UPDATE 49: FEBRUARY 1 TO FEBRUARY 28, 2013
PDP FUNDERS GROUP
Items in blue or purple should be hyperlinked to the full text version; if I have made mistakes
many apologies. If you have any issues that you would like to include in the Update please
send them to Jane Rowley (jtfrowley@btinternet.com).
FUNDER ANNOUNCEMENTS (SINCE FEBRUARY 1, 2013)
Gates Foundation
26 February 2013:
Gates Foundation Names Dr. David Shoultz to Lead Grantee and Partner Engagement
The Bill & Melinda Gates Foundation today announced that Dr. David Shoultz has been appointed
Director of Grantee and Partner Engagement. Previously a Deputy Director with the foundation’s
Global Health Program, Dr. Shoultz has worked closely with a number of the foundation’s grantees
and partners. He joined the Bill & Melinda Gates Foundation in April 2009.
Dr. Shoultz is responsible for advancing the foundation’s commitments to have quality interactions,
clear and consistent communication, and ongoing feedback with grantees. He will ensure that the
foundation’s partnerships remain strong and continue to improve in order to achieve our collective
goals. …
27 February 2013:
Innovative Partnership Reduces Cost of Bayer's Long-Acting Reversible
Contraceptive Implant By More Than 50 Percent
An unprecedented group of public and private sector partners has finalized an agreement that will
make Jadelle®, an effective, long-acting, reversible contraceptive implant, available to more than 27
million women in the world's poorest countries at a more than 50 percent price reduction over the
next six years.
The Jadelle Access Program – developed and supported through a partnership between Bayer
HealthCare AG, the Bill & Melinda Gates Foundation, the Clinton Health Access Initiative (CHAI), the
Governments of Norway, the United Kingdom, the United States and Sweden, and the Children’s
Investment Fund Foundation (CIFF) and the United Nations Population Fund (UNFPA) – builds on
momentum generated at the July 2012 London Summit on Family Planning, where global leaders
pledged to provide an additional 120 million women in developing countries with contraceptive
access by 2020. It also supports the recommendations of the UN Commission on Life-Saving
Commodities by helping to shape global markets in order to increase the availability of quality, lifesaving commodities at an optimal price and volume.
Under the signed agreement, Bayer is reducing the current price of its contraceptive implant,
Jadelle®, from US$18 to US$8.50 per unit, effective 1 January 2013, in more than 50 countries
globally, including those deemed least likely by the United Nations (UN) Secretary-General to meet
the Millennium Development Goals (MDGs) on maternal and child health by 2015. The device, which
has been pre-qualified by the World Health Organization (WHO) since September 2009, provides
effective contraception for women for up to five years. …
US - NIH
8 February 2013:
Immune system protein in semen boosts HIV spread in female genital tissue
An immune system protein normally found in semen appears to enhance the spread of HIV to tissue
from the uterine cervix, according to researchers at the National Institutes of Health.
The protein interleukin 7 (IL-7) belongs to a family of proteins that regulate the immune response. IL7 is present in normal semen, and occurs at especially high levels in the semen of men with HIV.
The researchers developed a culture system of small pieces of tissue from the cervix and used this
system to simulate male-to-female transmission of HIV, which causes AIDS. They observed the spread
of the virus in cervical tissue under controlled laboratory conditions. In the presence of IL-7 at levels
typically found in semen of men with HIV, the virus spreads to the tissue more readily than it spreads
to tissue not treated with IL-7.
UPDATE 49: FEBRUARY 1 TO FEBRUARY 28, 2013
According to the study authors, the finding raises the possibility that IL-7, alone or in combination
with other molecules, can foster male-to-female transmission of HIV. Similarly, they note, it’s possible
that the level of IL-7 in semen may determine how infectious a particular HIV-positive male is for a
female sexual partner. Also, researchers may one day be able to prevent or delay the spread of HIV
by blocking seminal IL-7.
20 February 2013:
NIH-funded researchers begin trial of Shigella vaccine candidates
Researchers have launched an early-stage human clinical trial of two related candidate
vaccines to prevent infection with Shigella, bacteria that are a significant cause of diarrheal illness,
particularly among children. The Phase I clinical trial, funded by the National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of Health, will evaluate the vaccines for
safety and their ability to induce immune responses among 90 healthy adults ages 18 to 45 years. The
trial is being conducted at the Cincinnati Children’s Hospital Medical Center, one of the eight NIAIDfunded Vaccine and Treatment Evaluation Units in the United States.
