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    Originally posted by Wise Young View Post
    Eric,

    What financial resources model do you have in mind? The for-profit model has been and is still being tried. For example, I helped found Acorda Therapeutics for that reason. A non-profit model is possible but funding to start a non-profit therapeutics company is hard to get, unless one is a Rockefeller or a Gates. A government funded model is also possible but that is essentially what an NIH-funded laboratory would be.

    Wise.
    Dr. Young have you considered or has anyone ever tried arranging some sort of deal with a huge biotech company? from what i know about tech development labs no one puts out more monney towards research than corporate companies. they may demand results more than academic research but funding will not be a problem unless they see a piece of research as fruitless... I know Geron is out there but I bet if we could convince more corporate interests sci is worth looking into we could affect the funding gap...

    Comment


      Originally posted by Eric.S View Post
      Dr. Young have you considered or has anyone ever tried arranging some sort of deal with a huge biotech company? from what i know about tech development labs no one puts out more monney towards research than corporate companies. they may demand results more than academic research but funding will not be a problem unless they see a piece of research as fruitless... I know Geron is out there but I bet if we could convince more corporate interests sci is worth looking into we could affect the funding gap...
      Eric,

      All biotech companies are struggling in terms of funding. Many scientists do work with biotech companies who are funding the clinical trial trials. For example, I work with Stemcyte and Acorda. We are discussing trials with GalaxoSmithKline, Novartis, Pfizer, Johnson & Johnson, and others. Is that what you mean?

      Wise.

      Comment


        Over here many companies is now working together in a network for finding cancer cures, maybe a similar model could be set up for SCI cures. I know several organizations and key people are interested. http://www.oslocancercluster.no/content/view/13/26/

        Comment


          Originally posted by Leif View Post
          Over here many companies is now working together in a network for finding cancer cures, maybe a similar model could be set up for SCI cures. I know several organizations and key people are interested. http://www.oslocancercluster.no/content/view/13/26/
          Leif, this is very unusual. Perhaps you can find out more about this. In the United States, collaboration between many companies is rare unless is it to set standards. Wise.

          Comment


            Originally posted by Wise Young View Post
            Leif, this is very unusual. Perhaps you can find out more about this. In the United States, collaboration between many companies is rare unless is it to set standards. Wise.
            Or prices. Or to defeat or pass regulation.
            Foolish

            "We have met the enemy and he is us."-POGO.

            "I have great faith in fools; self-confidence my friends call it."~Edgar Allan Poe

            "Dream big, you might never wake up!"- Snoop Dogg

            Comment


              Originally posted by Foolish Old View Post
              I would remind folks who think that human trials should begin immediately that there are enormous costs to conducting "proper" ethical and scientific trials. There have been several "therapies" delivered for-profit to people that by-passed the more rigorous and costly standards of "good practice". Have any of these therapies produced cure?

              What is the real world short-cut to cure? Not the "if I were king and ruled the world" short-cut, but the one that real doctors and real companies and real governments could deliver to real patients to produce real cures?
              Let me summarize what it takes to get a clinical trial going in the United States, Europe, and China for the purposes of showing that a treatment is safe and effective to the regulatory agencies for approval.

              First, one must have a therapy that satisfies GMP (Good Manufacturing Practice) criteria. In other words, everything in the therapy must be documented and certified to be safe for humans. The manufacturing practice must conform to industry standards.

              Second, the therapy should have been judged to be safe in large and small animal studies. Small animals usually refer to rodents. Large animals include rabbits, cats, dogs, monkeys. These safety tests must be done according to industry standard.

              Third, clinicians must be identified who are willing to carry out the clinical trials. Once these clinicians are identified, then one must meet frequently with them until a consensus is reached concerning the clinical trial protocol and to ensure that the clinicians and their staff are trained to do the trial.

