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8/19/2019 The Gain-of-Function Deliberative Process (Carrie Wolinetz)
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Zdk Mfob-la-AubctolbJkionkrftovk Xrlckss
Cfrrok J. ]liobktz, XdJ Fsslcoftk Jorkctlr alr Scokbck Xliocy
Laaock la Scokbck Xliocy, BOD
8/19/2019 The Gain-of-Function Deliberative Process (Carrie Wolinetz)
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>
Xrleltobm Milnfi Dkfitd Skcuroty
tdrlumd Ioak Scokbcks ^kskfrcd
F rlnust ioak scokbcks rkskfrcd kbjkfvlr os crotocfi tl prleltobm
punioc dkfitd fbj wkii-nkobm ob iomdt la kvlivobm tdrkfts plskj nyeocrlnofi pftdlmkbs.
• [SM supplrts f jovkrsk ioak scokbcks rkskfrcd plrtali ol
• ^kskfrcd obvlivobm pltkbtofiiy jfbmkrlus pftdlmkbs dfvk
obdkrkbt nolsfakty fbj nolskcuroty ros`s
• Sfakiy rkfiozobm tdk nkbkaots la sucd rkskfrcd rkquorks kaakctovk
pliocoks, prfctocks, fbj lvkrsomdt
8/19/2019 The Gain-of-Function Deliberative Process (Carrie Wolinetz)
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Sfakty stfbj-jlwb fbj Bftolbfi NolsfaktyStkwfrjsdop Elbtd
Akjkrfi Kxpkrts Skcuroty Fjvoslry Xfbki
(AKSFX) ^kplrt
Afst-Zrfc` Fctolb Cleeottkk lb Skikct Fmkbt^kmuiftolbs (AZFC-SF^) ̂ kplrt
Mfob-la-Aubctolb Jkionkrftovk Xrlckss
3
Strkbmtdkbobm Nolsfakty fbj Nolskcuroty
ob Ioak Scokbcks ^kskfrcd
^kckbt ifn obcojkbts dfvk spurrkj f skroks la pliocy fctovotoksny tdk [SM foekj ft rkobalrcobm cleeotekbts tl nolsfakty,
nolskcuroty, fbj rksplbsonik clbjuct la rkskfrcd felbm fii
stf`kdlijkrs.
8/19/2019 The Gain-of-Function Deliberative Process (Carrie Wolinetz)
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SpkbjobmLutsojk BOD
Spkbjobm
ft BOD
Fs pfrt la f rkbkwkj kepdfsos lb nolsfakty fbj nolskcuroty, tdk ros`s
fbj nkbkaots fsslcoftkj wotd mfob-la-aubctolb (MLA) rkskfrcd frk
nkobm cfrkaui iy rk-kxfeobkj.
• MLA stujoks frk lbk fpprlfcd tl fjjrkssobm aubjfekbtfi scokbtoa oc
qukstolbs.
• MLA stujoks dfvk tdk pltkbtofi tl7
Dkip jkaobk tdk aubjfekbtfi bfturk la dlst-pftdlmkb obtkrfctolbs
Kbfnik fsskssekbt la tdk pfbjkeoc pltkbtofi la kekrmobm
obakctolus fmkbts
Obalre punioc dkfitd fbj prkpfrkjbkss kaalrts
Aurtdkr ekjocfi clubtkrekfsurk jkvkilpekbt
Mfob-la-Aubctolb ^kskfrcd
:
8/19/2019 The Gain-of-Function Deliberative Process (Carrie Wolinetz)
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Ckrtfob MLA stujoks dfvk rfoskj nolsfakty fbj nolskcuroty
clbckrbs.
• Cluij kbmobkkrkj pftdlmkbs plsk f pfbjkeoc tdrkft oa
tdky wkrk tl nk fccojkbtfiiy lr obtkbtolbfiiy rkikfskj arle
f ifnlrftlry<
• Cluij tdk obalreftolb mkbkrftkj arle ckrtfob MLA stujoksnk eosuskj tl tdrkftkb punioc dkfitd lr bftolbfi skcuro ty<
Xliocy qukstolbs7
– [bjkr wdft clbjotolbs cfb tdksk stujoks nk sfakiy
clbjuctkj<
– Sdluij tdos typk la rkskfrcd nk clbjuctkj ft fii<
;
Clbckrbs fnlut Ckrtfob MLA
Stujoks
8/19/2019 The Gain-of-Function Deliberative Process (Carrie Wolinetz)
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1
MLA Jkionkrftovk Xrlckss fbj
^kskfrcd Aubjobm Xfusk
Jkionkrftovk Xrlckss
Zdk [SM fbblubckj f prlckss tl rk-kvfiuftk tdk
pltkbtofi ros`s fbj nkbkaots fsslcoftkj wotd MLA
rkskfrcd obvlivobm pftdlmkbs wotd pfbjkeoc pltkbtofi.
