GHIT Fund

ANNUAL R E PORT

2 019

E

GHIT Fund

ANNUAL R E PORT

2 019

CONTENTS

01

Igniting Innovation, #Together

03

Global Dialogue

05

Advancing Portfolio

07

Clinical Candidates

09

Strategic Plan Progress

11

Invested Partnerships in FY 201913

GHIT R&D Forum 201917

Preparing Innovations for Success

19

Delivering Impact throughDiversity, Equity, and Inclusion

21

Communications

23

Finances

25

Leadership

27

Acknowledgment

29

02

IgnitingInnovation,
Together
FY 2019 represents a landmark year for GHIT, Japan, andthe groundwork for the UN General Assembly High-Level

global health alike, and we are proud to share the highlights

Meeting on UHC in September 2019, when world leaderswith you. During the creation of this annual report, the 2020

adopted the UN Political Declaration on UHC, the most

COVID-19 pandemic placed intense pressure on the entire

comprehensive health agreement ever made at this level.

world, further challenging communities already struggling

The declaration highlights the value of R&D, focused inwith neglected diseases, and underscoring the criticalparticular on innovative financing for new products andimportance of public-private partnership (PPP) andtechnologies and emphasizing cross-sector collaboration andResearch and Development (R&D). Investing in productnew models for sustainable investment.

development for patients with malaria, tuberculosis (TB),
and neglected tropical illnesses is more important than ever,Tangible R&D progress

and GHIT is committed to mobilizing our network,

In FY 2019, GHIT invested USD 39.2 million in 19

knowledge, and experience in ever more creative andprojects. Newly awarded unique and innovative projects

flexible ways to ensure continuity. We can unite--andare critical to further strengthen our pipeline (P.13-16).

innovate--together, in spite of our physical distance, andTo date, our current investments total USD 209 million.

without forgetting compassion for others.

Currently, 25 discovery projects, 17 preclinical projects,
and 6 clinical trials are under way. Our most advanced

As we reflect on FY2019 milestones, we also look forward. We

clinical candidates are progressing, with World Healthare grateful for the opportunity to serve the global health R&D

Organization (WHO) endorsement and/or approval from

community and neglected patients worldwide, both of whosea stringent regulatory authority expected within the next

resilience and strength continues to astound us.

several years. These innovations include a urine-based
rapid tuberculosis diagnostic kit and a pediatric

03

R&D: a critical component of “Health for all”

formulation of the gold-standard drug for

GHIT partners and stakeholders convened at the G20

schistosomiasis (P.09-10). Getting these innovations

Summit and Tokyo International Conference on African

into the hands of the patients who need them mostDevelopment (TICAD7) in Japan in August 2019, as well as

represents a concrete realization of GHIT’s mission andduring numerous other major global health events.

vision. Additionally, we held our second R&D Forum in

High-level side events complemented the Government ofDecember 2019, which enabled our development

Japan’s steadfast prioritization of global health andpartners to connect in person to ideate around the global

Universal Health Coverage (UHC) in key discussions

health R&D process broadly, share lessons learned, andamong world leaders. Japan’s long-standing leadership infurther empower our network of innovators across the

UHC continued to make headlines into the autumn, laying

globe (P.17-18).

Bridging R&D and access and delivery

mobilize Japanese science and pharmaceutical capabilities

Because innovation without access is meaningless, we arein partnership with our global network of partners. We do

dedicated to ensuring that our development partners

this to push the boundaries of global health R&D so thatconsider access and delivery at every stage of the R&D

innovative tools can reach those who need them most.

process. We have also created, together with theEndorsement and approval of our first products are firmly

Government of Japan and United Nations Development

in sight.

Programme’s Access & Delivery Project (ADP), a thriving
global platform for critical, ongoing global dialogue

With every year we continue to see the limitless potential of

between funders, innovators, and access and delivery

global health R&D; our job is to deliver on it. We continue

stakeholders to discuss common challenges and needs, andto be inspired and emboldened by the passion, energy,

to jointly identify solutions. Furthermore, in March 2020 wecreativity, and unwavering commitment of our funders,were pleased to announce a new partnership with Unitaid,

partners, governors, and staff, as well as the broader globalaligning GHIT’s strength in product development andhealth community of which we are honored to be a part.

Unitaid’s expertise in promoting access to and scale-up of#Together, we will ignite innovation -- in times of both

health innovations (p.19-20).

crisis and calm.

Diversity, equity, and inclusion
We are proud to name diversity, equity, and inclusion (DEI)
as a high-level institutional priority, explicitly recognizing it
as an essential part of GHIT’s DNA through several internaland external efforts. We do this because we believe that DEI
is essential to the creation of new ideas, driving innovation,and enhancing operational excellence. That, in turn, helps us
contribute to better health for all through our global R&D
partnerships. In recognition of our efforts, Global Health
50/50, an evidence-based international platform to advance
DEI action and accountability in global health, featured
GHIT in its Stories of Progress (P.21-22).
Looking forward, and reflecting with appreciation

Catherine Kaseri Ohura

Hiroki Nakatani

In FY 2020 our focus remains steadfast: continue toCEO and Executive Director

Board Chair & Representative Director04

Global Dialogue
June 2019
Health20 Summit,
Tokyo

Auxiliary events at TICAD7,
Yokohama

In line with the G20 Summit in May 2019 hosted by theGovernment of Japan (GOJ), GHIT co-hosted with theindependent G20 Health and Development Partnership the“Financing for Global Health Innovation & Sustainable
Development” conference, which addressed innovative
financing mechanisms in health, innovation for antimicrobial
resistance and pandemics, and UHC.

The 7th Tokyo International Conference on African Development(TICAD7) was held in Yokohama, Japan, with the theme “Advancing
African Development through People, Technology, and Innovation.”
GHIT, together with the GOJ and Japanese pharmaceuticalcompanies, WHO, UNDP, and NGO/NPOs co-hosted several
high-level side events focused on unique collaborations with African
partners, promising innovations utilizing Japan’s technology andinnovation, and uniting efforts globally to combat neglected diseases
in Africa for achieving UHC and the SDGs.

Photo Credit: The G20 Health and Development Partnership

October05

AugustNovemberWorld Health Summit,
Berlin

Women Leaders in Global HealthConference, Kigali

Together with leaders from the European & Developing
Countries Clinical Trials Partnership (EDCTP), the Global Fund,
WHO, and German Federal Ministry of Education and Research,
GHIT examined the clinical development of novel medical
technologies for poverty related infectious diseases throughcreative collaboration and strategic alliances.

As a sponsor, speaker, and mentor, GHIT joined 1000+ global healthleaders and young professionals in Rwanda to discuss women's
leadership and career development, and how best to change theglobal health gender imbalance.
Photo Credit: University of Global Health Equity

September
Uniting Efforts for Innovation,
Access and Delivery at UNGA:
Back-to-back technical meetings,
New York City

Leaders across sectors urged the global community to maintainand increase momentum toward the elimination of neglecteddiseases and to continue development of life-saving tools,
delivering those innovations to neglected patients,
strengthening health systems, and supporting African
ownership.
Photo Credit: TICAD7 JAGntd/GHIT

GHIT hosted technical meetings on the sidelines of the 2019 UN
General Assembly (UNGA) with the Government of Japan and
UNDP-ADP. Discussions addressed planning for access anddelivery in the R&D process, improving efficiency and use oftarget product profiles, costing and funding strategies, better
engagement with country stakeholders, and resource
mobilization.
Photo Credit: Uniting Efforts for Innovation, Access, and Delivery

DecemberFebruary 2020

GHIT R&D Forum,
Tokyo

Uniting Efforts for Innovation,
Access, and Delivery, Bangkok

GHIT’s biennial R&D Forum convened more than 100 R&D
partners and funders from across the globe to share progress andlessons learned about GHIT-invested projects and acceleratepartnership-driven innovations.