US - USAID
4 February 2013:
Annual Program Statement for Microbicide Research, Development, and
Introduction, Round 2
We are pleased to announce that information regarding the USAID funding opportunity entitled
“Annual Program Statement for Microbicide Research, Development, and Introduction, Round 2” is
now available on www.grants.gov. The specific objectives of Round 2 along with information on
application submission can be found by searching under “Find Grant Opportunities” or “Grant Search”
for the following Funding Opportunity Number: APS-OAA-13-000001.
Wellcome Trust
6 February 2013:
Dr Ted Bianco to be appointed Acting Director of the Wellcome Trust
Dr Ted Bianco, currently Director of Technology Transfer at the Wellcome Trust, is to be appointed
Acting Director of the Trust following the departure of Sir Mark Walport on 14 March.
Dr Bianco, who has worked at the Trust since 1999, will lead the executive team until a permanent
appointment is made. Recruitment of a new director is at an advanced stage. …
13 February 2013:
New centre to accelerate drug development for diseases of low-income countries
A major new centre to boost the development of drugs to tackle the foremost diseases of low-income
countries is to be created at the University of Dundee.
There is an urgent need for new drugs to treat infectious diseases of low-income countries, such as
tuberculosis (TB), malaria and African sleeping sickness. Despite significant efforts in early stage drug
discovery, there is a bottleneck when it comes to the lead optimisation stage of molecules targeting
these diseases.
Lead optimisation is a key stage in the drug discovery process, where early leads are improved
through cycles of design, synthesis and testing to identify potential drugs that are suitable for testing
in a clinical setting. It is a labour-intensive process requiring significant laboratory resources over
several years.
To address this need, Professor Paul Wyatt and colleagues at the Drug Discovery Unit (DDU) at the
University of Dundee, with joint funding from the Wellcome Trust and the Bill & Melinda Gates
Foundation, are establishing 'A Centre of Excellence for Lead Optimisation for Diseases of the
Developing World'. The Dundee centre represents a £6.5 million investment over five years and will
create 11 new posts. …
22 February 2013:
The value of HIV treatment scale-up
Increased access to antiretroviral therapy has raised adult life expectancy by more than 11 years since
2004 in a community with high HIV prevalence, according to a study published today in the journal
‘Science’. The observed increase in life expectancy - one of the most rapid in the history of public
health - confirms that the benefits ofantiretroviral therapy far outweigh the costs of providing
UPDATE 49: FEBRUARY 1 TO FEBRUARY 28, 2013
treatment and have important implications for government investment decisions in public health
programmes.
Researchers at the Wellcome Trust Africa Centre for Health and Population Studies (Africa Centre)
followed more than 100 000 people in rural KwaZulu-Natal, South Africa, collecting data on births and
deaths to measure adult life expectancy between 2000 and 2011.
