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UPDATE 59: DECEMBER 1 TO DECEMBER 31, 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 ([email protected]). FUNDER ANNOUNCEMENTS (SINCE DECEMBER 1, 2013) BILL & MELINDA GATES FOUNDATION 17 December 2013: Susan Desmond-Hellmann Named Chief Executive Officer of the Bill & Melinda Gates Foundation The Bill & Melinda Gates Foundation has selected Susan Desmond-Hellmann, M.D., M.P.H., as its next chief executive officer. Currently the chancellor of the University of California, San Francisco (UCSF), Desmond-Hellmann will assume her role on May 1, 2014. … An oncologist by training, Desmond-Hellmann is a recognized leader on issues of higher education, public health, drug development, regulatory innovation and health policy. She has led UCSF since August 2009, when she became the first woman to serve as the university’s chancellor, overseeing all aspects of the university and medical center’s strategy, academic programs and operations. She has extensive experience in product development, and a deep understanding of how to bridge applied research to delivery of product. Prior to her tenure at UCSF, she was President of Product Development at Genentech, where she led the development and introduction of two of the first gene-targeted therapies for cancer, Avastin and Herceptin. … 19 December 2013: Gates Foundation Awards Grants to Develop Urine Powered Fuel Cells, Waterless Toilets and Solar Steam Sterilizers The Bill & Melinda Gates Foundation today announced Phase II winners as part of its Grand Challenges Explorations (GCE) initiative focused on water, sanitation and hygiene, including one grant to do further research on microbial fuel cells which could power cellphones with urine. … NORWAY - GLOBVAC 10 December 2013: GLOBVAC calls for proposals 2014 Please note the upcoming calls for proposals from the Programme for Global Health and Vaccination Research: - Proposals for Support for Events/workshops, with deadline 12 February and 3 September 2014. The approximate amount available will be announced in the calls. The February call will soon be out. - Proposals for Researcher Projects and Young Scientist Grants, with deadline foroutlines 3 September 2014 and for full proposals mid-April 2015. The approximate amount available, guidelines and specifications will be given in the call texts. - Proposals for Innovation Projects for the Industrial Sector, with deadline 15 October 2014. The approximate amount available, guidelines and specifications will be given in the call text. Please note that the call texts will be published at the latest six weeks prior to the deadline. All announcements will be published on the RCN website. … 19 December 2013: Call for ideas for large game-changing research topics The Programme for Global Health and Vaccination Research welcomes suggestions from the research community for "game-changing" topics in global health research. Based on this input, the programme will decide on which topics to be announced in a planned call for proposals. In the 2013-2020 period special funds will be earmarked for large projects identified as being of particular strategic value to the GLOBVAC programme and/or as having a potentially high, international impact. Suggestions that explore international co-funding opportunities are strongly encouraged. The large projects must also reflect one of the five thematic areas listed below. UPDATE 59: DECEMBER 1 TO DECEMBER 31, 2013 GLOBVAC is planning to launch a specific call for large projects that fulfil these requirements. Please note that this call will come in addition to, and in parallel with, the regular calls of the GLOBVAC programme. … US - NIH 2 December 2013: NIH announces plan to increase funding toward a cure for HIV/AIDS At a White House event today to mark the 25th annual World AIDS Day, President Obama announced that the National Institutes of Health plans to redirect AIDS research funds to expand support for research directed toward a cure for HIV. NIH plans to invest an additional $100 million over the next three fiscal years on this increasingly promising area of HIV/AIDS research. … Funding for these new initiatives will come from existing resources and a redirection of funds from expiring AIDS research grants over the next three years. NIH Director Francis S. Collins, M.D., Ph.D., said, “Flat budgets and cuts from sequestration have had a profound and damaging impact on biomedical research, but we must continue to find ways to support cutting-edge science, even in this environment. AIDS research is an example of an area where hard-won progress over many years has resulted in new and exciting