GHIT Fund Advancing Portfolio · advancements. For the semi-annual progress report, partners...
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Acquire Library/ Strains Develop Target Research Report Validate Assays Prepare Assay Validation Plan Develop Assays Prepare Assay Development Plan Identify Target(s) Conduct Target Research Prepare Target Research Plan SCREEN GO TARGET RESEARCH GO Screen Library/ Strains Evaluate Hits Prepare Lead Optimization Plan Optimize Lead(s) Evaluate Optimized Lead(s) Develop Optimized Lead Report Prepare Preclinical Plan Conduct Preclinical Study Analyze Preclinical Data Prepare IND Address IND Q&A Address IND Q&A Develop TPP Develop Product Development Plan Plan Ph1 Program Enroll Ph1 Study Plan Ph2a Program Enroll Ph2a Study Conduct Ph2a Study Analyze Ph2a Data Prepare Ph2a Study Report Plan Ph2b Program Enroll Ph2b Study Conduct Ph2b Study Plan Ph2 Program Enroll Ph2 Study Conduct Ph2 Study Ph2 Data Analyzed Plan Ph3 Program Enroll Ph3 Study Conduct Ph3 Study Analyze Ph3 Data Prepare Dossier Address Dossier Q&A Prepare Supplemental Lic/PQ Dossiers Address Supp Lic/ PQ Dossier Q&A Screen Initiated Assay Validation Completed Assay Validation Initiated Assay Dev. Completed Assay Dev. Initiated Target(s) Identified Target Research Completed Target Research Initiated Screen Completed Develop Screen Report Prepare HTL Plan Hits Identified Generate Lead(s) Lead Gen Initiated Evaluate Lead(s) Lead Gen Completed Develop HTL Report Leads Identified LEAD OPT. GO HIT TO LEAD GO Lead Opt Initiated Lead Opt Completed Candidate(s) Identified PRECLINICAL GO Preclin Initiated Preclin Completed Prepare Preclinical Report Preclin Data Analyzed IND GO IND Filed IND Approved TPP Developed PHASE 1 GO Ph1 FPI Conduct Ph1 Study Ph1 LPI Analyze Ph1 Data Ph1 LPO Prepare Ph1 Study Report Ph1 Data Analyzed PHASE 2a / PHASE 2 GO Ph2a FPI Ph2a LPI / Ph2 FPI Ph2a LPO Ph2a Data Analyzed / Ph2 LPI PHASE 2b GO Ph2b FPI / Ph2 LPO Ph2b LPI Analyze Ph2b Data Prepare Ph2b Study Report Prepare Ph2 Study Report Ph2b LPO / Ph2 Data Analyzed Ph2b Data Analyzed PHASE 3 GO Ph3 FPI Ph3 LPI Ph3 LPO Prepare Ph3 Study Report Ph3 Data Analyzed LICENSE GO Dossier Filed Develop Supplemental Lic./PQ Plan 1st Licensure Granted SUPP. LIC / PQ GO Supp. Lic/ PQ Submitted Prepare for Delivery Add’ l Lic/ PQ Granted LAUNCH GO DRUG DEVELOPMENT Target Disease Collaboration Partners 1 Investment (USD) 2.3 Malaria 10,352,089 11,286 570 1,849,333 75,582 31,000 7,558 - 75,582 1,043,531 1,105,170 1,959,774 Malaria Malaria Malaria Malaria Malaria Chagas disease, Leishmaniasis Malaria, Chagas Disease, Cryptosporidium, Leishmaniasis Chagas disease, Leishmaniasis Malaria Malaria Malaria Malaria Malaria Chagas disease, Leishmaniasis Chagas disease, Leishmaniasis 5,308,616 119,000 Chagas disease, Leishmaniasis Chagas disease, Leishmaniasis 150,000 Chagas disease, Leishmaniasis Tuberculosis 204,990 Tuberculosis Tuberculosis Tuberculosis 500,000 982,436 Chagas disease 882,350 Chagas disease Malaria 207,754 