The study reveals a dip in adult life expectancy between 2000 and 2003 to just 49 years; however,
from 2004 onwards, asantiretroviral therapy (ART) became available through the public sector health
system, life expectancy began to rise dramatically, reaching over 60 years in 2011. …
PDP PRESS RELEASES (SINCE FEBRUARY 1, 2013)
AERAS
4 February 2013:
Data from Historic Phase IIb Clinical Trial for Tuberculosis Vaccine Candidate
MVA85A Published in The Lancet
Results of a first-of-its-kind clinical trial of a novel TB vaccine candidate show the candidate vaccine
was safe and well tolerated, but did not confer efficacy in prevention of TB disease when
administered as a boost to Bacille Calmette-Guerin (BCG), the currently used TB vaccine. The clinical
trial of the TB vaccine candidate MVA85A was a Phase IIb safety and efficacy trial in 2,797 infants
living in the Western Cape province of South Africa. The successfully completed trial, conducted at
the highest international standards, was a major global undertaking with the involvement and
support of a large number of organizations that joined forces to conduct this historic trial. …
4 February 2013:
Statement by Tom Evans, MD, Interim CEO: First TB Vaccine Efficacy Study in Almost
a Century Provides Key Insights
Results of a first-of-its-kind clinical trial of a novel TB vaccine candidate announced today show the
candidate vaccine was safe and well tolerated, but did not confer efficacy in prevention of TB disease
when administered as a boost to Bacille Calmette-Guerin (BCG), the currently used TB vaccine. The
clinical trial of the TB vaccine candidate MVA85A was a Phase IIb safety and efficacy trial in 2,797
infants living in the Western Cape province of South Africa. The candidate was safe and well tolerated
in the population tested. …
DNDi
15 February 2013:
DNDi Latin America receives 2013 Carlos Slim Award for Innovations in Neglected
Disease Drug Development
Today the Drugs for Neglected Diseases initiative (DNDi) in Latin America received the Carlos Slim
Health Award for 10 years of exceptional work and achievements in research and development (R&D)
to deliver new treatments for neglected patients in the region. The $100,000 award will be presented
at a ceremony in April in Mexico City. …
The award will contribute to DNDi’s current efforts to develop new, safer, more effective drugs in
Latin America for Chagas disease and leishmaniasis, another deadly and debilitating neglected tropical
disease. …
26 February 2013:
DNDi Receives BBVA Foundation Award for Development Cooperation for Delivering
New Treatments for Neglected Diseases
Today in Madrid, Spain, the Drugs for Neglected Diseases initiative (DNDi) received the BBVA
Foundation ‘Frontiers of Knowledge and Culture Award for Development Cooperation’. This EUR
400,000 award will be presented at a ceremony in Madrid, Spain, in June of this year.
Médecins Sans Frontières Spain nominated DNDi for this award for having delivered six new
treatments for neglected diseases, notably Chagas disease, leishmaniasis, sleeping sickness, and
malaria, in less than 10 years, while building sustainable research capacity in disease-endemic
countries.
The award is conferred annually to initiatives that excel in areas such as research to address particular
UPDATE 49: FEBRUARY 1 TO FEBRUARY 28, 2013
global challenges, in domains including basic sciences (physics, chemistry, mathematics); biomedicine;
ecology and conservation biology; information and communication technologies; economics; finance
and management; contemporary music; climate change; and development cooperation. …
27 February 2013:
DNDi Welcomes Medicines Patent Pool Collaboration Agreement with ViiV
Healthcare as Important Precedent for Facilitating Development of Paediatric ARV
Formulations
The Drugs for Neglected Diseases initiative (DNDi) welcomes today’s announcement by the Medicines
Patent Pool of a new collaboration with ViiV Healthcare. This collaboration will facilitate the
development of urgently needed, new paediatric ARV formulations through the licensing of patents
from various companies.
‘As we move ahead in the development of a 4-in-1 combination of ARVs for infants and toddlers with
HIV, this collaboration is encouraging and timely’, said Marc Lallemant, Head of Paediatric HIV
Programme, DNDi. ‘We hope that other key stakeholders will follow suit’, he added.
An estimated 3.4 million children under 15 years of age are living with HIV/AIDS. Only 28% of those
children in urgent need of treatment are receiving it, compared to 54% of adults. Without treatment,
half of all HIV-positive children will die before the age of two, and 80% will die before they turn five.
DNDi hopes that this agreement will bring other relevant patent holders to the table in order to
expedite the development of appropriate ARV combinations and formulations for children with
HIV/AIDS anywhere in the world.
DNDi is currently working with Cipla Ltd and other partners to develop an improved first-line therapy
for infants and toddlers with HIV/AIDS, with support from UNITAID, the French Development Agency
(AFD), and Médecins Sans Frontières (MSF).
EVI
1 February 2013:
Major commitment achieved for development of vaccines against pregnancyassociated malaria
The European Commission (EC) recently committed ~€6 million to the PlacMalVac project that has as
objective the clinical development of a vaccine candidate against pregnancy-associated malaria
(PAM). Dr. Odile Leroy, Executive Director of the European Vaccine Initiative (EVI) -one of the five
partners involved in PlacMalVac- said that “together with another grant recently awarded to EVI by
the German Federal Ministry of Research and Education (BMBF) to support two other projects related
to PAM -PRIMALVAC and PAMCPH-, EVI has been instrumental in the mobilisation of €16 million for
the development of vaccines against this type of malaria which specifically affects a particularly
vulnerable demographic group: pregnant women”. …
19 February 2013:
Stakeholders celebrate 15th anniversary of European Vaccine Initiative
European Vaccine Initiative marks 15th anniversary with symposium on global health and diseases of
poverty.