possibilities in basic and clinical science in AIDS that must be pursued. … 17 December 2013: NIH names leadership, research units for restructured HIV/AIDS clinical trials networks Principal investigators and clinical trials units (CTUs) have been chosen to lead and conduct the research of five HIV/AIDS clinical trials networks through 2021. The effort is directed and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Total funding for the networks’ leadership and the CTUs is expected to reach $225 million in 2014, the first year of operation. … Planning for restructuring of the HIV/AIDS clinical trials networks began in 2010 and involved extensive consultations with researchers, clinicians, nurses, patient advocates and other activists, and people living with HIV or at risk for infection. The new awards are intended to expand the scope of the network’s current activities to include the treatment and prevention of other infectious diseases, notably tuberculosis and hepatitis, which are the most significant co-infections for people who are infected with HIV or at risk for infection. The new structure is designed to increase collaboration across the networks, create transparent mechanisms for network leaders to solicit and support ideas from the research community, and develop a means for external researchers to tap into the networks’ clinical trial infrastructure and capacity. … WELLCOME TRUST 10 December 2013: Antibiotic-resistant typhoid likely to spread despite drug control programmes Restricting the use of antibiotics is unlikely to stop the spread of drug resistance in typhoid fever, according to a study funded by the Wellcome Trust and published in the journal 'eLife'. The findings reveal that antibiotic-resistant strains of Salmonella Typhi bacteria can outcompete drugsensitive strains when grown in the laboratory, even in the absence of antibiotics. 18 December 2013: Wellcome Trust publishes Annual Review 2013 The Wellcome Trust’s Annual Review 2013 is now available, presenting a selection of our major activities and achievements in the year from October 2012 to September 2013. .. PDP PRESS RELEASES (SINCE DECEMBER 1, 2013) DNDi 5 December 2013: Research & Development for Diseases of the Poor: A 10-Year Analysis of Impact of UPDATE 59: DECEMBER 1 TO DECEMBER 31, 2013 the DNDi Model Today, at a scientific meeting at Institut Pasteur, France, entitled ‘Best Science for the Most Neglected: Where Do We Stand Ten Years On?’, co-organized with Institut Pasteur and MSF and in collaboration with PLOS, the Drugs for Neglected Diseases initiative (DNDi) marks its 10-year anniversary by issuing a report that explores the lessons learned from a decade of research and development (R&D) of new treatments for neglected diseases via a cost-effective, innovative, not-forprofit drug development model. The report also comes at the time of discussions at the WHO aiming at gaining Member State agreement on ‘demonstration projects’ meant to provide evidence for the feasibility and sustainability of collaborative and open approaches to R&D for the health needs of developing countries. … DVI 9 December 2013: Dengue Vaccine Initiative awarded grant from Germany for development of new dengue vaccines in Brazil and Vietnam The Dengue Vaccine Initiative (DVI) announced today that it has received a 1 million Euro award from the German Federal Ministry of Education and Research (BMBF), the first time it has received such a grant from Germany. The funds will be used to support the development of new dengue vaccines in collaboration with the Instituto Butantan, a biomedical research center in São Paulo, Brazil, and Vabiotech, a vaccine manufacturer in Hanoi, Vietnam. … While there is no dengue vaccine currently available, progress towards one has accelerated in recent years, and a range of dengue vaccine candidates are currently in clinical phases. The award from BMBF will support the development of dengue vaccines by local manufacturers in Brazil and Vietnam, two countries greatly impacted by dengue. DVI scientists and external experts will work with the Instituto Butantan and Vabiotech. The dengue vaccines being developed at the Instituto Butantan and VaBiotech is a live attenuated tetravalent vaccine (LATV) candidate that was licensed from the U.S. National Institutes of Health (NIH). The vaccines consist of four modified strains of the dengue virus. First clinical studies in the U.S. have shown that the NIH vaccine candidate is safe and immunogenic. … EVI 5 December 2013: New Chair and Vice Chairs for EVI's Scientific Advisory Committee (SAC), and new Chair of the Board At its recent Board meeting, 5 December 2013, the Board approved