shifts that impact human health.Read More
In my Map of Biomedicine blog posts, so far, I’ve focused on how diagnostics get to market. But you may recall that way back in my first post I discussed the major themes of the map - what I called ‘vignettes’. The first vignette was the development of diagnostic tests, which is what I’ve focused on so far. Those blog posts are being collected and expanded in an e-book which will be released soon, so keep an eye out for that.Read More
Last night, 5AM Solutions' Chief Science Officer Will FitzHugh was among the honorees at SmartCEO magazine's Washington Executive Management Awards. If you haven't worked with him directly, you might know Will from this blog. Most recently, he was the author of the Map of Biomedicine series (stay tuned for an upcoming ebook...) and he has also written about newborn screening and big data.