Partnerships in Promoting Innovation

and Managing RiskScientific and Financial Innovation in AIDS

Vaccines

International AIDS Vaccine Initiative

Labeeb M. AbboudGeneral Counsel

September 11, 2007

International AIDS Vaccine Initiative

Mission

To ensure the development of a

safe, effective, accessible,

preventive HIV vaccine

for use throughout the world

11 years old

180 staff, 5 offices (Amsterdam, Delhi, Johannesburg, Nairobi, NY), active in 23 countries

$85 million annual budget

Integrated R&D ProgramEmphasis on applied research and product development – targeting gaps and promoting rational vaccine design

Industrial project management

40+ R&D partnerships

6 vaccine candidates into clinical trials

Trials in 12 countries

Policy & Advocacy

Country and Regional ProgramsSustained commitment to the developing countries

Political will & finance

Research & Development

Clinical trials

Production Health & delivery systems

Access & uptake

An integrated approach to speed an AIDS vaccine Mechanisms of Innovation:

Implement expanded R&D program

Improve the product development pipeline

Address major scientific obstacles

Strengthen LDC clinical testing infrastructure

Secure and sustain global commitment

Enhance global political and financial support

Promote public policy for R&D and access

Change policy environment

Increase private sector engagement

Enhance delivery systems

Engage LDC partners

Build support for trials and future demand

Increase LDC science capacity

Foster research consortia

Refine the model Ensure efficient R&D, internal and partnership processes

Innovative IP arrangements

Future Directions to Advance the Vaccine Field

Screening Test of Concept Trials (STOC)Early look at efficacy through small scale trials in high-risk volunteersPrioritizing resources by allowing early failuresAccelerating clinical timelines (3 to 5 years)

Replicating Viral VectorsScience now indicates that replicating vectors may be necessary for an effective AIDS vaccineIAVI initiating innovative vectors program to prioritize replicating vectorsCurrently liaising with regulatory agencies to ensure risk analysis is commensurate with the impact of HIV

Innovation FundFunding highly novel ideas to overcome critical scientific challengesSmall grants to assess proof-of-conceptIf successful can roll into IAVI’s product development portfolio

IAVI gratefully acknowledges the support of our donors