We need an Open Source Insulin! We need a team to be able to start investigating methods that could be used to increase the yield, and decrease the post-expression processing steps currently required to produce insulin.

I've got a team in mind.

USYD iGEMers- what do you think?

That’s fantastic! Keep me updated throughout the project, I’m more than happy to help with this process if I can. Also, good luck with the competition!

I have designed a single chain insulin that I won’t be patenting, would you like to improve upon what I’ve developed?

Hi! As a part of the not-for-profit group Insulin for Life, I currently work to export insulin from Australia to all corners of the globe. We haven’t had any issues with the activity of the insulin we distribute, even though we don’t use any cold chain transportation. I think that any insulin you design, just like the human insulin you’re looking to produce, will be thermostable enough for global transportation without cold storage.

Also, just be careful with how much you adapt the insulin you design. Endocrinologists are hesitant to put their patients on biosimilars because they can never be taken off that specific biosimilar. Generally, if a person is taken off one insulin biosimilar and put on a different analogue, they will suffer from an allergic reaction to the new insulin!

Would you like some quick tips on how to figure out if you will be free to market the insulin you have developed. Basically we would be looking at the patent landscape including granted patents and patent applications to see whether you wouldcould infringe if your developed molecule was formulated and sold on the market.

The main thing you need to read when looking at a patent to begin with is the claims. If you read a claim, and your proposed product falls within the scope of any single claim, then you would infringe the patent (and could be open to a law suit). However, if your product doesn’t fall within the scope of that claim you would not infringe. One thing to be aware of, howwver, is that “patents” are published at the application stage and also again after they are granted. If they are granted at all. So the first thing you do is check the status of the application at the time it was published. If it was just an application, then the claims may be broader than what would ultimately issue from the Patent Office, or indeed, no claims may gain aceptance and the application may lapse. If you fall within a claim of an application its best to dig deeper and see if the patent is likely to be granted by getting any available examination reports for that application, or any foreign equivalent identified through patent family searches. Its not a quick and easy job!

– If I were you, I’d consider all the insulins on the market, taking a particular focus on Single Chain Insulins. We already know that the human insulin hormone itself is off patent, but you may want to check that subsequent patents on methods of manufacture or particular formulations or compositions weren’t granted and are still active today. Checking process patents in general, especially for your Bacillus expression system, would be important too. Patents for processes and advanced compositions are generally patented by the original owners as a way to extend the monopoly over their product.

Investigating whether a product is able to marketed legally is a very time intense process invoving muliple searches and months of analysis. The whole process genrally is conducted over multiple years (to account for the patent black spot – 18 months in which applications remained unpublished) and cost over $100,000 if many aspect of the product need to be cleared.

Hey, also don't forget there are also different types of insulin and we need them for different things - so their actual physiological effect is really important. I’ve used both before but am currently using short acting only with my insulin pump.

In our opinion, coaxing generic manufacturers to produce your insulin will be a hard feat considering the impassable barriers to entry, including a Good Manufacturing Practice certification for insulin production.

Good Manufacturing Practice, or GMPs for short, are licenses required by a manufacturing plant to produce a therapeutic drug to be sold commercially. This makes sure that the processes used by a plant are meeting quality standards and product specifications. These generally cost around US$100M for a manufacturing plant to receive. This barrier is restricting a considerable amount of small businesses from entering the biosimilar insulin market.

But hold on, you guys have something that could be considered a ‘new to market’ drug, which means you could patent this yourselves and raise money through investors who are comfortable that your company will function to produce profits, rather than a single insulin.

We just raised $16, 656 through some crowd funding though, which is 227% of what we needed to kick start our lab work. If anything, this shows that when moneys needed to be raised, we can raise what we need and more!

Yeah, you guys really are the proof of concept the industry needs to start seriously looking into insulin production.

you could, but because of the way that the current pumps are made for a specific insulin analogue, you’d have a hard time selling it without your own insulin. It also wouldn’t really aid the issue of inaccessibility that are currently felt in many places in the world.

Hi everyone! As a diabetic myself, I am quite accustomed to injecting myself with insulin, so I wouldn’t worry too much about not having a pump, especially in dire circumstances.

Yes. It’s a rough estimate and highly dependent on the product, but generally that’s our rule of thumb.

Guys, that’s a great idea, but we have GMPs for a reason. Safety is more paramount than simply meeting demand. Regulating something like that would be way more of a nightmare than it’s worth.

In order to make a global impact, you really need to build a business around your products, patents and all. Raising funds will be a lot easier when you start a start-up in conjunction with us, as many businesses with much less appeal have made millions of dollars after just a few years here.

Hey guys, slow down a little. Discovering promising compounds is only one step in the process. It is the in-human trials that are needed to convince regulators the drug should be registered that is the real challenge for open source drug development. How are you going to fund that? If you want to get a drug to market entirely open-source without industry involvement you will probably need to consider “open source clinical trials”, and organise a network of people that are willing to do the necessarily research on a non-profit basis.

You should also start thinking about how the initial manufacturing plant begins. If I were you, I’d find a country that has a high demand for insulin and is currently very undersupplied. Build your plant there, following the regulatory guidelines required for that country. Once your Human Insulin production starts making a profit, you can begin phasing in your Winsulin. Get Winsulin off the ground with your human insulin production.

This might be a nice way to start. We currently have a large amount of processes that we have to go through in order to transport insulin from one country to another. Custom imports are different between countries, some of which are time and resource intensive to manoeuvre through. Localising your operation in one location may be a better way of organising this before expanding.

Would you have anywhere specifically in mind?

We have had huge demand for insulin in Tanzania in Africa. Their diabetic population is quite large and is expected to grow significantly as better diagnostic tools are implemented, as estimated 2/3rds of their diabetic population are currently undiagnosed in Africa alone. The South East Asian, and Pacific rim regions also need to be closely monitored.

So, maybe Tanzania or somewhere similar would work? You should strongly consider forming a start-up, and withhold Winsulin from the open source sphere to pursue this. Global impacts require profit margins and intellectual protection.