Kat Kelley

The TB Alliance, a member of the Global Health Technologies Coalition, announced last week that it will be starting Phase 1 clinical trials for a new tuberculosis (TB) drug candidate. The drug, known as TBA-354, is the first new TB drug to advance to clinical trials in six years, despite the paucity of highly effective and easily administered TB treatments. TBA-354 was developed by the TB Alliance, in partnership with the University of Auckland and the University of Illinois-Chicago, using compounds from the nitroimidazole class of chemicals, which are known to be effective against drug-resistant strands of TB. The World Health Organization (WHO) estimates that US$2 billion per year is needed for TB research and development (R&D), yet in 2013, only $676.7 million was invested. The Atlantic took an in-depth look at gaps in reproductive health R&D, highlighting common side effects of leading contraceptives and reviewing the results of clinical trials conducted between 2008 and 2011 for a contraceptive injection for men. The article also identifies contraceptive technologies currently in the pipeline, including a reversible version of a vasectomy, an improved diaphragm, a remote-controlled implant, and more. A drug-resistant form of malaria endemic to Cambodia and found in Southeastern Myanmar has spread north to the border Myanmar shares with India. While the strain is resistant to artemisinin, the most effective agent against malaria, it can still be combatted with other drugs. Dr. Charles Woodrow, the lead author on the study, explained that in Cambodia, treatment for the resistant strain involves "combining three drugs, extending courses from three days up to five days." Scientists fear that if this new strand were to establish a foothold in India, it could rapidly spread across the globe. WHO estimates that US$750 million annually is needed to prevent and treat neglected tropical diseases (NTDs), yet current foreign aid amounts to only $300 million per year. Due to the financial climate in donor countries, WHO is calling for increased domestic funding in countries where NTDs are endemic. Dirk Engels, Director of the Department of Control of NTDs at WHO, has stressed the importance of interventions that combat multiple NTDs, such as large-scale, affordable vector control programs and diagnostic interventions.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Newsweek took an in-depth look at the work of Sanaria, a small biotechnology organization striving to develop a vaccine to effectively eradicate malaria. Naturally-acquired immunity is common in malaria-endemic regions, however, it takes an estimated three years for children to develop even partial immunity. The team at Sanaria has produced a vaccine that is considered the safest and most effective vaccine to date, preventing malaria in 100 percent of participants in initial trials. The vaccine defends against Plasmodium falciparum, the parasite responsible for nearly all fatal cases of malaria. Despite the success of initial trials and accolades such as the 2014 Vaccine Industry Excellence Award for “Best Prophylactic Vaccine,” Sanaria struggles to get adequate coverage or funding to continue, let alone escalate, the development of the vaccine. A virulent new form of HIV has been reported in Cuba, leading to an accelerated transition from HIV to AIDS. The HIV virus must attach itself to certain 'receptors,' or proteins on the cell membrane, before entering the human cell. The virus has historically attached itself first to the protein CCR5, and after several years it develops the ability to attach to the CXCR4 protein, a development which often correlates to the transition to AIDS. The aggressive new strand is recombinant, a variant of the virus resulting from a combination of multiple strands of HIV. Researchers at the Ku Leuven’s Laboratory for Clinical and Epidemiological Virology have seen particularly high levels of both the virus and the RANTES molecule in patients. The RANTES molecule, a natural part of the human immune response, combats HIV by attaching to the CCR5 proteins, which prevents the virus’s ability to enter the cells, resulting in the virus adapting to attach to the CXCR4 proteins. Patients with the new, recombinant strand may develop AIDS within just three years of infection, before many are even diagnosed with HIV. Mother Jones examined the impact of climate change on the spread of infectious diseases, and the role that vaccines can play in mitigating that impact. Climate change, and in particular, extreme climate events, can not only weaken existing health systems, but higher temperatures and levels of rainfall are actually correlated to increased cases of certain diseases, such as rotavirus. As Alistair Woodward, an epidemiologist at the University of Auckland explained, “ensuring that people are vaccinated is a logical thing to do as part of managing the risks of a rapidly changing climate.”

