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Thread: Alliance For Renegerative Medicine (ARM)

  1. #11
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    I was talking more in general and globally above about foundations, organizations and associations, but you are right GRAMMY, such think-tank’s or coordinated - pinpointed to the task with clear goals - umbrella organizing is good, still, don’t fall into the trap thinking that others will do tings for you and fix everything just because one has a associated connection to a united group of different organizations/associations with an agenda of paper written common goals. It doesn’t work like that, as we know. For tings to be fruitful and to materialize it requires time, energy and efforts from the bottom-to-up philosophy, meaning it requires efforts all the way from the single individuals, the grassroot, through associated associations and organizations all the way, all the way up, with constructive dialogue and pressure building all the way for setting timelines on strategies, establishing of statement documentation and so on and putting it out in live. Nothing of this comes by itself, all requires dedicated peoples behind it, whom has enough stamina and energy that can be into this for the long haul for producing in small steps for a long term bigger goal. That should be the philosophy, and if tings comes sooner rater than later, all good, still, efforts must be long term with an focus, and not loose canon efforts just enjoying the game for shorter periods. At least, that is what I think and believe in. Keep up the good work.

  2. #12
    If other countries continue to look at the USA for innovative research, funding, FDA approval and helpful legislation for regenerative medicine...the ARM will be critical in meeting those needs. Nobody goes it alone and finds success. We must have a strong group coordinated to assist with regenerative medicine on healthcare innovation.

    Despite the promise of regenerative medicine obstacles include insufficient funding for product development and clinical trials, an unclear regulatory pathway for new technologies, inconsistent reimbursement policies, and a general lack of awareness of the potential for regenerative medicine to help us.

    The Alliance developed this plan to provide a strategic framework that will complement the legislative proposals included in the Regenerative Medicine Promotion Act of 2011, which the US House of Representatives introduced as H.R. 1862 in May 2011.

    This legislation calls for the creation of a Regenerative Medicine Coordinating Council among federal government stakeholders, establishment of different funding mechanisms for public–private research projects and preclinical work needed to file an investigatational new drug apppplication, and increased funding for regulatory science research at FDA.

    The Regenerative Medicine Promotion Act of 2011—along with the national strategy—are essential to US efforts to maintain international leadership in healthcare innovation. SCI organizations should pull up into the front row!
    Last edited by GRAMMY; 07-07-2011 at 11:42 AM.

  3. #13
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    Quote Originally Posted by GRAMMY View Post
    If other countries continue to look at the USA for innovative research, funding, FDA approval and helpful legislation for regenerative medicine...
    If other countries looked at Norway and especially Oslo Cancer Cluster, one would get an good idea on how to do things as for translation research.

  4. #14
    @ Leif, Has Norway started a UCBC/Lithium clinical trial yet?
    Last edited by GRAMMY; 07-07-2011 at 11:55 AM.

  5. #15
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    Quote Originally Posted by GRAMMY View Post
    @ Leif, Has Norway started their UCB/Lithium clinical trial yet?
    No (and you know that), and there is a joint agreed reasoning behind that along with possible collaborating partners.

  6. #16
    Quote Originally Posted by Leif View Post
    Nothing of this comes by itself, all requires dedicated peoples behind it, whom has enough stamina and energy that can be into this for the long haul for producing in small steps for a long term bigger goal. That should be the philosophy, and if tings comes sooner rater than later, all good, still, efforts must be long term with an focus, and not loose canon efforts just enjoying the game for shorter periods. At least, that is what I think and believe in. Keep up the good work.
    I agree 100%.

  7. #17
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    Quote Originally Posted by GRAMMY View Post
    I agree 100%.
    GRAMMY. Norway can do clinical trials on SCI and will work for any improvements that can help SCI. Aside, as dr. Wise Young has commented on, many times, in this forum, if current phases II studies, like if phase I/II don’t show any efficiency, although phase I and II don’t measure, as for significance and statistics as for stats, one does not move to phase III. This logic is good, I find, come to phase II improved or III, then Norway too will act. Aside, the reasoning behind the basics of the science behind this is sound, used cells, no known side effects and the theorem and basal studies shows that growth factor introduced cell systems to an injured spinal cord can have some benefits, at least in animal models in a lab, and if one wants to go further all knows new remedies and approaches has first to be tested on humans, if so or making therapies valid these days, for US citizens maybe for getting therapies paid for by insurance companies, for countries like mine that all whom wants it can have it for free and that all of us living in great countries then can be good advocates to help our fellow SCI brothers and sisters in other countries to help them too. We really have to think global, to help any with SCI.

  8. #18
    All best wishes for Norway.

    The USA has it's own problems to deal with concerning SCI and the future of regenerative medicine. Our problems differ in many many ways. We can't rebuild the system in place, so we have to fight down many paths along the way. It's imperative to pick the right battle at the right time with right people to make a difference that counts. Lets hope that ARM can help make a difference that will really count. They have some serious soldiers lined up to do battle.