Malaria 1,284,520 Malaria 1,016,129 560,000 5,428,979 3,840,893 8,268,923 10,365,743 6,034,137 Malaria 7,499,822 60,000 Malaria 68,400 Malaria 150,000 Malaria 49,500 Malaria 65,836 Malaria 5,590,092 Malaria 1,290,883 Malaria 150,000 Malaria 41,963 Tuberculosis Tuberculosis Tuberculosis Leishmaniasis Leishmaniasis Lymphatic filariasis, Onchocerciasis Soil-transmitted helminthiasis 583,383 2,727,117 2,639,622 150,000 1,342,440 10,070,310 Dengue 10,241,632 2,843,214 Malaria Malaria 132,000 Tuberculosis 79,200 Tuberculosis 1,103,160 Tuberculosis 150,000 Tuberculosis 99,986 Tuberculosis 2,003,324 Chagas disease Chagas disease Schistosomiasis 1,002,996 15,924,407 5,606,388 Leishmaniasis 2,526,217 Mycetoma 4,214,187 Malaria Tuberculosis 110,000 750,000 ID T5-134(3) H9-104 S3-113 S3-112(4) S3-114 S3-115(4) S4-211(2) S4-212(3) S3-111(3) H4-101 S5-111 S5-112 S7-111 S7-112 S8-111 S9-111 G4-107(3) G3-113 G9-215 G4-105(2) G3-112(3) G4-108 G5-120 G18-112 G6-108 S3-131(2) T6-101 S3-132(2) S3-133(3) S4-231 S4-232(2) S5-131 S5-132 S5-232(2) S5-231 S7-131 G3-109 T6-203 G3-218 S3-121 S5-222 S3-122 S3-123 S3-124 G6-217(2) S5-221(3) H4-201(3) G4-208(2) G3-209(2) G3-212(4) G5-205 G5-211(2) G7-106 S7-221 S9-121 T7-278 G7-101 S8-131 H6-201 Screening Platform Target Identification Target Validation Hit Identification Lead Identification Lead Optimization Preclinical Development Phase 1 Clinical Development Phase 2 Clinical Development Phase 3 Clinical Development Registration Hit-to-Lead Platform Product Development Platform Target Research Platform DISCOVERY PRECLINICAL CLINICAL REG Note: 1 includes past and present Collaboration Partners' logos 2 The awarded amount refers to the conditional investment figure agreed at the initiation of each project. 3 GHIT invests using Japanese yen. US dollar amounts represent conversions from Japanese yen, solely for the reader’s convenience, at JPY 100 = USD 1. ver6.4 2020.3.31 Copyright © 2013 - 2020 Global Health Innovative Technology Fund GHIT Fund Advancing Portfolio Plan Ph2 Program Enroll Ph2 Study Conduct Ph2 Study Analyze Ph2 Data Prepare Ph2 Study Report Plan Ph3 Program Enroll Ph3 Study PHASE 2 GO PHASE 3 GO Ph2 FPI Ph2a Data Analyzed Ph2 LPI Ph2 LPO Ph3 FPI Ph3 LPI CURRENT STATUS For example, a successful investment in a Phase 2 clinical trial would yield one stage gate and five milestone advancements. For the semi-annual progress report, partners designate the current state of the project by specifying the project’s current activity. For example, completing the study portion of the Phase 2 clinical trial by the second reporting period would credit the project with one stage gate and four milestone advancements. A green triangle represents a continued investment. Project Scope vs Current Reporting Period Status 1st PROJECT SCOPE 2nd PROJECT SCOPE CONTINUATION Legend STAGE ACTIVITY MILESTONE STAGE-GATE Discontinued Successfully completed Current Status
Transcript of GHIT Fund Advancing Portfolio · advancements. For the semi-annual progress report, partners...
