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  • #31
    Originally posted by GRAMMY View Post
    Vance was spot on with many important observations that had been entirely overlooked. Good job.
    Great that he acknowledged the impact of the NASCIC panel - "The effect on the audience was strong. Many of the researchers I spoke to were surprised and actually offended"

    Too bad they probably don't care - "Several left the meeting early, realizing that they had little to learn that could shape their research over the next few years"

    Few of them want change, they are happy the way things are. The disruption needs to be pushed from high above, otherwise nothing will ever change.


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    • #32
      Originally posted by niallel View Post
      Great that he acknowledged the impact of the NASCIC panel - "The effect on the audience was strong. Many of the researchers I spoke to were surprised and actually offended"

      Too bad they probably don't care - "Several left the meeting early, realizing that they had little to learn that could shape their research over the next few years"

      Few of them want change, they are happy the way things are. The disruption needs to be pushed from high above, otherwise nothing will ever change.


      I disagree with the whole "they probably don't care and few want change" stuff as that simply isn't true (along with being antagonistic and defeatist).

      There's obviously some disappointment and stunned people because in the age of the internet, cell phones and open access journals, people were expecting more than a standard meeting agenda suitable for two decades ago. (There was an unmistakable time warp, the death of expertise if you will at that meeting...)

      People were probably expecting something more along the lines of a "disruption meeting" to include the FDA being seated for CT discussions, a NCATS team seated to discuss translation strategies, primate lab personnel to discuss opponents, open database proponents, statisticians, CRO's, relevant biotech companies and investors. Without the proper seats being filled for discussion, there is no "disruption".

      Knowledge about SCI research and science today is not a wall where information has been held back and not reaching the people. It is sometimes a flood, overwhelming our critical thinking in what it takes to move the field forward and get therapies out to the people. Not to promote a narrative or agenda, but people and organizations really do need to utilize expertise at their disposal if they are to ever make a difference.
      http://spinalcordresearchandadvocacy.wordpress.com/

      Comment


      • #33
        Originally posted by GRAMMY View Post
        I disagree with the whole "they probably don't care and few want change" stuff as that simply isn't true (along with being antagonistic and defeatist).

        People were probably expecting something more along the lines of a "disruption meeting" to include the FDA being seated for CT discussions, a NCATS team seated to discuss translation strategies, primate lab personnel to discuss opponents, open database proponents, statisticians, CRO's, relevant biotech companies and investors. Without the proper seats being filled for discussion, there is no "disruption".

        Knowledge about SCI research and science today is not a wall where information has been held back and not reaching the people. It is sometimes a flood, overwhelming our critical thinking in what it takes to move the field forward and get therapies out to the people. Not to promote a narrative or agenda, but people and organizations really do need to utilize expertise at their disposal if they are to ever make a difference.
        This sounds like the most intelligent feedback I've seen. I can only imagine the frustration of going to a conference expecting to learn from and challenge key players, only to find they are not there.

        Comment


        • #34
          Originally posted by GRAMMY View Post
          I disagree with the whole "they probably don't care and few want change" stuff as that simply isn't true (along with being antagonistic and defeatist).

          There's obviously some disappointment and stunned people because in the age of the internet, cell phones and open access journals, people were expecting more than a standard meeting agenda suitable for two decades ago. (There was an unmistakable time warp, the death of expertise if you will at that meeting...)

          People were probably expecting something more along the lines of a "disruption meeting" to include the FDA being seated for CT discussions, a NCATS team seated to discuss translation strategies, primate lab personnel to discuss opponents, open database proponents, statisticians, CRO's, relevant biotech companies and investors. Without the proper seats being filled for discussion, there is no "disruption".

          Knowledge about SCI research and science today is not a wall where information has been held back and not reaching the people. It is sometimes a flood, overwhelming our critical thinking in what it takes to move the field forward and get therapies out to the people. Not to promote a narrative or agenda, but people and organizations really do need to utilize expertise at their disposal if they are to ever make a difference.
          What you say is true and I don't disagree, but there is another side that I was thinking about.
          If the disruption isn't going to happen from the top, then why do the scientists not disrupt themselves? If they don't then it must be because they are happy with the current situation.