              Fourth, the clinical trial protocol must be written up and submitted to the institutional review board (IRB) for approval. Investigational drug/device applications (IND) must be submitted to the regulatory agency of each country. In the U.S. and China, these are the FDA and sFDA respectively.

              Fifth, in addition many groups (including the ChinaSCINet) have the clinical trial protocol reviewed by an industry group called Western IRB which hires experts to ascertain that the clinical trial is well designed and fits international ethical standards.

              Sixth, money must be raised, clinical trial agreements must be signed between a sponsoring organization (usually a company... the company that is paying for the trial), and the institution(s) carrying out the trial. The costs vary but any hospitalization and rehabilitation will cost $100K/patient.

              Seventh, patients that fit the inclusion criteria and are not kicked out by the exclusion criteria must be recruited. Informed consent must be obtained from each of the patients. Laboratory tests and imaging information must be obtained to confirm.

              Eighth, the cell transplants or other therapies must be prepared. In the case of umbilical cord blood cell transplants, for example, HLA-matched units must be obtained, prepared, shipped, and tested. The cells must match pre-established standards.

              Nine, the subjects are examined by a designated person or team to ensure that all the examinations are the same and of the highest standard.

              Ten, the subjects are randomized to therapy. The treatment is given and the clinical trial protocol is implemented, including set followup periods that are typically a year or more. The data is collected, confirmed, reconfirmed by third parties. After all the data is collected and certified, then the randomization is unblinded for data analysis.

              Wise.

              Comment


                Originally posted by Wise Young View Post
                Leif, this is very unusual. Perhaps you can find out more about this. In the United States, collaboration between many companies is rare unless is it to set standards. Wise.
                Wise. I used to have good contact some years ago (and still have) with some of the folks (scientists and professors) which did the groundwork for establishing this cluster for cancer cures when many of us worked together to change our biotechnology law (to allow also hESC research among other tings). This cancer cluster also has overlapping activities with our new newly established Norwegian Center for Stem Cell Research http://www.stemcellnorway.org/?k=ncs/frontpage where some of these scientists and professors also are involved, -the stem cell center is headed by professor Joel Glover (neurobiologist and SCI researcher). He knows all the details on how the cancer cluster was established. When you will be over here we could; in addition to the SCI trials, also discuss a little how this cluster was created. That could be very interesting as for looking into if similar tings could be done for a SCI cure cluster. Prof. Joel Glover and others are interested in looking at ways to better focus on spinal cord injury therapies with more focus on SCI research, translation research and more clinical trials for SCI. I also know that other patient (user) organizations over here and others too are interested in looking into such. Could be interesting discussions and I’m sure you’re know-how on SCI would be greatly appreciated.

                Comment


                  Originally posted by Leif View Post
                  Wise. I used to have good contact some years ago (and still have) with some of the folks (scientists and professors) which did the groundwork for establishing this cluster for cancer cures when many of us worked together to change our biotechnology law (to allow also hESC research among other tings). This cancer cluster also has overlapping activities with our new newly established Norwegian Center for Stem Cell Research http://www.stemcellnorway.org/?k=ncs/frontpage where some of these scientists and professors also are involved, -the stem cell center is headed by professor Joel Glover (neurobiologist and SCI researcher). He knows all the details on how the cancer cluster was established. When you will be over here we could; in addition to the SCI trials, also discuss a little how this cluster was created. That could be very interesting as for looking into if similar tings could be done for a SCI cure cluster. Prof. Joel Glover and others are interested in looking at ways to better focus on spinal cord injury therapies with more focus on SCI research, translation research and more clinical trials for SCI. I also know that other patient (user) organizations over here and others too are interested in looking into such. Could be interesting discussions and I’m sure you’re know-how on SCI would be greatly appreciated.
                  Thanks. This would be an excellent model for the California Institute of Regeneration as well. Wise.

