7 ms·

People don't seem to realize how expensive it is to bring a new pharmaceutical drug to market and why this approach won't work. A typical drug will cost betwee

by ig1 12y ago

People don't seem to realize how expensive it is to bring a new pharmaceutical drug to market and why this approach won't work. A typical drug will cost between $1bn-$2bn and take about a decade of work by the time it hits the shelves. (http://en.wikipedia.org/wiki/Drug_development http://en.wikipedia.org/wiki/Drug_development has details for those interested) Crowdfunding at those sort of levels just isn't feasible yet.

jonlucc 12y ago
Worse, I fear that cancer patients and their loved ones will get overly enthusiastic about this. Then, when they donate tons of money and it fails, they are out money, time, and a drug. This is the reason pharmaceutical companies are cautious about contacting patient advocacy groups.
- dnautics 12y ago
  Good point. This is something i wrestled with. It's very likely this will fail (for both social and scientific reasons). At the very least though if it fails for scientific reasons, since experiments will be openly disclosed (unlike the siloed process at pharma r&d) - we will learn something - even if that something is "don't try making this drug again".
  - rgoddard 12y ago
    If I am donating to a charity which funnels money to research, how is this all that different? I think you can tap into a similar set of population and motivations for the donations. One of the upsides with this sort of approach is that you have a great opportunity to involve the donors in the overall process. The experiment can be used to provide a view into the nitty gritty of the scientific process and more specifically drug research. Of course to do this well will take a significant effort to communicate everything effectively. On the other hand, as you mentioned, you don't want to create false hope. To mitigate this you would want to work on managing expectations on the potential results and consequences of those results are. Either way you should be able to gather useful information/experience on both the scientific experiment and the social experiment.
- collyw 12y ago
  I would like to think that the existing funding of research has mechanisms in place to fund the "best" types of research, which makes me ask why the need for crowd funding? It sounds cool initially but having seen some nonsense that was crowd funded I am not so sure. http://physics.stackexchange.com/questions/39456/the-z-torque-how-can-it-be-shown-intuitively-that-it-does-not-work http://physics.stackexchange.com/questions/39456/the-z-torqu... The article talks about the research being patent free, but surely there are options available to fund research that allow this, or am I wrong?
  - irollboozers 12y ago
    You can't really blame them, Kickstarter is composed of artists, not scientists.
exratione 12y ago
You don't need to crowdfund any more than it costs to convince a group with $1bn that they can make money on this by spending that to commercialize your demonstration. That is often just a few million, or even less, depending on how compelling your data and how good your connections. Most of that $1bn and decade of time is make-work created by ever more risk-averse regulators. The actual process of creating something, making a product, and gathering reasonable data on safety is a fraction of that.
- jonlucc 12y ago
  Wouldn't a group with $1bn to spend want a patent to ensure they would get a return on that money?
  - refurb 12y ago
    That's what I don't get. Sure you could crowdfund a few preclinical experiments. But where do you get the ~$100M to get it approved? It would be awesome if someone said "here's $100M, don't worry about paying me back", but I wouldn't count on it.
- ig1 12y ago
  Why would a company invest a $1bn on a drug they can't patent ? Also drug companies can't just decide they don't want to get FDA approval because it's too much work. They have to work within existing regulations whether they like them or not.
- Fomite 12y ago
  I'm curious to hear about what parts of the clinical trial process are "make-work" and which are "reasonable data on safety".
zobzu 12y ago
It actually says millions of USD or billions. ie not necessarily 1 billion+ I'm also wondering/suspecting these costs are very much tied to the USA which has a pretty specific model and costs involved. I wouldn't be surprised if the development, of similar quality, would be much cheaper outside the USA. (yes i have noticed this guy is crowdfunding from the USA)
- pinaceae 12y ago
  still needs to be approved by the FDA, as the rest of the world is using this for guidance. majority of drug development is not the actual science work, but tons of paperwork and audit trails. as history has proven if you play fast and loose here a lot of people will be hurt or killed. you need to document every step along the way. and once clinical trials start, the scrutiny increases, a lot. there is a now a fast track for very promising breakthrough drugs, but getting this designation is very hard and relies on proven, documented science.
  - dnautics 12y ago
    This is exactly why I'm only interested in crowdfunding a single, early stage, experiment.
    - collyw 12y ago
      Are there not public grants available it this stage?
      - dnautics 12y ago
        Short answer is. I'm not a faculty in a university since I tried and choose not to try any longer. I'm not in pharma because of patents. So getting a public grant is hard. It's even harder because my old boss is now in charge of the relevant funding stream and she shouldn't be working with grants that further her former avenue of research.
        12y ago
dnautics 12y ago
That's like saying it takes 7 billion to make a company that competes with facebook, and you'll never get 7 billion series A funding. Trivially true, but to compete with facebook is a process, and not all stages of a process use the same funding mechanisms.
- vvvv 12y ago
  Would you like to sign up for a buggy minimum viable drug treatment?
  - theworst 12y ago
    Not every startup has to produce a "minimum viable" product. Treatments also do not have to start with human trials.
  - grecy 12y ago
    If I had terminal cancer, absolutely!
    - dubcanada 12y ago
      I'm with this guy, if I have terminal cancer. I'll try a remedy made from dirt if it has a chance. I mean what's to lose, at that point my body becomes a free testing lab.
- ig1 12y ago
  What's the plan for the rest of the money, grants ?
  - dnautics 12y ago
    Grants and big donors to push through preclinical and a for profit partner for clinical is my vision, but I am open minded to alternatives.
    - thefreeman 12y ago
adamt 12y ago
I will freely admit I know very little about the pharmaceutical world, but my (perhaps dumb) question is what scope is there to disrupt these typical costs. For example it used to be that space programs cost billions, yet India has just put a Mars orbital in place for $74m. I am old enough to remember when it was the received wisdom that people believed an e-commerce website would cost $1m, yet many startups launch their first site with less then 0.1% of that. How much of that $1bn-$2bn typical cost is open to similar levels of disruption?
- Kalium 12y ago
  If you can always be right about every drug, every time, at every stage, then perhaps quite a bit. Of course, multiple years of trials is still going to be very expensive. A lot of the costs seem to be linked to the fact that failures are common at every stage. Which is why there is a lot of time, money, and energy being put into reducing failure rates. There's not an easy "insert disruption here" point.
- Fomite 12y ago
  You can make way cheaper drugs than $1-2 billion (fidaxomicin was developed by Optimer for 200some million) by being very, very picky about your targets, and not failing. But it's not a trivial thing to disrupt, and there are some costs that are just out and out fixed (clinical trials are spendy).
unclebunkers 12y ago
Any time someone says something won't work, what they should be saying is "No one has figured out how to make this work yet".
- chc 12y ago
  Unless you're asserting that you have figured it out, I don't understand why you'd point this out.
  - unclebunkers 12y ago
    Because I hate the negativity.
  - McDiesel 12y ago
    Because negativity is a bane on scientific progress. People who claim something can't be done are foolish. Claiming a negative - claiming something you can't prove - is anti-intellectual at best, downright ignorant at worst. There is no need to claim something can't be done. It serves absolutely no purpose. The only possible outcome that negativity can have is to stop someone from trying, when really - thats the heart of scientific discovery. We can't fly, we can't break the sound barrier, we can't we can't we can't. History is full of people who claim we can't. But history forgets those people, and remembers the ones who actually did.

