About Our Integrated Human Practices
We spent a considerable amount of time looking out into the real world to figure out how our project would best solve the issues of insulin unaffordability and inaccessibility. Key advisors and stakeholders aided the decisions we made along the way. Not only did our project integrate with the advice of individual people, but these individuals became integrated into a big conversation between us all.
Specifically, these conversations were around how we Apply the design, the Project Design itself and ultimately how we best present this project to the real world as a business.
Under each of the below headings, you fill find the conversations we had with these stakeholders which integrated into our final product. Please enjoy reading through our journey!
Our Original Project Design
Originally when we started this project, we were facinated by the idea of single chain insulins, but were hesitant to develop our own due to the vast array of new patent applications that were on the market. Human Insulin was in the clear of any patents, however due to its series of post-purification methods and low thermostability, we thought that developing a business model that had to keep up with high transportation costs, especially when open source, would be a difficult operation.
Read the conversation below to find out how these people influenced our Project Design:
- Anthony Di Franco Our foreign friend began the Open Insulin project.
- Meow-Ludo Meow-Meow Meow-Meow is infamous for his work at Biofoundry.
- Dr Peter Arvan An insulin researcher.
- Nick Coleman Our Supervisor.
- Neil Donelan Neil distributes insulin vials all across the world.
- Jeni A local pharmacist.
- Len Mancini A partner of Maxwells Patent Lawyers.
- Edwina Wang A type I diabetic.
Firstly, Human insulin purification takes a long time and, depending on the method used, can be very expensive. We investigated alternatives to this process, and we came up with a few expression systems that could be used to improve the folding of insulin inside Escherichia coli and Bacillus subtilis.
Secondly, insulin is currently stored at 4°C to preserve its activity. Keeping insulin at this temperature in cold storage chains while it’s being transported is incredibly difficult. This is especially so in lower economic countries, where we hope our insulin will be able to be sold.
So we thought, what if we designed our own, single chain, open source insulin that is also thermostable?
From our predictive modelling, we predict the Winsulin will be a short acting insulin. We also believe that our Winsulin will not fall into the ‘biosimilar’ category, as it is not simply an adaptation on a current market therapy, but an entirely new design altogether.
Our Final Project Design
As you can see, developing human insulin as a therapy became a lot more operational and useful following the discussions with Neil, which showed that insulins do not need to be refrigerated to maintain levels of activity. Furthermore, we developed a series of expression systems to compare the relative yields, and costs of purification, to determine whether or not we could optimise human insulin production. But ultimately, with the blessings of Dr Peter Arvan, we were able to develop our own Single Chain Insulin, and Len Mancini was able to confirm that our optimised Winsulin is in fact outside of all patent claims.
Our Original Applied Design
As technology is evolving faster than therapies can develop, we originally wanted to design an insulin pump to go along with our Single Chain Insulin. This is so that all diabetics are able to utilise our new insulin, and we are not forcing individuals to start injecting themselves again. Furthermore, we assumed that clinical trials would be required in the future for both of our Human Insulin and Winsulin, and that ultimately want to pursue a single one due to the extreme costs of clinical trials. We were also only considering an open source project, as this seemed to fit the most with the international collective movement of Open Insulin.
- Len Mancini A partner of Maxwells Patent and Trademark Attorneys and IP Lawyers.
- Anthony Di Franco Our foreign friend over in the USA began the Open Insulin.
- Edwina Wang A type I diabetic.
- Nick Coleman Our Primary Investigator.
- Biofoundry The local biohack lab.
Our Final Applied Design
Following these discussions, we decided to follow the mantra "Keep it Simple, Stupid" and just focus on synthesising insulin from bacteria, rahter than producing an insulin pump alongside it. We also decided to model the activity of our Winsulin to determine what kind of insulin it is. This will also be important information for future endeavours. Furthermore, we became a little more comfortable with the idea of going open source with our Winsulin also. However, these talks also demonstrated that raising the initial capital for manufacturing plants may be a little difficult given the start up costs, specifically Good Manufacturing Practice approvals.
Our Original Entrepreneurship Plan
Originally, we were full steam ahead on the open source direction. We planned on raising capital through crowd funding measures and with angel investors. Other open source tools were considered, such as Public Investment 'matching' schemes and Private Trading Schemes.
- Mike Nichols A local entrepreneur mentor at the INCUBATE Hub at Sydney University.
- Narcyz Ghinea A specialist in access to high cost medicines (specifically cancer drugs).
- Neil Donelan Neil distributes unopened, unexpired insulin vials all across the world.