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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

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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.