by ig1 12y ago

jonlucc 12y ago

Worse, I fear that cancer patients and their loved ones will get overly enthusiastic about this. Then, when they donate tons of money and it fails, they are out money, time, and a drug. This is the reason pharmaceutical companies are cautious about contacting patient advocacy groups.

dnautics 12y ago
Good point. This is something i wrestled with. It's very likely this will fail (for both social and scientific reasons). At the very least though if it fails for scientific reasons, since experiments will be openly disclosed (unlike the siloed process at pharma r&d) - we will learn something - even if that something is "don't try making this drug again".
- rgoddard 12y ago
  If I am donating to a charity which funnels money to research, how is this all that different? I think you can tap into a similar set of population and motivations for the donations. One of the upsides with this sort of approach is that you have a great opportunity to involve the donors in the overall process. The experiment can be used to provide a view into the nitty gritty of the scientific process and more specifically drug research. Of course to do this well will take a significant effort to communicate everything effectively. On the other hand, as you mentioned, you don't want to create false hope. To mitigate this you would want to work on managing expectations on the potential results and consequences of those results are. Either way you should be able to gather useful information/experience on both the scientific experiment and the social experiment.
collyw 12y ago
I would like to think that the existing funding of research has mechanisms in place to fund the "best" types of research, which makes me ask why the need for crowd funding? It sounds cool initially but having seen some nonsense that was crowd funded I am not so sure. http://physics.stackexchange.com/questions/39456/the-z-torque-how-can-it-be-shown-intuitively-that-it-does-not-work http://physics.stackexchange.com/questions/39456/the-z-torqu... The article talks about the research being patent free, but surely there are options available to fund research that allow this, or am I wrong?
- irollboozers 12y ago
  You can't really blame them, Kickstarter is composed of artists, not scientists.

exratione 12y ago

You don't need to crowdfund any more than it costs to convince a group with $1bn that they can make money on this by spending that to commercialize your demonstration. That is often just a few million, or even less, depending on how compelling your data and how good your connections. Most of that $1bn and decade of time is make-work created by ever more risk-averse regulators. The actual process of creating something, making a product, and gathering reasonable data on safety is a fraction of that.

