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In this guest post, Jenny Howell—senior policy & advocacy associate at PATH working with the GHTC—writes about the new budget compromise that re-opened the federal government, as well as the effect of the government shutdown on health research programs. After more than two weeks of a federal government shutdown, with concurrent concerns about the threat of the debt ceiling being reached this week, policymakers finally reached a deal last night to re-open the government. Details of the budget compromise are finally starting to emerge, including the impact on global health research and development (R&D) programs. Things looked grim on Tuesday night after House Speaker, Rep. John Boehner (R-Ohio), was unable to get enough support from his own party for a House bill to reopen the government and raise the debt ceiling. Thankfully, Senate Leaders were quick to ease fears and announced they had come up with a bi-partisan deal early Wednesday morning. After more than two weeks of a federal government shutdown, with concurrent concerns about the threat of the debt ceiling being reached this week, policymakers finally reached a deal last night to re-open the government. Congress approves Senate plan The Senate’s proposal extends current government spending levels through January 15th, 2014, immediately re-opening the government and allowing federal employees to return to work this morning. The debt limit would be extended through February 7th, 2014, giving Congress more time to work out a permanent deal and avoid default on US debt obligations. After all the drama around delaying the Affordable Care Act (ACA), the Senate plan changes very little, only requiring stricter income verification requirements for determining who is eligible for federal subsidies through the ACA. The proposal also calls for a budget conference, made up of appointed members from both chambers of Congress who will be tasked with reconciling House and Senate budgets and agreeing to a long-term spending plan by December 13th, 2013. Unable to come up with their own plan to end the government shutdown and short on time, House Republicans voted to approve the Senate’s deal late last night, avoiding a default that would have put the nation’s credit rating at risk and potentially sent the economy into relapse. Impacts of the shutdown Despite the agreement, after 16 days of only a partially operating government, impacts were felt deeply across the nation. With the shutdown coming on the back of the budget sequester, research activities have been particularly hard hit, with four of the five Nobel-prize winners currently employed by the government furloughed. NIH Three-fourths of the staff at the National Institutes of Health (NIH) were furloughed. While the NIH has continued to provide care for patients in ongoing clinical trials, admitting new patients and beginning new trials has halted for all but the most critical life-threatening cases. In a typical week the NIH admits 200 new patients, in the wake of the shutdown, only 12 new patients have been admitted for trials. CDC Almost as hard hit as the NIH, the shutdown has meant that two-thirds of the staff at the Centers for Disease Control and Prevention (CDC) were furloughed. The timing of the shutdown comes just at the peak of flu season, significantly altering the CDC’s ability to monitor the spread of influenza and engage in vaccination outreach. NSF The National Science Foundation (NSF) furloughed 98 percent of its staff and has completely stopped issuing any new research grants. As federal employees come back to work and normal government functions resume, it will be hard to deny the long-term impact that the 16-day shutdown had across our nation. We may never know what discoveries have been delayed and whose health has been put at risk from the shutdown, but we’re hopeful lawmakers will stop playing games and will move forward with long-term solutions.

In this guest post, Elisabeth Wilhelm, senior media specialist at the International AIDS Vaccine Initiative (IAVI), writes about the need to invest in the next generation of researchers and scientists in sub-Saharan Africa. Young people in countries suffering most from the AIDS epidemic want to have their say in development decisions to fight the disease. That’s what Sydney Hushie from the Global Youth Coalition on HIV and AIDS and fellow youth panelists stressed repeatedly during a United Nations’ General Assembly side event at the end of September in New York. And discussions at this year’s AIDS Vaccine Conference in Barcelona reinforced the insight that it will be the young scientists of today who will drive the innovation toward vaccines—among other new prevention technologies—that will help get to zero new HIV infections tomorrow. Access to quality education not only can help prepare tomorrow’s HIV and AIDS scientists—it can also help them beat the odds of becoming tomorrow’s patients. Nearly half of all new HIV infections globally occur in young adults of 15 to 24. The more education, the lower is the risk that young people will contract HIV. They want to learn: In a study in Zimbabwe, home to the world’s seventh-highest HIV prevalence, boys and girls were very interested in health-related issues such as HIV and sex. It will be the young scientists of today who will drive the innovation toward vaccines—among other new prevention technologies—that will help get to zero new HIV infections tomorrow. Photo: IAVI/Sokomoto The opportunities for young people to take an active role in this global fight remain as limited as their access to health care and to secondary education—as well as their countries’ investments in science, technology, and math (STEM), especially in sub-Saharan Africa. Tanzania and Kenya have the lowest post-secondary education rankings among 61 countries. Ghanaian students’ performance in the Trends International Mathematics and Science Study, for example, ranked second-to-last out of 45 countries surveyed in 2003. South Africa was ranked last by the World Economic Forum in quality of math and science education out of 62 countries. For those students in sub-Saharan Africa who beat the odds of completing a secondary education, many end up working or studying somewhere else—and the developing world can ill afford this “brain drain.” The World Economic Forum ranked 62 countries by their post-secondary graduation rates—Kenya came in 41st and Tanzania 50th. Their departures aren’t surprising. The World Bank estimated that skilled workers account for only 4 percent of the total workforce in sub-Saharan Africa, but 40 percent of those who leave their home countries. Scientists pick up and leave, too; indexes of published peer-reviewed articles show sub-Saharan Africa’s contribution to world science production hovers below 1 percent of total global output. IAVI and partners, such as the Kenya Vaccine Initiative and the Uganda Virus Research Institute, collaborate to help establish research centers and implement training programs and encourage the adoption of Good Clinical Practice. In Rwanda, the First Lady partnered with us to train young scientists in vaccine research, and across sub-Saharan Africa, we support fellowships that help local labs, local clinicians, and scientists become experts in their fields. Their vital research propels us closer to finding an AIDS vaccine. These scientists, together