Marissa Chmiola

  The development of new diagnostic, treatment, and prevention products is fundamental to accelerating the decline of the global tuberculosis (TB) burden, panelists from the World Health Organization (WHO), the National Institutes of Health (NIH), and the Bill & Melinda Gates Foundation agreed on during a panel discussion hosted by the Center for Strategic and International Studies (CSIS) on Monday. CSIS panelists say R&D is fundamental to meeting new global TB targets. Photo: PATH/Satvir Malhotra CSIS hosted the panel on the occasion of the release of its summary report Strategic US Leadership – Essential to Address the Global Tuberculosis Pandemic—which examines US approaches to tackling TB both in the United States and abroad. The report concludes that the United States needs to better lead, coordinate, and prioritize its TB efforts, as well as increase fiscal and other resources devoted to the issue. Among its recommendations, the report encourages the United States to create robust, long-term research partnerships with key institutions in select emerging economies to promote the discovery and development of new TB tools. During the panel discussion, Dr. Mario Raviglione—director of the global TB program at WHO—discussed the ambitious TB targets put forward in a World Health Assembly resolution including the goal of achieving 95 percent reduction in TB deaths by 2035. He noted that the model for achieving this target assumes the introduction of new TB diagnostics, medicines, or vaccines and said achieving this target will not be possible without investments in research and development (R&D) that result in the introduction of new interventions. The panelists agreed that while the United States will continue to drive efforts toward the development of new TB tools, middle-income countries and rising economies also have an important role to play as well. Dr. Peter Small—deputy director of the TB program at the Gates Foundation—noted that many of these emerging economies also have high TB disease burdens so they are uniquely positioned to contribute. Dr. Small said he believes that it is important for these nations to increase their R&D capacity and investments in science and that US leadership in fostering R&D capacity within these nations will prove key to the long-term development of more frugal and locally-viable TB products. Dr. Tony Fauci—director of the National Institute of Allergy and Infectious Diseases at NIH—agreed with Dr. Small’s statements regarding the need to forge TB partnerships and collaborations with our emerging economy partners. As an example of successful collaborations, he mentioned the increased use of co-principal investigator projects, where a researcher form the United States and a researcher from a different country collaborate on a research project with each of their home countries providing part of the funding. The panelists discussed not only the need for improved collaboration and coordination with other nations, but also the need for enhanced coordination within the United States. Dr. Fauci said while he believes there should be a concerted, coordinated R&D effort by the US government, it needs to be approached carefully. He said he believes fundamental research at the early stages needs to remain somewhat spontaneous, but that he sees a need for greater coordination downstream. A common theme throughout the discussion was the lack of adequate financial resources to meet the demands of a growing and complicated pandemic. Dr. Fauci mentioned the decreasing purchasing power NIH now as a result of stagnated federal funding over the last few years. He noted that as a result, NIH has less flexibility to jump on promising TB research. Dr. Fauci said he believes our country needs to reevaluate how we think about biomedical innovation and research funding—arguing that the US research budget should not be thought of as discretionary funding, but rather an item that needs to be automatically increased each year like cost of living increases. Panelists were also asked to consider the best arguments to convince US policymakers to increase investment in R&D for TB. Dr. Fauci said advocates should talk about how we live in a global community in which we can’t think of it as “our disease versus their disease”—that the United States has an economic and security interest in tackling TB. He also said the TB community should not see HIV as a source of competition for funding, but rather hold it up as an example of the impact that can be realized as a result of robust investments throughout the development process. Dr. Raviglione agreed, noting that within just a few years of the emergence of the AIDS epidemic, the world had already developed diagnostic tests and a few years later developed antiretroviral treatments. Dr. Raviglione said this is a very visible example of the results that can be achieved for a disease through strong investment in R&D.  

