Prospective Models of Vaccine Security Collaborations in Research and Development

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1 Prospective Models of Vaccine Security Collaborations in Research and Development Georges Thiry, PhD IVI (International Vaccine Institute) Phuket, Oct 01, 2014

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

3 Research and Development Research Develop Deliver Lab Lab Scale- Pilot Regulatory Manufacture Animal Pre-Clinic Clinic Use Epidemiology, Marketing, Regulatory

4 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

5 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

6 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

7 Example : manage consortium European Foundation - Supports the development of new TB vaccines - Accessible and affordable to all people

8 TB research centers in Europe The Netherlands: Uni Leiden NVI UK: Uni Oxford (3x) Belgium: GSK France: Inst.Pasteur Paris (2x) Inst. Pasteur Lille CNRS Toulouse (5x) Institut Mérieux Spain: Uni Zaragoza/Biofabri (2x) Denmark: SSI (4x) Germany: VPM Max Planck (2x) Uni Tübingen Switzerland: Uni Zürich Uni Geneva Italy: Uni Padua Finland: FIT Biotech

9 Manage expertise in Development Research Development PDT - CDT Entry criteria: Candidate(s) selected Process feasible Proof of concept in animals Source: G. Thiry, TBVI Go Human 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

10 Manage product development Discovery Pre-clinic Ph 1 Ph 2 Ph 3 MA Market Gate From To 1 Discovery Preclinical 2 Preclinical Phase 1 1 st in man 3 Phase 1 Phase 2 4 Phase 2 Phase 3 5 Phase 3 Market authorization 6 MA Introduction 10

11 Manage animal testing Guinea pigs Non human primates Head to head comparison of multiple candidates

12 Manage community: annual meeting

13 Example: industries Source:

14 BioNet Suppliers R&D GMP 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) DCVMN

Example: Capacity in Regulatory - Dengue DVI NRA: Indonesia, Malaysia, The Philippines and Thailand Brazil, Columbia, Mexico Meetings in Brasilia, March

15 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 Preparing for dengue vaccine introduction in ASEAN countries: recommendations from the first ADVA regional workshop.

16 Example: ADVA, surveillance, advocacy 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 ASEAN Dengue Vaccine Advocacy Regional surveillance system Data base Diagnostics Modeling Set up a base line

17 Network for vaccine R&D ( )

18 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.

19 Thank you

DCVMN AND VACCINE SECURITY IN ASEAN REGION. ASEAN Countries on Opportunities for Regional Vaccine Security 1-3 October, 2014.

DCVMN AND VACCINE SECURITY IN ASEAN REGION ASEAN Countries on Opportunities for Regional Vaccine Security 1-3 October, 2014. Phuket - Thailand Developing Countries Vaccine Manufacturers Network (DCVMN)