What is Oligo₂Insulin?
Motivated by the 'Open Science' movement spearheaded by BioFoundry, Oligo₂Insulin is a team of volunteers seeking to correct the tragic undersupply of Insulin in the global market. We take inspiration from Banting, Best and Collip who saw the potential of Insulin as a miracle treatment and sold their Intellectual Property for $3 in 1922. Despite their philanthropic intentions, the price has remained beyond the purchasing power of over half the world for nearly a century.
Our team wishes to demonstrate Top -> Bottom production of purified, native Human Insulin from E. coli for a variety of industrial scales. Our hope is that by aggregating this knowledge and supplying (free-of-charge) our modified E. Coli to generic manufacturers, we will be able to disrupt the Pharmaceutical Industry's insulin oligopoly once and for all.
Why is this a problem? Why hasn't it been fixed?
The intellectual property protecting classic Human Insulin expired in 2014, yet the 'Patent Cliff' that normally results from the entrance of Generics never occurred. Three companies possessed a 92% market share in 2016 - with the majority of their sales occurring within developed nations that enjoy lucrative pharmaceutical benefit schemes. There is no financial incentive to produce the older, off-patent Human Insulin as it would only undercut their valuable analogue market. Understanding the legal distinction between Human Insulin and it's substitute Analogue Insulin is crucial to untangling the complex weaves of market control exhibited here.
What is Analogue Insulin? What benefits do these products convey?
"The evidence indicates that across Type 1 and 2 diabetes, for both rapid- and
long-acting analogue insulins, there is no clear advantage over human insulins, with
inconsistent statistically significant advantages and lack of clinically important benefits.
Analogue insulins have not consistently been demonstrated to be cost-effective, and
uncertainty remains regarding the association between analogue insulins and increased cancer risk."
WORLD HEALTH ORGANISATION, 2011
While this quote seems damning of Analogue Insulins, their potential to revolutionise Diabetes treatment should not be understated. Type 1 Diabetes sufferers can enjoy a normal lifestyle with standard Human Insulin, however Basal + Long-Acting analogues can significantly reduce injection frequency and incidence of Hypoglycemia. Single-chain thermostable analogues could significantly simplify shipping and storage in arid areas and more advanced insulin pump/analogue systems reduce the impact of the disease on patient lifestyle.
NONE OF THESE FACTORS EXCUSE THE PRICE OF HUMAN INSULIN. Advancement in the potential of insulin treatment will not console the 50 million people whose purchasing power precludes them from accessing this miracle drug. By keeping Human Insulin prices in lockstep with their Analogues, these three companies hold international pharmaceutical benefit schemes hostage - costing the developed world billions of dollars, and the developing world millions of lives.
Collusion or a natural result of low competition?
How can the Open Science movement fix this state of affairs?
BioFoundry is not the first, nor last company to observe the struggle of Diabetes sufferers in low-middle income countries. Many African nations have specialised companies dedicated to improving access to Insulin, however they will face an uphill battle until someone rectifies the supply chain. Open Insulin, run by Counter Culture Labs in America were one of the first in the democratic science movement to attempt to solve this problem, raising over $16,000 from angel investors and generating a huge quantity of positive press in 2015/2016.
BioFoundry approached CCL with the offer of a collaborative partnership at the end of 2016 and we've been quite overwhelmed with the volunteer support that this project has inspired. Now working with a dedicated team of 20 volunteers, BioFoundry hopes to expand on the valuable research and development performed by CCL. It's been an exceptional example of online, open collaboration in the 21st century, simultaneously revealing the power of citizen science and the limitations of the academic sector to respond dynamically to changing market conditions.
How can YOU help?
If you're interested in getting involved in the science here at BioFoundry, or wish to reproduce/advance our results in your own lab...
If you're interested in the economics of this unique problem and wish to get to grips with one of the 21st century's biggest oligopolies...
If you're interested in the engineering challenges, supply chain management and Insulin Delivery Devices...
Then get in contact with us!