Experts representing key stakeholder groups from industry, academia, public health and research
institutes, funding bodies and other organisations will gather in Heidelberg on 26 February to
celebrate the 15th anniversary of the European Vaccine Initiative (EVI) -Europe´s first Product
Development Partnership- with a symposium on global health and diseases of poverty. Renowned
speakers from different national and international organisations related to vaccine research and
development, global health and international cooperation will present overviews of their current
activities and developments in the field. …
IAVI
5 February 2013:
New Senior Level Appointments in IAVI’s Medical Affairs Department
IAVI is very pleased to share some important news regarding the new appointments of two highlyvalued, integral senior staff in our Medical Affairs Department.
Pat Fast, most recently Chief Medical Office at IAVI, has transitioned into the role ofSenior Technical
UPDATE 49: FEBRUARY 1 TO FEBRUARY 28, 2013
Advisor in Research and Development, effective February 1, 2013. …
IAVI is also pleased to announce that Frances Priddy, MD, MPH, has been appointed to the position
of Chief Medical Officer and Executive Director for IAVI Medical Affairs, Research and Development,
in the New York office, reporting to Tom Hassell, VP Vaccine Development, effective February 1, 2013.
…
IPM
5 February 2013:
IPM Welcomes New Board Members Dr. Bruce Burlington and Tamar Howson
The International Partnership for Microbicides (IPM) today announced the appointments of Dr Bruce
Burlington and Tamar Howson to its Board of Directors. Together they bring an impressive
combination of experience in pharmaceutical product development, biotechnology and regulatory
affairs that will support IPM’s efforts to advance HIV prevention technologies, and new sexual and
reproductive health solutions for women around the world. …
PATH (including MVI and OWH)
5 February 2013:
PATH names Dr. Hing Sham to lead drug research and preclinical development
PATH’s Drug Development program has appointed Dr. Hing Sham as director, research and preclinical
development.
Dr. Sham brings an extensive background in drug discovery and research. He most recently served as
senior vice president of research at Elan Corporation, a neuroscience-based biotechnology company.
Previously, he was a distinguished research fellow in global pharmaceutical discovery at Abbott
Laboratories. …
12 February 2013:
PATH receives follow-on funding to scale up production of thermostable influenza
vaccines
The Strategic Science and Technology group of the Biomedical Advanced Research and Development
Authority (BARDA), a division of the US Department of Health and Human Services, has awarded
PATH US$2.5 million in follow-on funding to advance the development of thermostable influenza
vaccines, helping to extend product shelf life and ease logistics during vaccine introduction and rapid
deployment. …
20 February 2013:
New global forum connects TB advocates
A new online forum connects advocates, communicators, and others working on the front lines of
tuberculosis (TB) elimination with the latest information, training and funding opportunities, and
tools to enhance their work.
The online community of practice is aimed at advocates, trainers, communicators, and others working
in the advocacy, communication, and social mobilization fields to fight TB. PATH developed and will
moderate the forum in collaboration with partners. …
Sabin Vaccine Institute
7 February 2013:
New Study Highlights Chagas Disease as a Growing Health and Socio-economic
Challenge
Today, The Lancet Infectious Diseases published a new report that examines the global economic
burden of Chagas disease. In the first study of its kind, researchers measured the health and
economic impact of Chagas disease and found that the total economic burden of Chagas disease
matches or exceeds that of many more well-known diseases such as rotavirus, Lyme disease and
cervical cancer.
