Chapter 8.1 CS4: Public-Private Partnerships for Neglected Diseases
Opportunities to address pharmaceutical gaps for neglected diseases
Priority Medicines For Europe and the World
"A Public Health Approach to Innovation"
Background Paper for Review
Public-Private Partnerships for Neglected Diseases:
Opportunities to address pharmaceutical gaps for
neglected diseases
CASE STUDY 4
International AIDS Vaccine Initiative (IAVI)
By Elizabeth Ziemba, JD, MPH
7 October 2004
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Chapter 8.1 CS4: Public-Private Partnerships for Neglected Diseases
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Case Studies and Needs Assessment of Four Public-Private Partnerships
International AIDS Vaccine Initiative (IAVI)
Introduction:
The International AIDS Vaccine Initiative (IAVI) is a global organization
working to speed the development and distribution of preventative AIDS
vaccines by mobilizing support through advocacy and education, accelerating
scientific progress, encouraging industrial participation, and assuring global
access.1
History of IAVI:
In 1994 the AIDS epidemic was escalating and AIDS vaccine development
appeared not to be moving forward. In response to the crisis, the Rockefeller
Foundation convened an international meeting in Bellagio, Italy, bringing
together scientists, public health officials, leaders from the pharmaceutical
industry and from non-governmental organizations to discuss whether there
was a problem and if there was, to look at ways to move AIDS vaccine
development forward.2 Concluding that there was a gap-particularly in
applied vaccine development as well as no coordinated international scientific
or funding strategy, participants called for a new type of organization to
accelerate the development of AIDS vaccines.2 A scientific meting held in Paris
later that year proposed a radically different approach to HIV vaccine
development. These meetings became the impetus for the establishment of
IAVI as an international non-governmental agency to aggressively push this
agenda forward.2
In 1996, IAVI was established as a tax-exempt 501(c)(3) not-for-profit scientific
organization.3
Mission:
The sole mission of IAVI is “To ensure the development of safe and effective
preventive HIV vaccines appropriate for use throughout the world and, in
particular, in those areas most affected by HIV and AIDS”.4 IAVI focuses on
four action areas: Mobilizing support through advocacy and education;
accelerating scientific progress; encouraging industrial participation in AIDS
vaccine development; and assuring global access.5
The organization will reach its mission by (1) proving financial and technical
support to scientific partnerships joining industry, academia and government
to accelerate the research and development of promising vaccine concepts for
the developing world from preliminary laboratory studies to clinical trials in
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humans; (2) advocating for public policies that would make vaccine research a
political and economic priority—and ensure rapid global access once a vaccine
is developed, and (3) supporting the development and implementation of
strategies to increase understanding of the clinical trial process at the
community level.6
Disease Rationale:
First recognized in 1981, Acquired Immunodeficiency Syndrome (AIDS) is a
severe disease that represents the late clinical stage of infection with the
human immunodeficiency virus (HIV).7 Within several weeks to several
months after infection with HIV, many people develop an acute
mononucleosis-like symptoms including fever, headache, tiredness, and
enlarged lymph nodes that lasts for one or two weeks.7 8 Infected persons
may then be free of clinical symptoms for months or years before other clinical
signs appear.7 There are numerous opportunistic infections including
tuberculosis as well as cancers that are indicators of the immunodeficiency.7
HIV is transmitted from person to person through sexual contact, sharing of
HIV contaminated needles and syringes, transfusion of infected blood or
blood components, and the transplantation of HIV infected tissues or organs.7
The time from HIV infection to diagnosis of AIDS ranges from less than one
year to more than 15 years.7 During this asymptomatic period, the virus is
actively multiplying, infecting, and killing cells of the immune system. The
most obvious effect of HIV infection is a decline in the number of CD4
positive T cells (also called T4 cells) found in the blood -- the immune system's
key infection fighters. At the beginning of its life in the human body, the virus
disables or destroys these cells without causing symptoms.8
As the immune system worsens, a variety of complications start to take over.
