RIGHT (Research Investment for Global Health Technology, Korean GHIT)

November 2017

ROK intends to create a new public-private partnership modeled after successful Japanese GHIT fund

KRW 50B fund to support international collaborative research

for development of vaccines, drugs, &

diagnostics for global health

Foster growth of Korean vaccine industry (wo

rld’s 5th in 12 years)

Korean supply to global public mkt & new mkt entry

50%

Inspire international collaborative research

International public/private

partnership 25%

Contribute to global effort to defeat infectious diseases in developin

g countries

Development of safe, effective &

affordable Vxs 25%

Research Investment in Global Health Technology (RIGHT)1

An international public-private partnership dedicated to advancing global health technology and globalizing the Korean vaccine industry

ODA pass-through & back-office support (shared services)

Korean Pharmaceutical Companies

RoK Gov’t (MOHW)

Bill & Melinda Gates Foundation

1. Final name of fund pending; TBC by Launch Committee

Investment conditions • WHO Neglected Diseases plus TB, Malaria • Rx, Dx, Vx • Minimum 1 Japanese and 1 non-Japanese partner

Benchmark: the GHIT* business model * GHIT(www.ghitfund.org )

To date, GHIT has invested nearly $100M in global health projects

GHIT Funding Partners June 2017

GHIT is a public-private partnership; fund has grown to 25+ partners

RIGHT concept: pipeline/portfolio

Products:

Vaccines (60%~70%) +

mAb/biologics and diagnostics

Product Pipelines : focus on development (pre-clinical & clinical), with some investment in high-potential discovery projects

Target Diseases : Focus on global health, health R&D innovation, and Korean industry pipeline development

Target 6 to 10 projects launch in 2018

To be discussed among stakeholders through launch committee meetings

7

IVI and RIGHT operations

IVI is the ODA pass-through and has been asked to lead the establishment process

IVI will be the ongoing host and provide back-office services to RIGHT

RIGHT to be separate legal entity – public interest co. with separate governance structure (made up of Council, Board of Trustees, and Selection Committee)

Very important to strengthening relationships with both ROK & BMGF

– ROK sees this as way to develop Korean capabilities & build international partnerships

– BMGF invested in replicating GHIT; Bill & Melinda aware and supportive of the project

RIGHT governance

IVI Governance RIGHT Governance

IVI org. structure RIGHT org. structure

DG

BOT

SAG

CRL D&D VPD MERS/GDAC

EPI F&O GGA

Selection Committee

Strategy Dev't & Grant Mgmt.

Governance, Marketing,

etc.

Executive Director

Council

BOT

Back-office shared services (incl. space, Finance & IT)

Founding members

Strengths of the Korean Biotech Industry

• Korea has secured the safety and efficacy of medicinal products manufactured in Korea through:

Comprehensive GMP-accreditation system

Internationally-harmonized regulations, checked by MFDS before drug approval

• Home to rapid production capabilities, premium-quality products,

advanced facilities and equipment, and cutting-edge technology as well as a highly-skilled labor force in R&D and manufacturing

• Example of successful vaccine development in Korea: Euvichol, an Oral Cholera Vaccine, was developed by IVI & EuBiologics, with

research, development, and manufacturing all completed in Korea

Now WHO-prequalified and stockpiled, with >5 million doses

administered in 12 countries against endemic and

epidemic cholera

9

RIGHT Set-up Process

10

Launch Committee & Strategic Planning Advisory Groups will offer advice and support

throughout the establishment process, with Launch Committee acting as the ultimate

decision-making body

At launch, aim to have all governance bodies set-up and filled with appropriate members,

along with a small management team & investment mechanism that are ready to go

Responsibilities of advisory committees:

• Launch Committee to oversee RIGHT set-up process and align on:

• Scope (target disease, product, development stage), governance (incl. members), and success

factors

• Implementation plan, including fund management system, procedures, and standards

• Launch Committee to be comprised of all funding partners (MOHW, BMGF, companies), IVI, and

Prof. Cho

• Strategic Planning Advisory Group, made up of external experts (vaccine, drug, diagnostics)

and KOICA will:

• Provide input on scope, target diseases, and potential partners / project opportunities

• Help identify candidates for Project Selection Committee and Board of Trustees

RIGHT Launch Timeline

11

IVI, MOHW,

BMGF

Discussions

⇨ Consultation

Meetings ⇨

Expression for

Participation ⇨

All

Stakeholder

Meeting

⇨

Launch

Committee

Discussions

⇨ RIGHT

establishment

(June ~ July

2017)

(June ~ July

2017) (Aug 2017) (Sep 2017)

(Oct 2017~

Mar 2018) June 2018

Letters

expressing

interests

exchanged

between

MOHW and

BMGF

Multiple

individual and

group

meetings

among

MOHW/IVI/

companies

Expression for

participation

by 5

companies,

MOSF budget

approval

Discuss

perspectives

on the RIGHT

among all

stakeholders

Alignments on

scope and

governance

among all

stakeholders

Legal

establishment;

preparation

underway for

1st RFP

Q4 2017 – Q2 2018: Key Milestones and Timeline

We are here

International Vaccine Institute: An Introduction

IVI is an International Organization dedicated to Global Health

13

• UNDP initiative • First international organization in Korea (1997) • 35 countries and WHO as state parties

OECD-recognized International Organization (not for profit)