  9. #19
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    Quote Originally Posted by Leif View Post
    I was talking more in general and globally above about foundations, organizations and associations, but you are right GRAMMY, such think-tank’s or coordinated - pinpointed to the task with clear goals - umbrella organizing is good, still, don’t fall into the trap thinking that others will do tings for you and fix everything just because one has a associated connection to a united group of different organizations/associations with an agenda of paper written common goals. It doesn’t work like that, as we know. For tings to be fruitful and to materialize it requires time, energy and efforts from the bottom-to-up philosophy, meaning it requires efforts all the way from the single individuals, the grassroot, through associated associations and organizations all the way, all the way up, with constructive dialogue and pressure building all the way for setting timelines on strategies, establishing of statement documentation and so on and putting it out in live. Nothing of this comes by itself, all requires dedicated peoples behind it, whom has enough stamina and energy that can be into this for the long haul for producing in small steps for a long term bigger goal. That should be the philosophy, and if tings comes sooner rater than later, all good, still, efforts must be long term with an focus, and not loose canon efforts just enjoying the game for shorter periods. At least, that is what I think and believe in. Keep up the good work.
    Absolutely true. Well said.
    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature.

  10. #20

    Reengineering Translational Science: The Time Is Right Francis S. Collins

    Here is a related article written by the Director of the NIH outlining the work of the National Center for Advancing Translational Sciences (NCATS).

    http://stm.sciencemag.org/content/3/90/90cm17.full

    Despite dramatic advances in the molecular pathogenesis of disease, translation of basic biomedical research into safe and effective clinical applications remains a slow, expensive, and failure-prone endeavor. To pursue opportunities for disruptive translational innovation, the U.S. National Institutes of Health (NIH) intends to establish a new entity, the National Center for Advancing Translational Sciences (NCATS). The mission of NCATS is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of diseases and conditions. The new center’s activities will complement, and not compete with, translational research being carried out at NIH and elsewhere in the public and private sectors.

    The medical benefits of the current revolution in biology clearly cannot be achieved without vigorous and effective translation. Yet the triple frustrations of long timelines, steep costs, and high failure rates bedevil the translational pathway. The average length of time from target discovery to approval of a new drug currently averages ~13 years, the failure rate exceeds 95%, and the cost per successful drug exceeds $1 billion, after adjusting for all of the failures (1, 2). In this Commentary, I describe the goals, functions, and structure of the National Center for Advancing Translational Sciences (NCATS), a new entity currently being shaped by the U.S. National Institutes of Health (NIH) to reengineer the process of developing diagnostics, devices, and therapeutics.

    ADDRESSING THE BOTTLENECKS


    The translation of basic biological discoveries into clinical applications that improve human health is an intricate process that involves a series of complex steps: the discovery of basic information about the pathogenesis of a disease; an assessment of whether that information has the potential to lead to a clinical advance; development of candidate diagnostics, devices, or therapeutics; optimization of the candidates in preclinical settings; regulatory assessment of the data to determine the potential for human use; testing in human clinical trials; application for approval for widespread clinical use; and, ultimately, the assessment of approved diagnostics, devices, and therapeutics during widespread use in real-world settings.

    The upstream component of this developmental pipeline is progressing vigorously, aided by dramatic technological advances and associated basic insights into disease mechanisms—research that has been supported heavily by NIH and other funding agencies. The downstream end—premarket clinical trials—is traditionally the strong suit of the private sector because of its considerable expertise in assessing promising interventions. However, serious problems exist in the middle zone, in which attrition rates for candidate products are horrendously high. Many of the complex steps in this middle zone have been performed in the same way for a decade or more and have not been subjected to the kind of bold innovation that has characterized other branches of biomedical science. Thus, the time is right to take a comprehensive, systematic, and creative approach to revolutionizing the science of translation.

    To shape and sharpen this new vision, NIH now proposes to establish NCATS. Intended to serve as NIH’s catalytic hub for translational innovation, the new center will complement—not compete with—translational research at the NIH and elsewhere in the public and private sectors. Simply put, NCATS’s mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics, therapeutics, and devices across a wide range of human diseases and conditions.
    NCATS-supported researchers will seek to advance the science of translation by identifying bottlenecks in the therapeutic development pipeline that may be amenable to reengineering; experimenting with innovative approaches to reduce, remove, or bypass these bottlenecks; and evaluating these innovations by assessing their performance in real-world applications. All of this will be done in a transparent scientific environment, using NIH-based online resources to ensure that information about successes—and failures—is made swiftly available to all stakeholders.

    CHALLENGING THE STATUS QUO

    Basic science research conducted in the nonprofit sector has provided knowledge integral to clinical advances. NIH-supported scientists have played a fundamental role in the discovery of many receptors, enzymes, and disease-related pathways that spurred the development, by the private sector, of myriad therapeutics (36). But the research and development landscape has changed, and a new model is needed.

    Scientific advances have moved us from an era in which most drug development was based on a short list of a few hundred targets with great depth of understanding to an era in which molecular technologies provide thousands of new potential drug targets but limited information about their mechanisms and potential “druggability.” To give just one example, efforts that use the genome-wide association studies (GWAS) approach have revealed 1100 well-validated genetic risk factors for common diseases (7, 8). Given that many known drug targets have turned up in GWAS research (Table 1), it seems likely that previously unknown targets also lie hidden in the vast trove of GWAS data. Furthermore, in recent years research has uncovered the genetic bases of thousands of Mendelian disorders, suggesting possible interventional strategies for these rarer diseases and conditions.

    more..... http://stm.sciencemag.org/content/3/90/90cm17.full
    "Our lives begin to end the day
    we become silent about things that matter."
    - Martin Luther King Jr

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