GHIT, the GOJ, and UNDP ADP convened over 100 funders, innovators,
government officials, and experts for the Second Global Dialogue of theUniting Efforts for Innovation, Access and Delivery platform, on the sidelinesof the 2020 Prince Mahidol Award Conference. Stakeholders discussed therefinement of collective research, the funding landscape, and guidance on
investment cases for neglected diseases.

Sketched by: Alex Cagan06

Advancing Portfolio
Discovery
Drugs / Vaccines

Target Research

Diagnostics

Target ResearchPreclinical
Screening

Hit-to-Lead

Preclinical
Product Design

Malaria

Tuberculosis
Chagas disease

Chagas disease, Leishmaniasis

Chagas disease

Schistosomiasis

Neglected Tropical
Diseases

Dengue fever
Leishmaniasis
Leishmaniasis

Mycetoma

Co-investment

GHIT investment

300.0

69.1

USD

29.7

07

12.8
18.9

46.0

63.7

2013

2014

2015

200.0

56.8

150.0

51.1

32.4
98.6
2016

131.9
2017

250.0

169.9

209.2

100.0

50.0

2018

2019

US dollar amounts represent conversions from Japanese yen, solely for the reader’s convenience, at JPY 100 = USD 1.

0

Cumulative investments USD (in millions)

285M

76.0

Clinical
Phase I

Phase II

Phase III

Registration

Product Development

Product Validation

Product Validation

Registration

Ib

IIa

IIb

Mycetoma

Schistosomiasis

IIb

III

Investment Overview FY2013-FY201991

Lymphatic filariasis,Onchocerciasis

DiseaseMalaria

43.7%

Tuberculosis 12.0%
NTDs

Development
Stage

Intervention

44.3%

Total invested
partnerships
48 Active investments
43 Completed investments

128

Drugs

67.4%

Discovery

16.2%

Vaccines

25.2%

Preclinical60.2%

Total productdevelopment partners

Diagnostics

7.4%

Clinical

23.6%

47 Japanese partners
81 Non-Japanese partners

08

Clinical Candidates
As of March 2020, six clinical trials and/or field studies are underway in low-andmiddle-income countries. COVID-19 has affected the operation and progress of these projects,
but GHIT is working closely with our partners to mobilize our knowledge andresources to support these activities.

SJ733

Disease: Malaria
Intervention: Drug
Development Stage: Phase IIa
Country: Peru

SJ733 is a chemically novel and potent
antimalarial candidate entering Phase II
clinical trials for oral 3-day treatment of
non-severe malaria, based on adihydroisoquinolone platform and featuring
good oral availability, excellent safety
tolerability, and a low propensity forresistance. In humans, SJ733 is active
against blood and sexual stages andpossesses an excellent safety profile. SJ733
demonstrated rapid parasite killing in a
Phase Ib human challenge. Phase IIa trial
using SJ733 as a combination therapy will
be tested at the clinical site in Peru toevaluate its effectiveness in the field setting.

BK-SE36/CpG
Disease: Malaria
Intervention: Vaccine
Development Stage: Phase Ib
Country: Burkina Faso

Peru

SJ733 Malaria/Drug

PZQ

Disease: Schistosomiasis
Intervention: Pediatric Drug
Development Stage: Phase III
Countries: Côte d'Ivoire, Kenya,
Zimbabwe

09

The Pediatric Praziquantel Consortium isdeveloping the pediatric formulation of thegold-standard drug for schistosomiasis toaddress the unmet medical needs of infectedpreschool-age children. The new orally
dispersible tablet under investigation issmaller and adapted to younger children.
The study is now in Phase III clinical trials,
with ongoing enrolment in Kenya andapproval obtained for Côte d'Ivoire andZimbabwe to test the safety andeffectiveness of the new formulation.
Implementation research plans have also
advanced to assess acceptability and try
different models of care for the formulation.
Finally, GHIT is also supporting theConsortium on further refining theformulation’s regulatory, access, anddelivery strategies, including creating
linkages with key stakeholders like WHO
and planning for long-term financing forprocurement and supply chain mechanisms
to ensure timely and sustainable roll out.

TBLAM

Disease: Tuberculosis
Intervention: Diagnostic
Development Stage: Field Validation
Country: South Africa, Malawi, Zambia,
Tanzania, Uganda, and Vietnam(currently planned and may expand)This trial assesses the safety andreactogenicity of three doses of malaria
vaccine candidate BK-SE36, formulatedwith TLR9 ligand adjuvants K3 CpG
oligodeoxyribonucleotides (K3
CpG-ODN) in healthy adults and children
exposed to the Plasmodium falciparum
parasite in Burkina Faso. In parallel withthis study, partners initiated the preparatory
work for Phase II proof-of-concept (POC)
study including pre-clinical studies on the
new GMP lot of SE36 vaccine adsorbed onaluminium hydroxide (NPC-SE36) to show
suitable formulation for clinical trial testingand importation; delivery of a new GMP
lot of CpG-ODN (K3) as adjuvant forclinical trials; selection of Phase IIb clinical
trial sites; preparation for the clinical trial
documentation.

Burkina Faso

BK-SE36/CpG Malaria/Vaccine

This trial tests whether Fosravuconazole (E1224), anazole-class antifungal drug discovered by Eisai, may also
be effective against fungal mycetoma. Current treatment
for mycetoma is lengthy, expensive, and--with its 20-30%
success rate--barely effective. The trial being conducted byDrugs for Neglected Diseases initiative (DNDi), together
with Eisai and the Mycetoma Research Center (MRC), a
WHO Collaborating Center in Khartoum, Sudan,
compares the effectiveness of Fosravuconazole with thecurrent treatment, itraconazole. Fosravuconazole wasinitially developed by Eisai for treatment of other fungal
infections and has a proven safety profile and shows
strong antifungal activity against fungal mycetoma. If
successful, Fosravuconazole would offer a more effective
and affordable alternative treatment of shorter duration.
The trial is currently in Phase II in Sudan, the country
where the disease is most prevalent and where thegovernment is uniquely committed at the highest levels to
address this scourge. After a preliminary blindedevaluation in February 2019, which showed promising
results, the DSMB (Drug Safety Monitoring Board) of
Sudan recommended increasing the enrolment number to165, which in itself is a positive sign. GHIT is also
supporting the development partners in preparations forearly access by catalyzing discussions on regulatory
pathways, including WHO PQ (Pre-qualification).

