The time has long been overdue to wish you all well and share the progress we've been making, and the occasion of welcoming the new year is the perfect time to do so.
In the past year, our team in the lab, led by Yann, has made tremendous progress, engineering two strains of yeast to produce a modified proinsulin protein, and an enzyme to convert the modified proinsulin into insulin glargine. This strategy should enable efficient production of that type of insulin (a long-acting variant) with a minimum of complexity. Yann has produced a small sample of the product of this process and we're arranging to have it tested now. So, our first major milestone ― the production of insulin at lab scale ― is almost complete. Once that's done, we'll add a protocol for a rapid acting insulin to our portfolio to round it out with everything needed to effectively treat both types of diabetes with either injections or pumping. This should be much easier than the initial development we're about to complete.
Our work was recently profiled by the Wall Street Journal here:
…and we've continued to receive a lot of attention from the press and independent documentary film making teams who recognize the urgency of the problem of access to insulin and other crucial medicine and how the incumbent system is undermining that access.
Very soon, work on creating the organizational and technological infrastructure to deliver on the promise of decentralized manufacturing of insulin and other biopharmaceuticals will begin in earnest. Alongside the ongoing work in the lab, we've started to research how to organize small scale production in a way that will address what are perhaps the main problems in how the incumbent system works: the complexity, the misalignment of incentives and interests among all the parties in the complex system, the lack of competition to serve the needs of people with medical needs, and the related lack of freedom of people with medical needs to choose what is best from their perspectives.
In the strategy that is emerging, we're considering the following tactics to fix the problems:
- Open Hardware Production Platform. The process technology to make insulin and other biopharmaceuticals at a small scale should be straightforward to develop and capable of efficient production. Initial, fairly crude estimates suggest that we can build a highly automated system that integrates a bioreactor, a purification and formulation system, and QA tests in a platform that would fit in the space of a large table or the corner of a room and cost from ten thousand to a few tens of thousands of dollars. It could have a capacity from a few tens to about a hundred liters of culture, and based on typical yields obtained in industry, one such system could produce enough insulin for a few tens to a hundred thousand people. This would enable a “microbrewery” model of production ― instead of, or in addition to, only a few colossal factories in the world, there could be a few dozen or a few hundred in every city, and insulin could be produced much closer to where it is needed, which would give access to it to people who live in areas that currently lack the infrastructure for it to be transported to them. This could also make the supply chain safer by making it easier to track, contain, and recall and replace any bad batches that are produced, as Gallegos and Peccoud noted in their recent piece on the Discover Magazine blogs. It turns out that operating at a large scale produces much worse problems than it solves for production of medicine, and small scale production makes the most sense from economic and safety perspectives as well as those of access and choice. Our ideas about the open hardware platform recently received an enthusiastic reception at MIT's Global Community Biosummit, and among many other potential collaborators, Africa OSH emerged in support (our current colleague Thomas is a leader of this project as well).
- Cooperative-Based Production. This new production technology will not just enable, but will need new forms of organization to realize its potential. We're looking to precedents in how computing technology with similar traits ended up with its associated economic activity organized around nonprofit foundations to steward the technology, and to precedents in how other local, primary-stakeholder-focused businesses have been organized as cooperatives. They suggest that we can put the stewardship of the production technology under a nonprofit with global scope, and organize the actual manufacturing in franchised, local cooperatives which are primarily owned, managed, and financed by the people using the medicine. We are also looking at developing these organizations in cooperation with local organizations with existing stakes in providing health care such as city and state governents, pharmacies, hospitals, and unions. This will eliminate the possibility of one of the most significant problems with the incumbent system, which is the tendency to treat patients in whatever way maximizes profits rather than in ways that serve their best interests. The starkest example of this is the enormous disparity of resources devoted to treating diabetes versus curing it. So it's my hope that patient owned and controlled organizations can develop a cure much more effectively than the incumbent corporate system has, which has let much promising research languish despite regular promises of cures being imminent that go back several decades. But production of medicine at a small scale, despite being overwhelmingly the norm historically, is unprecedented in the current regulatory regime in the US. Preliminary indications are that we can find a niche where compliance will not be overly burdensome, but we are preparing for thorough legal research to refine our strategy on this.
- Internal Organization and Fundraising. To successfully pursue these newer, broader and deeper aspects of our work, and to make the most of the enthusiastic reception our project has gotten from the public, we are looking at setting up more effective systems to organize ourselves and to keep in contact with and involve our supporters. This includes better organized ways of publishing project updates, staying in touch with donors, and opening up our work for collaboration, especially the open hardware project, as well as better aligning our work with that of existing patient organizations in the diabetes world. Up to this point, we've still mainly had our heads down in the lab, making sure to put technical progress on our first milestone first. Now, we'll need to expand into these new areas. In order to do so, we're planning a larger fundraiser for the spring, but to get there and to continue on from there on a strong foundation, we'll need support in laying the foundations now.
So those are our resolutions for the new year and beyond!
In order to help us along as we lay the foundations to pursue work on these new frontiers, I'd like to invite you all to make a tax-deductible donation before the year ends at midnight tonight, which you can do at openinsulin.org/donate, and to share this message with your friends, loved ones, and anyone you know who cares about making medicine work for people instead of letting it continue the opposite way around.
Here's to a happy and healthy 2019 for everyone! I hope you can join us in our work to make it much healthier for many more people.
Anthony Di Franco
Founder, Open Insulin