Breakthroughs Blog: Research Roundup

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.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Kathy Neuzil, director of Vaccine Access and Delivery at PATH, reflects on the lessons learned from Meningitis Vaccine Project (MVP) in light of the achievement of its final milestone: World Health Organization prequalification of an infant version of the meningitis A MenAfriVac® vaccine. MenAfriVac® was approved for people aged 1 to 29 years in 2010, and has since been used to effectively protect 215 million people in sub-Saharan Africa. Neuzil attributes MVP’s success to the tenacity of its team and the inclusion of country partners at every stage from product development to distribution. A new type of antibiotic may be the key to treating drug-resistant infections, according to a study published in Nature last week. The antibiotic, teixobactin, was extracted from dirt, and fights infections by targeting the fatty molecules that bacteria use to build their cell walls. While most antibiotics target the bacteria’s DNA, which can be easily mutated, the study’s lead researcher, Kim Lewis, believes it would take at least 30 years for the fatty molecules to mutate and thus develop resistance to teixobactin. The antibiotic has been successfully tested on mice with no side effects, and could be available for use in humans in five to six years. Johnson & Johnson has started human trials of an experimental Ebola vaccine in the United Kingdom, and hopes to expand testing to approximately 2,000 people by mid-February. Johnson & Johnson has produced over 400,000 courses of the vaccine and has invested significantly in the Danish pharmaceutical company Bavarian Nordic to develop a booster shot to enhance the efficacy of the vaccine and to promote long-term protection against Ebola. Dr. Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), sat down with Ryan Hohman of Friends of Cancer Research last week to discuss hot topics in FDA drug policy. Hamburg affirmed the FDA’s commitment to expediting research and development of new treatments, stating that in this “critical time for biomedical research and innovation” the FDA has a role to play in “translating all of the exciting new discoveries and opportunities and science into real world products that matter for people.”