E1224

Disease: Mycetoma
Intervention: Drug
Development Stage: Phase IIb
Country: Sudan

Vietnam

Sudan

TBLAM TB/Diagnostic

E1224 Mycetoma/Drug

UgandaTBLAM TB/Diagnostic

Côte d'Ivoire

PZQ Schistosomiasis/Pediatric Drug

ZambiaTBLAM TB/Diagnostic

ZimbabwePZQ Schistosomiasis/Pediatric Drug

Kenya

PZQ Schistosomiasis/Pediatric Drug

Tanzania

DAR-901 TB/Vaccine
TBLAM TB/Diagnostic

Malawi

TBLAM TB/Diagnostic

South Africa
TBLAM TB/Diagnostic

This project aims to develop a highly sensitive, rapid point-of-care TB test to diagnose thedisease from urine in high-risk, HIV-infected individuals. The project is a partnership
between Fujifilm, which developed the technology, and FIND (Foundation for Innovative
New Diagnostics) and is currently at the field validation stage. A review of the preliminary
data by the WHO Guideline Development Grou (GDG) in May 2019 gave a positive
outlook, with recommendations for additional studies to cover population groups not
originally covered in the study. For example, HIV positive patients with higher CD4 cellcounts and a broader geographical coverage. The prospective studies are being conducted(or planned) in South Africa, Malawi, Zambia, Tanzania, Uganda, and Vietnam, withpossibility to expand. These are expected to end by Q4 2020, with targeted WHO GDG
review by Q1/Q2 2021 due to changes in the WHO GDG set-up procedures. Fujifilm also
submitted a dossier to the Global Fund/Unitaid-sponsored Expert Review Panel for
Diagnostics, an early access mechanism that allows countries to use Global Fund or
Unitaid money to procure technologies that do not have Stringent Regulatory Authority
approval. Additional operational research is also planned by FIND’s independent partners,
such as Medicines Sans Frontiers, McGill University, and KNCV. More data is also
expected from Fujifilm-led independent studies with multiple research partners. GHIT isalso supporting the partnership to facilitate the SILVAMPTM TBLAM’s transition tovolume manufacturing, pricing strategy, and country entry and adoption through setting up
strategic access and delivery partnerships.

DAR-901

Disease: Tuberculosis
Intervention: Vaccine
Development Stage: Phase IIb
Country: Tanzania

DAR-901 is the only novel TB booster vaccine
candidate based on inactivated whole cell derived
from Mycobacterium obuense that has shown
efficacy in humans. The DAR-PIA trial is a PhaseII study of the DAR-901 booster conductedamong 13-15 year old adolescents in Tanzania.
Unlike most TB vaccine trials that test whether avaccine prevents full blown TB disease, the
DAR-PIA trial tests whether DAR-901 works
even earlier and prevents the initial TB infection.
After two years of follow-up, all participants will
be retested to determine if those in the vaccine
group had a reduced risk of new TB infection.

10Strategic Plan
Progress
R&D: Investments in Product Development
Further leverage innovations from Japanese biopharma and academia
Target Research

Progress by

March 2020

Target byMarch 2023

Lead Identification

Preclinical

Diagnostics

4

6
Leads

Candidates

5

5
Leads

Candidates

Five innovative diagnostics
identified and funded

Five hit-to-lead programs

Eight preclinicalcandidates identified

Diagnostics

7

8

Diagnostics

Lead Identification

Malaria

Malaria● Development of LFA platform for improving sensitivity ofpoint-of-care assays for infectious disease with main focus on TB
and malaria. Asahi Kasei Corporation, and Biopromic AB. [2018]● Commercial development of a saliva-based malaria asymptomaticand asexual rapid test (SMAART-1). CellFree Sciences Co. Ltd.,ERADA Technology Alliance, Ltd., Frontier Institute Co., Ltd.,
Oasis Diagnostics Corp., and the University of Florida. [2019]● New hit-to-lead activity for new anti-malarials between MMV and
Takeda. Takeda Pharmaceutical Company Limited, Medicines for
Malaria Venture (MMV). [2018]● Proteasome inhibitors as new potent antimalarials. Takeda
Pharmaceutical Company Limited, MMV, The University of
Melbourne’s Bio21 Molecular Science and Biotechnology Institute.
[2019]● Development of nucleoside sulfamates as novel antimalarials. Takeda
Pharmaceutical Company Limited, MMV, The University of Melbourne’s
Bio21 Molecular Science and Biotechnology Institute. [2019]

NTDs● Production, validation, and use of the Leishmanin skin test for
detection of Leishmania exposure and immunity. Institute ofTropical Medicine (NEKKEN) Nagasaki University, Gennova
Biopharmaceuticals Ltd., McGill University, U.S. Food and Drug
Administration, and the Ohio State University. [2019]● MycEXomics, development of a field-friendly point-of-carediagnostic test for mycetoma. RIKEN, Hospital General de Mexico,
Mycetoma Research Centre, University of Khartoum, and Erasmus
University Medical Center. [2019]11

Hit Identification

TB● Hit-to-lead development of novel anti-TB natural products. Daiichi
Sankyo RD Novare Co., Ltd., The Global Alliance for TB Drug
Development [2018]● Hit-to-lead development of phenotypic and mechanism-based
screening hits. Takeda Pharmaceutical Company Limited, The Global
Alliance for TB Drug Development. [2019]● Hit-to-leade development of phenotypic screening hits. Chugai
Pharmaceutical Co., Ltd., The Global Alliance for TB Drug
Development [2019]

GHIT’s Strategic Plan 2018-2022 was developed in 2017. The R&D pillar specifies
targets at each development stage so that tangible results and impacts from GHIT
investments can be evaluated objectively.

ved
Appro
ved
Appro

Advance R&D investment pipeline and prioritize late-stage candidates
Phase I

Phase IIa

Phase IIb

Phase III

Registration

1
FIH

0
POC

Product

5

3

Products

FIH

Five First in Human (FIH)
clinical trials conducted

1
2

POC

Three clinical candidates with Proof of Concept (POC) achieved

Two products approved by astringent regulatory authority

Design of clinical trials (e.g., PhIa/b, PhIIa/b) and point of testing for proof of concept depends on regulatory science; depiction above is only representative.

Preclinical
Malaria● Preclinical and clinical development of SJ733, a novel PfATP4
inhibitor for the treatment of severe malaria. Eisai Co., Ltd.,
University of Kentucky. [2019]● Preclinical studies of potent Gwt1p inhibitor toward IND for
antimalarial agent with novel mechanism of action. Eisai Co., Ltd.,
MMV. [2019]

NTDs● Development and production of cGMP lots of a novel tetravalentdengue virus-like particle (VLP) vaccine. Institute of Tropical
Medicine (NEKKEN) Nagasaki University, The Johns Hopkins
University, Latham BioPharm Group, National Institute of Infectious
Diseases, and VLP Therapeutics. [2018]● Preclinical development of an anti-dengue virus antibody thatneutralizes all four serotypes. Chugai Pharmaceutical Co., Ltd., andA*STAR's Singapore Immunology Network (SIgN). [2018]● Development of a novel immune therapy to reduce or prevent typicalpost-treatment sequelae of visceral leishmaniasis. University ofTokyo, International Center for Diarrheal Disease Research
Bangladesh, and Infectious Disease Research Institute. [2018]● Live attenuated prophylactic vaccine for leishmaniasis. Institute ofTropical Medicine (NEKKEN) Nagasaki University, Gennova
Biopharmaceuticals Ltd., McGill University, The Ohio State
University. [2019]● Development of AWZ1066S, a small molecule anti-Wolbachia
candidate macrofilaricide drug. Eisai Co., Ltd., University ofLiverpool, Liverpool School of Tropical Medicine. [2019]

Phase I
● Fujifilm SILVAMPTM TBLAM – a sensitive point-of-care TB test.
Fujifilm Corporation and FIND [2018]

Registration● Fujifilm SILVAMPTM TBLAM – a sensitive point-of-care TB test.
Fujifilm Corporation and FIND [CE Marked in 2018][Year] = The year when GHIT and/or partners met the milestone in the strategic plan.

12

Invested Partnerships in FY 2019
Made-in-Japan, next-generation vaccine platform
effective for multistage Plasmodium for infants
Malaria / Vaccine
Target Research Platform

Kanazawa University, Hokkaido University, Jichi Medical University,
Toyama University, University of Cambridge
Screening Platform

Hit-to-Lead Platform

Many people living in tropical areas are demonstrably co-infectedwith helminths and malaria, which are known to adversely affectimmune responses to a number of different existing vaccines.
Based on the hypothesis that helminths and maternal antibodies are
critical host factors, this project aims to develop a highly effective
and durable next-generation multi-stage malaria vaccine that will
be effective against both the pre-erythrocytic stage andsexual-stage parasites based on two viral vectors for African
infants with pre-existing helminths and maternal antibodies.

