The PediatricPraziquantel On behalf of the Consortium, Consortium 4_4 Remco de Vrueh.pdf · Cesol...
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Transcript of The PediatricPraziquantel On behalf of the Consortium, Consortium 4_4 Remco de Vrueh.pdf · Cesol...
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ThePediatric PraziquantelConsortiumHelpingchildrenwithSchistosomiasis
December8th,2017
OnbehalfoftheConsortium,Dr.RemcodeVrueh(Lygature)Consortiumcoordinator
GHITFundR&DForum,Tokyo
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Anewpublic-privatepartnershiptoaddressahighunmetmedicalneedinyoungchildren
HighPrevalence
HighMedicalneed
Pre-schoolagedchildrenneglected
Estimated27MioyoungchildreninfectedoratriskofschistosomiasisinSub-SaharanAfrica
Currenttreatment(praziquantel 600mgtablets)cannotbeadministeredtoyoungchildren
à clear unmetmedicalneedforasuitablepediatric formulationforthechildrenaged3months
to6years
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ConsortiumBoard
ConsortiumTeam
Internationalnon-profitR&DConsortiumwithafocusonextendedpartnershipintoendemiccountries
InternationalExpertPanel(WorldHealthOrganization)
asobserver
Continuallyseekingfundingandadvicefromexternalexpertsandpartners
Grants:Bill&MelindaGatesFoundationGHITFund(3x)
Inkindand/orincashcontribution
Exitbegin ofOct 2017
Foundedin2012
ThePediatricPraziquantelConsortium
UniversitéFélixHouphouët-Boigny(Coted’Ivoire)
Tojoin endofDec 2017
KEMRI(Kenya)
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Cesol 600 mgCurrent commercial tablet
PZQ new ODT 150 mg tablet
Trueinnovation
L-PZQandrac-PZQoro-dispersibletablets(ODTs)
• Orallydisintegrating
• Improvedtaste• Conventional
manufacturingprocess
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Completed(2015)
TwoPhaseIBioavailabilitystudies(SouthAfrica)
Completed(2015)TasteStudyofthenewODTsinAfricanchildren(Tanzania)
Ongoing(2016)
PhaseIIPK/PDdosefindingStudy(IvoryCoast)
Planned(2018)
PhaseIIIconfirmatorytrials(Kenya/IvoryCoast)
FullclinicaldevelopmentprogramforPZQ-ODTs
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Capacity building- Strengthening Health infrastructure
11.03.2016,pre-study visit
BEFORE
15.06.2016,initiation visit
AFTERClinical research facility annex refurbished (Ivory Coast - Man region)
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Capacity building- Strengthening R&Dinfrastructure
StudyteamsupervisedbythePI(Prof. N’Goran),membersoftheMerck&SwissTPHteam
BloodsamplingandDryBloodSpotmethod
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Nextsteps:Regulatory&Manufacturingplan
1stregistrationEMAarticle58
andWHOPre-
qualification
Clinicalprogram
WHOEOI
Safetydatabasebuildup-
ConductPharmacovigilancestudywithWHOinvolvement
RegistrationinAfricanendemiccountries(WHOcollaborativeprocedure)*
Manufacturinglaunchreadiness
(Farmanguinhos)
StartProcurementforindividualcase
management
LaunchinfirstAfricanendemiccountries
Largescaledistributionforprophylacticuse
2016-2019 End2019 End2020 End2020
2020
20232019
TechTransfertolocalAfricanmanufacturer
(tbd)
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OnekeyforsuccessCommunication&stakeholderengagement
ConsortiumTeamandBoardrepresentativestogetherwithAfricanregulatoryexperts(Geneva,2014)
AccessexpertmeetinginQ32018Keystakeholders:Consortiumpartners,ourfunders,NTDcontrolprogramfunders,WHO,UNICEF,KOLsandpossiblyendemiccountrydecisionmakers
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http://www.pediatricpraziquantelconsortium.orghttp://www.merckgroup.com/mghi.html