PDP FUNDERS GROUP
UPDATE 8: SEPTEMBER 1 TO SEPTEMBER 30 2009
PDP Funders Announcements (since September 1, 2009)
Gates
Foundation
2 September 2009
 Proposals Sought for Round 4 of Grand Challenges
Explorations
The Bill & Melinda Gates Foundation announced today that it is
now accepting proposals for Round 4 of Grand Challenges
Explorations, an initiative to encourage bold and unconventional
research on new global health solutions. Proposals are being
accepted through November 2, 2009.
The program offers scientists, inventors, and entrepreneurs the
chance to earn $100,000 grants to further their work. Projects
showing success will have the opportunity to receive additional
funding up to $1 million.
The topic areas for which proposals are being accepted for this
round are:
• Create New Ways to Protect Against Infectious Disease;
• Create New Technologies for Contraception;
• Create New Ways to Induce and Measure Mucosal Immunity;
• Create Low-Cost Diagnostics for Priority Global Health
Conditions.
One of the primary objectives of Grand Challenges Explorations is
to involve scientists around the world who do not typically work in
the health field and may have never applied for a grant before.
This includes those with innovative ideas in Africa, Asia, and other
parts of the developing world; people working in the private sector;
and young investigators.
24 September 2009
 Gates Foundation Launches Campaign to Highlight
Success of U.S. Global Health Investments
The Bill & Melinda Gates Foundation today launched the Living
Proof Project: U.S. Investments in Global Health are Working, a
multi-year awareness campaign to highlight the extraordinary
success of the U.S. government’s efforts to improve health around
the world.
The Living Proof Project will show that U.S-supported initiatives to
fight malaria, AIDS, and other diseases are saving and improving
the lives of millions of people in poor and developing countries –
and as a result, empowering them to lead more productive lives.
The campaign kicked off today with a new web site
(www.livingproofproject.org) and advertisements in Washington,
DC that highlight compelling success stories in global health.
USAID
3 September 2009

Family Health International Awarded Preventive
Technologies Agreement from USAID
Family Health International (FHI) announced that the US Agency
for International Development (USAID) has awarded the
organization the Preventive Technologies Agreement (PTA),
providing up to $175 million in funding over five years to continue
FHI's evaluation of innovative HIV-AIDS prevention technologies
and strategies.
The award, which continues nearly 40 years of USAID support for
prevention research leveraging FHI's scientific expertise, involves
the completion of two clinical trials of antiretroviral drugs for
prevention, and the development of new trials and other research
and scientific support activities that advance USAID's global
agenda for HIV prevention, including the integration of family
planning and HIV services.
Wellcome
Trust
17 September 2009
 Wellcome Trust and Merck launch joint venture to develop
affordable vaccines for low-income countries
The Wellcome Trust and Merck & Co., Inc. today announce the
creation of the MSD-Wellcome Trust Hilleman Laboratories, a
unique research and development joint venture with a not-for-profit
mission to focus on developing affordable vaccines for diseases
that commonly affect low-income countries.
The joint venture marks the first time a research charity and a
pharmaceutical company have partnered to form a separate entity
with equally shared funding and decision-making rights. Pairing
two of the world's preeminent healthcare institutions provides an
opportunity to integrate the best of both to drive the investment
and expertise needed to develop and deliver vaccines to lowincome countries.
The heart of this concept is the creation of a sustainable R&D
organisation that operates like a business, but with a not-for-profit
operating model, to address the vaccine needs of low-income
countries. As well as developing new vaccines in areas of unmet
need, the Hilleman Laboratories will also work on optimising
existing vaccines, an important and powerful way of increasing the
impact of vaccination in resource-limited settings. By working in
partnership, the Wellcome Trust and Merck seek to achieve what
neither can do alone.
Awards made in August not included in the previous issue
European
Commission
20 August 2009
 CRIMALDDI - European co-ordination of antimalarial drug
discovery
The European Commission is funding a two year, €500,000
project to co-ordinate European and international research into the
development of new drugs to treat malaria.
