Over on YMB very interesting post about the critic
Post# of 30066
Posted On: 09/15/2014 9:26:16 PM
Over on YMB very interesting post about the critical need for a test that would identify AlZ and PD candidates for testing. Lympro may just be what is needed......Gerald, give us the numbers!
jegfsu over on YMB posted a very interesting thread on the critical need for an agent to identify PD and ALZ patients (by implication) to enable testing to run more smoothly. The need is recognized, and it is a screaming need. Will LYMPRO fill the gap??? If it does, the rewards will be immense............patience.....so tough, but so worth it in the end....
Alzheimer’s disease drug-development pipeline: few candidates, frequent failures.
Jeffrey L Cummings1*, Travis Morstorf2 and Kate Zhong1
In the decade of 2002 through 2012, 244 compounds were assessed in 413 trials for AD. Of the agents advanced to Phase 3 (and excluding those currently in Phase 3), one was advanced to the FDA and approved for marketing (1.8%). Excluding the 14 compounds currently in Phase 3, the overall success rate for approval is 0.4% (99.6% attrition). This is among the lowest for any therapeutic area [13,14].
The developmental time lines for conducting two Phase 3 trials needed to satisfy FDA requirements is substantially shorter for symptomatic agents than for disease-modifying compounds. For symptomatic cognitive enhancers in Phases 2 and 3, the trials were 20 and 34.6 weeks in duration, whereas trials of disease-modifying agents were 47.6 and 90.9 weeks in Phase 2 and Phase 3, respectively. The total duration of a trial is the length of time devoted to recruitment plus the treatment period; in some cases, the trial length included an open-label extension. The period of recruitment varies and is often longer than anticipated by the sponsor, because recruitment of AD patients is slower than expected for many trials [15]. The total time that a compound resides in any phase of the development pathway is a combination of duration of all the trials performed (some may be done concurrently) and time for analysis and decision making.
Gentlemen and ladies..."The period of recruitment varies and is often longer than anticipated by the sponsor..."
The number one reason why so many AD trials fail? Now what might possibly help these sponsors expedite their recruitment phase? Music, please..........
And the Final Jeopardy answer is......."What is Lympro?"
Correct- we are all winners!!!!!!!! Le
jegfsu over on YMB posted a very interesting thread on the critical need for an agent to identify PD and ALZ patients (by implication) to enable testing to run more smoothly. The need is recognized, and it is a screaming need. Will LYMPRO fill the gap??? If it does, the rewards will be immense............patience.....so tough, but so worth it in the end....
Alzheimer’s disease drug-development pipeline: few candidates, frequent failures.
Jeffrey L Cummings1*, Travis Morstorf2 and Kate Zhong1
In the decade of 2002 through 2012, 244 compounds were assessed in 413 trials for AD. Of the agents advanced to Phase 3 (and excluding those currently in Phase 3), one was advanced to the FDA and approved for marketing (1.8%). Excluding the 14 compounds currently in Phase 3, the overall success rate for approval is 0.4% (99.6% attrition). This is among the lowest for any therapeutic area [13,14].
The developmental time lines for conducting two Phase 3 trials needed to satisfy FDA requirements is substantially shorter for symptomatic agents than for disease-modifying compounds. For symptomatic cognitive enhancers in Phases 2 and 3, the trials were 20 and 34.6 weeks in duration, whereas trials of disease-modifying agents were 47.6 and 90.9 weeks in Phase 2 and Phase 3, respectively. The total duration of a trial is the length of time devoted to recruitment plus the treatment period; in some cases, the trial length included an open-label extension. The period of recruitment varies and is often longer than anticipated by the sponsor, because recruitment of AD patients is slower than expected for many trials [15]. The total time that a compound resides in any phase of the development pathway is a combination of duration of all the trials performed (some may be done concurrently) and time for analysis and decision making.
Gentlemen and ladies..."The period of recruitment varies and is often longer than anticipated by the sponsor..."
The number one reason why so many AD trials fail? Now what might possibly help these sponsors expedite their recruitment phase? Music, please..........
And the Final Jeopardy answer is......."What is Lympro?"
Correct- we are all winners!!!!!!!! Le
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