Today we published two papers discussing the development of biohacked medicines spearheaded by the DIYBio movement. This revolution could dramatically change the way patients access life-saving drugs.
In an opinion entitled “The Open Insulin Project: A Case Study for Biohacked Medicines“, in collaboration with Warren Kaplan (Boston University), we make the argument that emerging innovation ecosystems challenge the complex intellectual property and regulatory landscape surrounding drug development in the United States. A prime example is an initiative known as the Open Insulin Project. The goal of the project is to sidestep patents and enable generic manufacturers to produce cheaper insulin. However, the US regulatory environment, not patent exclusivity, is the main barrier to insulin affordability. If the Open Insulin Project succeeds in releasing an open protocol for insulin manufacturing, follow-on work could enable a number of new insulin production ecosystems, including ‘home-brewed’ insulin. Regulators will need to consider how to proceed in a future where commercial pharmaceuticals remain unaffordable, but patients are empowered to produce drugs for their personal use using personal bioreactors originally developed as educational tools that could be repurposed for manufacturing medicines.
We also published in The Conversation, a version of this analysis targeting a broader readership. Check it out, it includes some great pictures and thought-provoking analogies with wine-making and ground beef.