For many people, the first signs of infection are large lymph nodes or "swollen
glands" that may be enlarged for more than three months. Other symptoms
often experienced months to years before the onset of AIDS include: Lack of
energy, weight loss, frequent fevers and sweats, persistent or frequent oral or
vaginal yeast infections, persistent skin rashes or flaky skin, pelvic
inflammatory disease in women that does not respond to treatment, and
short-term memory loss.8 Some people develop frequent and severe herpes
infections that cause mouth, genital, or anal sores, or a painful nerve disease
called shingles.8 Children may grow slowly or be sick a lot.8
The onset of AIDS is signaled by opportunistic infections and symptoms
including: Coughing and shortness of breath; seizures and lack of
coordination; difficult or painful swallowing; mental symptoms such as
confusion and forgetfulness; severe and persistent diarrhea; fever; vision loss;
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Chapter 8.1 CS4: Public-Private Partnerships for Neglected Diseases
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nausea, abdominal cramps, and vomiting; weight loss and extreme fatigue;
severe headaches; and coma.8
Without effective anti-HIV treatment, about half of infected adults develop
AIDS within ten years of infection while the incubation period in infants and
children is less.7
No cure exists for HIV/AIDS. A handful of drugs are available to slow the
spread of HIV in the body and delay the start of opportunistic infections while
other drugs interrupt virus replication at a later stage in its life cycle.8
Combination treatments are often used to slow drug resistance to treatment
with many severe side effects.7
Because no vaccine for HIV is available, the only way to prevent infection by
the virus is to avoid behaviors that put a person at risk of infection, such as
sharing needles and having unprotected sex.8 The risk of HIV transmission
from a pregnant woman to her baby is significantly reduced if she takes AZT
during pregnancy, labor, and delivery, and if her baby takes it for the first six
weeks of life.8
Treatment advances have yielded important new AIDS therapies, but the cost
and complexity of their use put them out of reach for most people in the
countries where they are needed the most. In industrialized nations where
drugs are more readily available, side effects and increased rates of viral
resistance have raised concerns about their long-term use.9
At the end 2003, UNAIDS estimates that more than 40 million men, women
and children worldwide are living with AIDS or HIV, the virus that causes
AIDS.10 From the first case recorded in June 1981 through the end of 2002,
more than 20 million people have died of AIDS.10 Although there are powerful
medicines now available to treat HIV infection, these drugs are not cures, and
they remain out of the reach of most of those who could benefit from
them. Counting both those who have died and those currently living with the
virus, in the past two decades more than 60 million people have been
infected.10
In 2003, 5 million people were newly infected with HIV.10 There were an
estimated 14,000 new infections daily, or nearly 600 infections every hour
everyday. More than 95% of new infections are occurring in developing
countries.10 Best current projections suggest that tens of millions more people
will become infected with HIV by the end of the decade, mostly in developing
countries—unless the world succeeds in mounting a drastically expanded,
global prevention effort.10
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Please refer to Appendix 8.1.4 for a summary of the AIDS pandemic by
geographical region.
Current Organizational Composition, Partners, and Funding:
Organization:
The organization is operated and managed by its Board of Directors, Scientific
Advisors Committee, Policy Advisors Committee, and Management Team
and Staff.
Board of Directors
IAVI’s Board of Directors provides strategic guidance and oversight for the
organization. In 2003, four members completed their two terms and extensions:
Gordon Douglas, Richard Feachem Jacques-François Martin, and Jaap Goudsmit.
After serving for eight years, Peter Piot became an ex-officio advisory member and Ian
Gust, in his new capacity as chair of IAVI’s Scientific Advisory Committee,
became the SAC liaison (ex-officio). The Board also welcomed two new members: John
D. Evans and Michel Greco.11
Please refer to Annex 8.1.3, Section D, for a complete list of Board of Director
members.
