5 ms·

How hard would it be to found an insulin startup? This seems like the kind of problem designed to be intractable, the "busy work" of bureaucratic private health

by ipnon 4y ago

How hard would it be to found an insulin startup? This seems like the kind of problem designed to be intractable, the "busy work" of bureaucratic private health care systems.

Ericson2314 4y ago
I'm told Marc Cuban is failing right now, but I don't think that dude ever did anything difficult.
usrn 4y ago
It sounds to me like the modern process is just working up GMO yeast matabolites. I feel like the main issue is probably going to be patents and not something technical.
- colinmhayes 4y ago
  Can’t you use older recipes?
  - usrn 4y ago
    My understanding is that the older stuff is actually cheap, it's just much harder to manage and that's what people don't like.
  - idealmedtech 4y ago
    Most older expired IP insulin just isn't very convenient to use for most people; it requires more intense participation from the people using it, so you tend to get worse results (imagine if you had to actively think about breathing in enough oxygen every single waking hour of your life -- it's exhausting). The longer acting, more specialized insulins are still heavily patented. When insulin takes longer to work, the person using it has to think less about the insulin and actually gets to live their life rather than think about blood sugar all day. Now, if you closed the loop and used older insulins, you'd have good control and less issues since a computer would bear the cognitive load, but glucose control, especially in the outpatient setting, is ridiculously hard. If you think you can solve it though, give it a shot. It's a multi billion dollar market and a lot of lives you can improve.
- gpm 4y ago
  Do state governments have to respect patents? Edit: Answering myself here, they do not: https://www.vorys.com/publications-2574.html https://www.vorys.com/publications-2574.html
  - HWR_14 4y ago
    Yes, state governments have to respect patents. So does the federal government. However, many patents that are issued in association with a research grant include a clause that allows the government to use the patent without charge. I have no idea if any/many insulin patents are included in such clauses.
    - deleted 4y ago
      [deleted]
pg_bot 4y ago
Depends on the type of insulin you want to make, but if you want to be at the cutting edge it would likely cost around a billion dollars. You have to avoid the intellectual property minefield on the manufacturing side. The production of insulin and its delivery mechanisms are heavily patented and the big pharma companies will shut you down if you infringe on anything. If you want a reference for this happening you can google 'lusduna'. Plus you have to make it through the FDA, which is its own can of worms. The 505(b)(2) is still not a cakewalk but at least it will give you 3-5 years of market exclusivity so you can recoup your costs. (Wait you can get market exclusivity for a biosimilar with an expired patent? That should sound insane to anyone not in healthcare.) Then you have to actually manufacture and distribute your product. There are extremely high capital costs to get set up. For reference, Novo Nordisk's insulin manufacturing facility in North Carolina is 328,000 sqft and staffed by ~500 people 24/7. Just to get a comparable facility up and running you're talking about 400-500 million dollars in capital cost. Sanofi, Eli Lily, and Novo Nordisk have spent billions over the last decade upgrading and maintaining their facilities. I would suspect it's about the hardest project you could tackle if you were a startup.
- idealmedtech 4y ago
  No one in their right mind would build manufacturing from scratch. Contract manufacturers exist to do relatively cheap design work in exchange for access to their expensive-to-build (but cheap to use by comparison) manufacturing facilities. I can't speak to drug manufacturing, but I know from experience that when it comes to medical devices, you save almost 10x in up front fixed cost by outsourcing, like California is doing. You spend more per unit, but still profit, so you can build a healthy warchest while you accumulate experienced personnel to build out a more vertically integrated manufacturing process.
  - pg_bot 4y ago
    With regard to insulin 3 companies control 90% of worldwide production. I'm not aware of a third party manufacturer that can actually produce modern insulins at scale. Even if they existed, they still have to work around the issues previously stated. It is unlikely that you would be able to partner with the big players as they have no incentive to help a competitor and they are already running at full capacity. You probably don't have any other option than to build it yourself. Medical devices are frankly a lot simpler than making new drugs. (I know they are still exceptionally challenging)
vpilcx 4y ago
There's already a insulin project where they're trying to open source (or something like that) insulin. They just made headway this year or the year before, but it seems like they're a long way from having any kind of effect.

by ipnon 4y ago

How hard would it be to found an insulin startup? This seems like the kind of problem designed to be intractable, the "busy work" of bureaucratic private health care systems.

