Hansi J. Dean

International AIDS Vaccine Initiative

The Value of Product Development

Partnerships in Vaccine Innovation

The Product

Development

Partnership Model

A non-profit partnership of public and private organizations that

Addresses a clear public health need for which the perceived

commercial market is small

Facilitates partnerships that bring together expertise, resources

and investments of public, philanthropic and private sectors

towards highly focused public health goals

Assume the risk and cost of product development, in exchange

negotiating licensing and IP rights to ensure that eventual

products will be available at an affordable price to the

populations who need them most

Strengthens research and manufacturing capacity in most

affected countries

PDPs: harnessing the product development

cycle for global health needs

Basic Research

Applied Research

Product Design

Early Development

Late Development

Efficacy Trials

National &

academic

institutions

Biotech /

SMEs

Multinational pharma

& biotech

Product Development Partnerships (PDPs)

EDCTP

Delivery & Access

PDP Impact on Global Health

ENCOURAGES INDEPENDENT INDUSTRY

INVESTMENT ….by improving market

information for developing countries such

as disease burden, health system and user

requirements and product demand

ENHANCED ABILITY TO

DEVELOP NEW PRODUCTS

BEYOND THE INITIAL

TARGET….by strengthening

infrastructure for research

and clinical trials in

developing countries

STRONG PIPELINE

of candidates in

development:

vaccines, drugs

and diagnostics for

HIV, malaria, TB,

parasites, diarrheal

diseases....

>10 PRODUCT

LAUNCHES

Top 12 PDP Donors

Policycures.org G-Finder Report 2013

Total $350M

These 12 donors

provided 93% of PDP

funding in 2012

Operating Models

Business Models

Less virtual

Manage products and

conduct key activities

More virtual

Partner-managed

or outsourced

Product "owners"

In-license or

own product IP

Product intermediaries

Limited/no product IP

ownership

No single “PDP Model”

BCG analysis, 2009

VAC Human hookworm vaccine initiative

IAVI's mission is to ensure the development of safe,

effective, accessible, preventive HIV vaccines for use

throughout the world. Our vision is a world without AIDS

Imagine a World Without AIDS

IAVI is a product development partnership, which fill gaps and accelerates

HIV vaccine R&D by bridging government and foundation funding with

academic and industry capabilities

USAID

UK DFID Netherlands US NIH

Japan Ireland

Norway

Denmark

Private Sector & Other

BMGF

Government and private sector funding

IAVI’s niche: To bridge basic research to advanced product

development, translating vaccine concepts into the clinic

R&D partnerships Regional partnerships Advocacy and outreach

Research labs to identify

new vaccine leads

Research consortia

Product development to

advance IAVI and others’

candidates

Clinical trials

Clinical research

centers in Africa

International academic

and biotech partners

Joint IAVI-India lab

Advocacy and outreach

from community to

international level

Policy on HIV vaccine

potential impact, access

IAVI is building on successes to address key HIV

vaccine challenges

Successes

Focus on African &

Asian HIV clades

27 phase I/II trials Advance next generation

candidates to efficacy trials

Vaccines that address

HIV variability

Discovery of HIV broadly

neutralizing antibodies which

define conserved targets

Design vaccines which elicit

broadly neutralizing antibodies

to prevent infection

Advance new T cell immunogen

designs to control infection

Challenges

2.3 million

Number

of new

infections

in 2012

The job isn’t finished until a safe, effective

HIV vaccine is available for everyone

Optimism for an AIDS-free generation

Research continues to yield clues to how we might

rationally design an effective HIV vaccine, yet many

scientific challenges remain. When we do succeed,

an HIV vaccine will be the main driver to not only

accelerate the decline of new HIV infections — and

to do so more efficiently and cost-effectively — but

also to maintain an AIDS-free generation once we

get there. While an HIV vaccine will be integral to

achieving an AIDS-free generation, it also will be

essential to realizing our ultimate goal: a world

permanently without HIV/AIDS.

Imagine a World Without AIDS

Anthony S. Fauci, July 11, 2013