• HQ and labs at Seoul National University • Field programs in 29 countries: Asia, Africa, Latin America • 12 nationalities in workforce of ~130

Global Vaccine Research Institute

VISION: Developing countries free of suffering from infectious disease

MISSION: Discover, develop and deliver safe, effective and affordable vaccines for global public health

IVI’s Approach

IVI’s Capabilities

Process development Technology transfer Building human, technical infrastructure Clinical trials / capacity building Clinical development leading to WHO prequalification Epidemiology / disease surveillance Strengthening surveillance systems Vaccine R&D accelerator Pediatric Dengue Vaccine Initiative (2003) Dengue Vaccine Initiative (2010) Global Dengue and Aedes Transmitted Disease Consortium (2016) 15

Global alliance management • Philanthropies:

• Governments: Korea, Sweden, India

• Universities/research institutes

• Companies:

01

02

03

04

05

06

07

Vaccine Pipeline

PRECLINICAL CLINICAL

Bivalent inactivated oral cholera vaccine

LICENSURE/WHO PQ

Vi-DT typhoid conjugate vaccine

Bivalent typhoid/paratyphoid conjugate vaccine

Shigella vaccine

Norovirus vaccine

Heptatis A vaccine

Vi-PspA conjugate vaccine

Achievements

Vaccine innovation, R&D

• Introduced global public-private partnership paradigm for vaccine development in Asia

• Industry partners: - SK Chemicals (Korea), PT Biofarma (Indonesia), Incepta Vaccine (Bangladesh) - tech transfer and support

for typhoid conjugate vaccine (partners: Gates Foundation, US NIH)

- EuBiologics (Korea), Shantha Biotechnics (India), VaBiotech (Vietnam) – tech transfer and support for

oral cholera vaccine (partners: Gates Foundation, GHIF)

- GeneOne Life Science (Korea) – clinical trial support for MERS vaccine (partner: Samsung)

- Instituto Butantan (Brazil), VaBiotech – clinical trial support dengue vaccine

(partner: German Government)

Capacity-building

• IVI’s International Vaccinology Course for Asia-Pacific Region –running for 17 years to train >1,000

• WHO-TDR EDTCP Fellowship partner

• IVI labs in Andong, Gyeongbuk Province, Korea; and Kolkata India

Products

• Oral Cholera Vaccine – developed world’s first affordable cholera vaccine; WHO-prequalified and stockpiled; >5 million doses administered in 12 countries against endemic and epidemic cholera

• Typhoid Conjugate Vaccine – clinical trials in Philippines ongoing

• MERS DNA-based Vaccine – partnering with GeneOne to develop their MERS vaccine, first to test in humans

Global Health • Cholera vaccinations – Tanzania, Malawi, Nepal, Ethiopia, Bangladesh and India

• First to provide scientific evidence of typhoid burden in Africa and global burden of cholera

Emergency cholera vaccination in Nsanje District, Malawi supported by IVI, WHO, Korean Ministry of Foreign Affairs and Malawi’s Ministry of Health in April, 2015.

© Lorenzo Pezzoli / WHO

Euvichol, Korea’s first cholera vaccine for global health, developed by IVI and EuBiologics

17

Current Projects & Future Opportunities

18

International Vaccine Institute Target Diseases:

Target diseases must meet the following criteria:

High burden in global

health Matches IVI capabilities

Disease relevance

in Asia Donor Preferences

Established Projects

Typhoid

• Support accelerated development and introduction of

portfolio of typhoid vaccine candidates

• Continued disease surveillance

• Develop next generation typhoid/para-typhoid vaccine

MERS

• Support development and introduction of multiple MERS

vaccine candidates

Cholera

• Engage in studies to optimize the use

• Facilitate studies that oversee OCV introductions

• Provide technological and strategic support to Vabiotech,

Eubiologics, and Incepta

Dengue

• Coordinate Dengue Vaccine Initiative (DVI) to accelerate

introduction of new dengue vaccines to poor

• Support product development for next follow-on candidates

Shigella

• Support Asia-based activities leading to WHO Pre-Q of

vaccine candidates as part of PATH's overall activities

Pneumococcal

• Support SK's Pneumo candidate with support from BMGF

Early/Future Projects

Norovirus

• Support ROK activities in norovirus Vx development

Hepatitis A – Hepatitis B

• Support ROK activities in HAV/HBV Vx development

Inactivated Rotavirus Vaccine (funding?)

• Support US CDC candidate?

• ?Korean manufacturer

EV71: Hand, foot & mouth disease vaccine (funding?)

• Asian problem

• Evaluation of manufacturers

Hepatitis-E (funding?)

• Support efforts to measure disease burden

• Support WHO Pre-Q of vaccine candidate

Group A Strep (funding?)

• Develop funding platform/PDP mechanism for GAS

vaccine development

Inactivated Rotavirus Vaccine (funding?)

• Support US CDC candidate

• ?Korean manufacturer

Human Papilloma Virus

• Single dose

Coalition for Epidemic Preparedness Innovation

(CEPI)

• MERS, Lassa, Nipah (Jenner), Lassa (Inovio)

EV71: Hand, foot & mouth disease vaccine

(funding?)

• Regional problem (Asia)

• Evaluation of manufacturers

Hepatitis-E (funding?)

• Support WHO Pre-Q of vaccine candidate

Group A Strep (funding?)

• Develop funding platform/PDP mechanism for GAS

vaccine development

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