          I'll give you some examples of things that have happened to me over the last year when funding projects.
          1) Asked that they go down the compassionate use path while they jointly follow the full availability FDA regulatory path. I was told that's not the way things are done.
          2) Request they map out a full path to the clinic to be followed if this project is successful. I was told they might seek external companies at a later stage. I took this to mean they couldn't care less about what happens after the research, if they did they would embrace it now.
          3) Ask for acute and chronic to be done in parallel. They agreed, then went ahead and only did the acute stuff, promising chronic later.
          4) Ask for next steps and told the next steps are to trial in other illnesses, so they can make the market bigger. So we fund this so they can move on to playing in the labs with other stuff, really?

          All of these things have been happening for too long, and will continue to happen unless they disrupt themselves and think of the end goal.

          Comment


          • #35
            ...

            Originally posted by niallel View Post
            What you say is true and I don't disagree, but there is another side that I was thinking about.
            If the disruption isn't going to happen from the top, then why do the scientists not disrupt themselves? If they don't then it must be because they are happy with the current situation.

            What kinds of unhappiness do you propose they self inflict to make a difference in their laboratory?

            I'll give you some examples of things that have happened to me over the last year when funding projects.
            1) Asked that they go down the compassionate use path while they jointly follow the full availability FDA regulatory path. I was told that's not the way things are done.

            Correct. FDA regulatory paths and compassionate use designations are not in a scientists wheel house. Not even close. Those calls are made by biotech companies and their boards and then agreements ultimately consummated by the designated hospitals involved with the therapy very late in the planning if at all.

            2) Request they map out a full path to the clinic to be followed if this project is successful. I was told they might seek external companies at a later stage. I took this to mean they couldn't care less about what happens after the research, if they did they would embrace it now.

            An accurate full path map would be near impossible with changes being made to accommodate regulatory measures, lack of funding along the way and a million other things that come up in the valley of death. Realistically, you're requesting someone put a pipe dream to paper but it's not of much use other than that. There's never been such an easy well laid plan that's resulted in bringing a therapy to market.

            3) Ask for acute and chronic to be done in parallel. They agreed, then went ahead and only did the acute stuff, promising chronic later.

            Without knowing the specifics, I've seen plans changed due to many unforeseen circumstances such as staffing, grant declines and deadlines, budget overages, student issues, supply shortages, animal death, etc. Always expect changes along the way because you're dealing with live people, live animals and a million variables. Research and people are not stagnate. Stay in tune with your project and see it to completion even though the road is bumpy. There are no guarantees even the very best run labs.

            4) Ask for next steps and told the next steps are to trial in other illnesses, so they can make the market bigger. So we fund this so they can move on to playing in the labs with other stuff, really?

            Yes, really! SCI oftentimes must have other diseases involved to leverage the business aspect. It's the money piece. SCI usually doesn't have enough of it to bring anything through the valley. If it did, you'd have therapies on the market. Depending on the therapy, you'll maybe need stroke, MS, heart, ALS... It's a given. With that being said, don't be deterred in your determination to influence the direction of the research. Keep talking, keep building the relationships and show your dedication, promise more and prepare to deliver. If you give up the lead or find it too difficult to stay in front, then it's over. Pick up your toys and move to a different project. Half of the battle is learning the ropes and working within the perimeters that's laid out in front of you. You seriously don't have decades left to rewrite all the rules to your satisfaction. Leave those challenges to other diseases and governments. Focus and move on with the important business at hand rather than getting bogged down in every little difficulty that arises.
            http://spinalcordresearchandadvocacy.wordpress.com/

            Comment


            • #36
              Originally posted by GRAMMY View Post
              What kinds of unhappiness do you propose they self inflict to make a difference in their laboratory?
              Come on, I don't think you need to take the straw man argument with me. We are talking about disruption, disruption is not doing the same thing over and over.
              There is the odd scientist who are doing things in a different way, I'm sure you know many more examples than me.