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Sarah Alexander—director of external relations for the Global Alliance to Prevent Prematurity and Stillbirth—writes about the recent groundswell of momentum surrounding maternal and child health and the role research and development (R&D) can play in helping more babies have a healthy start to life. Researchers at the University of Tokyo are bioengineering rice to transform it into a low-cost storage and delivery mechanism for drugs to combat cholera, rotavirus, and other infectious diseases and contagious illnesses. The researchers say that bioengineering the vaccines or antibodies into rice would allow them to be stockpiled and stored at room temperature, avoiding cold chain issues that exist with existing vaccines. Geno de Hostos—director of research and preclinical development at PATH’s Drug Development Program—writes about how an integrated approach to tackling diarrheal disease can save thousands of children’s lives each year. He argues that R&D efforts focused on new drugs and vaccines hold tremendous potential, and there is a need to sustain appropriate funding to achieve more progress. The Bill & Melinda Gates Foundation announced funding for 55 projects through its Grand Challenges Explorations initiative program which funds innovative ideas to address global health and development problems. Grant recipients include several projects to improve condom design, “cologne” for cows that alters their smell to mimic humans in order to divert disease-carrying insects from people, and two projects to improve the vaccine cold chain, among others. Dr. Margaret Hamburg—commissioner of the US Food and Drug Administration (FDA)—writes on the FDA Voice blog about the World Health Organization’s passage of a resolution to strengthen regulatory systems. She notes the unique challenges and opportunities faced by regulators because of globalization and the extraordinary increase in the global supply of medical products, and she discusses the increasing efforts by nations to collaborate to share information and reduce system inefficiencies.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Kaitlin Christenson, director of the GHTC, summarizes news out of the World Health Assembly (WHA) impacting the global health research and development (R&D) community including debates on the post-Consultative Expert Working Group on Research and Development: Financing and Coordination and post-2015 development agenda, and themes related to regulatory system strengthening, access to essential medicines, and the value of R&D. Renate Baehr—executive director of Deutsche Stiftung Weltbevoelkerung—writes about the next rendition of the European & Developing Countries Clinical Trials Partnership and how its expansion will impact more lives in low- and middle-income countries. She discusses how the program has been broadened to include neglected tropical diseases and how African countries will now fully participate in the group’s governance and decision making. The Canadian government announced it would provide $12 million to Grand Challenges Canada to finance innovations to improve maternal and child health in the developing world. The funding will support 65 projects to be implemented across 25 low-and middle-income countries. The announcement came in advance of the Canadian Prime Minister’s global summit on maternal, newborn, and child health taking place in Toronto from May 28-30. Wired reports on the passage of a resolution at WHA to create a global action plan to tackle the emerging problem of antibiotic resistance that will include exploring technology innovations in diagnostic testing and new drug development. The article notes that some experts believe this will not do enough to stem the problem and are calling for the creation of an intergovernmental body on antibiotic resistance that would be similar to the Intergovernmental Panel on Climate Change.

The global health research community has a reason to celebrate this weekend. Yesterday, Senator Patty Murray (D-WA) introduced in the US Senate a significant piece of global health legislation that would strengthen global health research programming within the US Agency for International Development (USAID) and improve coordination of global health research and development (R&D) across the US government. The legislation—known as the 21st Century Global Health Technology Act—is companion legislation to the House version of the bill, HR 1515, which was introduced by Representatives Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL) in April 2013 and is now awaiting consideration in the House Foreign Affairs Committee. The House and now Senate introduction of the bill shows a growing recognition among US policymakers of the critical role investments in research and innovation play in improving public health worldwide.The 21st Century Global Health Technology Act would strengthen global health research programming within the USAID and improve coordination of global health R&D across the US government.Senator Murray and the House authors set out to create legislation that would (1) encourage the development of health products that are affordable, culturally appropriate, and easy to use in low-resource health systems, and (2) would—importantly in these fiscally-constrained times—cost taxpayers nothing. Thus, this legislation doesn’t mandate new funding. Instead it focuses on improving efficiency, coordination and cooperation across agencies and existing programs.The bill focuses on three main areas. The legislation: Establishes USAID’s mandate to conduct global health R&D and calls on the agency to create an overarching strategy which would help fill current gaps. Asks USAID to coordinate and collaborate with other agencies to create a cross-government strategy for global health research. Codifies into law USAID’s Health Tech program—which focuses on developing medicines and health products for use in low-resource settings. Let’s break down the significance of each of the bill’s three main impact areas:Strengthening USAID global health R&D mandate While recognizing the historic work of USAID in developing new products for use in the developing world, the bill