Alister Craig, Liverpool School of Tropical Medicine as Chair of EVI SAC. Two Vice Chairs were also approved: Long time member, Ingileif Jónsdóttir, Landspitali University Hospital and Faculty of Medicine, University of Iceland, and James Robertson, retired, who joined SAC this year. The new Chair of the Board is Clemens Kocken, Biomedical Primate Research Centre. IAVI 10 December 2013: Alex Coutinho becomes Chair, Eric Goosby and Lord Fowler join IAVI Board The International AIDS Vaccine Initiative (IAVI) is pleased to announce that Dr. Alex Godwin Coutinho has taken over the role of Chair of its Board of Directors, and U.S. Ambassador Eric Goosby and the Rt. Hon. the Lord Fowler have become new members of the Board. … 16 December 2013: IAVI Receives RWJF Grant to catalylze a human vaccines project The International AIDS Vaccine Initiative (IAVI) has received a $378,000 grant from the Robert Wood Johnson Foundation to convene international scientists and public-health experts to explore the creation of a Human Vaccines Project that could collectively leverage technological advances to accelerate the development of new vaccines against AIDS, tuberculosis, malaria, and other major diseases. “New approaches are critically needed,” said Wayne C. Koff, IAVI Chief Scientific Officer and Principal UPDATE 59: DECEMBER 1 TO DECEMBER 31, 2013 Investigator of the grant. “Despite major advances in vaccine discovery and immune-system monitoring, common questions hinder development of vaccines against many diseases. Solving these trans-vaccinology questions in a global consortium could be transformative for individual and public health. IAVI is once again proud to serve as a catalyst in cutting-edge science by convening a forum to open this conversation.” IDRI 19 December 2013: IDRI Announces Evolution of Leadership Roles As IDRI’s 20th year comes to a productive close with diagnostics on the market, vaccines in clinical trials, and drugs being discovered for the world’s most devastating infectious diseases, the organization today announced leadership plans for the future. On Jan. 1, 2014, Stewart Parker, IDRI CEO, will transition into a new role as Senior Advisor to IDRI, while maintaining her seat on IDRI’s Board of Directors. Parker, a well-known figure in Seattle’s biotech community, having served as CEO of Targeted Genetics, joined IDRI in March 2011 to spearhead a three-year plan to develop resources – financial, human and physical – to support IDRI’s scientific efforts. … Erik Iverson, who currently serves as IDRI’s Executive Vice President of Business Development and External Relations, has been promoted to President, Business and Operations. Prior to joining IDRI in 2011, Iverson served as Associate General Counsel at the Bill & Melinda Gates Foundation. At the Gates Foundation, he was the second attorney on staff, worked for over seven years within the foundation's Global Health Program, and led the development and implementation of the foundation's Global Access policy. … MMV 10 December 2013: State-of-the-art laboratory to study new antimalarials opens in Jakarta Last week, the Dean of the Faculty of Medicine, University of Indonesia in Jakarta, Dr Ratna Sitompul, officially opened a new Laboratory of Pharmacokinetics. Supported by MMV and the UK Department for International Development (DFID), the new lab is equipped and staffed to conduct pharmacokinetic and pharmacodynamic (PK1/PD2) analysis of future antimalarials being trialled in the region. … 19 December 2013: Tafenoquine successfully completes Phase IIb clinical trials The results of the Phase IIb study investigating tafenoquine plus 3 days of chloroquine for the treatment and prevention of Plasmodium vivax(relapsing) malaria have been published today in The Lancet.1Tafenoquine is in development with GSK and MMV. While Plasmodium falciparum is the deadliest of malaria parasites, P. vivaxhas proven the most elusive to cure. It has a dormant liver form (the hypnozoite) that can reactivate any time between 3 weeks and several years – leaving its victims vulnerable to the effects of multiple relapses of malaria. The Phase IIb study recruited more than 300 patients with confirmed P. vivax malaria from seven centres in Brazil, Peru, India and Thailand – some of the countries most severely affected by relapsing malaria. The study defined 300 mg as the optimal dose to take forward into Phase III, as this dose was found to have an acceptable overall benefit–risk profile. “Tafenoquine shows potential as a drug to prevent further episodes of relapsing malaria, and could be a key tool to control and eventually eliminate malaria,” said Dr Timothy Wells, MMV’s Chief Scientific Officer. 