Scientific Advisors Committee
An internationally recognized Scientific Advisory Committee (SAC) meets
annually to review the state-of-the-art in AIDS vaccine development and to
advise IAVI on new initiatives under consideration.11
Subcommittees of the SAC meet quarterly, or as needed, to provide additional
advice regarding the state-of-the-art in AIDS vaccine research, project
management, and the conduct of clinical trials of AIDS vaccines in the
developing world.11
Please refer to Annex 8.1.3, Section D, for the current members of the Scientific
Advisors Committee.
Policy Advisors Committee
IAVI strengthened its policy capacity by establishing a Policy Advisory
Committee in 2002 to serve as a sounding board on key issues and assist the
policy team in setting priorities, reviewing policy research proposals, and
expanding IAVI’s network in the field. IAVI received over 155 nominations
for the committee—encompassing a broad range of experts from 23
countries—making the selection process extremely challenging.11
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Please refer to Annex 8.1.3 Section D for the current members of the Policy
Advisors Committee.
Management and Staff
Of the four PPP-PDs reviewed in this paper, IAVI has the largest staff and
infrastructure. With operations in over 22 countries and with a mission that
includes a substantial advocacy component, IAVI employs staff in numerous
departments including: Executive Office; Research and Development; Public
Policy; Country and Regional Programmes; Communications; Resource
Development; Finance and Administration; and Human Resources.
Information about IAVI’s President and Chief Executive Officer, Dr. Seth
Berkley and other team members is available at the IAVI website at
http://www.iavi.org/about/team.asp.
Partners:
IAVI has numerous partners that are involved as scientific collaborators,
policy advocacy partners and donor partners.12 The partners are drawn from
the public and private sectors as well as government and non-governmental
organizations. The European Union is a donor and policy advocacy partner of
IAVI.12
Funding:
IAVI has raised more than $271 million US dollars from a variety of sources
including: Starr Foundation ($9,000,000.00), Canadian International
Development Agency, (31,637,417.00), Rockefeller Foundation ($8,961,000.00),
Alfred P. Sloan Foundation ($5,000,000.00), Government of the Netherlands
($23,686,718.00), Global Forum for Health ($400,000.00), Angel Music Ltd.
($115,662.00), Vincent P. Belotsky Jr. Foundation ($325,000.00), Crusaid UK
($321,402.00), UK Department for International Development ($21,559,897.00),
Swedish International Development Agency ($487,287.00), Government of
Norway ($2,413, 779.00), Government of Ireland ($4,605,288.00), Ittleson
Foundation ($40,00.00), Levi Strauss Foundation ($50,000.00), John M. Lloyd
Foundation ($20,000.00), Mercury Phoenix Trust ($151,070.00), James B.
Pendleton Charitable Trust ($250,000.00), Tides Foundation/John Lee Fund
($5,000.00), Joint United Nations Programme on HIV/AIDS ($288,679.00), US
Agency for International Development ($26,500,000.00), Vanderbilt Family
Foundation ($4,000.00), Becton Dickinson Company ($1,000,000.00), John D.
and Catherine T. MacArthur Foundation ($25,000.00), New York Community
Trust ($100,000.00), Government of Denmark ($1,798,469.00), Elton John AIDS
Foundation ($321,090.00), World Bank ($4,765,000.00), GlaxoWellcomePositive Action Programme ($12,547.00), Bill and Melinda Gates Foundation
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Challenge Grant ($100,000,000.00), Bill & Melinda Gates Foundation
($26,500,000.00), Until There’s A Cure Foundation ($850,000.00) and
individual donors.13
Strategy and Pipeline Overview
Strategy
In its efforts to end the AIDS pandemic through the development of a vaccine,
IAVI’s strategy is three fold:14



Provide financial and technical support to scientific partnerships
joining industry, academia and government to accelerate the research
and development of promising vaccine concepts for the developing
world from laboratory studies to clinical trials in humans
Advocate for public policies that makes vaccine research a political
and economic priority and to ensure rapid global access once a vaccine
is developed
Support the development and implementation of strategies to increase
understanding of the clinical trial process at the community level.