with the members of communities, offer guidance on designing clinical studies and developing vaccines that meet local needs. They also help ensure supportive local policies and sustained local funding—because we’re in it for the long haul, too. IAVI and partners, such as the Kenya Vaccine Initiative and the Uganda Virus Research Institute, collaborate to help establish research centers and implement training programs and encourage the adoption of Good Clinical Practice. Photo: IAVI/Courbet Other organizations are also paying attention to young scientists and advocates, whom they see as an investment in the future. The Global HIV Vaccine Enterprise has taken the lead in engaging and connecting Young and Early Career Investigators at scientific conferences, and other product development partnerships and research organizations, such as the European & Developing Countries Clinical Trials Partnership have made expanding young scientists’ research opportunities a priority. AVAC, a global advocacy prevention group, also builds an advocacy network to build in-country support for youth AIDS advocates. We cannot succeed in overcoming the challenges to developing a vaccine without our many partners, representing the best homegrown talent in sub-Saharan Africa and India. But we look to the next generation to help finish the job. Local perspectives will spur local innovations and foster new approaches to work in the lab and in the field. We can help by promoting more in-country innovation, supporting robust STEM education, and engaging young people earlier in academic settings throughout the Global South. The next generation of AIDS researchers could successfully bring one of human history’s most devastating and long-lasting pandemics to a close. Let’s give them a boost.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Results of a large-scale Phase III clinical trial of the most clinically advanced malaria vaccine candidate—R TS,S—showed that the vaccine candidate continues to protect young children and infants from clinical malaria up to 18 months after vaccination. A new analysis of two HIV vaccine trials shows that the investigational vaccines stimulated a critical immune response in infants born to HIV-positive mothers, researchers reported at the AIDS Vaccine 2013 conference in Spain. Janet Woodcock—head of the US Food and Drug Administration's Center for Drug Evaluation and Research—is retiring in more than a year, but the drug industry is already worrying about who will replace her. The New York Times reports that the federal government has continued to enroll ill people in clinical trials at the National Institutes of Health since the government shutdown began, but the pace has slowed dramatically. PATH and China National Biotec Group Co., Ltd., recently announced that a new Japanese encephalitis vaccine has been prequalified by the World Health Organization, paving the way for expanded access to millions of children in Asia at risk of this disease.

In this guest post, Tricia Aung—the GHTC’s regulatory associate—writes about a new database that provides easy access to information on global health regulatory information. Before they can improve the lives of patients and communities, new global health technologies must undergo rigorous testing and evaluation to ensure that they are safe and effective. National regulatory authorities—like the US Food and Drug Administration (FDA) in the United States—are responsible for protecting the public health throughout this process, making sure that clinical trials are conducted safely, and reviewing trial results to determine whether the benefits of potential products for the population outweigh the risks. Since many global diseases are endemic in countries with limited regulatory capacity, getting regulatory approval can be a huge roadblock to getting products clinically tested, manufactured, and delivered. Regulations vary by country, so developers of new vaccines, drugs, and other health products often face the challenge of understanding and juggling numerous sets of regulatory requirements. This is further complicated by the fact that in many developing countries, it can be difficult to find information on regulatory requirements. The Global Health Regulatory Requirements Database provides consolidated access to country-level regulatory requirements, thereby aiding product developers, multilateral organizations, and advocates with getting products through clinical trial approval and designing programs to strengthen regulatory capacity. Photo: Richard Franco. The Global Health Regulatory Requirements Database, a new tool developed by the GHTC and supported by the Bill & Melinda Gates Foundation, is designed to help address this regulatory information gap. The database provides consolidated access to country-level regulatory requirements, thereby aiding product developers, multilateral organizations, and advocates with getting products through clinical trial approval and designing programs to strengthen regulatory capacity. Currently featuring 17 countries in Africa, Asia, and Latin America, the database is a central repository of high-level regulatory information and links to key guidance documents and regulatory resources. The database also offers users easy navigation from country to country and separates technology-specific information into three categories: drugs, vaccines, and diagnostics. Key data points include: Contact information for national regulatory authority representatives. Overview of clinical trial and product registration requirements, including data requirements, costs, estimated timelines, and pharmacovigilance requirements. Description of ethics review processes. Background on collaborations with other regulatory agencies, multilateral organizations, and capacity-building and harmonization initiatives. For example, the FDA offers trainings to enhance regulatory capacity building in developing countries. The agency also contributes to global efforts to improve regulatory harmonization in conjunction with partners like the World Health Organization. The database was designed to include a broad base of information, making it useful to many audiences. For example, researchers and regulatory affairs professionals can find the information they need to formulate effective regulatory strategies to gain approval to conduct clinical trials and market products. Creating a more informed, strategic regulatory plan that satisfies country requirements can help reduce regulatory delays that inhibit products from reaching people. The database also promotes systemic change by capturing the current state of national regulatory authorities in developing countries. It can help guide advocates in efforts to develop advocacy strategies to improve and streamline global regulatory processes. Further, stringent regulatory authorities, such as the FDA, and public health organizations can use the database to identify opportunities to provide technical assistance at the country level to strengthen the capacity of regulatory authorities, and encourage harmonization and policy reform. To deliver new health technologies to people as quickly and safely as possible, there needs to be a strong plan for regulatory approval and an enabling environment that supports regulatory review. The database can help address these needs and inspire lasting changes in the global health regulatory space.