Stopping for the moment.......

[Stargazer]

on the TSC project until I can get more information. What little I've learned is....

Two directors. One is Rothenberg.

Close affiliation with a for profit company named Curagen (I believe drug company) with Rothenberg as CEO and his wife as director of research.

Rothenberg's awards are for entrepreneur of the year and a corporate leadership award.

None of the scholarly papers linked on Rothenberg mention Rothenberg Institute. No endorsements by any of the hospitals or universities mentioned.


I'm anal about my cpu time and just want to make sure it isn't going to make some individual or corporation rich. Hopefully, I'll find my answers:)

[Chelle]

Interesting.. let us know what you find out, please...

[Rids]

Fair enough Stargazer, your computers, your choice :)
Personally, well if it helps find a cure for something I couldn't give a monkeys who gets the credit :D

[Terminator]

:eek: don't like the sound of that, let's us know what you find out :(

[bubbadog]

In the meantime Stargazer, might I suggest another project? :cunning:

[^7_of_9]

I say everyone joins the search for little green men so that way when we do find them they can give us all the cures for the diaseses. That way we kill about 50 birds with one stone. ;)

[Chelle]

Unless the little green men give us 50 NEW diseases :scared:

:D

[^7_of_9]

But a diasese by where you grow a new head or a tail can't ALWAYS be a bad thing now can iit ? :rolleyes:

[bubbadog]

Um yeah...ever seen Independence Day, 7?

[Rids]

Yeah, they could well see us as parasites and cleanse the planet :D

[bubbadog]

I know people who would make that a justifiable conclusion ;)

[N2OCapri]

two parter post copied from main TSC forum


Hello,
I'm from V0X's team, too, and have participated (and still do, in some cases) in mumerous distributed computing projects, especially in the health field (Folding@Home, Genome@Home, UD THINK, distributedfolding.org).
I have a question regarding the intellectual property of scientific discoveries and drugs resulting from this distributed computing project. I could not find detailed information about this on the childhooddiseases.org site, but I may have looked in the wrong places.
Now, I'm no day-dreamer and I know that virtual screening is but the very first stage of a long and, above all, costly process until drugs are developed and 'hit the market'. The testing of potential candidates in real (not 'in silico') labs and clinical trials require lots of financial resources, probably more than a single charity, university or other non-profit organisation could pay for.
So, I expect that at some point pharmaceutical companies will become involved in this process and expect a share in potential profits. What I, and I'm sure from the passionate discussions I recall from last April when United Devices' THINK project started many others (as soon as they learn about your very intersting project), would like to know is:
a) at which point will pharmaceutical companies become in the drug development process
b) how much of potential revenues from drugs being marketed and which originated (in whole or in part) from this distributed computing research will go to non-profit organisations and thus directly benefit further research?
c) will results be published in a peer-reviewed journal?
d) what is the exact role of CuraGen in this research (as Mr Rothberg is its CEO)

I know these are very detailed questions and you might have contracts not allowing you to disclose this detailed business information, but I would appreciate any clarification you could give.
I would take any bet that these are questions that will be asked a lot once this project becomes more widely known and any missing clarity might unfortunately result in lots of people choosing not to participate from my experience in the distributed computing community. So, pro-active information might be a good thing :-)
As an example of how United Devices/Oxford handled this, here is a link to their Intellectual Property Statement they released after similar inquiries and a link to an article saying that Prof. Graham Richards, head of the Oxford research group has donated his 25 % share in Inhibox, the company that will perform further analysis of the UD THINK results, to the National Foundation for Cancer Research, so that at least 25% of any benefits of drugs developed by them should benefit further research.

Thanks a lot for any answers,
Jerome

[N2OCapri]

Jerome,

Lots of good questions.

Our goal is to make drugs to cure TSC, a rare childhood disorder. If we do that we will also learn about many aspects of cancer. The entire field of recombinant DNA, and the entire biotechnology industry came from people studying soil bacteria (Why when one bacteria ate another the later's DNA did not take over? The answer was restriction enzymes and the birth of an industry).

When we understand TSC, we will have a better understanding of Cancer.

Now to your questions:

a) Pharma will help when we can show them we have compelling evidence we have a potential drug they can make money from. Either from helping people with TSC related cancers, or with other cancers. Until then we plan on funding all the pre-IND (before you submit to the FDA) ourselves. Once we submit to the FDA we will enlist the help of the TS alliance, a public charity that is the center of supporting TS patients to do the clinical trials.

b)100% of profits we get will be plowed back into the Rothberg Institute to do more research. We are a Not-for-profit organization. We are also sponsoring research through the TS alliance at academic sites for target discovery as well as for follow-up on results we generate. We give this money with NO restrictions, except we ASK researchers to share their results. If they don't, we will not fund them again.

c) Yes, results will be published in peer review (I have the covers of both Cell and Nature, and love to publish so my mom see's the work .