jonlucc 12y ago
Wouldn't a group with $1bn to spend want a patent to ensure they would get a return on that money?
- refurb 12y ago
  That's what I don't get. Sure you could crowdfund a few preclinical experiments. But where do you get the ~$100M to get it approved? It would be awesome if someone said "here's $100M, don't worry about paying me back", but I wouldn't count on it.
ig1 12y ago
Why would a company invest a $1bn on a drug they can't patent ? Also drug companies can't just decide they don't want to get FDA approval because it's too much work. They have to work within existing regulations whether they like them or not.
Fomite 12y ago
I'm curious to hear about what parts of the clinical trial process are "make-work" and which are "reasonable data on safety".

zobzu 12y ago

It actually says millions of USD or billions. ie not necessarily 1 billion+ I'm also wondering/suspecting these costs are very much tied to the USA which has a pretty specific model and costs involved. I wouldn't be surprised if the development, of similar quality, would be much cheaper outside the USA. (yes i have noticed this guy is crowdfunding from the USA)

pinaceae 12y ago
still needs to be approved by the FDA, as the rest of the world is using this for guidance. majority of drug development is not the actual science work, but tons of paperwork and audit trails. as history has proven if you play fast and loose here a lot of people will be hurt or killed. you need to document every step along the way. and once clinical trials start, the scrutiny increases, a lot. there is a now a fast track for very promising breakthrough drugs, but getting this designation is very hard and relies on proven, documented science.
- dnautics 12y ago
  This is exactly why I'm only interested in crowdfunding a single, early stage, experiment.
  - collyw 12y ago
    Are there not public grants available it this stage?
    - dnautics 12y ago
      Short answer is. I'm not a faculty in a university since I tried and choose not to try any longer. I'm not in pharma because of patents. So getting a public grant is hard. It's even harder because my old boss is now in charge of the relevant funding stream and she shouldn't be working with grants that further her former avenue of research.
      - 12y ago

dnautics 12y ago

That's like saying it takes 7 billion to make a company that competes with facebook, and you'll never get 7 billion series A funding. Trivially true, but to compete with facebook is a process, and not all stages of a process use the same funding mechanisms.

vvvv 12y ago
Would you like to sign up for a buggy minimum viable drug treatment?
- theworst 12y ago
  Not every startup has to produce a "minimum viable" product. Treatments also do not have to start with human trials.
- grecy 12y ago
  If I had terminal cancer, absolutely!
  - dubcanada 12y ago
    I'm with this guy, if I have terminal cancer. I'll try a remedy made from dirt if it has a chance. I mean what's to lose, at that point my body becomes a free testing lab.
ig1 12y ago
What's the plan for the rest of the money, grants ?
- dnautics 12y ago
  Grants and big donors to push through preclinical and a for profit partner for clinical is my vision, but I am open minded to alternatives.
  - thefreeman 12y ago

adamt 12y ago

I will freely admit I know very little about the pharmaceutical world, but my (perhaps dumb) question is what scope is there to disrupt these typical costs. For example it used to be that space programs cost billions, yet India has just put a Mars orbital in place for $74m. I am old enough to remember when it was the received wisdom that people believed an e-commerce website would cost $1m, yet many startups launch their first site with less then 0.1% of that. How much of that $1bn-$2bn typical cost is open to similar levels of disruption?

Kalium 12y ago
If you can always be right about every drug, every time, at every stage, then perhaps quite a bit. Of course, multiple years of trials is still going to be very expensive. A lot of the costs seem to be linked to the fact that failures are common at every stage. Which is why there is a lot of time, money, and energy being put into reducing failure rates. There's not an easy "insert disruption here" point.
Fomite 12y ago
You can make way cheaper drugs than $1-2 billion (fidaxomicin was developed by Optimer for 200some million) by being very, very picky about your targets, and not failing. But it's not a trivial thing to disrupt, and there are some costs that are just out and out fixed (clinical trials are spendy).

unclebunkers 12y ago

Any time someone says something won't work, what they should be saying is "No one has figured out how to make this work yet".

chc 12y ago
Unless you're asserting that you have figured it out, I don't understand why you'd point this out.
- unclebunkers 12y ago
  Because I hate the negativity.
- McDiesel 12y ago
  Because negativity is a bane on scientific progress. People who claim something can't be done are foolish. Claiming a negative - claiming something you can't prove - is anti-intellectual at best, downright ignorant at worst. There is no need to claim something can't be done. It serves absolutely no purpose. The only possible outcome that negativity can have is to stop someone from trying, when really - thats the heart of scientific discovery. We can't fly, we can't break the sound barrier, we can't we can't we can't. History is full of people who claim we can't. But history forgets those people, and remembers the ones who actually did.