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by ig1 4281 days 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 has details for those interested)

Crowdfunding at those sort of levels just isn't feasible yet.

6 comments

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.
What's the plan for the rest of the money, grants ?
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.
Doesn't that fall apart when the for profit partner needs to pay the other $990 million dollars and then still cannot patent the drug?
I don't know. It's certainly a risk, but there's only one way to find out. I think there are companies willing to do it (cipla is one that I'm thinking about approaching).
I'd like to see more of a potential plan here - otherwise I'm afraid that making a drug un-patentable would make it /less/ likely that it goes to market.

I believe I've seen evidence of exactly that happening as margins for a drug are very low if it can't be protected (via IP), and the cost to bring a drug to market is so high.

I see many problems with current IP system - but I don't see how this is avoidable in a completely commoditizable generic drug market.

If I'm making some incorrect assumptions here, I'd love to know!

Would you like to sign up for a buggy minimum viable drug treatment?
If I had terminal cancer, absolutely!
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.
Not every startup has to produce a "minimum viable" product. Treatments also do not have to start with human trials.
Oh yes. I forgot scientists produce life saving medicine from their dorm rooms all the time. How could I forget.
> Oh yes. I forgot scientists produce life saving medicine from their dorm rooms all the time. How could I forget.

That's more common than most people realize (meaning something being discovered through work in an unrelated context). Look at the discovery of Penicillin as one example, there are many others.

"Remember that thing that happened in 1928" is hardly a compelling case. That's like saying you can build a major telecom company without computers because Bell did it.
> "Remember that thing that happened in 1928" is hardly a compelling case.

And that wasn't what I said -- Penicillin is just one example. Look at the polymerase chain reaction, thought up during a late-night drive by a graduate student and now ubiquitous in biology and medicine. Look at the first polio vaccine, created at very low cost by someone who was so sure of his results, and so short of funds, that he used his own children as test subjects.

Examples abound. One need only look.

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.
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".
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.
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-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?

You can't really blame them, Kickstarter is composed of artists, not scientists.
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?

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).

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.

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".
Unless you're asserting that you have figured it out, I don't understand why you'd point this out.
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.

Because I hate the negativity.
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.

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.

Wouldn't a group with $1bn to spend want a patent to ensure they would get a return on that money?
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.
I'm curious to hear about what parts of the clinical trial process are "make-work" and which are "reasonable data on safety".
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)

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.

This is exactly why I'm only interested in crowdfunding a single, early stage, experiment.
Are there not public grants available it this stage?
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.
> 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.

That's one very depressing thought. I understand her reasons, but I see the existence of them as a failure in getting all of us to a rational society. All the best. I'll contribute, what I can.