Transcriptions
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thank you for the these are the times when i wish i had my own private jet and i
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could could have just landed myself amongst all of you but that's not going to have so
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that may say by what average discussion that was overall in the context of
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the panelists and the questions in summary what we heard will is
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and it ends of the observed differences we had uh it's
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from different therapeutic areas from her again for maria and from valerie
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as regulators without from option then to now uh in terms of way particularly i
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think by the f. d. a. is and mash is really encouraging to hear
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how the evolution of this topic f. d. a. is taken on and
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the whole perspective is progressively getting to replace closer to where we can potentially be
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able to answer some of the questions so i think that's very encouraging
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and then also that but you know around maze advocacy uh engagement in europe
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no matter which way we we no matter what we had in which uh we
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we look at this i think at a very high level i would say
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gender differences the perceived you observe differences does impact safety and efficacy
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it's not exclusive to either one it does seem to impact well in the context
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of what we heard from maybe marie and valerie if that is the case
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and if we take into consideration the ask to close that gap on this one of the panelists
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the real question we had was do we need to reconsider the way we test drops
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testing doctors clinical research and companies particularly you were doing global research
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do not do development for a single country they do across joe graphics
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if that is the case the testing question for us is is
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it good enough to to leave things as they are and
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allows things to a ball bottom up or do we really want to take the bull by the whole in here
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and do some uh much much bold uh and bigger thinking or
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even destructive thinking and say what a if we actually
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brought this topic up at a higher level in the context of i. c. h. o. i. c. h. just guidelines
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fall many of the job of fees that are probably represented in that room
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around how to approach a particular disease all safety in a consistent way
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so what do we even take it up one level for the just
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like we did with out simon i did mention alzheimer's last year
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couple of years of hard work with the w. h. o. actually put it then into the global health assembly
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is this a big enough problem for us to even consider taking the evidence
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we have so far and integrating it into a white paper for example
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and taking it for the as a proposal to any one of the
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larger institutions like ice age will uh w. h. o. to
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see what they consider putting this topic on the agenda because that's all we can do right now is on the agenda
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and that's really play my thinking as the moderator listening to all of the conversations if
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we leave it as it it's things will evolve maybe it could be ball
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not sure but you will be bold in its own a pace it is not
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a priority if we look at that's why we're here today discussing this
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in the context of a global or universal clinical research but if there is evidence
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here for us to feel comfortable enough shall we take a much oldest that's
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really what i want to land as a moderate on this because that's that's why
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i'm go wait in terms of thinking like we need to the mall
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then just waiting for the steeple bottom up so many balls that that was just would pop
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up everyone but as the moderator session i think i'd like to in that by saying
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maybe a bit double the action do something tangible just to see how far will this
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take this in the context of regulators research is an incentive rising patients to be
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more engaged in input research that's it i think i've taken less than five minutes