RIGHT (Research Investment for Global Health Technology, Korean GHIT) November 2017

Transcription

1 RIGHT (Research Investment for Global Health Technology, Korean GHIT) November 2017

2 ROK intends to create a new public-private partnership modeled after successful Japanese GHIT fund Research Investment in Global Health Technology (RIGHT) 1 An international public-private partnership dedicated to advancing global health tech nology and globalizing the Korean vaccine industry RoK Gov t (MOHW) 50% Korean supply to global public mkt & new mkt entry Foster growth of Korea n vaccine industry (wo rld s 5 th in 12 years) Korean Pharmaceutical Companies 25% KRW 50B fund to support international collaborative research for development of vaccines, drugs, & diagnostics for global health International public/private partnership Inspire international collaborative research Bill & Melinda Gates Foundation 25% Development of safe, effective & affordable Vxs Contribute to global ef fort to defeat infectiou s diseases in developin g countries 1. Final name of fund pending; TBC by Launch Committee ODA pass-through & back-office support (shared services)

3 Benchmark: the GHIT* business model * GHIT( ) Investment conditions WHO Neglected Diseases plus TB, Malaria Rx, Dx, Vx Minimum 1 Japanese and 1 non-japanese partner

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

5 GHIT is a public-private partnership; fund has grown to 25+ partners GHIT Funding Partners June 2017

6 RIGHT concept: pipeline/portfolio Products: Vaccines (60%~70%) + mab/biologics and diagnostics Product Pipelines : focus on development (pre-clinical & clinical), with some investment in highpotential 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 7

8 RIGHT governance IVI Governance RIGHT Governance Council Founding members BOT BOT SAG Selection Committee DG Back-office shared services (incl. space, Finance & IT) Executive Director D&D CRL VPD MERS/ GDAC EPI F&O GGA Strategy Dev't & Grant Mgmt. Governance, Marketing, etc. IVI org. structure RIGHT org. structure

9 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

10 RIGHT Set-up Process 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 10

11 RIGHT Launch Timeline Q Q2 2018: Key Milestones and Timeline 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 1 st RFP We are here 11

12 International Vaccine Institute: An Introduction

13 IVI is an International Organization dedicated to Global Health VISION: Developing countries free of suffering from infectious disease MISSION: Discover, develop and deliver safe, effective and affordable vaccines for global public health Global Vaccine Research Institute HQ and labs at Seoul National University Field programs in 29 countries: Asia, Africa, Latin America 12 nationalities in workforce of ~130 OECD-recognized International Organization (not for profit) UNDP initiative First international organization in Korea (1997) 35 countries and WHO as state parties 13

14 IVI s Approach

15 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 07 Vaccine R&D accelerator Pediatric Dengue Vaccine Initiative (2003) Dengue Vaccine Initiative (2010) Global Dengue and Aedes Transmitted Disease Consortium (2016) Global alliance management Philanthropies: Governments: Korea, Sweden, India Universities/research institutes Companies:

16 Vaccine Pipeline PRECLINICAL CLINICAL LICENSURE/WHO PQ Bivalent inactivated oral cholera vaccine Vi-DT typhoid conjugate vaccine Bivalent typhoid/paratyphoid conjugate vaccine Shigella vaccine Norovirus vaccine Heptatis A vaccine Vi-PspA conjugate vaccine

17 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 Lorenzo Pezzoli / WHO Emergency cholera vaccination in Nsanje District, Malawi supported by IVI, WHO, Korean Ministry of Foreign Affairs and Malawi s Ministry of Health in April, 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 Euvichol, Korea s first cholera vaccine for global health, developed by IVI and EuBiologics 17

18 Current Projects & Future Opportunities Target diseases must meet the following criteria: High burden in global health Matches IVI capabilities Disease relevance in Asia Donor Preferences International Vaccine Institute Target Diseases: Established Projects Early/Future Projects Typhoid Support accelerated development and introduction of portfolio of typhoid vaccine candidates Continued disease surveillance Develop next generation typhoid/para-typhoid vaccine Norovirus Support ROK activities in norovirus Vx development Hepatitis A Hepatitis B Support ROK activities in HAV/HBV Vx development 18 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 Inactivated Inactivated Rotavirus Rotavirus Vaccine Vaccine (funding?) (funding?) Support US CDC candidate??korean manufacturer EV71: Human Hand, Papilloma foot & Virus mouth disease vaccine (funding?) Single Asian dose problem Coalition Evaluation for Epidemic of manufacturers Preparedness Innovation (CEPI) Hepatitis-E (funding?) Support MERS, efforts Lassa, to Nipah measure (Jenner), disease Lassa burden (Inovio) EV71: Support Hand, WHO foot Pre-Q & mouth of vaccine disease candidate vaccine (funding?) Group Regional A Strep problem (funding?) (Asia) Evaluation Develop funding of manufacturers platform/pdp mechanism for GAS Hepatitis-E vaccine development (funding?) Support WHO Pre-Q of vaccine candidate Group A Strep (funding?) Develop funding platform/pdp mechanism for GAS vaccine development F U T U R E

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