AcquireLibrary/Strains
Develop TargetResearch
Report
ValidateAssays
Prepare AssayValidation
Plan
DevelopAssays
Prepare AssayDevelopment
Plan
IdentifyTarget(s)
ConductTarget
Research
PrepareTarget
Research Plan
SCREENGO
TARGETRESEARCH
GO
ScreenLibrary/Strains
EvaluateHits
Prepare LeadOptimization
Plan
OptimizeLead(s)
EvaluateOptimized
Lead(s)
DevelopOptimized
Lead Report
PreparePreclinical
Plan
ConductPreclinical
Study
AnalyzePreclinical
Data
Prepare INDAddressIND Q&A
AddressIND Q&A
DevelopTPP
DevelopProduct
DevelopmentPlan
Plan Ph1Program
Enroll Ph1Study
Plan Ph2aProgram
Enroll Ph2aStudy
ConductPh2a Study
AnalyzePh2a Data
Prepare Ph2aStudy Report
Plan Ph2bProgram
Enroll Ph2bStudy
Conduct Ph2bStudy
Plan Ph2Program
Enroll Ph2Study
Conduct Ph2Study
Ph2 DataAnalyzed
Plan Ph3Program
Enroll Ph3Study
Conduct Ph3Study
Analyze Ph3Data
PrepareDossier
AddressDossier Q&A
PrepareSupplemental
Lic/PQ Dossiers
AddressSupp Lic/
PQ Dossier Q&A
ScreenInitiated
AssayValidationCompleted
AssayValidationInitiated
Assay Dev.Completed
Assay Dev.Initiated
Target(s)Identified
TargetResearch
Completed
TargetResearchInitiated
ScreenCompleted
DevelopScreenReport
Prepare HTL Plan
HitsIdentified
GenerateLead(s)
Lead GenInitiated
EvaluateLead(s)
Lead GenCompleted
DevelopHTL Report
LeadsIdentified
LEAD OPT.GO
HIT TOLEAD GO
Lead OptInitiated
Lead OptCompleted
Candidate(s)Identified
PRECLINICALGO
PreclinInitiated
PreclinCompleted
PreparePreclinical
Report
Preclin DataAnalyzed
INDGO
INDFiled
INDApproved
TPPDeveloped
PHASE 1GO
Ph1FPI
Conduct Ph1Study
Ph1LPI
Analyze Ph1Data
Ph1LPO
Prepare Ph1Study Report
Ph1 DataAnalyzed
PHASE 2a /PHASE 2 GO
Ph2aFPI
Ph2a LPI /Ph2 FPI
Ph2aLPO
Ph2a DataAnalyzed /
Ph2 LPIPHASE 2b
GOPh2b FPI /Ph2 LPO
Ph2bLPI
AnalyzePh2b Data
Prepare Ph2bStudy Report
Prepare Ph2Study Report
Ph2b LPO /Ph2 DataAnalyzed
Ph2b DataAnalyzed
PHASE 3GO
Ph3FPI
Ph3LPI
Ph3LPO
Prepare Ph3Study Report
Ph3 DataAnalyzed
LICENSEGO
DossierFiled
DevelopSupplementalLic./PQ Plan
1st LicensureGranted
SUPP. LIC /PQ GO
Supp. Lic/PQ Submitted
Prepare forDelivery
Add’ l Lic/PQ Granted
LAUNCHGO
DRUG DEVELOPMENT
TargetDisease
CollaborationPartners 1
Investment (USD)
2.3
Malaria
10,352,089
11,286
570
1,849,333
75,582
31,000
7,558
-
75,582
1,043,531
1,105,170
1,959,774
Malaria
Malaria
Malaria
Malaria
Malaria
Chagas disease,Leishmaniasis
Malaria, Chagas Disease,Cryptosporidium,Leishmaniasis
Chagas disease,Leishmaniasis
Malaria
Malaria
Malaria
Malaria
Malaria
Chagas disease,Leishmaniasis
Chagas disease,Leishmaniasis
5,308,616
119,000
Chagas disease,Leishmaniasis
Chagas disease,Leishmaniasis
150,000Chagas disease,Leishmaniasis
Tuberculosis
204,990Tuberculosis
Tuberculosis
Tuberculosis
500,000
982,436
Chagas disease
882,350Chagas disease
Malaria
207,754
Malaria 1,284,520
Malaria 1,016,129
560,000
5,428,979
3,840,893
8,268,923
10,365,743
6,034,137
