The Open Insulin Foundation (OIF) is a non-profit creating the means for communities in-need to have local sources of safe, affordable, high-quality insulin. However, we can’t do it alone. We envision localized production supported by local communities.
From Nov 15 to Dec 1, alongside World Diabetes Day, please donate whatever you are able to make affordable insulin a reality.
Diabetes is a crisis in the US. It extracts a heavy toll in loss of quality of life—and human life itself. The economic burden is massive. We need affordable insulin now.
- Diabetes is a chronic illness with no known cure that requires daily injections of insulin to survive. 122 million Americans live with diabetes or prediabetes
- 25% of people with diabetes in the U.S. have reported rationing insulin due to price, with severe health consequences [Yale study]
- With the lack of universal healthcare, absence of medicine price regulation, and the complexity of the supply chain, the price of insulin is at least 4X more in the US than in any other country [RAND study]
- And it's getting worse. Insulin prices have ballooned nearly 9x over the last 20 years period
Efforts to make insulin more affordable have not gone far enough.
- The government, Food and Drug Administration (FDA), created an abbreviated approval pathway for biosimilars (analog biologic medicines) to increase price competition among biologic medicines. Insulin is a biologic. [FDA announcement]
- However, the cheapest biosimilar to date is still sold at a significant markup, selling for $100/vial when manufacturing places costs at only $5/vial. [Semglee price]
- Many grass-roots organizations have taken to hammering policy to combat the huge price discrepancy, but, unfortunately, have seen limited success.
The Open Insulin Foundation is taking the problem into its own hands. To bring insulin prices down to cost, we're democratizing insulin production.
To do this, we're leveraging well-established biotechnology techniques, citizen scientists and the recent legislation on biosimilars to produce glargine (long-acting) and lispro (short-acting) insulin analogs. With an innovative business model, we plan to provide insulin at a more affordable price than any other insulin currently on the market.
Our progress to date:
- Engineer micro-organisms to produce insulin analogs - ONGOING
- Improve experimental conditions to achieve production quantity compatible with manufacturing - to start January 2021
- Compare the quality of our insulin to commercial ones for FDA approval - WE NEED YOUR HELP - to start spring 2021
- Partner with FDA approved manufacturing facility - to start during 2021
- Get FDA approval - 2022-2025
- Bring our insulin to the public - 2023-2030
To get FDA approval, we will need to prove that our insulin is similar to the commercial one. For that, we will need $10,000 to run experiments.
The experiments we’re planning:
- Check that our insulin has the correct sequence via Mass Spectrometry. This technique is versatile and can detect disulfide bonds. Quick fact: insulin has 3 disulfide bonds and they are essential for protein activity! ~ $3,000/sample
- Check the 3D structures of our insulin and commercial ones with NMR experiments. ~ $5,000/sample
- Compare the activity in-vitro with receptor binding experiments (SPR). Quick fact: Insulin is a hormone and interacts with receptors at the surface of the cell inducing glucose intake. ~ $1,500/pair
$10,000 for this set of experiments gives us a good picture of the quality of one of the insulin analogs we want to manufacture. However, $10,000 only covers a part of where we want to go. We will need complementary studies and much more to successfully file both our lispro and glargine analogs with the FDA.
So if you can, please help us reach this milestone and beyond. And, in turn, make affordable insulin a reality.
