UPDATE 50: MARCH 1 TO MARCH 29, 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 MARCH 1, 2013) Gates Foundation 4 March 2013: Ground Breaking Ideas Sought to Improve the Lives of Millions The Bill & Melinda Gates Foundation is accepting applications for Round 11 of its Grand Challenges Explorations initiative, an agile, accelerated grant program encouraging bold approaches aimed at improving the lives of the world’s poorest people. Anyone – students, scientists, entrepreneurs - with a transformative idea is invited to submit an easy, online, two-page application. "To overcome persistent health and development problems, we need new, game-changing ideas,” said Chris Wilson, Director of Global Health Discovery & Translational Science at the Bill & Melinda Gates Foundation. “Inspiration can come from anywhere and we are hopeful that this new round of Grand Challenges Explorations will uncover innovative approaches to improve lives around the world.” Since its launch in 2008, the Grand Challenges Explorations initiative has funded more than 800 grants in 52 countries. The program welcomes proposals from a broad spectrum of contributors, and encourages cross-discipline approaches. Topics for Grand Challenges Explorations Round 11: Develop the Next Generation of Condom Increasing Interoperability of Social Good Data – in partnership with Liquidnet for Good “One Health”: Bringing Together Human and Animal Health for New Solutions Labor Saving Strategies and Innovations for Women Smallholder Farmers New Approaches for Detection, Treatment, and Control of Selected Neglected Tropical Diseases Proposals are being accepted at www.grandchallenges.org through May 7, 2013. The Gates Foundation and an independent group of reviewers will select the most innovative proposals, and grants will be awarded within approximately four months from the proposal submission deadline. Initial grants are USD$100,000 each. Projects demonstrating potential will have the opportunity to receive additional funding up to USD$1 million. 6 March 2013: Global Vaccine Summit to Recognize Progress in Immunizing all Children Everywhere Under the patronage of His Highness General Sheikh Mohamed bin Zayed bin Sultan Al Nahyan, Crown Prince of Abu Dhabi and Deputy Supreme Commander of the UAE Armed Forces, and in partnership with United Nations Secretary-General Ban Ki-moon and Bill Gates, co-chair of the Bill & Melinda Gates Foundation, it was announced today that a Global Vaccine Summit will be held in Abu Dhabi on April 24-25, 2013. … US - NIH 4 March 2013: Daily-use HIV prevention approaches prove ineffective among women in NIH study Three antiretroviral-based strategies intended to prevent HIV infection among women did not prove effective in a major clinical trial in Africa. For reasons that are unclear, a majority of study participants — particularly young, single women — were unable to use their assigned approaches daily as directed, according to findings presented today by one of the study’s co-leaders at the Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta. The Vaginal and Oral Interventions to Control the Epidemic (VOICE) study, or MTN 003, was designed to evaluate the safety and efficacy of three HIV prevention strategies compared to placebo. The trial tested an investigational vaginal gel containing the antiretroviral drug tenofovir, a pill form of UPDATE 50: MARCH 1 TO MARCH 29, 2013 tenofovir (brand name Viread), and a pill containing a combination of tenofovir and emtricitabine (brand name Truvada). The study was sponsored and largely funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. In the trial, the three strategies were tested among 5,029 sexually active women 18 to 45 years of age at 15 sites in South Africa, Uganda and Zimbabwe. Nearly half of the study participants were under the age of 25, and most were unmarried (79 percent). Participants in each of the three groups were counseled to use their assigned pill or gel once daily and received free condoms, ongoing counseling on how to reduce their HIV risk, and testing and treatment for sexually transmitted infections. Prior to enrollment, all potential study participants engaged in an oral and written consent process explaining the details of the study. Study results presented today indicate that most VOICE participants did not adhere to the daily use schedule. Moreover, single women 25 years of age and younger were the least likely to use the investigational products and the most likely to become infected with HIV. The rate of new HIV infections among these young women was nearly 10 percent at some of the study sites in South Africa, reflecting a very high incidence of HIV infection among young women in these communities. … US - USAID 4 March 2013: VOICE HIV Prevention trial releases findings Today, the National Institutes of Health-funded Microbicide Trials Network presented final results from the VOICE HIV prevention clinical trial at the 20th Conference of Retroviruses and Opportunistic Infections (CROI) in Atlanta. The trial has been evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women – daily use of one of two different ARV tablets or of a vaginal gel. While the products were found to be safe, it appears that most participants did not use the products daily, as recommended. The U.S. Agency for International Development, through the President’s Emergency Plan for AIDS Relief, contributed support for the VOICE trial through the technical support and vaginal gel provided by one of our partners, CONRAD. … 20 March 2013: USAID releases third annual letter Today, Dr. Rajiv Shah, Administrator of the U.S. Agency for International Development (USAID), released the Agency’s third annual letter discussing ending extreme poverty and USAID’s “New Model” for development. The Annual Letter can be read here: http://www.usaid.gov/annual-letter 20 March 2013: USAID releases first USAID Forward progress report Today, the U.S. Agency for International Development released a progress report on its signature reform initiative USAID Forward at an event co-hosted by the American Enterprise Institute (AEI) and the Center for American Progress (CAP). The report can be viewed here: www.usaid.gov/USAIDForward. … Wellcome Trust 21 March 2013: Follow-up study describes declining efficacy of malaria vaccine candidate over four years Long-term follow-up of a phase II study from KEMRI-Wellcome Trust Research Programme and Oxford University researchers in Kenya shows that the efficacy of a malaria vaccine candidate, RTS,S, wanes over time and varies with exposure to the malaria parasite. … The findings will help to inform which populations are likely to benefit most from the vaccine candidate. They also have important implications for the design of future clinical trials of this and other vaccine candidates and highlight the importance of long-term follow-up studies for assessing vaccine efficacy. The study involved 447 children in Kilifi, Kenya, who had been part of an earlier phase II trial to assess the safety and efficacy of the vaccine candidate. Of the 447 children, 320 completed four years of follow-up. The analysis, which was published today in the 'New England Journal of Medicine', was designed to look at how well the vaccine candidate protects against malaria over time. Initial results from larger ongoing phase III studies showed that the candidate RTS,S vaccine reduced UPDATE 50: MARCH 1 TO MARCH 29, 2013 malaria over 12 months of follow-up by approximately half in young children and one-third in infants. The new findings on long-term follow-up of an earlier phase II study reveal that the vaccine efficacy dropped from 43.6 per cent protection against malaria in the first year to zero by the fourth year after vaccination. …. PDP PRESS RELEASES (SINCE MARCH 1, 2013) AERAS 18 March 2013: The Global Cost of TB: Investments Urgently Needed to Prevent Drug-Resistant Strains Today’s announcement by the World Health Organization and The Global Fund to Fight AIDS, TB and Malaria documents the urgent need to dedicate more resources to tuberculosis treatment and prevention. Recent studies suggest that tuberculosis may continue to evolve into superbugs that resist most, if not all, of our best medicines. According to the WHO, two regions – Africa and Europe -- are not on track to achieve the global target of halving the TB death rate. In the European Region[1] alone, there are 49 new cases and 7 deaths every hour from tuberculosis, posing a serious public health threat with a consequential economic burden of €2 billion a year in treatment costs. … AERAS & TBVI 25 March 2013: Global Scientific Experts Convene in Cape Town to Report on Progress toward Tuberculosis Vaccines At a time of growing global concern about the rising level of drug-resistant strains of tuberculosis in South Africa and worldwide, the world’s top TB vaccine experts are meeting this week, the first time this scientific forum has been held in Africa, where they will present new research aimed at advancing development of vaccines against the deadly airborne disease. … Among the new findings being presented at the conference are the results of modeling study by the London School of Hygiene & Tropical Medicine that suggest new efficacious TB vaccines for adolescent and adults could alleviate up to 67 million (50-83) cases and 8 million (5-12) deaths by 2050 in the 22 high-burden countries and is cost effective. Further research results show that within the remit of vaccine research the medium term needs of countries such as South Africa are likely to be best served by developing and testing vaccines that would be effective in adolescents and adults. New TB vaccines are essential if high TB burden countries are to meet the 2050 TB elimination goal. … FIND 19 March 2013: Increased support for the development of needed TB diagnostic tests FIND, the Foundation for Innovative New Diagnostics, and TDR, the Special Programme for Research and Training on Tropical Diseases, have joined forces to increase access to clinical reference materials needed in the development of diagnostics for tuberculosis (TB). Currently, there are no point-of-care tests recommended for use by the World Health Organization. As a result, TB often goes undiagnosed in people who do not have easy or close access to health care facilities, leading to untreated cases and avoidable deaths. “This new collaboration should accelerate the development of the point-of-care diagnostic tests that meet quality standards,” said TDR Director John Reeder. Academic and industry groups working on developing tests for tuberculosis are often stymied by the lack of sputum, serum, and other specimens needed for product development and validation. The TDR-TB Specimen Bank, which was launched in 2000 and has been refreshed on an ongoing basis ever since, contains samples from symptomatic respiratory patients with and without TB, collected from over a dozen geographically diverse countries. The new agreement is an important evolution that allows FIND to expand access to these materials by leveraging its biobanking capacity and connections to diagnostic research organizations and UPDATE 50: MARCH 1 TO MARCH 29, 2013 manufacturers. It will take over daily management of the bank and work with TDR to support increased use of the samples. “Sample access has always been a critical bottleneck in the development and evaluation of new diagnostics for TB”, said Mark Perkins, Chief Scientific Officer of FIND. “We are pleased to support TDR to maintain and distribute these precious materials, and believe that establishing a simple and centralized facility through which they can be accessed can stimulate additional test developers to work in this field”. The two organizations will provide open access to the samples of sputum, serum, saliva and urine collected in prospective studies, supported with full microbiologic examination and clinical follow-up. Materials are frozen on site, and maintained deep-frozen at a central distribution site. Each sample is linked to detailed clinical and microbiological information. IAVI 8 March 2013: IAVI celebrates International Women’s Day Women the world over have made enormous progress in obtaining the right to lead their lives as they choose. IAVI applauds that progress and lends its unequivocal support to the continuing struggle to ensure equal rights and protections for all women, everywhere. … In support of these women, we call for greater political leadership and continued support for the development of new biomedical strategies, such as vaccines, to prevent HIV. Offering women more choices and more control over how they protect themselves from HIV will support efforts to ensure the gender equity that is so essential to improving women’s lives. 27 March 2013: IAVI congratulates Marijke Wijnroks on appointment at Global Fund The International AIDS Vaccine Initiative (IAVI) congratulates Marijke Wijnroks, member of IAVI’s Board of Directors, on her appointment as Chief of Staff at the Global Fund to Fight AIDS, Tuberculosis and Malaria. Dr. Wijnroks has a long track record of leadership in the global fight against HIV/AIDS, and a strong commitment to prioritizing Sexual Reproductive Health and Rights (SRHR) and other global health issues in national and global development and health agendas. As the Netherlands’ Ambassador for Sexual and Reproductive Health and Rights and HIV/AIDS, she has been an invaluable source of advice and support for IAVI as we continue our mission to develop a safe and effective AIDS vaccine. … 28 March 2013: Researchers develop a promising new technology to aid HIV vaccine design A team of researchers at The Scripps Research Institute (TSRI) and IAVI report in the current issue of Science a novel strategy to aid the design of vaccines that can elicit broadly neutralizing antibodies against HIV. Their approach, which applies pioneering computational and genetic engineering techniques to create an HIV immunogen—the active ingredient of a vaccine—could have significant implications for the design of preventive vaccines against a wide variety of other pathogens as well. The current research derives from a recent surge in the structural and biological analysis of broadly neutralizing antibodies (bNAbs) isolated from people infected with HIV from around the world. Researchers suspect that if such antibodies could be elicited by vaccination, they might stop HIV in the earliest stages of infection. The immunogen devised by the TSRI-IAVI team is designed to elicit antibodies similar to a bNAb known as VRC01, which was isolated by the Vaccine Research Center (VRC) of the US National Institute of Allergy and Infectious Diseases. It has been shown in laboratory studies to neutralize more than 90% of the globally circulating variants of HIV. … IVCC 14 March 2013: Professor Janet Hemingway steps down as CEO LSTM Director Janet Hemingway is stepping down as CEO of IVCC of which LSTM is a founding partner. After seven years effectively executing both positions simultaneously both LSTM and IVCC continue to grow. During those years Professor Hemingway acted as CEO, chief fund-raiser and as chief