Malaria
7,499,822
60,000
Malaria 68,400
Malaria 150,000
Malaria 49,500
Malaria 65,836
Malaria 5,590,092
Malaria 1,290,883
Malaria 150,000
Malaria 41,963
Tuberculosis
Tuberculosis
Tuberculosis
Leishmaniasis
Leishmaniasis
Lymphatic filariasis,Onchocerciasis
Soil-transmittedhelminthiasis
583,383
2,727,117
2,639,622
150,000
1,342,440
10,070,310
Dengue 10,241,632
2,843,214
Malaria
Malaria
132,000
Tuberculosis 79,200
Tuberculosis 1,103,160
Tuberculosis 150,000
Tuberculosis 99,986
Tuberculosis 2,003,324
Chagas disease
Chagas disease
Schistosomiasis
1,002,996
15,924,407
5,606,388Leishmaniasis
2,526,217Mycetoma
4,214,187Malaria
Tuberculosis 110,000
750,000
ID
T5-134(3)
H9-104
S3-113
S3-112(4)
S3-114
S3-115(4)
S4-211(2)
S4-212(3)
S3-111(3)
H4-101
S5-111
S5-112
S7-111
S7-112
S8-111
S9-111
G4-107(3)
G3-113
G9-215
G4-105(2)
G3-112(3)
G4-108
G5-120
G18-112
G6-108
S3-131(2)
T6-101
S3-132(2)
S3-133(3)
S4-231
S4-232(2)
S5-131
S5-132
S5-232(2)
S5-231
S7-131
G3-109
T6-203
G3-218
S3-121
S5-222
S3-122
S3-123
S3-124
G6-217(2)
S5-221(3)
H4-201(3)
G4-208(2)
G3-209(2)
G3-212(4)
G5-205
G5-211(2)
G7-106
S7-221
S9-121
T7-278
G7-101
S8-131
H6-201
Screening Platform
Target IdentificationTarget Identification Target Validation Target Validation Hit IdentificationHit Identification Lead IdentificationLead Identification Lead OptimizationLead Optimization Preclinical DevelopmentPreclinical Development Phase 1 Clinical DevelopmentPhase 1 Clinical Development Phase 2 Clinical Development Phase 2 Clinical Development Phase 3 Clinical Development Phase 3 Clinical Development RegistrationRegistration
Hit-to-Lead Platform Product Development PlatformTarget Research Platform
DISCOVERY PRECLINICAL CLINICAL REG
Note: 1 includes past and present Collaboration Partners' logos 2 The awarded amount refers to the conditional investment figure agreed at the initiation of each project. 3 GHIT invests using Japanese yen. US dollar amounts represent conversions from Japanese yen, solely for the reader’s convenience, at JPY 100 = USD 1.ver6.4 2020.3.31
Copyright © 2013 - 2020 Global Health Innovative Technology Fund
GHIT Fund Advancing PortfolioPlan Ph2Program
Enroll Ph2Study
Conduct Ph2Study
Analyze Ph2Data
Prepare Ph2Study Report
Plan Ph3Program
Enroll Ph3Study
PHASE 2GO
PHASE 3GOPh2 FPI
Ph2a DataAnalyzedPh2 LPI Ph2 LPO Ph3 FPI Ph3 LPI
CURRENT STATUS
For example, a successful investment in a Phase 2 clinical trial would yield one stage gate and five milestone advancements. For the semi-annual progress report, partners designate the current state of the project by specifying the project’s current activity. For example, completing the study portion of the Phase 2 clinical trial by the second reporting period would credit the project with one stage gate and four milestone advancements. A green triangle represents a continued investment.
