hiv vaccine development: an industry perspective
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HIV Vaccine Development: An Industry Perspective. Jim Tartaglia, PhD Vice-President R & D sanofi pasteur, Ltd. Toronto, Canada. XVI International AIDS Conference A World Without AIDS: The Long Road to Effective HIV Vaccines August 15, 2006. - PowerPoint PPT PresentationTRANSCRIPT
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HIV Vaccine Development: An Industry Perspective
Jim Tartaglia, PhD
Vice-President R & D
sanofi pasteur, Ltd.
Toronto, Canada
XVI International AIDS Conference
A World Without AIDS: The Long Road to Effective HIV Vaccines
August 15, 2006
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HIV Vaccine Development: An Industry Perspective
Industry is….Committed to the global efforts to develop an HIV vaccine(s)
Open to evolving public-private partnerships that aim to facilitate R & D efforts for HIV vaccines globally
Receptive to novel access paradigms that aim to ensure the delivery of effective HIV vaccines to the people who need them most and in a timely fashion
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Conventional Vaccine Development
Pre-clinical POC/Pre-clinical Pre-clinical POC/Pre-clinical DevelopmentDevelopment
Clinical Development/ Clinical Development/ IndustrializationIndustrialization
Test Convalescent
sera
Antigen selection
5-15 Years
Cultivate Microorganism
Clone genes
Test immunogenicity
Purify components
Identify components
Vaccine
5-15years
Killed vaccines
Live attenuated vaccines
Subunit vaccines
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Evolution in Vaccine Technologies
Inactivated
Live, attenuated
Subunit/rprotein
Adjuvants (Limited)
Inactivated
Live, attenuated
Subunit/rprotein (simple;complex)
Vector-based
Devices/alternate delivery
Immunoadjuvants (targeted)
2000 2020
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Vaccine R&D Timeline
Many years 2-4 years 6-8 years 1 year 2 years continue
DISCOVERY RESEARCH DEVELOPMENT REGISTRATION
• Antigen production• Assay development• Animal model dev.• Preclinical tox
Phase I•Safety•Initial•immunogenicity
Phase II a• Dose finding• Dose/schedule
finding• Immunogenicity
Phase II b• Early POC
Phase III• Large scale
safety +• Lot to lot
consistency +• Non inferiority
(combos) or• Efficacy
LaunchPreclinical
POC
Industrial Investment
File
• Identification of target antigens
• Understanding of pathologies
• Natural historyof disease
• Done mostly outside
of the “Big Pharma”
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Challenges Facing the Vaccine Industry
Success of vaccines – people no longer fear many diseases
Consumers expect perfect vaccines
Highly effective
No side effects
Increased complexity and difficulty of regulatory environment
• Increased cost and length of development
• Increased resource drain associated with maintaining marketed products
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Scientific “Waves” in HIV Development
1984 – 1994 Recombinant envelope (rEnv)
1994 – 2003 T-cells based + rEnv (Prime-Boost)
2003 – Present Next generation T-cell based + Next generation rEnv
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Vaccine Development is Iterative
Research Development Commercial
‘Proof of concept’ in humans is a key milestone
Several candidates are tested before the right one is identified
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What is Proof of Concept?
Demonstrable vaccine-effect in Phase II studyAcquisition endpointVirological endpoint
Broadly reactive serum neutralizing activity against primary viral isolates
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Even After Proof of Concept in Humans.. Many Questions Remain
‘Vaccine effect’--Clinical significance of surrogate endpoint
Genetic background
Risk profile
Mode of transmission
Subtype-specificity
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Investment Hurdles
HIV Vaccine R & D challenges
Need for novel technologies
Significant global clinical development hurdles
Defining investment milestones
Challenges with increasingly complex partnerships
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Traditional Vaccine Development Model for Developing Countries
IndustryR&D
Clinical Trials
Development of industrial capacity
Manufacturing
Financing:
Industry gave:Tiered Pricing
Public SectorCommitments to procure vaccines
Infrastructure:Cold chain
Storage facilities
Clinical logistics
Financing:Public sector/donors gave:
Bulk purchasing
Vaccine Development Purchase & Delivery
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R&D
Development of industrial capacity
Clinical trial partnerships
Manufacturing capacity
Access to IP and technology
Regulatory Capacity
Demand Estimates
Improvements in delivery infrastructure
Commitment to purchase vaccines at acceptableprices and for an acceptable term
To ensure a vaccine will be delivered as quickly as possible, industry, the public sector, NGOs and donors must work simultaneously, in partnership
Global Responsibility
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A Model for Ensuring Access
Partnerships among industry, the public sector and donors
with guarantees of purchase, regulatory harmonization, tax
credits and other incentives for industry to manufacture
vaccines for developing countries
Greater access to technology or bulk product for eligible
countries with technical capacity
New regional regulatory approaches
New regional plants: Industry or publicly-owned
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Partnerships Must Have a Shared Vision
Appropriate governance and communication is needed
Vaccine development is an iterative process Failures will precede successSuccess may be relative to specific populations; may require multi-component regimensAddressing implications for impecfect early generation vaccines
It is important to discuss the role of industry now
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No Company, Government or NGO Alone Will be Able to
Carry the BurdenGovernments, academia, NGOs, donors and industry
must work together to allow for the most effective means for developing and providing access to a vaccine(s) for
those who need it the most, as quickly as possible.