scientific officer in a number of areas within vector control. As IVCC expands its portfolio in UPDATE 50: MARCH 1 TO MARCH 29, 2013 vector control product development and broadens its funding base Professor Hemingway indicated to the Board of IVCC that she felt that the senior management team of IVCC needed to be strengthened by the appointment of a full-time CEO and she wished to concentrate part-time on helping to deliver future funding. …. MMV 6 March 2013: Ray Chambers appointed by UN to step-up financing for health related-MDGs The UN Secretary-General Ban Ki-moon has announced the appointment of Ray Chambers as his Special Envoy for Financing of the Health-Related Millennium Development Goals (MDGs) and the renewal of his mandate on malaria. In this newly created role, Ray will promote increased investment by the public and private sectors to reduce child and maternal mortality, HIV/AIDS, malaria, tuberculosis and other diseases by 31 December 2015, the internationally agreed deadline for achieving the MDGs. … 7 March 2013: Eurartesim® (dihydroartemisinin-piperaquine) registered in first African country Ghana has become the first African country to approve Eurartesim®, a high-quality, fixed-dose combination of dihydroartemisinin-piperaquine (DHA-PQP). DHA-PQP is one of the artemisinin combination therapies (ACTs) recommended by WHO’s Standard Treatment Guidelines for the treatment of uncomplicated P. falciparum malaria. Developed by Sigma-Tau in partnership with MMV,Eurartesim was approved by the European Medicines Agency in 2011. … 20 March 2013: Quinolones: breathing new life into an old class of compounds to tackle malaria Today, Science Translational Medicinepublishes details of a series of potent compounds active against malaria with transmission-blocking potential. The 4-(1H)-quinolone-3-diarylethers were discovered by an MMV project team led by Professors Mike Riscoe, at Oregon Health & Science University, and Roman Manetsch, at the University of South Florida, over 60 years after the discovery of endochin – the first antimalarial quinolone. Endochin was never followed up at the time due to a lack of activity in humans. Today, however, these quinolones have been optimized and demonstrated to be highly active against the blood stages of both major species of malaria parasite (Plasmodium falciparum andPlasmodium vivax). They have also been shown to have excellent liver-stage activity as well as inhibitory effects on the stages that lead to malaria transmission. These quinolones target the same biological pathway as atovaquone – the main component of the antimalarial, Malarone® (atovaquone/proguanil), but are likely to be much cheaper to produce and have also been shown to be effective against parasite strains that have developed resistance to atovaquone. …. Sabin Vaccine Institute 5 March 2013: New Study Suggests Potential Shift in Burden of Pneumococcal Disease New studies revealed today by Latin American researchers and global health leaders suggest that the highest burden of deadly pneumococcal disease in Latin America may be shifting to adults as countries successfully immunize more infants with new vaccines. The experts called for increased disease monitoring and more surveillance to understand the full extent of pneumococcal disease in the Americas, including its economic impact, and to devise effective strategies to prevent it. … March 2013: Two opinion pieces from Sabin President Peter Hotez on NTDs 20 March: Ending the neglect. Science Omega 25 March: The Disease Next Door. Foreign Policy TB Alliance 4 March 2013: David Norton Appointed to TB Alliance's Board of Directors TB Alliance, a not-for-profit organization with the mission of developing better, faster-acting, and UPDATE 50: MARCH 1 TO MARCH 29, 2013 affordable TB treatments, announces the election to its Board of Directors of David Norton, former Company Group Chairman of Global Pharmaceuticals for Johnson & Johnson (J&J). Mr. Norton brings to TB Alliance nearly 40 years of experience within the pharmaceutical sector, and is noted for his strategy in charting the growth of J&J’s pharmaceuticals group. … 18 March 2013: UNITAID and TB Alliance Call For More Action Against Childhood Tuberculosis In spite of an estimated 500,000 new annual cases of children with tuberculosis (TB), there are no appropriate medicines for them, UNITAID and the TB Alliance warn. TB, one of the world’s most neglected diseases with almost no new treatments developed in the past 50 years, is one of the top ten causes of childhood death. TB mostly affects the world’s poorest; among those, the most vulnerable are children. With no alternatives available, treatment providers for children are forced to adapt medicines for adults as best they can, such as by cutting pills. This leads to improper treatment, treatment failure, spread of this highly-contagious disease, and conditions ripe for the development of drug-resistant strains of the bacteria. In response to this need, UNITAID is funding a TB Alliance project to better understand the