Project Scope vs Current Reporting Period Status
1st PROJECT SCOPE 2nd PROJECT SCOPE
CONTINUATIONLegend
STAGE ACTIVITYMILESTONESTAGE-GATE
DiscontinuedSuccessfully completedCurrent Status
Develop DevFeasibility
Report Report
ConductDevelopment
Feasibility
PrepareDevelopment
Feasibility Plan
Develop TechFeasibility
Report
ConductTechnicalFeasibility
Prepare TechFeasibility Plan
DevelopConcept
Dev Report
DevelopConcept
Prepare ConceptDevelopment Plan
DevelopmentFeasibilityCompleted
TARGETRESEARCH
GO
Prepare ProductDesign Plan
DesignProduct
Develop ProductDesign Report
Prepare ProductDevelopment Plan
DevelopProduct
Prepare OperationalEvaluation Plan
Conduct OperationalEvaluation
Prepare OperationalEvaluation Report
Analyze EvaluationData
PrepareDossier
AddressDossier Q&A
PrepareSupplemental
Lic/PQ Dossiers
AddressSupp Lic/
PQ Dossier Q&A
DevelopmentFeasibilityInitiated
DEVELOPMENTFEASIBILITY
GO
TechnicalFeasibilityCompleted
TechnicalFeasibilityInitiated
TECHNICALFEASIBILITY
GO
ConceptDevelopmentCompleted
ConceptDevelopment
InitiatedPRODUCT
DESIGN GOProduct Design
InitiatedProduct Design
CompletedPRODUCT
DEVELOPMENT GOProduct Development
Initiated
Develop ProductDevelopment Report
Product DevelopmentCompleted
Prepare AnalyticalEvaluation Plan
ANALYTICALEVALUATION GO
Prepare AnalytiocalEvaluation Report
Conduct AnalyticalEvaluation
Analytical EvaluationInitiated
Operational EvaluationInitiated
OPERATIONALEVALUATION GO
Analytical EvaluationCompleted
Operational EvaluationCompleted
Evaluation DataAnalysis Initiated
Develop EvaluationReport
Evaluation DataAnalysis Completed
LICENSEGO
DossierFiled
DevelopSupplementalLic./PQ Plan
1st LicensureGranted
SUPP. LIC /PQ GO
Supp. Lic/PQ Submitted
Prepare forDelivery
Add’ l Lic/PQ Granted
LAUNCHGO
ValidateAssays
Prepare AssayValidation
Plan
DevelopAssays
Prepare AssayDevelopment
Plan
DevelopConcept
Prepare ConceptDevelopment
Plan
IdentifyAntigen(s)
ConductAntigen
Research
PrepareAntigen
Research Plan
AssayValidationInitiated
TARGETRESEARCH
GO
Prepare TechPlatform ID
Plan
Identify TechPlatform
PreparePreclinical
Plan
ConductPreclinical
Study
AnalyzePreclinical
Data
PreparePreclinical
Report
PrepareIND
AddressIND Q&A
DevelopTPP
Plan Ph1Program
Enroll Ph1Study
Plan Ph2aProgram
Enroll Ph2aStudy
ConductPh2a Study
AnalyzePh2a Data
Prepare Ph2aStudy Report
Plan Ph2bProgram
Enroll Ph2bStudy
Conduct Ph2bStudy
Plan Ph2Program
Enroll Ph2Study
Conduct Ph2Study
Ph2 DataAnalyzed
Plan Ph3Program
Enroll Ph3Study
Conduct Ph3Study
Analyze Ph3Data
PrepareDossier
AddressDossier Q&A
PrepareSupplemental
Lic/PQ Dossiers
AddressSupp Lic/
PQ Dossier Q&A
AssayValidationCompleted
AssayDevelopmentCompleted
AssayDevelopment
InitiatedConcept Dev.
CompletedConcept Dev.
InitiatedAntigen(s)Identified
AntigenResearch
Completed
AntigenResearchInitiated
TechPlatfrom ID
Initiated
Develop TargetResearch
Report
Prepare LeadAntigen
Optimization Plan
TechPlatform IDCompleted
OptimizeAntigen Lead(s)
Antigen LeadOpt Initiated
EvaluateOptimized
Antigen Lead(s)
Develop LeadAntigen Opt
Report
Antigen LeadOpt Completed
OptimizedAntigen(s)Selected
PRECLINICALGO
LEADANTIGENOPT GO
PreclinInitiated
PreclinCompleted
PreclinData
AnalyzedINDGO
INDFiled
INDApproved
Develop ProductDevelopment
Plan
TPPDeveloped
PHASE 1GO
Ph1FPI
Conduct Ph1Study
Ph1LPI
Analyze Ph1Data
Ph1LPO
Prepare Ph1Study Report
Ph1 DataAnalyzed
PHASE 2a /PHASE 2 GO
Ph2aFPI
Ph2a LPI /Ph2 FPI
Ph2aLPO
Ph2a DataAnalyzed /
Ph2 LPIPHASE 2b
GOPh2b FPI /Ph2 LPO
Ph2bLPI
AnalyzePh2b Data
Prepare Ph2bStudy Report