The CRIMALDDI project (Coordination, Rationalisation and
Integration of Antimalarial Drug Discovery and Development
Initiatives) is being led by the Liverpool School of Tropical
Medicine (LSTM) and brings together key players in the
antimalarial drug discovery fields including the World Health
Organisation, the Medicines for Malaria Venture (MMV) and
leading research organisations across Europe.
Professor Steve Ward, Deputy Director of LSTM and Scientific
Coordinator of the CRIMALDDI project explained: “New drugs to
prevent, treat and eventually eliminate malaria are desperately
needed if we are to make an impact upon the millions needlessly
dying from this disease each year. Antimalarial drug research and
development (R&D) programmes are in operation across Europe
and throughout the world, but too often these initiatives are
uncoordinated and time and money is spent going over old
ground.”
CRIMALDDI will address this by assessing research in Europe
and internationally. It will develop a prioritised roadmap for
antimalarial drug discovery efforts in Europe and a 5-year action
plan to deliver on this roadmap. An expert advisory group will
provide external validation and ensure that the plans are practical
and appropriate. CRIMALDDI will also seek to formulate strategies
to ensure better co-ordination of R&D, remove barriers to drug
development and facilitate the dissemination of results.
PDP Press Releases (since September 1, 2009)
DNDi
22 September 2009
 NECT: Improved treatment for sleeping sickness now
available
NECT (Nifurtimox-Eflornithine Combination Therapy), the first
new treatment in 25 years against Human African trypanosomiasis
(HAT) or sleeping sickness - is now available. Endemic countries
have now begun the process of ordering the new combination
treatment and kits through the World Health Organization (WHO).
Developed by DNDi and its partners, NECT cuts the cost of
treatment by half and significantly reduces the burden on health
workers.
29 September 2009
 Eisai and DNDi Enter into a Collaboration and License
Agreement To Develop a New Drug for Chagas
Disease
Eisai Co., Ltd. (“Eisai”) and the Drugs for Neglected Diseases
initiative (DNDi), a non-profit independent foundation, announced
today that they have signed a collaboration and license agreement
for the clinical development of a promising new drug for the
treatment of Chagas disease, a fatal infectious disease that
threatens 100 million people in Latin America and the Caribbean.
Ravuconazole, an anti-fungal drug discovered and developed by
Eisai, has been shown in in vitro and in vivo to have potent activity
against the pathogen responsible for Chagas disease. Under the
terms of the agreement, DNDi shall retain sole responsibility for
the clinical development to assess the safety and efficacy of
E1224, which is a pro-drug of ravuconazole, in patients with
Chagas disease within endemic countries. Eisai shall provide
DNDi with its scientific expertise in clinical development as well as
supply the drug for the clinical studies. Eisai shall also have the
option to become the industrial partner with DNDi to manufacture,
register and make available E1224 at an affordable price to the
public sector in endemic countries.
FIND
14 September 2009
 AbD Serotec and FIND sign agreement to develop
temperature stable antibodies for in vitro diagnostics
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX)
announced today that its research and diagnostic antibody
segment AbD Serotec has initiated a research collaboration with
FIND (Foundation for Innovative New Diagnostics), a Swiss
foundation that develops, evaluates and accelerates the
implementation of new diagnostic tools for poverty-related
diseases such as TB, malaria and sleeping sickness. The goal of
the research alliance is to establish a series of heat-stable
HuCAL-based antibodies as key components of novel diagnostic
tests that are robust in tropical climates. Using MorphoSys’s
proprietary HuCAL technology, AbD Serotec will identify heatstable fully human antibodies specific for rapid diagnostic test
applications for parasite detection. Financial details of the
agreement were not disclosed.
Currently, rapid diagnostic test applications can allow detection of
parasite antigens in a finger prick blood sample. However, most
commercial diagnostic tests are developed for storage and use at
25-30ºC. High disease burden countries usually have higher
ambient temperatures, which can lead to test degradation
especially when taking into account the need for delivery to
relatively remote locations in the developing world. Thus,
temperature stability and prolonged shelf-life of diagnostic kits are
critical factors for improving infectious disease control.