IAVI has been very effective in implementing its strategy and has brought
leadership to the AIDS vaccine field including:15







Created and begun implementing the Scientific Blueprint for AIDS
Vaccine Development, a strategic plan to guide the world's scientific
effort.
Invested more than US$280 million in the several innovative
international vaccine development partnerships, bringing together
researchers and scientists in industrialized and developing countries,
to move promising vaccine candidates toward clinical testing.
Negotiated important intellectual property agreements to help ensure
that the fruits of IAVI's research will be readily available in developing
countries.
Established the first periodical devoted to chronicling HIV vaccine
research, IAVI Report, which has more than 10,000 readers in 115
countries.
Laid the foundation for national AIDS vaccine programs in South
Africa, India, and China.
Put AIDS vaccines onto the global policy agenda and won significant
increases in government funding for AIDS vaccine research and
development.
Helped establish a World Bank task force to study new financial
mechanisms to spur the development, and eventual purchase, of AIDS
vaccines for developing countries.
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IAVI has made significant progress in helping the world achieve the goal of an
effective AIDS vaccine by catalyzing the international community, articulating
a pathway for the development of an AIDS vaccine, and advocating for
increased investment and competition in the development of an AIDS
vaccine.17
Pipeline
IAVI maintains a database of AIDS vaccines in human clinical trials being
conducted.16 The database reflects a large number of human clinical trials
involving various partners in the public and private sectors.16
From the first trial in 1987 to 1996, 23 vaccine candidates underwent phase I
trials, 2 candidates phase II trials, and 2 candidates phase I/II trials. 17 From
1997 to the end of 2002, 34 candidate vaccines underwent phase I trials, 6
candidate vaccines phase II trials, 7 candidates phase I/II trials and 2
candidate vaccines phase III trials.17
Outlook and critical constraints:
IAVI contracted with an independent group of experts to conduct an
evaluation of the organization to assess whether the organization had met its
key goals as articulated in its strategic plans.17 This evaluation sets out in
detail IAVI’s successes as well as the considerable challenges it faces in the
years ahead.
The evaluation emphasizes several areas of constraint for IAVI including the
complexity and cost of vaccine development. “Taking vaccines from
discovery to production is exceptionally complex and enormously expensive
and this will be especially the case for AIDS vaccines. The high cost of such
efforts may require IAVI to explore a variety of partnerships for its research
and development efforts that it may not have considered earlier”.17 An
immediate challenge for the organization is raising $400 million it requires to
meet its work plan to 2008. The situation is further complicated “by the fact
that slow vaccine development or development of a vaccine by others before
IAVI can develop one might lead to ‘donor fatigue’ or the risk of having
IAVI’s being seen as ‘overcapitalized’.”17 Towse et al estimates the shortfall
in funding to be in excess of $800 million.Error! Bookmark not defined.
These financial challenges are indeed substantial.
The independent evaluation points to specific organizational challenges that
reflect the challenges of public-private partnerships including the level of
transparency in scientific collaborations, the level of control between and
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among the partners, and approaches to intellectual property rights in the
development of products.17
The evaluation team credits IAVI with being an effective and positive force in
the development of an AIDS vaccine as well as raising the political profile of
HIV/AIDS. 17
As the field of AIDS vaccine research changes, IAVI will need to respond to
those changes to continue to be effective in its mission.
Contact information:
The headquarters for the International AIDS Vaccine Initiative is located in
New York City with offices in the Netherlands, Kenya and India.
New York Office
110 William Street, Floor 27
New York, NY 10038-3901
USA
Tel: +1 212 847 1111
Fax: +1 212 847 1112
Europe Office
Visitors address:
Nieuwezijds Voorburgwal 21, Floor 5
Amsterdam, The Netherlands
Postal address:
Postbox 15788
1001 NG, Amsterdam
Tel: +31 20 521 0030
Fax: +31 20 521 0039
East Africa Office
Floor 16, Rahmutulla Tower, Upperhill Road
PO Box 340 KNH 00202, Nairobi
Tel: +254 20 273 1463
Fax: +254 20 273 1462
India Office
193, Floor 1, Jorbagh
New Delhi, 110003, India
Tel: +91 11 2464 2374 / 75, 2465 2668 / 69
Fax: +91 11 2464 6464
Please send general inquires to info@iavi.org
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References and key documents consulted:
IAVI 2003 Annual Report
Independent Evaluation of the International AIDS Vaccine Initiative, April
2003, Prof. Richard Skolnik et als.
