GHIT Fund 2.0
Strategic Plan
FY2018 – FY2022

HOW WE WORK
Government

Foundations

Industry

Innovative Financing for
Global Health R&D

Global Open Innovation

GHIT Fund (GHIT) is a global health R&D fund,

GHIT catalyzes open innovation between Japanese andwhich invests in non-profit product development for

non-Japanese entities across the globe to accelerate

HIV/AIDS, malaria, tuberculosis, and neglected

product development for patients who suffer fromtropical diseases. GHIT's funding partners, including

neglected diseases. GHIT invests in innovative productthe Government of Japan, Bill & Melinda Gates

development by integrating Japan’s science andFoundation, the Wellcome Trust, and global life

pharmaceutical technologies and capabilities with

sciences companies, have committed over USD 200M

global networks and resources.

for GHIT 2.0 (FY2018 - 2022).

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Rigorous Portfolio Management

Access & Delivery Strategy Appraisal

GHIT monitors and evaluates project progress

GHIT provides strategic guidance to productbiannually together with product development partners

development partners on their access and delivery

using gold standard industry metrics. We promptly

strategies for late-stage candidates, in collaboration

retire research that does not bear fruit. This approachwith domestic and international partners. Key issues

enables efficient use of our limited resources and helps

considered include demand forecast; regulatory

us realize tangible impact more quickly.

strategy; financing strategy; manufacturing,procurement, and supply chain; and policy andadvocacy.

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GHIT 1.0: Tangible Results
As of March, 2018

FY2013 – FY2017

R&D: Investments in Product Development
Target Research

Hit Identification

Lead Identification

Preclinical

Active investments

8

11

9

14

Completed investments

3

8

3

9

Excellence through Good GovernanceJapan’s first international Public Interest Incorporated Association
Certified in June, 2014 as Japan's first internationally governed and managed public interest incorporation

Managed conflicts of interest through good governance
Established transparent, independent governance model that features a robust firewall between funders
and institutional investment and organizational decision-making; additionally, all industry partners areprecluded from any investment decision making and all institutional operations

Investment, not philanthropy
Introduced rigorous investment management system to track and evaluate progress, end unsuccessfulprojects early, and accelerate innovations$¥ £Financial Strategies
Expanded funding partners and increased funding capacity
Launched in 2013 as a USD 100 million fund with 10 partners; today in 2017, as a result of new andrenewed commitments, funding exceeds USD 145 million, with 26 partners

Leveraged co-investment
Leveraged investment impact through co-investment from domestic and international entities

Replenished GHIT 2.0
Secured commitments of over USD 200 million for GHIT 2.0 replenishment
3Total Investment

132

USD

M

Total Invested
Partnerships

74

Total ProductDevelopment Partners

103

Phase I

Phase IIa

Phase IIb

1

1

5

GHIT 1.0
Committed Capital

145

USD

GHIT Cumulative
Committed Capital

M

USD

Phase III

345

M

Registration

Design of clinical trials (e.g., PhIa/b, PhIIa/b) and point of testing for proof of concept depends on regulatory science; dep iction above is only representative.
For more details on partnerships and progress on our portfolio, please visit GHIT’s website:
https://www.ghitfund.org/impact/portfolio/advance/

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Partnership for Delivery
Developed Access Policy
Developed GHIT Data Access Policy and Product Access Policy

Defined Target Product Profiles
Solicited proposals based on clearly defined target product profiles (TPPs) for low-and middle-income
countries; TPPs align the unique needs of end-users with desired product attributes and performance criteria

Partnered with United Nations Development Programme (UNDP)
Worked closely with UNDP’s Access & Delivery Partnership, which helps low- and middle-income
countries address bottlenecks within their health systems so that GHIT-funded innovations can reachmore people, faster

Developed Access & Delivery Strategy
Developed late-stage candidate access and delivery strategies framework for development partners,
including such issues as demand forecast; regulatory strategy; financing strategy; manufacturing,procurement, and supply chain; and policy and advocacy; initiated its appraisals

Product development organizations partnering with Japan

42
Japan

7

Asia

17
Europe22

North America

8South America

7

Africa4

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GHIT 2.0: Strategic Plan
FY2018 – FY2022

GHIT utilizes Japanese science and pharmaceutical capabilities to accelerate
product development (i.e., drugs, vaccines, and diagnostics) for HIV/AIDS,
malaria, tuberculosis, and neglected tropical diseases

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

Hit Identification

Lead Identification

Preclinical

5
Leads

Candidates

Five hit-to-lead programs

Eight preclinicalcandidates identified

58

Five innovative
diagnostic technologies
identified and funded(Target Research Platform &Product Development Platform)

Excellence through Good Governance
Ensure and further enhance corporate governance andinstitutional development● Two successful audits by the Cabinet Office of Japan (conducted every three years)● Five successful financial audits by an external and independent auditor● Five successful internal audits by the GHIT management team (results reported to Chief

Executive Officer & Board of Directors)● Biennial review and sign-off by Board of Directors of updated GHIT policies including
Governance Manual$¥ £Financial Strategies
Maximize efficiencies in fund management and co-funding strategies● Maintain overhead cost (at or below 5%)

Maintain uniquely low overhead cost in order to maximize investments in R&D● Increase leveraging factor (to 2.0)

Leveraging factor = ( GHIT’s investment + co-investment by other organizations) / (GHIT’s
investment) = 1.5 as of December, 2017

Develop and execute a replenishment plan for GHIT 3.0● Successfully replenish GHIT 3.0 (FY2023 - FY2027)

Ensure sustainable operations of GHIT and continued acceleration of product development
5

ved
Appro
ved
Appro

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

Phase IIa

Phase IIb

Phase III

Registration

5

3
POC

Products

Five First in Human (FIH)
clinical trials conducted

Three clinical candidates with Proof of Concept (POC) achieved

Two products approved by astringent regulatory authority

FIH

2

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.

Refine strategies to maximize global health R&D excellence and outcomes● Six preclinical investments and four clinical investments reviewed for effectiveness in the field● Annual portfolio review approved by the Portfolio and Launch Strategy Committee (PLSC), a standing committee of the GHIT Board of Directors

Partnership for Delivery
Strengthen capacity to appraise access and delivery strategies forlate-stage candidates● 10 access and delivery strategies for late-stage investments reviewed by PLSC, and reported to

the Board of Directors

Leverage UNDP and other global network partners
for product delivery preparedness● Six access and delivery strategies shared and discussed with UNDP and other global partners● Six meetings convened between development partners and relevant global partners for each of

the access and delivery strategies aforementioned with the goal of in-country access anddelivery support● Present GHIT's access and delivery strategies at more than 20 conferences or events

Disclaimer: This document contains forward-looking statements and actual results may be materially different from those expected in the forward-looking statements due to a number of risks anduncertainties, including, but not limited to, whether we can sustain funding, achieve successful progression of products through the R&D process, and receive regulatory approvals.

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Partners & Sponsors
Full Partners

Associate Partners

Affiliate Partners

Sponsors

Ark Hills Sengokuyama Mori Tower 25F,
1-9-10 Roppongi, Minato-ku,
Tokyo 106-0032 Japan
TEL: +81-36441-2032 FAX: +81-36441-2031
www.ghitfund.org

ver1.2 2018.3.31
GHIT invests using Japanese yen. US dollar amounts represent conversions fromJapanese yen, solely for the reader’s convenience, at JPY 100 = USD 1.