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Open Insulin, 'DIY bio' and the future of pharma
The development, manufacture and sale of pharmaceutical drugs in the United States is a complex landscape involving intellectual property and strict federal regulations. But according to Colorado State University scientists, the status quo of the U.S. pharmaceutical market may soon be turned on its head. That's due in part to a growing community of do-it-yourself "biohackers" who are disrupting business-as-usual for pharmaceutical discovery, development and distribution. A Sept. 13 perspective piece in Trends in Biotechnology [DOI: 10.1016/j.tibtech.2018.07.009] [DX] frames these emerging issues, and predicts how the pharmaceutical industry, and the U.S. regulatory environment, will need to change in response.
[...] The authors use the California-based Open Insulin Project as a case study of how the DIY bio movement might shape the future of medicine. Founded in 2015, the project's creators are trying to increase competition in the insulin market by developing and releasing an open-source protocol for manufacturing off-patent insulin.
Why does the Open Insulin Project exist in the first place? Insulin is 100 years old, but it remains prohibitively expensive for many patients, with some uninsured patients paying up to $400 a month for this life-saving medicine. People are angry, and in some cases, people are dying, from lack of access to affordable insulin.
(Score: 2) by PartTimeZombie on Tuesday September 18 2018, @09:54PM
I live in a country with proper civilised socialist medicine, and from what I understand the national drug buying agency offers potential suppliers a "take it or leave it" price for anything that is not under a patent, and as they can easily work out the cost of manufacture, that price is very, very low.
There will be multiple manufacturers world wide, so if they are offered a supply contract for (say) 12 months, with guaranteed volumes, the small margin is probably no big deal.