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8/4/2019 Vaccine Development, From the Lab to the Clinic (Jim Tartaglia)
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Vaccine Development:From the Lab to the Clinic
Jim Tartaglia, PhD
Vice-President, R & D
Sanofi Pasteur
AIDS Vaccine 2011
Bangkok, Thailand
September 12, 2011
8/4/2019 Vaccine Development, From the Lab to the Clinic (Jim Tartaglia)
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HIV Vaccine Development:An Industry Perspective
Key Messages
HIV vaccine development follows same principles aswith other vaccine efforts
HIV vaccine development has certain unique hurdles
HIV vaccine development/deployment requirespublic/private partnerships
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Vaccines How Do They Differ fromDrugs?
Biologicals vs. Chemicals
Preventative rather than therapeutic
Considered by many to be commodities
Impacts compliance, willingness to pay and acceptance
of side effects
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Challenges Facing the VaccineIndustry
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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Vision for New Vaccines
Clear, shared understanding of the future:
Disease Impact/Public-health need
Epidemiology, morbidity, mortality and socio-economic impact
Demand
Realistic product profile, production & presentation
Realistic assessment of development costs and timelines
Clear vision of future demand, price and financing
Realistic assessment of public-health value, in the context of otherpreventive measures
Political Will
Shared commitment to need, priorities, demand, price and costPartnerships
Risk sharing
Leveraging resources and expertise
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Elements of a Target ProductProfile (TPP)
Indications
Populations
Geographical coverage
Route of administration
Presentation
Co-administration
Post-license activities
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Vaccine R&D Timeline
Many years 2-4 years
DISCOVERY RESEARCH
Antigen production Assay development Animal model dev. Preclinical tox
PreclinicalPOC
6-8 years
DEVELOPMENT
Phase ISafetyInitialimmunogenicity
Phase II a Dose finding Dose/schedule
finding Immunogenicity
Phase II b Early POC
Phase III Large scale
safety+
Lot to lotconsistency
+ Non inferiority
(combos)or
Efficacy
Industrial Investment
1 year 2 years continue
REGISTRATION LCM
Launch
File
Identification oftarget antigens
Understandingof pathologies
Natural historyof disease
Done mostlyoutside
of the BigPharma
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Vaccine Development Decision Gates
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Goals of Pre-Clinical Development
Know your product
Vaccine candidates should be appropriately characterizedto insure material can be consistently produced
Is the product safe ?
Vaccines are given to healthy individuals, especiallypediatric populations, limited tolerance to adverse events
Is the product immunogenic in animals?
Is the product effective in animal models?
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Clinical Development Plan (CDP):
Vaccine formulation
Recommended vaccination schedule (primary course,
booster)
Safety
Immunogenicity
Efficacy
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Phases of CDP:
Phase I
Phase IIa
Phase IIb
Phase III
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HIV Vaccine R & D Challenges
Need for novel technologies/complex regimens
Significant global clinical development hurdles
Interplay between clinical research and clinical
developmentDefining investment milestones
Challenges with increasingly complexpartnerships
Strict traditional industry
development paradigm is
insufficient
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Sustained industry partnership for allcomponents is essential to success
It is imperative to secure industry partnership to
ensure a cohesive strategy for:
Product profile
Regulatory strategy
Clinical supply
Approaches to access
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No Company, Government orNGO Alone Will be Able toCarry the Burden
Governments, academia, NGOs, donors and industrymust work together to allow for the most effective meansfor developing and providing access to a vaccine(s) for
those who need it the most, as quickly as possible.