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. US Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg announced last week that she intends to resign from her position in March. The FDA’s Chief Scientist Dr. Stephen Orstroff will serve as the interim Commissioner. Dr. Robert Califf, founding director of the Clinical Research Institute at Duke University, and recently appointed deputy commissioner for Medical Products and Tobacco at the FDA, is expected to be the principal candidate to fill the role permanently. The Global Health Innovative Technology (GHIT) Fund and the Gates Foundation launched a Grand Challenge last week to combat neglected diseases, including malaria, tuberculosis, Chagas disease, and visceral leishmaniasis. The Fund intends to grant US$2 million per year for the research and development (R&D) of new drugs, vaccines, or diagnostics, and up to $1 million per year for each product. GHIT also announced last week that it will invest $637,000 into the development and testing of chemical compounds in the pursuit of more effective products to prevent and treat malaria. The funding will be directed into a partnership between GHTC member Medicines for Malaria Venture and Japanese pharmaceutical company Daiichi Sankyo. Policy Cures—an independent research group and author of the annual G-FINDER report which analyzes global spending on global health R&D—released its first-ever report on reproductive health R&D for developing countries. The report reveals that just $88 million was spent on developing country-specific reproductive health R&D in 2013, $63 million of which was spent on contraceptive R&D. The report explores the limited funding and major gaps in reproductive health R&D, highlighting the need for affordable products that are easily delivered, administered, or stored; have multiple purposes; and do not have major side-effects. A recent study reveals that the United Kingdom’s top 25 universities—in terms of public funding for medical research—spend just 1.7 percent of their health research budgets on neglected diseases. The London School of Hygiene & Tropical Medicine topped the list, spending 68 percent of their health research on diseases that impact people in developing countries, however, all but 5 of the top 25 allocated less than 10 percent of their medical research budgets to neglected diseases.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Last April, Representatives Fred Upton (R-MI) and Diana DeGette (D-CO) launched the 21st Century Cures initiative, holding hearings and consultations to identify ways that Congress can accelerate Americans' access to new treatments from the development to delivery stage. A discussion draft of the legislation was released last week by Republican members of the House Energy & Commerce Committee. Senator Lamar Alexander (R-TN) announced on Thursday that the Senate Health, Education, Labor and Pensions committee will release legislation to complement the 21st Century Cures Act, stating that “One of the committee’s top priorities this year will be modernizing the Food and Drug Administration [FDA], helping to get treatments and medicines to patients as quickly and as safely as possible.” President Obama submitted his annual budget request to Congress yesterday, in which he asked for US$1.2 billion to fight antimicrobial resistance. This funding would be invested into developing new antibiotics and diagnostics, monitoring drug-resistant infections, and preventing the spread of resistant “superbugs,” particularly in healthcare settings. Obama also asked for $280 and $77 million, for the Centers for Disease Control and Prevention and FDA, respectively, to combat the overuse of antibiotics in both humans and livestock. Last week witnessed major wins for vaccine development and access. The US Agency for International Development announced that the US Government will commit $1 billion to Gavi, the Vaccine Alliance, over the next four years. Pfizer, Inc., a major American pharmaceutical company, pledged to reduce the price of its pneumococcal vaccine by 6 percent in poor countries. The announcement has been greeted with disparate responses. Kate Elder, a vaccines policy advisor at Doctors without Borders called the price cut "tiny" and "inadequate," however Bill Gates warned that such criticism discourages pharmaceutical companies from investing into the research and development of drugs for developing countries. Serum Institute of India is currently developing several products intended to rival existing vaccines and to be sold at significantly lower prices. The Institute’s human papillomavirus vaccine could be available as early as 2018, and the manufacturers plan to sell it at one-third of the price of Merck & Co.’s Gardasil vaccine.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Trials of an experimental Ebola vaccine candidate developed by GlaxoSmithKline (GSK) and the US National Institutes of Health (NIH) will begin in Liberia within the next few weeks. The vaccine has been successfully tested on 200 volunteers in the United States, United Kingdom, Switzerland, and Mali. GSK sent an initial 300 doses to Liberia on Friday and plans to ultimately enroll 30,000 volunteers in the trial. GSK and NIH are partnering with Merck & Co to inject 10,000 volunteers each with the GSK/NIH vaccine, a vaccine candidate developed by NewLink Genetics Corp, and a placebo. National Geographic took an in-depth look at three tropical diseases that present an emerging threat to Americans: dengue, Chagas, and chikungunya. The article highlights the need for research and development (R&D) of improved diagnostics for Chagas, and vaccines for chikungunya and dengue. All three diseases are spread by insects, and specialists fear they could spread to insect populations in the United States. Bill and Melinda Gates released their annual letter last week, in which they discussed the progress they hope to see in the next 15 years in global health and development. The Gates Foundation is making an ambitious bet—that the lives of poor people will improve faster in the next 15 years than ever before. They are calling on decision-makers involved in the post-2015 development agenda processes to make realistic goals. The letter emphasizes the importance of innovation in improving the lives of people in poor countries, claiming “these breakthroughs will be driven by innovation in technology—ranging from new vaccines and hardier crops to much cheaper smartphones and tablets.”

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Johnson & Johnson announced that it will share detailed information on its clinical trials through Yale University’s Open Data Access Project. This will include data on all Johnson & Johnson medical devices, diagnostics, and drugs approved since the beginning of 2014. "An open data movement is really gaining momentum," according to Dr. Victor Dzau, president of the Institute of Medicine, however "we need to develop a culture that supports data sharing, and we need to provide incentives and develop trust." The European Medicines Agency, which regulates drug approvals in Europe, is also contributing to the open data movement, and plans to publish detailed data for all new drugs approved by the agency. The Japan Times took an in-depth look at the Global Health Innovation Technology Fund (GHIT), a Tokyo-based member of the Global Health Technologies Coalition and a partnership between the Japanese government, five major pharmaceutical companies, the Bill & Melinda Gates Foundation, and the United Nations Development Program. GHIT seeks to promote the research and development of treatments for infectious diseases by subsidizing the costs for biotech companies and facilitating partnerships between the private and public sector. The Fund has contributed to the development of 30 drugs since its establishment in 2013, including several neglected tropical diseases such as leishmaniasis, schistosomiasis, and dengue fever. The ONE blog identified five major, deadly diseases for which vaccines are currently being developed. The blog highlights challenges to development and provides updates on leading vaccine candidates for HIV and AIDS, Malaria, Tuberculosis, Ebola, and cancers, including liver cancer caused by hepatitis C.