Chagas disease infects an estimated 10 million people worldwide, with most cases occurring in Latin
America. It is a parasitic infection transmitted through an insect commonly known as the "kissing
bug.” Its symptoms range from acute respiratory and intestinal infections to strokes, liver and heart
disease. In some cases Chagas disease can be fatal. …
TB Alliance
UPDATE 49: FEBRUARY 1 TO FEBRUARY 28, 2013
25 February 2013:
PSI CEO Karl Hofmann Elected President of TB Alliance’s Stakeholders Association,
Joins Board of Directors
TB Alliance, a not for profit organization with the mission of developing new, improved, and
affordable TB treatments, announces the election of Karl Hofmann, President and CEO of Population
Services International (PSI), as President of the TB Alliance’s Stakeholders Association (SHA), thereby
assuming a seat on its Board of Directors. Mr. Hofmann brings to the TB Alliance deep experience in
building partnerships and tackling global health challenges including optimizing new product
introductions. …
TBVI
4 February 2013:
First result Phase IIb clinical trial: good basis for continued research
Today the results of a phase IIb clinical trial of tuberculosis vaccine candidate MVA85A were
published in The Lancet. This vaccine candidate, developed by the University of Oxford in
collaboration with many other partners, showed no significant efficacy in a trial in Worcester, South
Africa.
“We had hoped to see a higher efficacy rate than we see today,” says Jelle Thole, director of
TuBerculosis Vaccine Initiative (TBVI) and involved in the development of this vaccine in an early
stage. “But we are impressed with the successful completion of this trial which will provide us with a
unique opportunity to gain important knowledge on mechanisms of protection and to develop
correlates of protection. This will accelerate early selection of appropriate candidates and future
clinical trials. We congratulate the team of Prof. Helen McShane with this milestone achievement –
the first proof of concept trial in infants - , which, despite disappointing results, has moved the field
tremendously.” …
RECENTLY RELEASED PDP REPORTS/ BRIEFING PAPERS/ ARTICLES
Articles in Peer Reviewed Journals
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Safety and efficacy of MVA85A, a new tuberculosis vaccine,in infants previously vaccinated with
BCG: a randomised,placebo-controlled phase 2b trial. Tameris. MD et al. The Lancet, Early
Online Publication, 4 February 2013 doi:10.1016/S0140-6736(13)60177-4
Comparing the safety and immunogenicity of a candidate TB vaccine MVA85A administered by
intramuscular and intradermal delivery. Meyer J et al. Vaccine. 2013 Feb 4;31(7):1026-33. doi:
10.1016/j.vaccine.2012.12.042.
Lessons learnt from the first efficacy trial of a new infant tuberculosis vaccine since BCG.
Tameris M et al. Tuberculosis. Published online 13 February 2013.
The story of artesunate--mefloquine (ASMQ), innovative partnerships in drug development:
case study. Wells S et al. Malaria Journal 2013, 12:68 doi 10.1186/1475-2875-12-68 Published:
21 February 2013
Design, structure–activity relationship and in vivo efficacy of piperazine analogues of fenarimol
as inhibitors of Trypanosoma cruzi. Keenan M et al. Biorganic & Medicinal Chemistry.
http://dx.doi.org/10.1016/j.bmc.2013.01.050. Published online 31 January 2013
Serological and parasitological response in chronic Chagas patients 3 years after nifurtimox
treatment. Jackson Y et al. BMC Infectious Diseases 2013, 13:85 doi 10.1186/1471-2334-13-85.
Published 13 February 2013
Neopterin is a cerebrospinal fluid marker for treatment outcome evaluation in patients affected
by Trypanosoma brucei gambiense sleeping sickness. Tiberti N et al. PLoS Negl Trop Dis 7(2):
e2088. doi:10.1371/journal.pntd.0002088. February 2013.
Safety and efficacy of pyronaridine-artesunate in uncomplicated acute malaria: an integrated
analysis of individual patient data from six randomized clinical trials. Duparc S et al. Malaria
Journal 2013, 12:70 doi:10.1186/1475-2875-12-70. Published: 21 February 2013
Chronic Exposure to Plasmodium falciparum is associated with phenotypic evidence of B and Tcell exhaustion. Illingworth J et al. Immunol. 2013 Feb 1;190(3):1038-47. doi:
10.4049/jimmunol.1202438.
UPDATE 49: FEBRUARY 1 TO FEBRUARY 28, 2013
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A New European Neglected Diseases Center for Greece? Hotez PJ & Papageorgiou TD. PLoS
Negl Trop Dis 7(2): e1757. doi:10.1371/journal.pntd.0001757. Published Feb 28, 2013
Other PDP Publications/ Briefing papers
RECENTLY RELEASED PDP RELATED REPORTS/ BRIEFING PAPERS/ ARTICLES
Reports/ briefing papers/ books
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‘Post-registration medicinal products monitoring in sub-Saharan Africa’: meeting report. EDCTP.