Improving and accelerating the clinical pipeline of AIDS vaccines candidates
for use worldwide, Technical paper, 7-12 July 2002,
http://www.iavi.org/pdf/rd-agenda.pdf
IAVI 2003 Mid-Year Progress Report, January – June,
http://www.iavi.org/pdf/2003_mid-year_report.pdf
References to Case Study 4
IAVI website, www.iavi.org/about/overview.htm, accessed 19 May 2004.
IAVI website, http://www.iavi.org/about/history.asp, accessed 26 May 2004.
3 IPPPH website,
http://www.ippph.org/?page=/ippph/partnerships/name&thechoice=show&id=16&typobj=0&id_c
hapter=abstract, accessed 26 May 2004.
4 IAVI website, http://www.iavi.org/about/finance.asp, accessed 26 May 2004.
5 IAVI website, www.iavi.org/about/overview.htm; accessed 2 June 2004.
6 IAVI website, http://www.iavi.org/about/aboutiavi_qa1.asp, accessed 26 May 2004.
7 Chin J, Editor, Control of Communicable Diseases Manual, 17 th Edition, Washington DC, 2000.
8 National Institutes of Health website, http://www.niaid.nih.gov/factsheets/hivinf.htm, accessed 26
May 2004.
9 IAVI website, http://www.iavi.org/need/needs.asp, accessed 26 May 2004.
10 IAVI website, http://www.iavi.org/need/aboutepidemic.asp, accessed 26 May 2004.
11 IAVI Annual Report 2003.
12 IAVI website, http://www.iavi.org/about/donors.asp, accessed 2 June 2004.
13 IPPPH website,
http://www.ippph.org/index.cfm?fund=add&passyr=2002&page=/ippph/partnerships/name&thec
hoice=show&id=16&typobj=0&id_chapter=funding, accessed 26 May 2004.
14 IAVI website, http://www.iavi.org/about/aboutiavi_qa1.asp, accessed 2 June 2004.
15 IPPPH website,
http://www.ippph.org/?page=/ippph/partnerships/name&thechoice=show&id=16&typobj=0&id_c
hapter=impact, accessed 2 June 2004.
16 IAVI website, http://www.iavireport.org/trialsdb//, accessed 2 June 2004.
17 Independent Evaluation of the International AIDS Vaccine Initiative, April 2003, available on the
IAVI website at http://www.iavi.org/pdf/IAVIIndependentEvaluation.pdf
1
2
Also consulted:
Gardiner, E. (2003) “The price of Access: Making Drugs Available in Africa” London Business School.
http://www.ippph.org/index.cfm?page=/ippph/publications&thechoice=retrieve&docno=86.
Accessed February 19, 2004.
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Opportunities to address pharmaceutical gaps for neglected diseases
Kettler H, Towse A., Public private partnerships for research anddevelopment: medicines and
vaccines for diseases of poverty, 2002, London: Office of Health Economics.
Kettler H., Narrowing the gap between provision and need for medicines in developing countries,
2000, London: Office of Health Economics.
Kettler H, Modi R., Building local research and development capacity for the prevention and cure of
neglected diseases: the case of India, Bulletin of the World Health Organization: the International Journal of
Public Health, 2001:79 (8) 742-747.
Widdus, R., Public-private partnerships for health require thoughtful evaluation: editorials, 2003,
Bulletin of the World Health Organization: the International Journal of Public Health, 2003: 81 (4) 235.
Widdus, R., Public-Private Partnerships for Health: their main targets, diversity and future direction,
Bulletin of the World Health Organization: the International Journal of Public Health, 2001, 79 (8), 713-720.
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