              Originally posted by GRAMMY View Post
              Correct. FDA regulatory paths and compassionate use designations are not in a scientists wheel house. Not even close. Those calls are made by biotech companies and their boards and then agreements ultimately consummated by the designated hospitals involved with the therapy very late in the planning if at all.
              This was with a project that has moved to the corporate side, however with the scientists still involved in running the company.

              Originally posted by GRAMMY View Post
              An accurate full path map would be near impossible with changes being made to accommodate regulatory measures, lack of funding along the way and a million other things that come up in the valley of death. Realistically, you're requesting someone put a pipe dream to paper but it's not of much use other than that. There's never been such an easy well laid plan that's resulted in bringing a therapy to market
              Are we not talking about disruption? What you describe is the current state of play. Nothing is easy, however the current state of play is people taking the easiest path.
              I'm not talking about pipe dreams, I'm not talking about basic scientific research, but things that have already proven to deliver benefits.
              I'll give you an example. There are tons of trials out there asking for money for epidural stimulation. If someone wants to do a trial then its disingenuous to ask the community for money when you know there will be results, but you have no plan to move it forward.

              Originally posted by GRAMMY View Post
              Yes, really! SCI oftentimes must have other diseases involved to leverage the business aspect. It's the money piece. SCI usually doesn't have enough of it to bring anything through the valley. If it did, you'd have therapies on the market. Depending on the therapy, you'll maybe need stroke, MS, heart, ALS... It's a given. With that being said, don't be deterred in your determination to influence the direction of the research. Keep talking, keep building the relationships and show your dedication, promise more and prepare to deliver. If you give up the lead or find it too difficult to stay in front, then it's over. Pick up your toys and move to a different project. Half of the battle is learning the ropes and working within the perimeters that's laid out in front of you. You seriously don't have decades left to rewrite all the rules to your satisfaction. Leave those challenges to other diseases and governments. Focus and move on with the important business at hand rather than getting bogged down in every little difficulty that arises.
              This is a contradiction to your previous point of the scientists not having anything to do with business. I understand that this may be the case, especially when selling the treatment to get investors.
              However when you are offering them the money to do it this shouldn't become a necessity - unless greed comes in to it.
              Sometimes it's not the scientists, sometimes its their universities who are stopping this. I recently heard of an example where a company wanted to license the work someone had done, but the university wanted more money for the license. So they told the scientist to do the work on stroke and ALS. The scientist has no knowledge in these areas, so we are blocked - research that was government funded is dead. No one can use it, and no one else is interested. So who ultimately looses out? We do.

              Comment


              • #37
                I thought this was interesting at the end and how the author made a lot of comments on the translation and implementation.

                "If the SCI patient community wants touse its frustration to accelerate the development of speci c therapies, it may want to look at an aggressive top-down approach using a contractresearch organization model and have all studies done in parallel fromthe beginning to nd robust therapies. Angel investors or foundationsin it for the long haul will be needed. Alternatively, the National Centerfor Advancing Translational Sciences (NCATS) model of funding trans-lational research might work, but rock solid therapeutic targets will berequired. is strategy could lead to ?disruptions? that could dramati-cally accelerate the pace of development of novel therapeutics. "

                When the planning of this meeting occurred, it was intentionally planned to focus on the research phase, as it was an NIH conference, not an FDA or CMS directed Conference. Yes, more needs to be done to focus on improving the clinical translation and implementation of research and treatments for our community. I think it will require surveys from the community to understand what the threashold of acceptable efficacy is for different types of interventions.

                Comment


                • #38
                  ...
                  Originally posted by niallel View Post
                  Come on, I don't think you need to take the straw man argument with me. We are talking about disruption, disruption is not doing the same thing over and over.
                  There is the odd scientist who are doing things in a different way, I'm sure you know many more examples than me.

                  Not really, but there must be excitement brewing on it.

                  This was with a project that has moved to the corporate side, however with the scientists still involved in running the company.

                  Without knowing specific projects and players, it's impossible to make more than general observations.

                  Are we not talking about disruption? What you describe is the current state of play. Nothing is easy, however the current state of play is people taking the easiest path. I'm not talking about pipe dreams, I'm not talking about basic scientific research, but things that have already proven to deliver benefits.
                  I'll give you an example. There are tons of trials out there asking for money for epidural stimulation. If someone wants to do a trial then its disingenuous to ask the community for money when you know there will be results, but you have no plan to move it forward.