February 2013.
Promoting Access to Medical Technologies and Innovation. WHO, WIP, WTO. February 2013
Evaluation of PEPFAR. IOM Report. February 2013.
Renewing US leadership: Policies to advance global health research. Global Health Technologies
Coalition (GHTC). February 2013.
PDP RELATED NEWS/ ARTICLES (SINCE FEBRUARY 1, 2013)
HIV/AIDS
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Malaria
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TB
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NTDs
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Other
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27 February: GlaxoSmithKline unit joins patent pool for AIDS drugs
Long-term consistent use of a vaginal microbicide gel among HIV-1 sero-discordant
couples in a phase III clinical trial (MDP 301) in rural south-west Uganda. Abassa A
et al. Trials 2013. 7 February 2013
Adherence and Acceptability in MTN 001: A Randomized Cross-Over Trial of Daily
Oral and Topical Tenofovir for HIV Prevention in Women. Minnis AM et al. AIDS
and Behavior. 1 February 2013; 17(2)
Feasibility, Performance, and Acceptability of the Wisebag for Potential Monitoring
of Daily Gel Applicator Use in Durban, South Africa. van der Straten A et al. AIDS
and Behavior. 1 February 2013; 17(2)
An exploratory, randomized, crossover MRI study of microbicide delivery with the
SILCS diaphragm compared to a vaginal applicator. Pentlicky S et al. Contraception.
14 February 2013; 87(2):187-192.
Perspective: When to start ART in Africa--An urgent research priority. De Cock K &
El-Sadr W. NEJM. 20 February 2013
High coverage of ART associated with decline in risk of HIV acquisition in rural
KwaZulu-Natal, South Africa. Tanser F et al. Science. 22 February 2013;
339(6122):966-971.
Increases in Adult Life Expectancy in Rural South Africa: Valuing the Scale-Up of
HIV Treatment. Bor J et al. Science. 22 February 2013; 339(6122):961-965.
21 February: Salt pumps: A chink in the malaria parasite’s armour
25 February: New pack for Injectable Artesunate (InjAS) accepted by WHO
Prequalification
Primaquine to prevent transmission of falciparum malaria. White NJ. The Lancet
Infectious Diseases, Volume 13, Issue 2, Pages 175 - 181, February 2013
The Stability of Malaria Elimination. Chiyaka C et al. Science 22 February 2013: Vol.
339 no. 6122 pp. 909-910
Diagnostic accuracy of same-day microscopy versus standard microscopy for
pulmonary tuberculosis: a systematic review and meta-analysis. Davis JL et al. The
Lancet Infectious Diseases, Volume 13, Issue 2, Pages 147 - 154, February 2013
25 February: New test could speed leprosy diagnosis and treatment
27 February: USA Inviragen Advances DENVax into Second Stage of Ongoing Phase 2
Clinical Study
5 February: Task Force for Global Health receives grant to establish NTD research
center
6 February: WHO, WTO, WIPO Provide Policymakers Policy Options For Public
Health
UPDATE 49: FEBRUARY 1 TO FEBRUARY 28, 2013
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13 February: An optimistic era for global infectious disease control
26 February: Investing in the future: GHTC congressional briefing highlights
compelling benefits of global health research
WHO and the future of disease control programmes. Dye C et al. The Lancet,
Volume 381, Issue 9864, Pages 413 - 418, 2 February 2013
Promotion of access to essential medicines for non-communicable diseases:
practical implications of the UN political declaration. Hogerzeil HV et al. The Lancet,
Volume 381, Issue 9867, Pages 680 - 689, 23 February 2013
UPCOMING MEETINGS
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March 6 2013: Promoting Excellence in R&D For Global Health. Brussels. Seminar
during the EU Science: Global Challenges Global Collaboration Conference
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March 25-27 2013: Third Global Forum on TB Vaccines. Cape Town, South Africa
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April 30- May 2 2013: Global Health Product Development Forum. Seattle
October 20-24 2013: Seventh EDCTP Forum. Dakar, Senegal.
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