Under the terms of the agreement, FIND receives the rights for the
commercial use of heat-stable HuCAL-derived antibodies for in
vitro diagnostics. AbD Serotec will participate in sales of
diagnostic tests using such antibodies in industrialized countries. If
concluded successfully, the collaboration could be expanded to
cover other disease areas of relevance for FIND’s objectives.
IAVI
3 September 2009
 Two New Antibodies Found to Cripple HIV
Researchers at and associated with the International AIDS
Vaccine Initiative (IAVI), at The Scripps Research Institute, and at
the biotechnology companies Theraclone Sciences and
Monogram Biosciences have discovered two powerful new
antibodies to HIV that reveal what may be an Achilles heel on the
virus. They published their work in Science this week.
Researchers will now try to exploit the newfound vulnerability on
the virus to craft novel approaches to designing an AIDS vaccine.
Moreover, the global collaboration and process that led to the
discovery of the two new broadly neutralizing antibodies (bNAbs)
are likely to produce more such antibodies, which may in turn
reveal additional vulnerabilities of HIV, adding still more vitality to
the effort to develop a vaccine against AIDS.
24 September 2009
 The Scripps Research Institute and IAVI Host
Symposium to Launch Research Center Dedicated to
Solving the Neutralizing Antibody Problem
Today, the International AIDS Vaccine Initiative (IAVI) and The
Scripps Research Institute officially launched a new research
center, the IAVI Neutralizing Antibody Center at The Scripps
Research Institute. Scientists at the Neutralizing Antibody Center
will focus on designing AIDS vaccines that elicit antibodies that
work against a sufficient number of HIV types to protect from
infection with the virus.
24 September 2009
 IAVI Statement on Results of Phase III ALVAC-AIDSVAX
Trial in Thailand
The International AIDS Vaccine Initiative (IAVI) greeted with
excitement today’s announcement by the U.S. Military HIV
Research Program and the Thai Ministry of Public Health that,
according to an initial analysis, a prime-boost combination of two
AIDS vaccine candidates has shown partial efficacy in a phase III
efficacy trial in Thailand. The prime-boost combination appeared
to be about 31% effective at preventing infection with HIV.
TB Alliance
9 September 2009
 New TB Alliance Publication Explores “What Countries
Want” from New Regimens for Drug-Susceptible TB
Treatment shortening would be welcomed as a primary goal for
future TB drug regimens, according to a new study from the
Global Alliance for TB Drug Development.
The recently published study, "New TB Regimens: What Countries
Want," is one of the TB Alliance's recent initiatives to increase
market understanding. The report is an analysis of interviews with
211 key stakeholders in Brazil, China, India, Kenya and South
Africa - five countries with high TB burdens - and with 11 global
stakeholders. These 222 individuals influence global and countrylevel decisions to recommend and adopt new TB treatment
regimens.
…
The interviews and resulting report explore, for the first time, a
wide range of issues relevant to both the development and use of
new TB drug regimens, and offer new insight into how decision
makers prioritize various attributes when considering adoption of
new TB regimens. The results indicate that stakeholders desire a
new regimen based on: oral delivery, dosing consistent with
current local practices, availability as fixed-dose combinations
(FDCs) in most countries, a high degree of safety, without lasting
or serious side effects, or significant interactions with antiretroviral
(ARVs) or other essential medicines, and efficacy equal to or
greater than the current regimen. Concerns about potential
resistance to new TB drugs underscored the need to better
understand existing drug resistance and the options for treating
multidrug-resistant TB (MDR-TB).
Other PDP Related News
HIV Prevention
Technologies Vaccines
3 September 2009
Broad and Potent Neutralizing Antibodies from an African
Donor Reveal a New HIV-1 Vaccine Target
LM. Walker et al., Science 3 September 2009: 1178746v1
Broadly neutralizing antibodies (bNAbs), which develop over time
in some HIV-1–infected individuals, define critical epitopes for HIV
vaccine design. Using a systematic approach, we have examined
neutralization breadth in the sera of about 1800 HIV-1–infected
individuals, primarily infected with non–clade B viruses, and have
selected donors for monoclonal antibody (mAb) generation. We
then used a high-throughput neutralization screen of antibodycontaining culture supernatants from approximately 30,000
activated memory B cells from a clade A–infected African donor to
isolate two potent mAbs that target a broadly neutralizing epitope.
