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martianmoons
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How Will These New Drug(s) Proceed to Clinical Testing and To Market?

We understand our work is the very first step in a long and expensive path to bringing new drug(s) to market.

As such, who will proceed to do the work after our work is completed? That is, to move through the process of pre-clinical and clinical trials and ultimately to manufacturing and distribution to the end-users?

Thanks! :)
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Re: How Will These New Drug(s) Proceed to Clinical Testing and To Market?

Most likely some company in the private pharmaceutical industry will use this information for furture drug development. Since yellow fever and related illnesses are widespread there will be a large commercial demand for the drugs.
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martianmoons
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Re: How Will These New Drug(s) Proceed to Clinical Testing and To Market?

Most likely some company in the private pharmaceutical industry will use this information for furture drug development. Since yellow fever and related illnesses are widespread there will be a large commercial demand for the drugs.

That is what I am hoping!

I am further hoping that the researchers may already have a drug company(ies) that are interested and ready to use this research we are all doing! Perhaps even that they have some drug company funding for this WCG project, that would be the best scenario yet!

Would any of the project scientists care to comment? Thanks! :)
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[Edit 1 times, last edit by martianmoons at Sep 9, 2007 4:49:39 PM]
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twilyth
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Re: How Will These New Drug(s) Proceed to Clinical Testing and To Market?

I had thought that any results produced from using WCG resources had to be public domain. If so, any person or organization should be free to test possible drug candidates. I would think that would be a disincentive to drug companies who want exclusivity in return for absorbing the exorbitant costs of clinical trials.

However if the individual labs running on projects on WCG narrow down the list of possible drugs via in vivo testing or some other means, does that then give them exclusive rights to those compounds? I don't know.

If our work narrows targets down to a certain family of compounds and the labs develop one that didn't directly result from our prospecting, that would probably give the lab exclusive rights which they could then in turn transfer to a pharma company.

This is an interesting question because without exclusivity, no one is going to do the necessary clinical trials. You run into the same problem with natural remedies. Since a drug company can't market say niacin exclusively, no one is willing to do trials on how well it reduces blood cholesterol levels. In the US it is in fact now available by prescription (and has been for several years) but the script is for a version of the vitamin/drug compounded using a proprietary timed-release formula.

However if it is possible to get exclusive rights to a compound discovered in part by WCG's work, isn't that at odds with it's stated goals

Research We Support
World Community Grid supports research that is:

* Focused on solving problems to benefit humanity;
* Conducted by public or nonprofit organizations;
* Contributed to the public domain; and
* Accelerated by grid computing technology.

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Re: How Will These New Drug(s) Proceed to Clinical Testing and To Market?

You run into the same problem with natural remedies. Since a drug company can't market say niacin exclusively, no one is willing to do trials on how well it reduces blood cholesterol levels. In the US it is in fact now available by prescription (and has been for several years) but the script is for a version of the vitamin/drug compounded using a proprietary timed-release formula.


Sad but true. So many natural compounds hold a lot of promise, but (in the US at least) doctors/AMA(and sometimes media) usually advise against their use because they're not "FDA-approved" or have enough studies. There is little money to be made from them in comparison to pharmaceutical drugs, so there are usually few studies (except the much appreciated ones that come out of academia).

I think attitudes are changing though and the natural compounds are gaining ground as more research comes out.
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Re: How Will These New Drug(s) Proceed to Clinical Testing and To Market?

The work that WCG does is public domain. Any additional work done based on what the WCG has produced belongs to the organization that does that work. What WCG does is the very basic research in just screening for potential new drugs based exclusively on chemical bonding. Extensive and expensive work is needed to actually produce a new drug that works in humans, and the products of that work belongs to whoever does it.
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twilyth
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Re: How Will These New Drug(s) Proceed to Clinical Testing and To Market?

products of that work belongs to whoever does it


But how do you patent something that is public domain? Plus the compounds that we run bonding simulations on come from drug libraries which I think are also public domain.

To get a patent - at least in the US - I think you have to show that something is novel and unique. I don't see how you could claim that using results that are public domain which are based on compounds from public databases.

I'm sure someone at WCG has thought this through - I'd just like to know what the answer is.
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Re: How Will These New Drug(s) Proceed to Clinical Testing and To Market?

You run into the same problem with natural remedies. Since a drug company can't market say niacin exclusively, no one is willing to do trials on how well it reduces blood cholesterol levels. In the US it is in fact now available by prescription (and has been for several years) but the script is for a version of the vitamin/drug compounded using a proprietary timed-release formula.


Sad but true. So many natural compounds hold a lot of promise, but (in the US at least) doctors/AMA(and sometimes media) usually advise against their use because they're not "FDA-approved" or have enough studies. There is little money to be made from them in comparison to pharmaceutical drugs, so there are usually few studies (except the much appreciated ones that come out of academia).

I think attitudes are changing though and the natural compounds are gaining ground as more research comes out.


Natural remedies without testing and study are somewhat risky to use. The interaction with other drugs and foods is not known and can be dangerous. The actually effectness is not known and standardization of dosages is not there because different manufactures preparations can differ. Legitimate studies are not done to keep out potential drugs, they are just the method necessary to make sure new drugs are safe and effective, although the process is not perfect due to limited test subjects usually used in studies. Approved drugs can have problems once released for public use due to a larger group of users.
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Re: How Will These New Drug(s) Proceed to Clinical Testing and To Market?

products of that work belongs to whoever does it


But how do you patent something that is public domain? Plus the compounds that we run bonding simulations on come from drug libraries which I think are also public domain.

To get a patent - at least in the US - I think you have to show that something is novel and unique. I don't see how you could claim that using results that are public domain which are based on compounds from public databases.

I'm sure someone at WCG has thought this through - I'd just like to know what the answer is.


Improvements on existing devices can be patented, the same goes for improvements on existing molecules. In the WCG case, the promising molecule might need some changes to work in human systems and then the molecule can be patented. A patent for that molecule is fair because it allows the developer to recover the cost incurred for the work done.
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Re: How Will These New Drug(s) Proceed to Clinical Testing and To Market?

Yes indeed - we've gone into this in some depth with FAAH. The same things apply to DDDT.

In short, there is a long and expensive path from a drug lead to a tested and approved drug. It is generally to everyone's advantage to let the big pharma companies foot the bill for human trials. Along this path, there will be many processes and innovations that may potentially be patented. But the more work we do at WCG and release into the public domain, the harder it is to patent anything. All this will make it easier and cheaper to create generic drugs later, not restricted by these patents.

But yes, the big pharmaceuticals will probably get to market first, and will probably charge a lot. The generic drugs are the important goal, though.
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