barriers that manufacturers will have to overcome to enter the pediatric TB market and to work with those manufacturers to ensure that a correctly-dosed child-friendly formulation of existing first-line TB drugs will be available in a timely manner. This work will also help speed the development of other novel regimens for children that are now in the pipeline. … RECENTLY RELEASED PDP REPORTS/ BRIEFING PAPERS/ ARTICLES Articles in Peer Reviewed Journals An urgent call for a stronger, louder voice for TB vaccine advocacy. Tameris M et al. Tuberculosis. http://dx.doi.org/10.1016/j.tube.2013.02.016. Available online 14 March 2013. Methodology of Clinical Trials Aimed at Assessing Interventions for Cutaneous Leishmaniasis. Olliaro P et al. PLoS Negl Trop Dis 7(3): e2130. doi:10.1371/journal.pntd.0002130 New biomarkers for stage determination in Trypanosoma brucei rhodesiense sleeping sickness patients. Tiberti N et al. Clin Transl Med. 2013 Jan 7;2(1):1. doi: 10.1186/2001-1326-2-1 Advances in tuberculosis diagnostics: the Xpert MTB/RIF assay and future prospects for a pointof-care test. Lawn SD et al. The Lancet Infectious Diseases, Volume 13, Issue 4, Pages 349 361;doi:10.1016/S1473-3099(13)70008-2 Rational HIV Immunogen Design to Target Specific Germline B Cell Receptors. Jardine J et al. Science DOI: 10.1126/science.1234150. Published Online March 28 2013 Other PDP Publications/ Briefing papers Public-private partnerships for global health: How PATH advances technologies through cross-sector collaboration. PATH. March 2013. Other Materials Real Voices, a video series, featuring interviews with scientists, community members, advocates and others, who share their views about the need for microbicides women can use to reduce their risk of HIV infection. IPM. March 2013. Exposed, a series of short films, exposing the underreported global epidemic of TB and the movement for innovation to improve our tools to fight it. Aeras. March 2013 RECENTLY RELEASED PDP RELATED REPORTS/ BRIEFING PAPERS/ ARTICLES Reports/ briefing papers/ books The Advance Market Commitment for Pneumococcal Vaccines: Process and design evaluation. Evaluation commissioned by GAVI. Dalberg Global Development Advisors. 2013. G-FINDER Public Search Tool - 2011 data are now available. An Action Agenda to End AIDS. Quarterly Monitoring Report. amfAR and AVAC. March 2013 UPDATE 50: MARCH 1 TO MARCH 29, 2013 High-Level Conference on EDCTP2: proceedings and video available online. EDCTP. March 2013 PDP RELATED NEWS/ ARTICLES (SINCE MARCH 1, 2013) HIV/AIDS • • • • • • • • • • • TB • • • Other NTDs • Contraception • • Other • • • 4 March: VOICE Trial Results Underscore Need to Accelerate Development of Additional HIV Prevention Options for Women: PrEP strategies remain valuable prevention tool, says AVAC 6 March: Another blow for microbicide HIV prevention 6 March: Prevention measures - proposed HIV prevention trial in African infants using the antibody therapy VRC01 7 March: Human nature sinks HIV prevention trial 8 March: ANRS highlights results of EDCTP-cofunded PROMISE-PEP study 12 March: AIDS Center's new labs debut: US cuts may slow hunt for a vaccine Spray drying tenofovir loaded mucoadhesive and pH-sensitive microspheres intended for HIV prevention. Zhang T et al. Antiviral Research. 28 March 2013; 97(3):334-346. The cost and impact of scaling up pre-exposure prophylaxis for HIV prevention: A systematic review of cost-effectiveness modelling studies. Gomez G et al. PLoS Med. 28 March 2013; 10(3) 18 March : World Health Organization and Global Fund cite tuberculosis threat 25 March: EDCTP-funded projects for tuberculosis vaccines 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, Volume 381, Issue 9871, Pages 1021 - 1028, 23 March 2013 A major event for new tuberculosis vaccines. Dye C & Fine PEM. The Lancet, Volume 381, Issue 9871, Pages 972 - 974, 23 March 2013 Drug-resistant tuberculosis: time for visionary political leadership. Abubakar I et al. The Lancet Infectious Diseases, doi:10.1016/S1473-3099(13)70030-6. Early Online Publication, 24 March 2013 Integrating tuberculosis and HIV services in low- and middle-income countries: A systematic review. Legido-Quigley H et al. Trop Med Int Health. 28 March 2013; 18(2):199-211. Dengue vaccine efficacy trial: does interference cause failure? Swaminathan S et al.The Lancet Infectious Diseases, Volume 13, Issue 3, Pages 191 - 192, March 2013 6 March: New vision for contraceptive research and development Developing multipurpose reproductive health technologies: An integrated strategy. Harrison P et al. AIDS Research and Treatment. 1 March 2013 7 March: New details emerging about sequestration that indicate an uncertain future for global health R&D 8 March: New report finds that AMCs are promising solutions to global health challenges 25 March: Call for experts: EDCTP Strategic Advisory Committee and EDCTP Interim Strategic Advisory Committee UPCOMING MEETINGS April 30- May 2 2013: Global Health Product Development Forum. Seattle October 20-24 2013: Seventh EDCTP Forum. Dakar, Senegal.