In fact the results from the screen with information on the compounds will be available to everyone as they are generated (see statistics page). We are using compounds that can be purchased off the self, and I would love someone to scoop the researchers at the Rothberg Institute and Cure TSC before us. Really. The first 200,000 compounds are all available from the NCI for free for anyone to test.

d)CuraGen has no direct role in the research, or in the results. However, I always ask for help from people I know and trust, and a few CuraGen people on their own time are helping build the institute. A great group of people from Fox Chase and Yale are also helping (see our scientific advisors).

Thanks for the questions, we need your help. I would love the institute to become the best center for computational chemistry and we are dedicated to make this happen. I truly believe that over the next three years with the number of new structures being determined that if we can improve docking based virtual library screening we will be able to make great drugs and change people lives.

Jonathan

[Rids]

Good enough for me :thumbsup:

[Chelle]

That clarifies that :)

[bubbadog]

Originally posted by N2OCapri
Jerome,

Lots of good questions.


a) Pharma will help when we can show them we have compelling evidence we have a potential drug they can make money from. Either from helping people with TSC related cancers, or with other cancers. Until then we plan on funding all the pre-IND (before you submit to the FDA) ourselves. Once we submit to the FDA we will enlist the help of the TS alliance, a public charity that is the center of supporting TS patients to do the clinical trials.

That's a really nice feel-good answer. Unfortunately, it is utter :bs: An IND is submitted to the FDA long before Phase 3 clinical trials start. Phase 1 trials are animal studies. Phase 2 trials are testing in healthy volunteers to determine toxicities, side effects, elimiation half-life in humans, etc. Actual patients are not involved until Phase 3, which is sometimes years down the road. At the time of the Phase 2 trials, detailed information about the manufacturing processes must be submitted. Any changes to the process after that mean that the IND must be amended. It's all well and good for the TS Alliance to help with finding centers to do the studies on actual patients, but there is a huge amount of costly record-keeping and testing involved in this as well. Study centers, including hospitals, do it because they are paid to do so. Pre-IND work invloves not only analyzing the data, but producing the actual drug itself. You have to have physical product, not just theoretical compounds.


b)100% of profits we get will be plowed back into the Rothberg Institute to do more research. We are a Not-for-profit organization. We are also sponsoring research through the TS alliance at academic sites for target discovery as well as for follow-up on results we generate. We give this money with NO restrictions, except we ASK researchers to share their results. If they don't, we will not fund them again.

:roflmao: If Pharma won't get involved in the project until you prove they can make money at this, then I doubt very seriously that they will just decide to turn over any profits to the institute. All companies, incluing drug companies, exist to make money.

[Rids]

so this leaves us where? ....... :confused:

[bubbadog]

Apparently, still waiting for an answer.

Don't get me wrong, I am not trying to dissuade anyone from running this project. The fact is, pharmaceutical companies do a great deal of reasearch and development, and fund researchers in universities, etc all the time. It would not surprise me at all to find that a researcher or university took a distributed computing approach stretch the grant dollars and speed up the process. However, I do feel that we deserve honest answers to legitimate questions.

[N2OCapri]

ok I posted this on the TSC forum, lets go looking for answers to concerns..................

On a side note, stats are still very very screwed..............

[Stargazer]

Originally posted by bubbadog
In the meantime Stargazer, might I suggest another project? :cunning:

In the meantime......the Armada will continue full ahead on DF;)

[Stargazer]

Originally posted by bubbadog


That's a really nice feel-good answer. Unfortunately, it is utter :bs: An IND is submitted to the FDA long before Phase 3 clinical trials start. Phase 1 trials are animal studies. Phase 2 trials are testing in healthy volunteers to determine toxicities, side effects, elimiation half-life in humans, etc. Actual patients are not involved until Phase 3, which is sometimes years down the road. At the time of the Phase 2 trials, detailed information about the manufacturing processes must be submitted. Any changes to the process after that mean that the IND must be amended. It's all well and good for the TS Alliance to help with finding centers to do the studies on actual patients, but there is a huge amount of costly record-keeping and testing involved in this as well. Study centers, including hospitals, do it because they are paid to do so. Pre-IND work invloves not only analyzing the data, but producing the actual drug itself. You have to have physical product, not just theoretical compounds.



:roflmao: If Pharma won't get involved in the project until you prove they can make money at this, then I doubt very seriously that they will just decide to turn over any profits to the institute. All companies, incluing drug companies, exist to make money.

Thanks Bubba:) It's so much deeper than what is published. That's what scares me. Why not complete disclosure?

