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Trends Biotechnol. 2018 Dec;36(12):1211-1218. doi: 10.1016/j.tibtech.2018.07.009. Epub 2018 Sep 13.

The Open Insulin Project: A Case Study for 'Biohacked' Medicines.

Author information

1
Department of Chemical and Biological Engineering, Colorado State University, Fort Collins, CO, USA.
2
Bio-Link Australia Pty. Ltd., Melbourne, Australia.
3
Woodrow Wilson International Center for Scholars, Washington, DC, USA.
4
Department of Global Health, Boston University School of Public Health, Boston, MA, USA.
5
Department of Chemical and Biological Engineering, Colorado State University, Fort Collins, CO, USA. Electronic address: jean.peccoud@colostate.edu.

Abstract

New innovation ecosystems are emerging that challenge the complex intellectual property and regulatory landscape surrounding drug development in the United States (US). 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.

KEYWORDS:

biohacking; biologic drugs; biosimilar; insulin; intellectual property; regulation

PMID:
30220578
DOI:
10.1016/j.tibtech.2018.07.009
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