                  Without knowing in advance what specific examples are in your head, it's hard for me to guess and respond with any precision. Epidural stimulation is a different bag because they're using human subjects instead of rodents. They're working through the discovery phases the same as they would do in rodent but finding efficacy in various phases. There's never been prior situations in SCI quite like this one for them to draw experience from. Parts of it have gotten ahead of the usual routine of translation and investment. One can see that has caused difficulty. Perhaps good intentions and excitement will burn it to the ground until there is a rebuild. One cannot predict the future. I have my own guesses, but will share them another time...

                  This is a contradiction to your previous point of the scientists not having anything to do with business. I understand that this may be the case, especially when selling the treatment to get investors. However when you are offering them the money to do it this shouldn't become a necessity - unless greed comes in to it.
                  Sometimes it's not the scientists, sometimes its their universities who are stopping this. I recently heard of an example where a company wanted to license the work someone had done, but the university wanted more money for the license. So they told the scientist to do the work on stroke and ALS. The scientist has no knowledge in these areas, so we are blocked - research that was government funded is dead. No one can use it, and no one else is interested. So who ultimately looses out? We do.

                  No, I've seen situations such as this work out much different. Without knowing specifics who the "they" people are in all of your examples ... I've seen the scientist and advocates not give up and take the word of the licensing and business translation departments. Instead, meetings were set up with the Dean and Board of Reagents and the decision was overturned after they heard the total argument. It ultimately amounted to nothing more than a bump in the road so the work was not blocked. Sometimes "they" stand their ground and say No, not today, not on my watch, not on my mission.

                  http://spinalcordresearchandadvocacy.wordpress.com/

                  Comment


                  • #39
                    Originally posted by GRAMMY View Post
                    ...
                    All fair comments.
                    To be honest I'd love to call some of these people out - but apart from me venting I know it would cause more damage than good.

                    Judging by your counters to every point, either you are playing devils advocate (thats fair game) or you don't think there are any problems with how things are done?
                    As you are someone who is very much respected here, I'm sure everyone would love to hear your perspectives on what needs changing? What would you disrupt?

                    Comment


                    • #40
                      ...
                      Originally posted by niallel View Post
                      All fair comments.
                      To be honest I'd love to call some of these people out - but apart from me venting I know it would cause more damage than good.

                      Very wise call.

                      Judging by your counters to every point, either you are playing devils advocate (thats fair game) or you don't think there are any problems with how things are done?

                      No, heavens no, not a devils advocate. Each and every situation deserves it's own hard review and lessons gleaned from each one that others can learn from. Unfortunately these situations are complicated by circumstances beyond ones control. I guess my message is that after working in this field with funders, universities and scientists: there isn't a one size that fits all strategy. If I tried to apply something I learned from one situation into another, it didn't always work because the rules or circumstances were different. (Much of what I thought actually turned out to be irrelevant to the task at hand because of that). I learned not to judge each situation against every other experience I'd had. If you do, you'll find you are dead wrong. Each opportunity presents itself with different rules, different people, different science, different strategies. Flexibility, willingness to learn, collaboration and persistent hard ass work pays off. There isn't always a payday or success after working really hard on things either. Expect grave disappointments from time to time. Not giving up on your efforts is most important.

                      As you are someone who is very much respected here, I'm sure everyone would love to hear your perspectives on what needs changing? What would you disrupt?

                      Thank you for your kind comment. I would like to write pages on this. I'd have to break down into categories as there are many things that could use some changes that would apply to these situations. (Perhaps this is something I should do in my spare time). I'd save space to address the efforts that go up in smoke due to lack of effort, lack of planning, lack of buy in, lack of commitment, etc. while I'm at it.
                      I'd be everyone's target to @ me for months on end... damage control and fire hoses would be needed to disperse the hornets nest, yes.

                      http://spinalcordresearchandadvocacy.wordpress.com/

                      Comment


                      • #41
                        Originally posted by GRAMMY View Post
                        ...
                        Thanks Grammy, I'll keenly read if you get around to it.