20 December 2013: Breakthrough Therapy designation for potential new anti-relapse medicine for malaria GlaxoSmithKline (GSK) and Medicines for Malaria Venture (MMV) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation* for tafenoquine, an investigational medicine for the treatment and relapse prevention of Plasmodium vivaxmalaria. Tafenoquine is not yet approved or licensed for use anywhere in the world. Breakthrough Therapy designation is the newest of the FDA’s programmes aimed at accelerating the development and UPDATE 59: DECEMBER 1 TO DECEMBER 31, 2013 review times of drugs for serious or life-threatening conditions. P. vivax malaria is a neglected tropical disease and a major cause of uncomplicated malaria. It has a significant public health and economic impact primarily in South and South East Asia, Latin America and the horn of Africa, where the majority of the estimated 70-390 million annual clinical cases occur. The P. vivax parasite causes relapses from a dormant liver form established immediately after an infected mosquito bite. This dormant form leads to the reappearance of clinical malaria anywhere between a few weeks and several months after the initial infection. There is a need to provide alternative treatments to manage P. vivax relapse with shorter treatment regimens. The Breakthrough Therapy designation was granted based on the results from an international, multicentre, randomised Phase II clinical trial in more than 300 patients with uncomplicated P. vivax malaria. Headline results from this trial were presented at the American Society of Tropical Medicine and Hygiene Meeting in November 2013, and detailed results published in The Lancet in December 2013. Plans are underway to start a Phase III study in 2014. 24 December 2013: Takeda collaborates with MMV through GHIT Fund Takeda Pharmaceutical Company Limited announced today that it has entered into agreements with MMV to study DSM265 and ELQ300, two anti-malarial compounds, with the support of the Global Health Innovative Technology Fund (GHIT Fund). … Under the agreement, MMV will conduct DSM265 clinical studies in collaboration with Takeda using their research and development expertise. MMV and Takeda will also collaborate to solve a challenging formulation issue for ELQ300 using Takeda’s CMC (Chemistry, Manufacturing and Controls) expertise in solid oral dosage form development. … PATH 12 December 2013: PATH announces new managing director for international programs Dr. Diana Pallais, a Microsoft executive with extensive experience in business strategy, public-private partnerships, and global development, has been named to the newly created position of managing director for PATH’s international programs. … JOINT PDP PRESS RELEASE – FIND, MMV, DNDI 6 December 2013: Rise in R&D funding could set stage for malaria eradication via new drugs, vaccines, insecticides, & diagnostics A new analysis of funding trends in the global battle against malaria reveals that, over the last two decades, there has been a five-fold increase in annual funding for malaria research and development (R&D)—from US$131 million in 1993 to $610 million in 2011. Much of that increase took place after 2004, when support stood at $320 million.* The report projects that malaria R&D will require up to $8.3 billion over the next decade (2013-2022) to develop some of the new tools needed to sustain efforts to combat the disease; the midrange projection calls for investment of about $700 million annually. While currently in retreat, malaria still kills about 660,000 people—mostly young children in Africa—each year. The study warns that R&D investments are critical, given the emergence of drug resistance in the malaria parasite and insecticide resistance in the mosquito. … RECENTLY RELEASED PDP REPORTS/ BRIEFING PAPERS/ ARTICLES Articles in Peer Reviewed Journals The drug and vaccine landscape for neglected diseases (2000–11): a systematic assessment Articles/ PDP Related Reports Archives. Pedrique B et al. The Lancet Global Health, Volume 1, Issue 6, Pages e371 - e379, December 2013 Two Analogues of Fenarimol Show Curative Activity in an Experimental Model of Chagas Disease. Keenan M et al. Med Chem, 56 (24), pp 10158–10170. December 2013 Tuberculosis screening by tuberculosis skin test or QuantiFERON Gold In-Tube assay among an UPDATE 59: DECEMBER 1 TO DECEMBER 31, 2013 immigrant population with a high prevalence of tuberculosis and BCG vaccination. Painter JA et al. PLoS ONE 8(12): e82727. doi:10.1371/journal.pone.0082727 Tafenoquine plus chloroquine for the treatment and relapse prevention of Plasmodium vivax malaria (DETECTIVE): a