[Terminator]

Well I've had enough of it for now, not only the concern about what's happening behind the scenes, but screwed up stats aren't good for a DC project you just can't keep track of what's happening and the client is a PITA I've had a PC doing nothing for over 20 hours because it decided to stop 1 conformer after I checked it last night.

Not a happy Terminator :(

[Chelle]

With your fleet Terminator I can understand that :)

Well, Im not ready to pull out at the first smell of trouble. (and my fleet is running smoothly) I plan on doing more research on this when I get more time over the weekend. Seems to be a lot of speculation at this point.

[Chelle]

From their site:
http://www.childhooddiseases.org/cgi-tsc/ultimatebb.cgi?ubb=get_topic;f=5;t=000035

All,

We are re-working our statistics pages and you will continue to notice problems with them into the afternoon. You should still be able to upload/download tasks for your clients during this time. If you encounter any problems please let us know.

Ken

And another:
http://www.childhooddiseases.org/cgi-tsc/ultimatebb.cgi?ubb=get_topic;f=5;t=000036

All,

The project will be down for a very short while today while we are working on our statistics pages. During this time you will not be able to upload/download any candidates. If you client continues to have trouble uploading/downloading into this afternoon please let us know.

Ken

I'm also prepared to give them a chance to work out the stats issue.

[Rids]

I'm still here too hon :)
I crunch for fun and if the project does some good then all the better :p

[N2OCapri]

All my clients were showing a higher candidate total than was being reported on the site up untill an hour ago.............

Now.............

All my clients are showing the same as the site............


NOT because they fixed their stats but because they just casually blew away half a days production, no sorry no nothing..............

I'll let it run till tommorow but if is their attitude I'm afraid they can blow me.

I will not be treated in this cavalier and condescending attitude.

Sorry guys and gals I'm bitching here and I aint even on your team :(

[Chelle]

LOL, bitch away.. everyone else does :D

[Talon]

bitch away, N2OCapri, but lets try and refrain from the "blow me" phrases if we can please. :)

[bubbadog]

Don't misunderstand me, I agree with the aims of the project and I think it's a worthwhile goal. The fact is that one of the job criteria for university professors in scientific fields is to bring in grant money. Not all of that money comes from non-profit organizations; in fact, I would venture to say that only a small portion of it does. Governments and corporations "contract out" reesarch via the grant system all the time. Frankly, I don't have a problem with that, if indeed that turns out to be the case here. What I do have a problem with is being fed platitudes in lieu of a straight answer. I am not trying to dissuade anyone from running this project; if I ever manage to get my hands on another machine, I intend to run it myself. I am just saying that it is in the best interest of the project for those running it to be forthright in their answers.

[Chelle]

Looks like Data's pulled out too.

I'm undecided if they're holding out, or just plain not at liberty to discuss certain issues. Just because the public demands to know every aspect of a company, doesn't mean the company is obligated to disclose that information. Too many unknowns, and lack of information is unfortunately always viewed as withholding information which implies wrongdoing.

If it turns out there's no wrongdoing on their part, it's a shame the impact the bad publicity will make on the project itself.

[N2OCapri]

Originally posted by Talon
bitch away, N2OCapri, but lets try and refrain from the "blow me" phrases if we can please. :)

Soz..........

Gonna see what's happening in the morning but if there's no clear cut reply to the Intellectual Property thread, I'm gonna have to pull the plug on this one :(

[Rids]

I would like to respond to some of your questions and hope that I can deliver a satisfactory answer:

The VLS project is just a first step in the long path towards a drug candidate. It is highly unlikely that any compound pulled out of a commercially available library (with the possible exception of known and approved drugs with activity against TSC) will be anywhere close to a good drug candidate. When we perform VLS we are trying to reduce the total number of compounds we need to screen in both cell based (in vivo) as well as biochemical (in vitro) assays to obtain lead compounds. The lead compounds then undergo several cycles of optimization, in order to improve efficacy, as well as several properties that make a molecule "drug-like" (commonly referred to as ADME-Tox which are A - Adsorption, D - Distribution, M - Metabolism, E - Excretion and Tox for toxicity). A compound will only go into clinical trials once it has undergone optimization. The quantities of material required for clinical trials require an efficient synthesis and process for its production. This process will be worked out by chemist working at the institute as well as collaborators in both academia and industry.

The role of industry in the development of the drug will probably be limited to the manufacture and distribution of any drug “discovered” at the institute and is commonly done under license. Examples of such agreements are commonly found in the industry where small drug-discovery companies partner up with big-pharma to produce and distribute a drug under license.

I hope that I have answered some of your questions.

Kind regards
Wolfgang Hinz

--------------------
Wolfgang Hinz
Senior Research Scientist - Chemistry/Informatics
The Rothberg Institute
Guilford, CT
www.childhooddiseases.org

[Chelle]

Sounds reasonable to me :)