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Prospective Models of Vaccine Security Collaborations in
Research and Development
Georges Thiry, PhD IVI (International Vaccine Institute)
Phuket, Oct 01, 2014
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Content
• R&D • Examples of collaborations from international •
Examples involving ASEAN Countries • The ASEAN R&D Network •
Conclusions
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Research and Development
Research Develop Deliver
Lab Lab Scale- Pilot Regulatory
Manufacture
Animal Pre-Clinic Clinic Use
Epidemiology, Marketing, Regulatory
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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
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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
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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
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Example : manage consortium
European Foundation - Supports the development of new TB
vaccines - Accessible and affordable to all people
www.tbvi.eu
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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
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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
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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
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Manage animal testing
• Guinea pigs • Non human primates
– Head to head
comparison of multiple candidates
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Manage community: annual meeting
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Example: industries
Source: www.DCVMN.org
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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)
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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;
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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
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Network for vaccine R&D
(…)
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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.
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[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