Product Development Platform

Prof. Shigeto Yoshida
Kanazawa University

Protective and transmission blocking efficacies of theheterologous prime-boost immunization regimen will beassessed by sporozoite challenge and a direct membranefeeding assay in a robust, proven mouse model, and then theregime will be further optimized. The desired protection rateis greater than 90%. Surrogate markers responsible forprotection will be identified, and humoral and cellularimmune responses induced by the heterologous prime-boost
immunization regimen will be assessed.

Development of a novel Pvs25 nucleoside-modified
mRNA vaccine that induces potent and long-lastingtransmission-blocking immunity
Malaria / Vaccine
Target Research Platform

Ehime University, Mahidol University, University of Pennsylvania
Screening Platform

Hit-to-Lead Platform

The goal of this project is to develop a novel
nucleoside-modified mRNA vaccine that induces potent,
long-lasting transmission-blocking immunity and is able tointerrupt transmission of P. vivax from human to mosquito. The
vaccine target is the protein Pvs25, which is expressed on thesurface of the transmission-stage parasite, a well-validated
target. The nucleoside-modified mRNA encoding Pvs25 will bedelivered by lipid nanoparticles (LNP), an approach which has
been shown to be highly effective in other vaccines.

Product Development Platform

Dr. Jetsumon Prachumsri
Mahidol University

The project will test several mRNA-LNP formulations in animals
to identify the best candidate. It will also explore several routes ofadministration and immunization schedules. Vaccine efficacy will
be determined by the ability of the immune sera of immunizedanimals to block mosquito infection using a membrane feeding
assay with P. vivax parasites isolated in Thailand. In addition todeveloping a new transmission-blocking vaccine, the project also
investigates the immune mechanism that results intransmission-blocking activity.

MycEXomics aims to develop a field-friendly
point-of-care diagnostic test for mycetoma
Mycetoma / Diagnostic
Target Research Platform

RIKEN, Mycetoma Research Centre (MRC), University of Khartoum,
Erasmus University Medical Center, Hospital General de Mexico
Screening Platform

Hit-to-Lead Platform

Mycetoma is caused by more than 70 different causative agents,
but four of these are responsible for 79.5% of all mycetoma
cases world-wide. The current mycetoma diagnostics tools are
tedious, invasive of low sensitivity and specificity, andexpensive. Presently there is no point-of-care diagnostic test formycetoma. This project sets out to identify species-specificmarkers for the four most common causative agents ofmycetoma in urine and plasma of mycetoma patients.
13

Product Development Platform

Dr. Imad Abugessaisa
RIKEN

In order to identify these markers, the project will identify thecausative agent by isolating exosomes from the urine andplasma, isolate RNA from the exosomes and sequence it, andthen profile and transcriptomes identify markers. The markers
identified can later be used to develop point-of-care diagnostic
tools to detect early cases of mycetoma.

Hit-to-lead development of
Phenotypic screening hits
Chugai Pharmaceutical Co., Ltd., TB Alliance

Tuberculosis / Drug
Target Research Platform

Screening Platform

Hit-to-Lead Platform

Dr. Tatsuya Tamura
Chugai Pharmaceutical Co., Ltd.

Product Development Platform

This project aims to identify lead compounds for TB
utilizing hit compounds discovered from natural products inthe previous GHIT-funded research. This involves not only
improving the potency of the compounds against
Mycobacterium tuberculosis (M. tb), but also improving theirpharmacokinetic properties and safety liabilities todemonstrate their activity in animal models. Partners plan to
identify a compound at the end of the two-year period tomove to lead optimization.

The screening of natural products has been deemphasized inrecent years in the face of parallel syntheses and target-based
screening. By returning to this rich source of novel
antibiotics while also applying the most advanced synthetic
technology, project partners aim to combine the merits ofthese two approaches to create a new mechanism of action as
M. tb-active agents.

Hit-to-lead development of phenotypic andMechanism-based screen hit
Takeda Pharmaceutical Co., Ltd., TB alliance

Tuberculosis / Drug
Target Research Platform

Screening Platform

Hit-to-Lead Platform

Joint screening efforts by Takeda and the TB alliance toidentify potential new TB drugs identified two promising seriesof compounds. Of these series of compounds identified, one
emerged from phenotypic screening of Takeda’s compound
library for their ability to kill M.tb, and the second frommechanism-based screening of Takeda’s internal portfolio for
their ability to inhibit a particular enzyme in M.tb. The goal ofthis project is to improve their potency and properties andensure their safety to make them suitable for treatment. The

Dr. Yuichiro Akao
Takeda Pharmaceutical Co., Ltd.

Product Development Platformproject also aims to prove that the eventual drugs derived fromthese prototypes can be administered orally and in reasonable
doses to be widely accepted among TB patients worldwide.
Partners will synthesize several dozens of analogues in eachseries to evaluate them in the assay and, test selected analogues
in mice to evaluate their activity in animal models.

Development of AWZ1066S, a small moleculeanti-Wolbachia candidate macrofilaricide drug
Eisai Co., Ltd., Liverpool School of Tropical Medicine, University of Liverpool
Lymphatic filariasis / Drug
Target Research Platform

Screening Platform

Hit-to-Lead Platform

In the absence of a drug for Lymphatic filariasis (elephantiasis)and onchocerciasis (river blindness) that can kill adult worms,
current eradication programmes require many years of annual or
greater rounds of drug administration to large populations in therural communities blighted by these diseases. Partners havedemonstrated that adult worms can be killed by eliminating abacterium that they contain called Wolbachia. The antibiotic
doxycycline works in this way and proof of concept has already

Product Development Platform

Prof. Stephen Ward
Liverpool School of Tropical Medicine

been proven in human field trials, however it requires weeks ofdaily treatment and carries contraindications in young children
and pregnant women, who represent a large proportion of thetarget population. This project’s candidate drug has shownquicker and efficient activity than doxycycline and has a safe
profile in pre-clinical testing. Partners will complete a series ofPhase I clinical trials to assess safety in humans.

14

Lead optimization of a candidate series
active against Chagas disease
Daiichi Sankyo Company Limited, Drugs for Neglected Diseases initiative (DNDi)

Chagas disease / Drug
Target Research Platform

Screening Platform

Hit-to-Lead Platform

This project aims to create a safe and efficacious new oral
treatment for chronic Chagas disease, appropriate for acute patientsand that is safe to use during pregnancy. Existing drugs for Chagas
disease are associated with serious side effects and suboptimal
efficacy for chronic Chagas patients. Drugs for Neglected Diseases
initiative (DNDi) and Daiichi Sankyo Co., Ltd. have been

Product Development Platform

Dr. Takuya Ikeda
Daiichi Sankyo
Company Limited

collaborating since early 2016 on the development of the new
drug. This 2-year project aims to engineer this promising class ofcompounds into one optimized lead candidate for Chagas disease
and elucidate its mechanism of action by the end of Q1 2022. This
optimized lead candidate shall meet the criteria of the Chagas
disease Target Candidate Profile defined by DNDi.

