Prospective Models of Vaccine Security Collaborations in ...nvi.ddc.moph.go.th/AEC_2014/05.pdf• Regional surveillance system – Data base • Diagnostics • Modeling • Set up

Prospective Models of Vaccine Security Collaborations in Research and Development

Georges Thiry, PhD IVI (International Vaccine Institute)

Phuket, Oct 01, 2014

Content

• R&D • Examples of collaborations from international • Examples involving ASEAN Countries • The ASEAN R&D Network • Conclusions

Research and Development

Research Develop Deliver

Lab Lab Scale- Pilot Regulatory

Manufacture

Animal Pre-Clinic Clinic Use

Epidemiology, Marketing, Regulatory

Example: Transfer ‘product’

• IVI, International Vaccine Initiative

• Cholera whole killed vaccine – Vabiotech, Vietnam – To Shantha (Sanofi), India: Shanchol – To two additional partners in Asia

• Typhoid conjugate vaccine

– To Shantha – Three new partners, in Asia

Source: IVI web site

Example : Transfer ‘technology’

• University of Lausanne, Switzerland – Center of excellence for adjuvants and formulation – Course, training, tech transfer – Material transfer agreement – Projects with academia and industry

• INTRAVACC, NL

– Conjugation, process and QC – Tech transfer

Source: University of Lausanne – Nicolas Collin – Intravacc

Example : Technology Platform

• PATH, New Rotavirus program (ARVAC) – Four licensees of NIH Rotavirus vaccine – PATH created a technology platform available to all

• Cell line, viiral seeds • Process development and formulations • QC assays • Technical documents, SOPS • Expert supports: pre-clinic, clinic, RA

– Course, training, tech transfer

Source: PATH

Example : manage consortium

European Foundation - Supports the development of new TB vaccines - Accessible and affordable to all people

www.tbvi.eu

Germany: VPM

Max Planck (2x) Uni Tübingen

Spain: Uni Zaragoza/Biofabri (2x)

Switzerland: Uni Zürich Uni Geneva

France: Inst.Pasteur Paris (2x) Inst. Pasteur Lille CNRS Toulouse (5x) Institut Mérieux

Italy: Uni Padua

UK: Uni Oxford (3x)

Finland: FIT Biotech

Denmark: SSI (4x)

The Netherlands: Uni Leiden NVI

Belgium: GSK

TB research centers in Europe

PDT - CDT

Research Development

Entry criteria:

• Candidate(s) selected

• Process feasible

• Proof of concept in animals

• Develop plan and strategy

• Review process & characteristics

• Select manufacturer

• Review animal data; prepare tox & pre-clinical studies; select CRO

• Prepare clinical trial approval form

• Prepare protocol Ph 1& 2; select PI

• Project management & IP

Go Human

Manage expertise in Development

Source: G. Thiry, TBVI

10

Gate From To 1 Discovery Preclinical 2 Preclinical Phase 1 – 1st in man 3 Phase 1 Phase 2 4 Phase 2 Phase 3 5 Phase 3 Market authorization 6 MA Introduction

Discovery

Pre-clinic Ph 1 Ph 2 Ph 3 MA Market 1 2 4 3 5 6

Manage product development

Manage animal testing

• Guinea pigs • Non human primates

– Head to head

comparison of multiple candidates

Manage community: annual meeting

Example: industries

Source: www.DCVMN.org

BioNet

Suppliers R&D GMP

DCVMN

Hepatitis B (HBV) Influenza (Flu) Japanese Encephalitis (JEV) Measles Measles-Mumps-Rubella (MMR) Monovalent Oral Poliomyelitis (mOPV) Bivalent Oral Poliomyelitis (bOPV) Trivalent Oral Poliomyelitis (TOPV) Inactivated Poliomyelitis (IPV) Rabies (CPRV) Yellow fever (YF)

Acellular pertussis (recombinant aP) Haemophilus influenzae type b (Hib) Meningococcus ACYW135 (Men PS) Tetanus Toxoid (TT) Tuberculosis (BCG) Typhoid (Vi) Tetanus Diphtheria for adult (Td) Diphtheria, Tetanus, Pertussis (DTwP) Tetravalent vaccine (DTP-HBV) Pentavalent vaccine (DTP-Hib-HBV)

Example: Capacity in Regulatory - Dengue

• DVI • NRA:

– Indonesia, Malaysia, The Philippines and Thailand

– Brazil, Columbia, Mexico

• Meetings in – Brasilia, March 2013 – Bangkok, Oct 2013 – Jakarta, June 2014 – Beijing, Nov 2014 (DCVRN)

• Propose a new mechanism of a common review – For Phase 3 protocol; – For Marketing Approval;

Example: ADVA, surveillance, advocacy

ASEAN Dengue Vaccine Advocacy

• Regional surveillance system – Data base

• Diagnostics • Modeling • Set up a base line

Preparing for dengue vaccine introduction in ASEAN countries: recommendations from the first ADVA regional workshop. Thisyakorn U, Capeding MR, Goh DY, Hadinegoro SR, Ismail Z, Tantawichien T, Yoksan S, Pang T. Expert Rev Vaccines. 2014

Network for vaccine R&D

(…)

Conclusions

R&D is present (knowledge, know-how) and future (pipeline) R&D builds on education, innovation and

entrepreneurship, capacity (infrastructure, funds), environment (collaboration, regulation) Models and mechanisms build on willingness to

solve problems, to be effective, to share knowledge and … success.

[email protected] [email protected]

Thank you

Prospective Models of Vaccine Security Collaborations in Research and DevelopmentContentResearch and DevelopmentExample: Transfer ‘product’Example : Transfer ‘technology’Example : Technology PlatformExample : manage consortiumSlide Number 8Manage expertise in DevelopmentSlide Number 10 Manage animal testing Manage community: annual meetingExample: industriesBioNetExample: Capacity in Regulatory - DengueExample: ADVA, surveillance, advocacyNetwork for vaccine R&DConclusionsSlide Number 19