Prepare Ph2Study Report
Ph2b LPO /Ph2 DataAnalyzed
Ph2b DataAnalyzed
PHASE 3GO
Ph3FPI
Ph3LPI
Ph3LPO
Prepare Ph3Study Report
Ph3 DataAnalyzed
LICENSEGO
DossierFiled
DevelopSupplementalLic./PQ Plan
1st LicensureGranted
SUPP. LIC /PQ GO
Supp. Lic/PQ Submitted
Prepare forDelivery
Add’ l Lic/PQ Granted
LAUNCHGO
VACCINE DEVELOPMENT
DIAGNOSTIC DEVELOPMENT
CollaborationPartners
TargetDisease
CollaborationPartners
TargetDisease
Investment (USD)
Investment (USD)
2.3
2.3
Tuberculosis
Tuberculosis
Malaria
Schistosomiasis 779,036
Schistosomiasis 763,890
Tuberculosis 6,377,747
Malaria 993,031
Malaria 1,382,697
Malaria $728,831
Malaria 964,500
591,397
714,500
Malaria 3,903,504
Malaria 5,602,934
Malaria 972,951
6,349,620
Tuberculosis 373,561
1,423,590
3,450,277
612,902
5,831,957
5,652,366
766,099
2,000,000
Malaria
Malaria
881,900Malaria
Malaria
Dengue
Leishmaniasis
558,316Leishmaniasis
5,408,632Dengue
Dengue
Chagas disease
1,097,928Chagas disease
Malaria 930,571
Tuberculosis 1,000,000
4,096,664Leishmaniasis
Leishmaniasis 2,257,700
Mycetoma 285,938
Malaria 526,900
Malaria 960,772
ID
T5-142
G9-105
T7-105
G5-210
G5-201(2)
T18-157
G4-201
T7-272
G9-213
T9-260
ID
G3-118
G4-110
T7-274
G4-109(3)
G3-105
G5-214(2)
T6-207(2)
G9-111
T18-151
T9-252
T9-254
G3-102(2)
T6-110
G5-147
G4-111
G9-102
G4-102
G5-121
G6-109(2)
G5-115(2)
G8-111
G6-203
DISCOVERY PRECLINICAL CLINICAL REG
Concept DevelopmentConcept Development Technical FeasibilityTechnical Feasibility Development FeasibilityDevelopment Feasibility Product DesignProduct Design Product Development Product Development Product ValidationProduct Validation RegistrationRegistration
Product Development PlatformTarget Research Platform
Antigen IdentificationAntigen Identification Vaccine ConceptDevelopment
Vaccine ConceptDevelopment
Technology PlatformIdentification
Technology PlatformIdentification Lead OptimizationLead Optimization Preclinical DevelopmentPreclinical Development Phase 1 Clinical DevelopmentPhase 1 Clinical Development Phase 2 Clinical Development Phase 2 Clinical Development Phase 3 Clinical Development Phase 3 Clinical Development RegistrationRegistration
Product Development PlatformTarget Research Platform
Note: 1 includes past and present Collaboration Partners' logos 2 The awarded amount refers to the conditional investment figure agreed at the initiation of each project. 3 GHIT invests using Japanese yen. US dollar amounts represent conversions from Japanese yen, solely for the reader’s convenience, at JPY 100 = USD 1.ver6.4 2020.3.31
Copyright © 2013 - 2020 Global Health Innovative Technology Fund
GHIT Fund Advancing PortfolioPlan Ph2Program
Enroll Ph2Study
Conduct Ph2Study
Analyze Ph2Data
Prepare Ph2Study Report
Plan Ph3Program
Enroll Ph3Study
PHASE 2GO
PHASE 3GOPh2 FPI
Ph2a DataAnalyzedPh2 LPI Ph2 LPO Ph3 FPI Ph3 LPI
CURRENT STATUS
For example, a successful investment in a Phase 2 clinical trial would yield one stage gate and five milestone advancements. For the semi-annual progress report, partners designate the current state of the project by specifying the project’s current activity. For example, completing the study portion of the Phase 2 clinical trial by the second reporting period would credit the project with one stage gate and four milestone advancements. A green triangle represents a continued investment.
Project Scope vs Current Reporting Period Status
1st PROJECT SCOPE 2nd PROJECT SCOPE
CONTINUATIONLegend
STAGE ACTIVITYMILESTONESTAGE-GATE
DiscontinuedSuccessfully completedCurrent Status