Preclinical development of malariatransmission-blocking vaccine candidate
Pfs230D1+ formulated with SA-1 adjuvant
Malaria / Vaccine
Target Research Platform

Ehime University, Sumitomo Dainippon Pharma Co., Ltd., PATH
Screening Platform

Hit-to-Lead Platform

The goal of this project is to advance a novel candidate P.
falciparum (malaria) vaccine to the clinical testing stage. Thistransmission-blocking vaccine incorporates an optimized
immunogen, Pfs230D1+ formulated with a novel TLR7
adjuvant (SA-1). This project employs both an optimized
immunogen Pfs230D1+, which contains the key regions

Product Development Platform

Dr. C. Richter King
PATH

necessary for antibody mediated inhibition of P. falciparumtransmission, and a novel TLR7 adjuvant (SA-1) to promote a
potent and durable effect. The project will ideally conclude withclinical phase manufacturing and the filing of an Investigational
New Drug (IND) application to the U.S. Food and Drug
Administration (FDA).

Preclinical studies of potent Gwt1p inhibitor
toward IND for antimalarial agent with novel
mechanism of action
Malaria / Drug
Target Research Platform

Eisai Co. Ltd., Medicines for Malaria Venture (MMV)
Screening Platform

Hit-to-Lead Platform

Glycosylphosphatidylinositol (GPI) is a common moiety in all
eukaryotes which has a role in anchoring many proteins to thecell surface. Gwt1p, one of the essential enzymes in the GPI
biosynthesis pathway, was identified by Eisai as a novel target
for an antifungal drug. After conducting discovery research,
Eisai found that the GWT1 gene encoding Gwt1p enzyme ishighly conserved among eukaryotes, including Plasmodium
protozoa, the etiological pathogens for malaria. MMV and Eisai

15

Product Development Platform

Dr. Takaaki Horii
Eisai Co. Ltd.

succeeded in creating the candidate compound with improved
anti-Plasmodium activity and the long half-life required forsingle-dose malaria treatment. Partners aim to conduct
IND-enabling Good Laboratory Practice (GLP) preclinicalstudies on an antimalarial candidate compound with awell-characterized and novel mechanism of action identified ina project funded through a previous GHIT investment.

Production, validation, and use of Leishmaninskin test for detection of Leishmania
exposure and immunity
Leishmania / Diagnostic
Target Research Platform

Institute of Tropical Medicine (NEKKEN) at Nagasaki University, Ohio State University,
McGill University, Gennova Biopharmaceuticals, U.S. FDA
Screening Platform

Hit-to-Lead Platform

No tests are currently available to detect asymptomatic
Leishmania infection and immunity against the disease. The
objectives of this project are to produce and determine thestability of the L. donovani antigen (Leishmanin antigen),validate the Leishmanin skin test (LST) leishmanin antigen
in immune animals, validate the LST in visceralleishmaniasis-cured and asymptomatic infected individuals.

Product Development Platform

Prof. Abhay Satoskar
The Ohio State University

Project partners will establish a protocol for making
Leishmanin antigen from L. donovani parasites and produce
GMP grade Leishmanin for the LST. Immune responses will
also be analyzed in these preclinical animal models, followedby the validation of LST in visceral leishmaniasis patientsand asymptomatic individuals from endemic regions.

Commercial development of a saliva-based malaria
asymptomatic and asexual rapid test (SMAART-1)
Malaria / Diagnostic
Target Research Platform

CellFree Sciences Co. Ltd., ERADA Technology Alliance, Ltd.,
Frontier Institute Co., Ltd., Oasis Diagnostics Corp., University of Florida
Screening Platform

Hit-to-Lead Platform

Malaria rapid diagnostic tests (RDTs) have been a criticalcomponent of the eradication arsenal, but recent studies suggestthat the P. falciparum parasite has developed mutations that
effectively limit the diagnostic capacity of current RDTs toconfirm parasitic infection in the field. The project addresses
this limitation by producing and validating Saliva-based
Malaria Asymptomatic and Asexual Rapid Test (SMAART-1)
that have high enough sensitivity to diagnose asymptomaticcases with high reliability and greater acceptability, designed

Product Development Platform

Dr. Rhoel Dinglasan
University of Florida

especially for easier diagnostic screening of children. Productdevelopment draws on the new P. falciparum protein marker
PSSP17 identified by the University of Florida that could
replace presently used parasite markers, which a growing
prevalence of parasite mutations have rendered increasingly
ineffective. The PSSP17 protein is present in infected red blood
cells and is also present as a soluble molecule in the saliva of
individuals with clinical and subclinical infections.
Photo credit: Jasses S. Jones, University of Florida Health Communications

16

GHIT
R&D Forum 2019
GHIT’s biennial R&D Forum creates a special opportunity for over 100 of the institution’s
R&D partners and funders across the globe to share progress and lessons learned about
GHIT-invested projects, from discovery to clinical stages, and to connect people and acceleratepartnership-driven innovations. By doing so, further expanded and strengthened R&D ecosystems
for neglected patients have been built. Since the first R&D Forum in 2017, partnerships between
Japanese and non-Japanese partners have proliferated and flourished. We continuously endeavor tocatalyze and support these promising collaborations for neglected patients.

Dr. Atsuko Ochida

Ms. Lara Pandya

Associate Director
Drug Discovery Chemistry Laboratories
Neuroscience Drug Discovery Unit, Research
Takeda Pharmaceutical Company Limited

Strategic Partnerships Officer
European & Developing Countries
Clinical Trials Partnership(EDCTP)“Sharing our ideas with, and receiving constructive“We are proud to co-invest with GHIT in the paediatric PZQ

feedback from, experts in different fields are critical steps

Phase III trial, which is providing clinical data and support forfor shaping our research. The best science comes fromregistration of a new PZQ tablet formulation to treat

embracing and inviting diversity, and the inclusion ofschistosomiasis in preschool-aged children. GHIT’s R&D

different ideas. To address complex global healthForum facilitates open dialogue between researchers andchallenges, uniting with not only researchers likefunders that creates synergies and generates innovative ideas forourselves, but also funders, regulatory authorities,

greater impact through partnership. Collaboration andgovernments, international organizations, and NGO/NPOs

coordination between funders is now more critical than ever towill be essential. GHIT’s R&D Forum is the place where

accelerate R&D for neglected diseases and populations with

we can do this for neglected patients.”major unmet medical needs.”

Dr. Tomoko Ishino

Dr. Charles Mowbray

Associate Professor
Division of Molecular Parasitology
Protea-Science Center (PROS),
Ehime University

Discovery Director
DNDi“Joining forces to develop life-saving innovations with the global“While visiting Japan over the R&D Forum week, we had fruitfulcommunity is a source of great pride for me. Expanding our

discussions with many scientists at both public and private organizations

network proactively and exploring our potential beyond

and identified several exciting opportunities for new projects andacademia and Japan are critical to move our discovery science

partnerships. Over the years partnerships with Japanese organizations

and technology to the development stage. Global collaborationfrom discovery to clinical stages have become critical elements ofand open innovation plays a pivotal role in GHIT, and the R&D

DNDi’s portfolio. GHIT has been key to these many successes and has

Forum very literally demonstrates that. I believe that R&D

played a catalytic role in facilitating these collaborations and helping us

partnerships will continue to have a central role in lifting up theto access important new technologies for neglected patients. I am proudquality of science, accelerating product development, and gettingof and inspired by the fact that our Japanese partners’ motivation andtools to the patients who need them most.”

commitment to exploring the best science for the most neglected has onlygrown stronger from year to year.”17

Technology
Creativity
Connectivity
All drives innovation
Fostered from research
Realized with development
Your active and creative minds
Harmonized with other’s
Ignites innovation for those most neglected
Thinking bigger, thinking differently
Outside the box
We can nurture a new dawn where
Health is a right, not an option
Japanese innovation
Connecting the dots
Of global partnership
Changing health
To save millions of lives
Enabling equality
So that they can thrive
Together
We are all GHIT