gives an official mandate for USAID to conduct R&D across its portfolio by telling the agency that it should include research as part of each type of global health work it undertakes. This ensures health R&D remains a central focus of USAID’s work and makes sure current gaps across the agency’s portfolio are filled.Coordinating/collaborating with other agencies The US government is currently involved in 200 of the 365 global health products in the R&D pipeline, with work spread across many agencies including USAID, the National Institutes of Health, the Centers for Disease Control and Prevention, the Department of Defense and the Food and Drug Administration. That means there are a lot of cooks in the global health R&D kitchen. This bill calls on USAID to coordinate and collaborate with the other US agencies involved in global health to develop a “whole-of-government” approach to global health research and improve outcomes, leveraging US funding and ensuring US tax dollars are well spent. While the bill doesn’t mandate how that coordination should occur, it does require USAID to report to Congress progress made on this objective.Codifying US Health Tech program The Health Tech program has existed at USAID for over 25 years. It forges collaborations between the public and private sector—known as public-private partnerships—to develop health technology solutions for people in the developing world. It has produced many innovative products, such as the vaccine vial monitor—which changes color to indicate whether a vaccine has been stored at a proper temperature and remains effective. So if the program already exists and works, than why does “codifying” it matter? This legislation would make the Health Tech program an official part of US law. That’s important because in a difficult fiscal climate in which cuts are occurring, the program’s inclusion in US law helps protect it from elimination and assure it can continue to carry out its work.So what’s next for the bill? As we all know from the singing Bill on Capitol Hill, Senator Murray’s introduction of this legislation in the Senate represents one of the first steps in the long process it must go through to become US law. The bill will now be referred to the Senate Committee on Foreign Relations for further consideration.While the path ahead for the legislation is still uncertain, it’s worth pausing to celebrate this initial victory. The fact that this legislation has been championed by Senator Murray and such significant advocates in the House indicates recognition by US policymakers that global health R&D is both critical to US health and foreign policy goals and a smart economic investment. After all, sixty-four cents of every US dollar invested in global health research goes directly to US-based researchers.So this weekend when you are out with friends and family, raise a glass to Senator Murray for being a steadfast advocate and tirelessly working to advance US leadership in global health R&D.

Photo: AVACYesterday, May 18, marked the observance of World AIDS Vaccine Day­­–an annual event to focus attention on the need for a vaccine to prevent HIV infection and AIDS. Although three decades have passed since HIV and AIDS were first identified, more than 1.5 million people still die from AIDS and millions of others contract HIV each year. Despite advances in treatment and prevention, for every three people put on treatment, four others contract HIV. An AIDS vaccine is an important part of a long-term strategy to end the AIDS epidemic. Today, more government institutes, nonprofits, academic research labs, and pharmaceutical and biotechnology companies than ever before are engaged in the global effort to develop a vaccine. The road ahead may prove long and bumpy, but recent breakthroughs in science and technology have boosted confidence that an AIDS vaccine is achievable and on the horizon. Sustained political and financial support is critical to translating this promise into a product. See the infographic below from AVAC for key numbers that indicate the progress that has been made toward the development of an AIDS vaccine.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Two recent announcements occurred regarding US international collaboration on global health research and development (R&D). Earlier this week, the US National Institute of Allergy and Infectious Diseases and the Office of AIDS Research at the National Institutes of Health announced a collaborative project with the Indian Ministry of Science and Technology and Department of Biotechnology to fight tuberculosis in India as part of the Indo-US Vaccine Action Program. On Tuesday, the US Department of Health and Human Services and the European Commission released the first report of the Transatlantic Taskforce on Antimicrobial Resistance (TATFAR), which is a joint commitment by the US and EU to fight antimicrobial resistance. Dr. Lucas Otieno Tina—a physician and researcher at the Kenya Medical Research Institute/US Army Medical Research Unit-Kenya collaboration program—writes in AllAfrica.com about why he has spent his career working to develop a malaria vaccine. He also discusses the promise of the RTS,S malaria vaccine and his involvement in the clinical trials for the vaccine supported by PATH’s Malaria Vaccine Initiative. Last week, the NTD Roundtable—a group of global health partners committed to fighting neglected tropical diseases (NTDs) —hosted briefings in the US House of Representatives and Senate to discuss America’s leadership in the fight against NTDs and the need for greater NTD R&D. The briefings were attended by representatives from key House and Senate committees, the NGO community, and the African diplomatic corps. Among other topics, participants discussed the need for the development of new diagnostic tools and treatments for NTDs. TechCrunch reports about a grant from the Bill & Melinda Gates Foundation to Sure Chill Company in Wales, which has developed a way to store vaccines at a proper temperature without the need for an electrified or gas-powered refrigeration source. The technology reduces problems with vaccine distribution caused by vaccines that lose their efficacy without proper refrigeration.