                        Comment


                        • #42
                          ...
                          Originally posted by Skipow View Post
                          I thought this was interesting at the end and how the author made a lot of comments on the translation and implementation.

                          "If the SCI patient community wants to use its frustration to accelerate the development of specific therapies, it may want to look at an aggressive top-down approach using a contract research organization model and have all studies done in parallel from the beginning to end robust therapies. Angel investors or foundations in it for the long haul will be needed. Alternatively, the National Center for Advancing Translational Sciences (NCATS) model of funding translational research might work, but rock solid therapeutic targets will be required. This strategy could lead to "disruptions" that could dramatically accelerate the pace of development of novel therapeutics."

                          The author made them for good reason. Here are some basic core issues that cannot be overlooked. The NIH was created to safeguard the health of the country rather than to be an agency picking winners and losers. Somewhere along the way, it went astray. A realignment of core values going from projects back to people would hasten results. "Disruption" has to start with the NIH. et al. 2011 Nature: Few isolated research efforts have an immediate, substantial and durable impact; successful translation of basic research to practical applications occurs sparingly and with the average delays of almost three decades. The aim of science is to expand our knowledge base, which eventually yields useful applications. This is what scientists entered their profession to do.

                          When the planning of this meeting occurred, it was intentionally planned to focus on the research phase, as it was an NIH conference, not an FDA or CMS directed Conference.

                          That's the problem where disappointment and misplaced expectations for the coming decade(s) started for many. The silos were built in from the beginning if the seats were not filled with the necessary key players that have been mentioned previously. Strategic partners were not present.

                          To be fair with the Lemmon summary, the description and abstract of the meeting read...

                          SCI 2020: Planning for a Decade for Disruption in Spinal Cord Injury Research will bring together experts in the field of spinal cord injury research to debate the state of science and opportunities for moving forward in the next decade, in a panel and audience participation focused format. The objectives are:

                          1) To provide a critical multidisciplinary assessment of recent progress and gaps in SCI research across the basic, translational and clinical spectrum

                          2) To identify the key questions and top priorities to move the SCI field forward in the coming decade and

                          3) To disrupt existing silos and create multidisciplinary collaborations that will address the defined priorities for the short and long term.


                          Yes, more needs to be done to focus on improving the clinical translation and implementation of research and treatments for our community. I think it will require surveys from the community to understand what the threashold of acceptable efficacy is for different types of interventions.

                          Your thought might be right, as that part of the agenda never saw the light of day.

                          Lemmon: "But mismatches between research system realities (“where is the innovation”, grant duration versus the time it takes to do meaningful chronic studies in animals and people, etc.), clinical trial funding mechanisms, FDA approval processes, and patient needs and expectations will require dramatic changes in strategies and tactics. Those were not addressed at this meeting".
                          If people want cures or therapies to come out of all this research your tax dollars support at the NIH, the wheels need put into motion to change or the same path will be followed. I guess there is a difference in what people thought "disruption" was going to be. I harbor no ill will against those that got up and left the meeting that Vance was observing or the ones at home that disconnected their computers.
                          I kinda follow spinal cord injury research and NIH grants a tad bit over the years and I felt pretty time warped (circa 2000) with what I saw. The hours of "paralysissplaining" stuff should have been eliminated for more constructive time spent on important issues not even touched.
                          Not that I honestly expect much change, but Good Golly Miss Molly this is 2019. "Disruption" was a heavy duty mislabel on what was scheduled and the agenda that actually happened.
                          Last edited by GRAMMY; 05-17-2019, 02:52 PM.
                          http://spinalcordresearchandadvocacy.wordpress.com/

                          Comment


                          • #43
                            Originally posted by niallel View Post
                            Thanks Grammy, I'll keenly read if you get around to it.
                            I will ripen it to a stage of utmost tact and diplomacy.
                            http://spinalcordresearchandadvocacy.wordpress.com/

                            Comment


                            • #44
                              Details of NASCIC's session are in the link below:

                              https://nasciconsortium.org/wp-conte...lts-NASCIC.pdf

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