This epitope is preferentially expressed on trimeric Envelope
protein and spans conserved regions of variable loops of the
gp120 subunit. The results provide a framework for the design of
new vaccine candidates for the elicitation of bNAb responses.
24 September 2009
 HIV Vaccine Study First to Show Some Effectiveness
in Preventing HIV
A Phase III clinical trial involving more than 16,000 adult
volunteers in Thailand has demonstrated that an investigational
HIV vaccine regimen was safe and modestly effective in
preventing HIV infection. According to final results released by the
trial sponsor, the U.S. Army Surgeon General, the prime boost
combination of ALVAC® HIV and AIDSVAX® B/E lowered the rate
of HIV infection by 31.2% compared with placebo.
"This is the first HIV vaccine candidate to successfully reduce the
risk of HIV infection in humans. We are very excited and pleased
with the outcome of this trial and congratulate all those who
participated in it," said Lieutenant General Eric Schoomaker,
Surgeon General, U.S. Army. "In addition, this study is an
outstanding example of international and interagency collaboration
involving many partners from the Thai and U.S. governments,
private companies, non-profit organizations and volunteers."
In the final analysis, 74 placebo recipients became infected with
HIV compared to 51 in the vaccine regimen arm. The efficacy
result is statistically significant. The vaccine regimen had no effect
on the amount of virus in the blood of volunteers who became
HIV-infected during the study. More detailed results of this study
will be presented next month at the AIDS Vaccine Conference,
October 19 through 22 in Paris, France.
The AVAC website provides a useful summary of information on
the Thai AIDS Vaccine Trial
HIV Prevention
Technologies
–
microbicides/
PREP
16 September 2009
 Clinical Trial of Antiretroviral-based HIV Prevention
Strategies for Women Now Under Way
A new, large-scale clinical trial is examining whether antiretroviral
medications normally used to treat HIV infection can also prevent
HIV infection in women when applied as a vaginal gel or taken as
oral tablets once daily.
The study, called Vaginal and Oral Interventions to Control the
Epidemic (VOICE) or MTN-003, will involve up to 5,000 HIVuninfected women at risk for HIV infection in four African
countries. The trial will test the safety and efficacy of two different
HIV prevention strategies: an investigational microbicide gel
containing the antiretroviral drug tenofovir, and oral tablets
containing tenofovir or a combination of tenofovir and emtricitabine
known by the brand name Truvada. The tablets would be taken
prior to exposure in an approach known as pre-exposure
prophylaxis, or PrEP. Testing a microbicide and PrEP in the same
trial will enable scientists to directly compare the two strategies in
terms of their safety and acceptability.
Notably, the VOICE study is the first efficacy study of an
investigational microbicide in which participants apply the gel once
daily rather than shortly before sexual intercourse. If found
effective, this approach would allow participants to choose
whether to use the gel in association with sexual activity or at
another time of day, permitting greater privacy and convenience of
use.
For more information about ongoing PrEP studies PreP Watch is
a useful source of information
28 September 2009
 Microbicides Development Programme announces
successful completion of last participant follow up
visit in MDP 301 Phase III trial of PRO 2000 Microbicide
gel
The Microbicides Development Programme announced on
Monday 28 of September 2009 that it had completed the follow up
of the last participant enrolled in the Phase III clinical trial
assessing PRO 2000 vaginal microbicide gel. The trial is
evaluating PRO 2000 vaginal microbicide gel for acceptability,
safety and effectiveness in reducing the risk of HIV transmission. It
is the largest microbicide trial to date and is being conducted in six
research centres in South Africa, Tanzania, Uganda and Zambia.
Most participants remained in the trial for a full year following their
enrolment but at one site, which enrolled couples, participants
were followed for up to two years. Routine reviews of unblinded
data from the trial were carried out by an independent monitoring
committee. ….
The final results of this phase III trial are expected to be available
by the end of November 2009.