18

Preparing Innovationsfor Success
Linking R&D to access and delivery every step of the way

We fundamentally believe that without access, innovation is

Our approach rests on two key pillars: a tactical, bottom-up

meaningless. Accordingly, GHIT is dedicated to ensuring

pillar that ensures development partners are creatingthat our development partners consider and prepare forcomprehensive product launch strategies to complement andaccess and delivery at every stage of the R&D process so

inform R&D, and a policy-focused top-down pillar thatthat our invested innovations can move quickly from the lab

launched a platform for critical, ongoing global dialogue

into the hands of the people and communities who needamong all relevant stakeholders about the inextricable linkthem most. While GHIT’s investments focus exclusively on

between R&D and access and delivery. GHIT partners with

R&D, facilitating critical access and delivery-focused

the Government of Japan and UNDP’s Access & Delivery

dialogue and partnerships play an important role in settingPartnership (ADP) on activities associated with the second

up those innovations for success.

pillar, entitled Uniting Efforts for Innovation, Access andDelivery. This platform fills a gap in opportunities forWith registration and approval now in sight for several

funders, innovators and access and delivery stakeholders to

products, these considerations become increasingly

discuss common challenges and needs, and to jointly

important. As a result, our approach leverages GHIT’s

identify solutions.

networks and unique positioning to influence and catalyze
strategic access and delivery partnerships. This ensures that
innovative health technologies have a direct impact on theirtarget populations, and, ultimately, on health outcomes.

Research & Development

Access & Delivery
Regulatory

Registration

Discovery

Clinical（PI-III)

Preclinical（FDA/EMA/PMDA）

World Health Organization（WHO-PQ）

Demand Forecast

Financing
Manufacturing

Procurement & Supply Chain

Policy & Advocacy
Regulatory Harmonization, Capacity Building (UNDP-ADP）¥
GHIT invests only in product development
Phase I to Phase II POC: Up to 75% of total investment
Beyond Phase II POC: Up to 50% of total investment

GHIT facilitates strategic partnerships
for Access and Delivery◀Top-down approach:

Facilitate creating platform for Innovations, Access and Delivery▶Bottom-up approach:

Ensure launch strategies for GHIT-invested clinical candidates

19

Patient

Uniting Efforts for Innovation,
Access and Delivery Global Dialogue

Partnership with Unitaid

Back-to-back technical meetings in New York City

framework to increase awareness of and access to(September 2019)

innovation and expertise in key areas such malaria, TB, andThe first meeting on the sidelines of the 2019 UN General

NTDs. In the context of achieving health-related SDGs andAssembly addressed how and when to start planning for

UHC, the framework facilitates continuous dialogue andaccess and delivery in the R&D process, improving

operates at a broad strategic level to align GHIT’s strength

efficiency and use of target product profiles (TPPs), andin product development and Unitaid’s expertise insharing lessons learned. The second examined costing andpromoting access to and scale-up of health tools. It also

funding strategies, strategies for better engagement withcoordinates actions to accelerate access to innovative

country stakeholders, investment cases, and sustainable,

solutions, focusing on products and technologies that cancoordinated resource mobilization.

deliver the most impact for vulnerable and underserved

In March 2020, GHIT and Unitaid signed a collaboration

populations and address the global health-related needs.
Second Global Dialogue in Bangkok (February 2020)
In addition to revisiting the above topics, stakeholders“Innovation is at the heart of Unitaid’s work and we are pleased to

discussed the refinement of collective research on accessbe able to create this platform for dialogue with GHIT. The Fundpolicies and practices in R&D, the neglected disease accesshas recognized strengths in product development, which complementand delivery funding landscape, and a guidance note on

those of Unitaid to identify innovation, promote access and ensure

investment cases for neglected diseases. The dialogue’s

scale-up by partners. I look forward to exploring opportunities withmarketplace approach facilitated meaningful connections

GHIT to deliver our strategic objectives of serving

between experts and country stakeholders.

vulnerable and underserved populations, andhttps://www.unitingeffortsforhealth.org/

bringing innovative solutions to achieve
universal health coverage.”

Dr. Philippe Duneton, Executive Director
20

Delivering Impact throughDiversity, Equity,and Inclusion
DEI as GHIT’s DNA
GHIT’s Management Team explicitly recognizes diversity,

GHIT’s internal DEI task force, set up in September 2019,equity, and inclusion (DEI) as critical to GHIT’s DNA.

is composed of C-suite leaders and individuals across

Why? A more diverse workforce and flexible work-styledepartments and holds regular meetings to identify

enables our team to maximize their full potential andchallenges and opportunities and discuss improvements toempowers them to leverage their creativity and productivity,internal DEI policies and programs. Externally, we havefueling new ways of thinking. Fostering an inclusive culture

initiated dialogue across a diverse range of sectors to sharethat encourages openness, respect, and fairness, and finds

best practices and lessons learned, as well as collaborations

value in differences and similarities so that all employees

for creating and accelerating more innovations and sustained

feel that they belong, is a day-to-day priority. Thesesocial change.

collective impacts bring innovative ideas and approaches,
and then lead to better organizational performance andsuccess. That, in turn, helps us contribute to better health for
all through our global R&D partnerships.

21

DEI

Innovation

Better Health“We have long known that DEI, including gender diversity, is key to effective,
innovative organizations. In the for-profit world, DEI relates directly to sales and profits.
In global health, where non-profit organizations are striving to create a healthier world, it is even morecritical to embrace DEI as a mechanism to maximize our ability to deliver on our missions…
DEI is not just a question of fairness, it’s a driver of success.”Catherine Ohura

CEO & Executive Director, GHIT Fund

Global Health 50/50
Global Health 50/50 is an
The Women Leaders in Global Health conference,

independent, evidence-driven

launched in 2017, takes place in a different country each

initiative to advance action andyear and brings together established and emerging leaders

accountability for genderfrom across sectors and cultures to work towards genderequality in global health. Its

equity in health leadership and to improve health for all.

yearly report and accompanying

At the 2019 conference in November in Kigali, GHIT

index provide comprehensive,

CEO Catherine Ohura spoke alongside Peru’s former

in-depth analysis of the

Minister of Health, the Rockefeller Foundation’s

gender-related policies and practices across 200 of theManaging Director of Health Programs, Nigeria’s Chiefworld’s most influential health and health policy

Humanitarian Coordinator, and Israel’s first woman toorganizations, including GHIT. The 2020 report provides

lead a governmental hospital on the "Leadershipan unprecedented birds-eye view of the global health

Labyrinth" panel, which featured honest discussion aboutsystem and warns that inequalities are impeding progress

the career growth of women across global health sectors.

towards health goals. In 2020 GHIT featured prominently

Additionally, as a Founding Partner of the event, GHIT

among Global Health 50/50’s Stories of Progress, making

sponsored a 100-person breakfast mentoring session fornotable strides across all 11 evaluation areas.

young professionals and students.
“The GHIT Fund stands out among
Japanese organizations for its
prioritization of gender equality and its
commitment to diversity, equity, andinclusion more broadly. While a smallorganization compared to its counterparts
across the globe, the presence of strong and committed
leadership within GHIT is already demonstrating positive
results. Over the past year, GHIT has made significant
progress in the Global Health 50/50 Index, and I
congratulate the team and the leadership for their success inpushing for gender equality that benefits everyone.”Prof. Sarah Hawkes
Co-founder of Global Health 50/50
Professor of Global Public Health, University College London
Photo Credit: University of Global Health Equity

22Communications
In FY2019, GHIT released a series of short films that highlighted global partnerships and innovativetechnologies to overcome global health challenges. Each film is available on our YouTube channel.
Additionally, GHIT is now active on social media. Please follow us for the latest news about us and our partners.