^kskfrcd Aubjobm Xfusk
Jkionkrftovk prlckss os fcclepfbokj ny f pfusk ob
aubjobm alr prlgkcts tdft efy nk rkfslbfniy
fbtocopftkj tl mkbkrftk obaiukbzf, EK^S, lr SF^Svorusks wotd kbdfbckj pftdlmkbocoty fbj/lr
trfbseossonoioty ob efeefis vof tdk rksporftlry rlutk.
8/19/2019 The Gain-of-Function Deliberative Process (Carrie Wolinetz)
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^os` & Nkbkaot
Fsskssekbts (^NF)Mrypdlb Scokbtoaoc clbjuctros` & nkbkaot fsskssekbts
la MLA stujoks
Bftolbfi Fcfjkeoks
Clbvkbk punioc alrues tlmkbkrftk nrlfj joscussolb
fbj rkckovk punioc fbj ltdkrstf`kdlijkr obput
BSFNNSkrvks fs tdk laaocofi
fjvoslry nljy alr prlvojobmfjvock lb lvkrsomdt la tdosfrkf la jufi usk rkskfrcd
[SM MLA
Xliocy
Jkvkilpekbt
Xrlckss
MLA Jkionkrftovk Xrlckss
=
8/19/2019 The Gain-of-Function Deliberative Process (Carrie Wolinetz)
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Zfs`
>
Xrlvojk alrefi rkcleekbjftolbs
tl tdk [SM lb tdk clbckptufi
fpprlfcd tl tdk kvfiuftolb la
prlplskj MLA stujoks
Jkiovkrfnik >
^kcleekbjftolbs tl tdk [SM
obalrekj ny tdk rksuits la tdk
ros` fbj nkbkaot fsskssekbts
fbj ltdkr
obput
Zfs`
>
Xrlvojk alrefi rkcleekbjftolbs
tl tdk [SM lb tdk clbckptufi
fpprlfcd tl tdk kvfiuftolb la
prlplskj MLA stujoks
Jkiovkrfnik >
^kcleekbjftolbs tl tdk [SM
obalrekj ny tdk rksuits la tdk
ros` fbj nkbkaot fsskssekbts
fbj ltdkr
obput
Zfs`
6
Fjvosk lb tdk jksomb,
jkvkilpekbt, fbj clbjuct la ros`‘
nkbkaot fsskssekbt la MLA stujoks
Jkiovkrfnik 6
Arfekwlr` alr tdk jksomb fbj
clbjuct la ros` fbj nkbkaot
fsskssekbts
la
MLA
stujoks
Zfs`
6
Fjvosk lb tdk jksomb,
jkvkilpekbt, fbj clbjuct la ros`‘
nkbkaot fsskssekbt la MLA stujoks
Jkiovkrfnik 6
Arfekwlr` alr tdk jksomb fbj
clbjuct la ros` fbj nkbkaot
fsskssekbts
la
MLA
stujoks
Zdk Cdfrmk tl tdk BSFNN
4
8/19/2019 The Gain-of-Function Deliberative Process (Carrie Wolinetz)
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Zoekiobk la Efglr Kvkbts ob tdk MLA
Jkionkrftovk Xrlckss
?
8/19/2019 The Gain-of-Function Deliberative Process (Carrie Wolinetz)
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BSFNN tl aobfiozk ots aobjobms fbj
rkcleekbjftolbs tl tdk [SM nfskj lbstf`kdlijkr akkjnfc` fbj fjjotolbfi obputs fbj
fbfiysos
[SM tl clbsojkr BSFNN rkcleekbjftolbs lb fclbckptufi fpprlfcd tl tdk kvfiuftolb la
prlplskj MLA stujoks tlwfrjs tdk jkvkilpekbt
la bkw pliocy
68
Bkxt Stkps
8/19/2019 The Gain-of-Function Deliberative Process (Carrie Wolinetz)
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Stf`kdlijkr obput os crotocfi tl fb kaakctovk pliocy
jkvkilpekbt prlckss.
BSFNN jrfat rkcleekbjftolbs fbj ekktobm vojkl frcdovks
fvfoifnik7 dttp7//lsp.lj.bod.mlv/laaock-noltkcdblilmy-
fctovotoks/nolskcuroty/bsfnn
Auturk lpplrtubotoks alr stf`kdlijkr pfrtocopftolb7
• BSFNN ekktobm (Sprobm >861)
• Kefoi fbytoek tl7
Stf`kdlijkr Obput
bsfnnHlj.bod.mlv
66
8/19/2019 The Gain-of-Function Deliberative Process (Carrie Wolinetz)
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• BOD Laaock la Scokbck Xliocy
– ]knsotk7 dttp7//lsp.lj.bod.mlv/
– Nilm7 dttp7//lsp.lj.bod.mlv/ubjkr-tdk-pliosclpk
– Zwottkr7 dttps7//twottkr.cle/cwliobktzbod
– Sunscronk tl tdk LSX iostskrv
• Skbj fb kefoi tl IOSZSK^QHiost.bod.mlv
wotd ’Sunscronk LSX\Bkws― ob tdk ekssfmk
• Scokbck, Sfakty, Skcuroty (S3) – dttp7//www.pdk.mlv/s3/Xfmks/jkafuit.fspx
Fjjotolbfi ^kslurcks
6>