Clinical Trials
25 September 2009

WHO provides primary status to the Pan African
Clinical Trials Registry in Africa
The Pan-African Clinical Trials Registry (PACTR) has been
accepted as a primary clinical trials registry – the first World
Health Organization (WHO) endorsed trials registry in Africa. This
registry will feed data into the global WHO International Clinical
Trials Registry Platform (ICTRP) search portal facilitating African
representation in the global picture of planned, ongoing and
completed clinical trials. The Registry is currently funded by the
European and Developing Countries Clinical Trials Partnership
Financing
(EDCTP) and coordinated by the South African Cochrane Centre
(SACC) at the Medical Research Council (MRC). …
Davina Ghersi, head of WHO's International Clinical Trials
Registry Platform (ICTRP), says the approval of PACTR as a
primary trials registry is a significant milestone in the quest for
transparency. "Our hope is that the PACTR will make it easier to
capture information about trials involving people in the region. We
look forward to filling the gap in our knowledge about clinical trials
in Africa."
Since registries “provide an essential tool to assess
completeness of the information about all initiated trials” and are
the “necessary first step to enable identification of all trials” and
the “tracking of their results” (Moja et.al.,
http://www.trialsjournal.com/content/10/1/56), having an African
based registry will benefit both Africa and the world as PACTR will
actively encourage trial registration.
September 23 2009
 Leaders commit new finance to tackle women’s and
children’s health in the developing world
An innovative health financing taskforce set up by world leaders
twelve months ago is today announcing a series of new financing
measures worth US$5.3 billion to save millions of women and
children in developing countries, whose lives are under increased
threat during the global economic crisis.
…
Government and business leaders are expected to announce
support for a number of recommendations:
• A US$1 billion
expansion of the International Finance Facility for Immunisation
(IFFIm)
• A new mechanism for making voluntary contributions when
buying airline tickets, expected to raise up to US$3.2 billion by
2015
• US$515 million for results-based funding programmes for health
• US$360 million worth of debt conversions – Global Fund's
Debt2Health Initiative
• Launch of a VAT tax credit pilot scheme called De-Tax, expected
to raise up to US$220 million a year in VAT resources
• The commitment to explore a second Advance Market
Commitment for life-saving vaccines
• New commitments by leaders of Nepal, Malawi, Ghana, Liberia
and Sierra Leone, to expand access to health services. This is
expected to result in 10 million more people having access to free
health services. Donors will announce new financing to support
these commitments.
New Publications
Sexual &
Reproductive
Health
Technologies
September 2009
 Advancing Prevention Technologies for Sexual and
Reproductive Health.
Report from a symposium held in March 2009 to accelerate the
development of multi-purpose technologies that prevent
pregnancy, sexually transmitted infections, and other common
reproductive tract infections.
Bio Ventures
for Global
Health
Publications
August 2009
 BVGH Global Health Primer
The 2009 BVGH Global Health Primer, now in its second edition,
is a resource for innovators in the global health community
interested in learning about research and development (R&D)
pipelines as well as for biotechnology innovators interested in
learning more about global health. It focuses on the 19 infectious
diseases that cause the greatest burden of disease – outlining the
technologies currently available, summarizing the current pipelines
for new products, and pointing out gaps in the drug, vaccine, and
diagnostic inventory. It also highlights the major players in global
health and in different disease areas.
August 2009
 Global Health Innovators: A collection of case studies
BVGH undertook these case studies to understand the
motivations and incentives underlying existing global health efforts
of leading biotechnology companies. These case studies analyze
how the main- stream biotechnology companies seek out
opportunities to contribute to global health, despite market and
funding constraints.
…
In highlighting the efforts of these seven biotechnology companies
and exploring the circumstances under which global health R&D
projects were developed and the manner in which they are
executed, we found extensive evidence that 1) biotechnology
companies have a critical role to play in global health R&D
partnerships, 2) global health R&D can support a biotechnology
company’s core commercial strategy, and 3) challenges faced by
parties exploring such partnerships can be overcome, and
dissimilar stakeholders can work together for mutual benefit and
significant global health impact.
PFG Calls & Meetings
Upcoming calls:
 Thursday October 8 at 16:00 UK time: Quarterly PFG Call
If you have any issues that you would like to include in the Update please send them
to Jane Rowley (jtfrowley@btinternet.com)