                  Comment


                    Originally posted by Foolish Old View Post
                    I would remind folks who think that human trials should begin immediately that there are enormous costs to conducting "proper" ethical and scientific trials. There have been several "therapies" delivered for-profit to people that by-passed the more rigorous and costly standards of "good practice". Have any of these therapies produced cure?

                    What is the real world short-cut to cure? Not the "if I were king and ruled the world" short-cut, but the one that real doctors and real companies and real governments could deliver to real patients to produce real cures?
                    We have harmonized EU standards for clinical trials. These are very strict, in some ways stricter than FDA regulations.

                    Comment


                      Originally posted by Wise Young View Post
                      Thanks. This would be an excellent model for the California Institute of Regeneration as well. Wise.
                      Good point. Joel also knows Hans Keirstead very well.

                      Comment


                        Originally posted by Foolish Old View Post
                        Or prices. Or to defeat or pass regulation.
                        There are no prices on cures over here, for the individuals that is.

                        Comment


                          Originally posted by Leif View Post
                          We have harmonized EU standards for clinical trials. These are very strict, in some ways stricter than FDA regulations.
                          And Wise has told us of the strict standards in China. My point was that real cures are the product of rigorous and expensive scientific investigation. The totally understandable frustration that leads some in our community to believe that scientists are purposely dragging their feet doesn't hold up to common sense consideration.

                          If these legitimate scientists started to immediately offer unproven "cures" in unregulated settings, the same critics would consider them "quacks".
                          Foolish

                          "We have met the enemy and he is us."-POGO.

                          "I have great faith in fools; self-confidence my friends call it."~Edgar Allan Poe

                          "Dream big, you might never wake up!"- Snoop Dogg

                          Comment


                            Originally posted by Leif View Post
                            There are no prices on cures over here, for the individuals that is.
                            I was talking more generally (not "cure" interested companies specifically) about industry collaboration in the U.S.

                            You will see some companies cooperate on issues like patent protection, government funding, fighting re-importation of prescription drugs, etc. But they rarely share information to advance the goal of scientific discovery.
                            Foolish

                            "We have met the enemy and he is us."-POGO.

                            "I have great faith in fools; self-confidence my friends call it."~Edgar Allan Poe

                            "Dream big, you might never wake up!"- Snoop Dogg

                            Comment


                              Originally posted by Foolish Old View Post
                              And Wise has told us of the strict standards in China. My point was that real cures are the product of rigorous and expensive scientific investigation. The totally understandable frustration that leads some in our community to believe that scientists are purposely dragging their feet doesn't hold up to common sense consideration.

                              If these legitimate scientists started to immediately offer unproven "cures" in unregulated settings, the same critics would consider them "quacks".
                              so, Whats more important consideration or results? thin line between quack and legendary figure. If I say I have the cure for cancer I'm a quack, if I really have the cure I'm a legend.... In the end nobody cares how you get there, all that matters is that you get there...

                              Comment


                                Originally posted by Eric.S View Post
                                so, Whats more important consideration or results? thin line between quack and legendary figure. If I say I have the cure for cancer I'm a quack, if I really have the cure I'm a legend.... In the end nobody cares how you get there, all that matters is that you get there...
                                Eric,

                                The line between quack and science is very sharp and clear. Clinical trials provide strong and credible evidence that a treatment is safe and effective. A quack may claim a cure but does not provide credible evidence for safety and efficacy.

                                Quacks sell unproven therapies, using testimonials as their primary support. Time and time again, testimonials have proven to be false and misleading. Everybody believes that the therapy works for them when they have paid for it. Unscrupulous quacks suppress negative testimony and broadcast the positive testimony.

                                You say that "nobody cares how you get there, all that matters is that you get there." This is not true. Lots of people care how you get there. Clinical trials are the only way that a therapy will be accepted by other doctors. It is the only way that insurance companies will pay for the therapies.

                                There is only one way to get there and that is with clinical trial evidence and regulatory approval. All the other route of testimonials are a waste of time, money, and emotions.

                                Wise.

                                Comment

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