First-ever clinical trial for
potential new effective,
lower cost mycetoma drug
Challenge Mycetoma (Eumycetoma), caused by a fungal
infection, slowly and progressively destroys soft tissue,
particularly on the feet. Mycetoma has no effective treatment andis currently managed with sub-optimal, expensive drugs carrying
strong side effects and often requiring surgery, including
amputation of affected limbs. In rare cases, it affects the lungs orbrain and can be fatal. In all cases, patients are unable to workand face severe social stigma.
https://youtu.be/zRCYMLTSr5A

Innovation Fosravuconazole, originally developed by Eisai
to treat other fungal infections, has a proven safety profile andshows strong in vitro antifungal activity against mycetoma.

A new pediatric formulation of
the gold-standard drug smaller in size, less bitter,and orally dispersible

This candidate drug can be administered once weekly andwould drastically improve patient compliance and reduce costs
for individuals and health systems alike. This drug, if
successful, could transform their quality of life.

Challenge Schistosomiasis is the second-most socioeconomicallydevastating parasitic disease after malaria. Exposure leaves infectedchildren vulnerable to increased risk for anaemia, stunting, and areduced ability to learn, although the effects are usually reversible withtreatment. Praziquantel (PZQ), an affordable, gold-standard drug, exists,
but treatment for preschool-aged children has not been implemented due
to several key obstacles: difficulty in swallowing and risk of choking
give the large-sized commercially available tablets and high rejection
rates due to bitter taste when pills are crushed and dispersed in liquids.
Innovation By utilizing Astellas’ formulation technology, the newpediatric tablets are about a quarter of the size of the existing commercial PZQ tablets
and are orally dispersible (can be taken with or without water). This, together withagents that minimize PZQ’s bitterness and improve the taste of the tablets, helps
children swallow more easily, which facilitates compliance and efficacy. In addition, thetablets are heat-stable in hot and humid African environments.

23

https://youtu.be/JirTRmJ8VKM

Novel, urine-based, point-of-care test for TB diagnosis forpeople living with HIV in low-resource settings
Challenge TB is leading cause of death in HIV Patients.
In order to provide appropriate care and treatment to HIV
patients, early diagnosis is essential. However, advanced
HIV-positive patients presenting for TB diagnosis areunable to produce a sputum sample and many patientscannot be diagnosed in time, which results in highmorbidity and high mortality. The world needs a
non-sputum based, rapid diagnostic tool that can be used in
LMICs with resource limited settings.
Innovation SILVAMP™ TBLAM uses patients’ urine todiagnose TB, detecting low concentrations of LAM(lipoarabinomannan), which is found in the cell walls of
https://youtu.be/xPV_XvYtDuI

mycobacterium tuberculosis. The partnership successfully
leverages FUJIFILM’s proprietary silver halide

FUJIFLM's SILVAMP

TM

amplification technology, originally developed for

TBLAM received the "GOOD

processing photographs, to create highly sensitive

DESIGN GRAND AWARD" -immunochromatography, which is capable of detecting

Japan's most prestigious design

viruses and bacteria.

award. This GHIT-invested
urine-based rapid diagnostic test for tuberculosis is highly evaluated by the Good DesignAward jury and the most popular design of the year in Japan. “We highly praised the ambition,technology and design that has made it possible to easily diagnose TB in developing countries
with a 70% sensitivity, which is equivalent to expensive diagnostic equipment…The utilizationof silver amplification technology, which is now considered nonessential, has reminded us theimportance of discovering new things by taking lessons from the past.”
https://www.g-mark.org/award/describe/49146

Follow us on

Twitter & LinkedIn@ GHITFund
Global Health Innovative Technology (GHIT) Fund

Selected media coverage in 2019

GHIT Fund

Asian Scientists, Financial Times, Japan Times, World Economic Forum,
The Chemical Daily, Forbes Japan, JIHO, Mixonline, Nikkei,
Yakuji Nippo, Yomiuri Shimbun etc

24

Finances
FY 2019 Financial summary
Balance Sheet
Assets (in millions)

JPY

USD

Current Assets
Fixed Assets

1,009.4
5,355.9

9.3
49.2

Total Assets

6,365.3

58.5

Liabilities (in millions)

JPY

USD

Current Liabilities
Non-current Liabilities

604.2
466.5

5.6
4.3

1,070.7

9.9

JPY

USD

Designated Net Assets
General Net Assets

5,294.6-

48.6-

Total Net Assets
Total Liabilities and Net Assets

5,294.6
6,365.3

48.6
58.5

Total Liabilities

Net Assets (in millions)

The US dollar amounts in this section represent translations of Japanese yen, solely for the reader’s convenience, at JPY108.81 = USD1, theexchange rate as of March 31, 2020. This financial summary is an excerpt from the GHIT Fund's financial statements, which were audited by Ernst &Young ShinNihon LLC. The GHIT Fund is a Public Interest Incorporated Association and is registered in Japan.

Our Funding Partners and Sponsors
Full Partners

PublicFull Partners

25

PrivateNet Assets Variation Statement
Change in General Net Assets (in millions)
Ordinary Income

JPY

USD

Grants Received
Contribution Received
Misc. Income

3,102.5
668.9
6.1

28.5
6.1
0.1

Total Ordinary Income

3,777.5

34.7

Operating Expenses
Management Expenses

3,629.3
148.2

33.3
1.4

Total Ordinary Expenses

3,777.5

34.7

JPY

USD

Grants Received and Others
Governments, NGOs, Multilateral Organizations
Foundations
Contributions Received

3,415.5
875.3
739.2

31.4
8.0
6.8

Total Grants and Contributions Received

5,030.0

46.2

Ordinary Expenses

Change in Designated Net Assets (in millions)

Full Partners

Associate Partners

Affiliate Partners

Sponsors

26

LeadershipCouncil
The Council consists of the Japanese government, various foundations, and private companies that provide funding to GHIT. The Council resolves important matters as provided byapplicable laws and regulations or the Articles of Incorporation, including appointment and dismissal of members of the Council and the Board of Directors, amendment of the Articles
of Incorporation, and approval of financial statements.

Tamaki Tsukada

Yasuyuki Sahara, MD, MPH

Trevor Mundel, MD, PhD

Jeremy Farrar, MD, PhD, FRCP

Astellas Pharma Inc.

Chugai Pharmaceutical Co., Ltd.

Director
Wellcome

Yoshihiko Hatanaka
Representative Director
Chairman of the Board

Tatsuro Kosaka
Representative Director
Chairman and CEO

Daiichi Sankyo
Company, Limited

Eisai Co., Ltd.

Shionogi & Co., Ltd.

Haruo Naito
Representative Corporate Officer
and CEO

Isao Teshirogi, PhD
President and CEO

Ambassador, Director-General for Global Issues
Ministry of Foreign Affairs

George Nakayama
Representative Director and Chairman

Senior Assistant Minister for Global Health
Minister's Secretariat
Ministry of Health, Labour and Welfare

President, Global HealthBill & Melinda Gates Foundation

Takeda Pharmaceutical
Company Limited
Christophe Weber
Representative Director
President and CEO

Board of Directors
The Board of Directors consists of global health experts and management professionals. In addition to overseeing operations by the Leadership Team, it also resolves important businessmatters, including approval of major rules, strategic plans, annual operational plans/budget, and funding decisions based on recommendations from the Selection Committee.