Ericson2314 4y ago

I'm told Marc Cuban is failing right now, but I don't think that dude ever did anything difficult.

usrn 4y ago

It sounds to me like the modern process is just working up GMO yeast matabolites. I feel like the main issue is probably going to be patents and not something technical.

colinmhayes 4y ago
Can’t you use older recipes?
- usrn 4y ago
  My understanding is that the older stuff is actually cheap, it's just much harder to manage and that's what people don't like.
- idealmedtech 4y ago
  Most older expired IP insulin just isn't very convenient to use for most people; it requires more intense participation from the people using it, so you tend to get worse results (imagine if you had to actively think about breathing in enough oxygen every single waking hour of your life -- it's exhausting). The longer acting, more specialized insulins are still heavily patented. When insulin takes longer to work, the person using it has to think less about the insulin and actually gets to live their life rather than think about blood sugar all day. Now, if you closed the loop and used older insulins, you'd have good control and less issues since a computer would bear the cognitive load, but glucose control, especially in the outpatient setting, is ridiculously hard. If you think you can solve it though, give it a shot. It's a multi billion dollar market and a lot of lives you can improve.
gpm 4y ago
Do state governments have to respect patents? Edit: Answering myself here, they do not: https://www.vorys.com/publications-2574.html https://www.vorys.com/publications-2574.html
- HWR_14 4y ago
  Yes, state governments have to respect patents. So does the federal government. However, many patents that are issued in association with a research grant include a clause that allows the government to use the patent without charge. I have no idea if any/many insulin patents are included in such clauses.
  - deleted 4y ago
    [deleted]

pg_bot 4y ago

Depends on the type of insulin you want to make, but if you want to be at the cutting edge it would likely cost around a billion dollars. You have to avoid the intellectual property minefield on the manufacturing side. The production of insulin and its delivery mechanisms are heavily patented and the big pharma companies will shut you down if you infringe on anything. If you want a reference for this happening you can google 'lusduna'. Plus you have to make it through the FDA, which is its own can of worms. The 505(b)(2) is still not a cakewalk but at least it will give you 3-5 years of market exclusivity so you can recoup your costs. (Wait you can get market exclusivity for a biosimilar with an expired patent? That should sound insane to anyone not in healthcare.) Then you have to actually manufacture and distribute your product. There are extremely high capital costs to get set up. For reference, Novo Nordisk's insulin manufacturing facility in North Carolina is 328,000 sqft and staffed by ~500 people 24/7. Just to get a comparable facility up and running you're talking about 400-500 million dollars in capital cost. Sanofi, Eli Lily, and Novo Nordisk have spent billions over the last decade upgrading and maintaining their facilities. I would suspect it's about the hardest project you could tackle if you were a startup.

idealmedtech 4y ago
No one in their right mind would build manufacturing from scratch. Contract manufacturers exist to do relatively cheap design work in exchange for access to their expensive-to-build (but cheap to use by comparison) manufacturing facilities. I can't speak to drug manufacturing, but I know from experience that when it comes to medical devices, you save almost 10x in up front fixed cost by outsourcing, like California is doing. You spend more per unit, but still profit, so you can build a healthy warchest while you accumulate experienced personnel to build out a more vertically integrated manufacturing process.
- pg_bot 4y ago
  With regard to insulin 3 companies control 90% of worldwide production. I'm not aware of a third party manufacturer that can actually produce modern insulins at scale. Even if they existed, they still have to work around the issues previously stated. It is unlikely that you would be able to partner with the big players as they have no incentive to help a competitor and they are already running at full capacity. You probably don't have any other option than to build it yourself. Medical devices are frankly a lot simpler than making new drugs. (I know they are still exceptionally challenging)

vpilcx 4y ago

There's already a insulin project where they're trying to open source (or something like that) insulin. They just made headway this year or the year before, but it seems like they're a long way from having any kind of effect.