multicentre, double-blind, randomised, phase 2b dose-selection study. Llanos-Cuentas A et al. The Lancet, Early Online Publication, 19 December 2013 Recent developments in tuberculosis vaccines. Marinova D et al. Expert Rev Vaccines, December 2013, Vol. 12, No. 12, Pages 1431-1448 , DOI 10.1586/14760584.2013.856765 Other PDP Publications/ Briefing papers An Innovative Approach to R&D for Neglected Patients: Ten Years of Experience and Lessons Learned by DNDi. DNDi. December 2013. PLOS and DNDi: A Decade of Open Access and NTD R&D. PLOS Medicine Collection, December 2013 The Search for an AIDS Vaccine. IAVI. December 2013. Voices of TB: Engaging Communities to Improve TB Research. TB Alliance Video. December 2013. From Pipeline to Product: Malaria R&D Funding Needs into the Next Decade. PATH. December 2013. RECENTLY RELEASED PDP RELATED REPORTS/ BRIEFING PAPERS/ ARTICLES Reports/ briefing papers/ books G-FINDER 2013 Report: Neglected disease research and development: The public divide. Policy Cures. December 2013. An Emerging Leader: Germany's Role in Neglected and Poverty-Related Disease R&D. Policy Cures. December 2013 Briefing Paper, Volume 3: Improving the affordability, availability, and acceptability of health technologies. GHTC. December 2013 Proceedings of the Second High-Level Meeting on EDCTP. EDCTP. December 2013. EDCTP Stakeholder Meeting on Malaria. EDCTP. December 2013. World Malaria Report 2013. WHO. December 2013. The Global Crisis of Drug-Resistant Tuberculosis and Leadership of China and the BRICS: Challenges and Opportunities - Summary of a Joint Workshop. IOM. December 2013. Research & Reality. AVAC Report 2013. AVAC. December 2013. PDP RELATED NEWS/ ARTICLES (SINCE NOVEMBER 1, 2013) HIV/AIDS Malaria 2 December: Obama announces funding for AIDS research, prevention 3 December: New research shows promise for possible HIV cure 3 December: EVMS lands big award for AIDS research 18 December: Animal vaccine study yields insights that may advance HIV vaccine research 31 December: Finnish HIV vaccine testing to begin Development and in vitro evaluation of a vaginal microbicide gel formulation for UAMC01398, a novel diaryltriazine NNRTI against HIV-1. Grammen C et al. Antiviral Research. 6 December 2013 Financing essential HIV services: a new economic agenda. Vassall A et al. PLoS Med. 17 December 2013; 10(2):e1001567. Immunological and virological mechanisms of vaccine-mediated protection against SIV and HIV. Roederer M et al. Nature. 18 December 2013. doi:10.1038/nature12893 11 December: World malaria report 2013 shows major progress in fight against malaria, calls for sustained financing Coverage of intermittent preventive treatment and insecticide-treated nets for the control of malaria during pregnancy in sub-Saharan Africa: a synthesis and meta- UPDATE 59: DECEMBER 1 TO DECEMBER 31, 2013 Other diseases • • Other analysis of national survey data, 2009–11. van Eijk AM et al. The Lancet Infectious Diseases, Volume 13, Issue 12, Pages 1029 - 1042, December 2013 Novel phenotypic assays for the detection of artemisinin-resistant Plasmodium falciparum malaria in Cambodia: in-vitro and ex-vivo drug-response studies. Witkowski B et al. The Lancet Infectious Diseases, Volume 13, Issue 12, Pages 1043 - 1049, December 2013 5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India: a cluster-randomised, double-blind, placebo-controlled trial. Bhattacharya SK et al. The Lancet Infectious Diseases, Volume 13, Issue 12, Pages 1050 - 1056, December 2013 Antibiotic resistance—the need for global solutions. Laxminarayan R et al. The Lancet Infectious Diseases, Volume 13, Issue 12, Pages 1057 - 1098, December 2013 3 December: Global Fund Final Tally: $12b Committed, But $1b Left on Table 9 December: WHO experts select eight global health R&D projects 11 December: Investing in R&D for neglected diseases: a public pull-out puts lives at risk Research and development for neglected diseases: more is still needed, and faster. Utzinger J & Keiser J. The Lancet Global Health, Volume 1, Issue 6, Pages e317 - e318, December 2013 Global health 2035: a world converging within a generation. Jamison DT et al. The Lancet, Volume 382, Issue 9908, Pages 1898 - 1955, 7 December 2013 Health technology assessment in universal health coverage. Chalkidou K et al. The Lancet, Volume 382, Issue 9910, Pages e48 - e49, 21 December 2013 UPCOMING MEETINGS January 7 2014: Evaluation methods for large-scale, complex, multi-national global health initiatives. London, UK. June 30 - 2 July 2014: Seventh EDCTP Forum. Berlin. Germany. July 20-25 2014: AIDS 2014. Melbourne. Australia. October 28-31 2014: HIV Research for Prevention 2014. Cape Town. South Africa.