Chair & Representative Director

Executive Director

Director and Professor of Global HealthLondon School of Hygiene and Tropical Medicine
Former Executive Director, UNAIDS

CEO, GHIT FundPeter Piot, MD, PhD

Mahima Datla

Daikichi Momma

Manabu Sumi, MD, PhD, MPH

Former Director-General, International Bureau
Ministry of Finance
Former Executive Director
International Monetary Fund representing Japan

Director, Global Health Policy DivisionInternational Cooperation Bureau
Ministry of Foreign Affairs

Kazuho Taguchi

Ann M. Veneman, JD

Project Professor
Global Research InstituteKeio University

Managing Director
Biological E. Limited

Director
Office of Global Health Cooperation
Ministry of Health, Labour and Welfare

Supervisory Board Member

Ko-Yung Tung, JD

Lecturer on Law, Harvard Law School,
Former Senior Vice President
and General Counsel, World Bank

27

Vice Chair

Hiroki Nakatani, MD, PhD, MHPEd

Former Executive Director, UNICEF
Former Secretary
United States Department of Agriculture

Ex-Officio

Stephen Caddick, PhD

Professor, University College London
Former Director of Innovations DivisionWellcome

Catherine K. Ohura, MS, PMP

Supervisory Board Member

Hikaru Ishiguro, LLM
Statutory Auditor
INSPiRE Corporation

Ex-Officio

Andrin Oswald, MD

Director, Life Sciences Partnerships
Bill & Melinda Gates Foundation

Selection Committee
The Selection Committee consists of domestic and international experts who have extensive knowledge and experience in research and development of drugs, vaccines, and diagnostics.
This committee evaluates investment proposals and reports from development partners and recommends investments to the Board of Directors. This committee includes no privatecompany representatives to avoid any conflict of interest between our backers and development partners.

Co-Chair

Co-ChairSophie Allauzen, PhD

Dennis Schmatz, PhD

Naoto Uemura, MD, PhD

Ralf Clemens, MD, PhD

Ann Mills-Duggan, PhD

Ken Duncan, PhD

Ken Ishii, MD, PhD

Kiyoshi Kita, PhD

Hiroo Koyama, PhD

Gerd Michel, PhD

Anna-Karin Tidén, PhD, MRSC

Rieko Yajima, PhD

Former Head, Infectious Diseases Research
Merck Research Labs, USA
Former Head, Research, MSD-Japan

Independent Vaccine Expert

Professor, Institute of Medical Science
University of Tokyo
Professor, the Laboratory of Vaccine Scienceat the Immunology Frontier Research Center(IFReC), Osaka University

Chief Scientific Officer
Vela Diagnostics

Professor, Department of ClinicalPharmacology and Therapeutics
Oita University Faculty of Medicine

Head, Seeding Drug Discovery FundBusiness Development, Innovations
Wellcome

Professor Emeritus, The University of Tokyo
Professor and Dean, Nagasaki University Schoolof Tropical Medicine and Global HealthIndependent Medicinal Chemistry Expert

Independent Diagnostic Expert

Deputy Director
Discovery & Translational Sciences
Bill & Melinda Gates Foundation

Platform Unit Leader
Drug Discovery Chemistry Platform Unit
RIKEN Center for Sustainable Resource Science

Director, Drug Discovery Innovation
SPARK Program in Translational Research
Stanford University School of Medicine

Leadership TeamThe leadership Team is responsible for the design and development of business and investment strategies and, upon Board approval, the execution of strategies, administrative operations,and organizational growth of GHIT.

Catherine K. Ohura, MS, PMP

Kio Yamabe, MBA

Daisuke Imoto, MBA

Kei Katsuno, MD, MPH

Nozomi Nakade

Miho Takazawa, MBA

Bumpei Tamamura, MPH

Hayato Urabe, PhD, MPIA

CEO

Senior Director, Investment Strategy& Business Development

Senior Director, Brand Communications

Chief Operating Officer

Senior Manager, CEO OfficeVice President
External Affairs & Corporate Development

Senior Director, Finance & Operations

Senior Director, Investment Strategy
Portfolio Development & Innovations

As of March 31, 202028

Acknowledgement
External Reviewers
The GHIT community's work could not progress without the vital support of these experts and their institutions.

Yukihiro Akeda

Jennifer GardinerJames LeDuc

Judy Sakanari

Pedro Alonso

Nisha Garg

Carole Long

Dirk Schnappinger

Peter Andersen

Ricardo Gazzinelli

Timothy Lu

Ami Shah Brown

Rip Ballou

Ann Ginsberg

Christian Mandl

George Siber

Lewellys Barker

Daniel Goldberg

John Mansfield

KJ Singh

Michael Barrett

Federico Gomez de las Heras

Greg MatlashewskiPeter Smith

Clif Barry

Glenda Gray

James McCarthy

David Soane

David Bell

Brian Greenwood

Joseph McCune

Lynn Soong

Marleen Boelaert

Sanjay Gurunathan

James McKerrow

Gerald Spaeth

Maria Elena Bottazzi

R. Kiplin Guy

Charles Mgone

Nathalie Strub-Wourgaft

Tom Brewer

Lee HallGerd Michel

atlas support

Martin Brusdeilins

Yoshihisa Hashiguchi

Toshiyuki Miura

Yasuhiko Suzuki

Simon Campbell

Thomas Hawn

Valerie Mizrahi

Marcel Tanner

Eric Chatelain

Chris HentschelKatsuhiko Mochizuki

John Telford

Philip ColeD. Gray Heppner

Kouichi Morita

Kaoru Terashima

Stewart Cole

Philip Hill

Charles Mowbray

Katsushi Tokunaga

Simon Croft

Toshihiro Horii

Peter Myler

Nadia Tourniporth

Roy Curtiss

Sanjay Jain

Daniel Neafsey

Bruno Travi

Peter Dailey

Takushi Kaneko

Christian Ockenhouse

Takafumi Tsuboi

Julian Davies

Niranjan Kanesa-thasan

Tsuyoshi Ogiku

Moriya Tsuji

Christine Debouck

Shigeyuki Kano

Giuseppe Pantaleo

Mickey Urdea

Thierry Diagana

Subhash Kapre

David Persing

Stephen WardThomas Dick

Paul Kaye

Meg Phillips

Tim Wells

Carter Diggs

Naoto Keicho

Punnee Pitisuttithum

Bruce Weniger

Boro Dropulic

David Kelso

David Pompliano

George Whitesides

Filip Dubovsky

Kent Kester

Dominick Pucci

Samuel Wickline

David Edwards

Akinori Kimura

Regina Rabinovich

Judith Wilber

Sabine Ehrt

Sue Kinn

Rino Rappuoli

Elizabeth Winzeler

Hiroyoshi Endo

Harajeshwar Kohli

Zarifah Reed

Dyann Wirth

Alan Fairlamb

Somei Kojima

Rebecca Richards Kortum

Michael Witty

Hermann FeldmeierPeter Kremsner

Paul Roepe

Paul Wyatt

David Fidock

Sanjeev Krishna

Eric Rubin

Kazuhisa Yoshimura

JoAnne Flynn

Michael KurillaPeter Ruminski

Takeshi Yura

Michael Free

Dennis Kyle

Philip Russell

Fidel Zavala

Takashi Fujitsu

Nancy Le Cam BouveretDavid Sacks

Donato Zipeto

Tamio Fujiwara
29

Funding Partners & Sponsors
Support from our generous funding partners and sponsors helps GHIT’s investments and operations advance and create meaningful impact.

Full Partners

Associate Partners

Affiliate Partners

Sponsors30

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