Breakthroughs Blog: NIH

As people across the globe celebrate World TB Day this week, several groups are highlighting the fact that the current tools to prevent, test, and treat tuberculosis (TB) are greatly outdated. The world has been “beyond antiquated in our approach” to developing new TB tools. That is how Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health, described a not-so-bygone era in the history of TB research and development (R&D). Fauci was speaking at a briefing organized by the Critical Path to TB Drug Regimensin partnership with the Global Alliance for TB Drug Development (TB Alliance), US Agency for International Development (USAID), NIAID, and the US Food and Drug Administration (FDA). During the event, representatives from key US government agencies made the case for the urgent need for new technologies in the TB toolkit. “It can’t take 40 years for us to get our next TB drug,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research stated, highlighting one of the lesser known facts about TB—that the newest drug was approved over 40 years ago. “We need to capitalize on the momentum we have,” she added. Many current TB drugs are toxic and have serious interactions with other medicines, and most regimens take over six months to complete. The disease kills 1.4 million people and infects 8.8 million each year. As people across the globe celebrate World TB Day this week, several groups are highlighting the fact that the current tools to prevent, test, and treat TB are greatly outdated. Photo credit: PATH Joining Fauci and Woodcock were Robert Clay, deputy assistant administrator for Global Health at USAID; Mel Spigelman, CEO of the TB Alliance; and Christine Lubinski, vice-president for Global Health at the Infectious Diseases Society of America (IDSA). All speakers stressed the urgent need to conduct R&D for new and improved TB prevention and treatment options. They also lauded the use of partnerships between non-profit organizations, private pharmaceutical companies, and US Government agencies in the development of new drugs and other technologies. Fortunately, the TB Alliance, a GHTC member and product development partnership (PDP), announced the launch of a new combination drug trial that could pave the way for the next generation in TB treatment approaches. The group has launched stage II trials for NC-002—a novel drug regimen combining a well-known generic TB drug with two new drug candidates. The trials will take place in South Africa, Tanzania, and Brazil, and results will be known in roughly a year. This trial is also the very first of its kind. It will test both patients with ‘drug sensitive’ TB, who do respond to current treatments, along with patients with multi-drug resistant TB (MDR-TB), who do not respond well to currently available treatment, to determine differences in the groups’ response to the new drug regimen. As Spigelman outlined, the potential impact of this trial is immense—it could reduce the costs of treating MDR-TB by 90 percent, as well as decrease treatment time by over 80 percent. This exciting news in TB drug development follows closely on the heels of new funding for new prevention tools. Last week, GHTC member Aeras announced that it received a grantfrom the Bill & Melinda Gates Foundation of up to $220 million over five years to conduct R&D for new TB vaccines. Aeras stressed that it is developing new TB vaccines against the backdrop of a significant increase in drug-resistant strains of the disease worldwide. Additionally, today Aeras—along with the TuBerculosis Vaccine Initiative and the STOP TB Partnership—also announced a new blueprint for TB vaccine development. "To develop a new TB vaccine that will be fully effective, researchers, donors, and other partners will need to collaborate and coordinate their efforts as they address tough research questions," said Dr. Lucica Ditiu, executive secretary of the Stop TB Partnership. "We cannot allow ourselves to be overwhelmed by either the costs or the obstacles. It is time to be bold and dare to do more in TB, especially in supporting the development of a new vaccine." As we recognize World TB Day, the need for new and better prevention, diagnostic, and treatment options for the disease is clearer than ever before. And it’s encouraging that GHTC members like Aeras and the TB Alliance—along with many other partners—are at the forefront of R&D efforts to create these desperately needed health tools.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. As the international community marks World TB Day, GHTC members Aeras and the Global Alliance for TB Drug Development announced research projects for new tuberculosis (TB) prevention and treatment tools. National Institutes of Health (NIH) Director Francis Collins testified at a Congressional hearing on the agency’s budget. Collins emphasized NIH’s commitment to fund basic biomedical research as the agency’s highest priority. Rajiv Shah, head of the US Agency for International Development, was also on Capitol Hill this week to discuss the agency’s budget with members of Congress. "While foreign assistance represents less than one percent of our budget, we are committed to improving our efficiency and maximizing the value of every dollar," Shah said at the hearing. Alberto Gutierrez—director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health—writes about how the FDA is helping to improve access to TB diagnostic tools.

Phil Carroll, senior policy communications associate at PATH, writes about Marc LaForce, recently retired director of the Meningitis Vaccine Project. This post is part of an ongoing effort on Breakthroughs to highlight leaders and heroes in global health research and development (R&D). Marc LaForce’s career at PATH has been nothing but illustrious. He came to our organization in 2001 to lead a project that had more than a few skeptics. Funded by the Bill & Melinda Gates Foundation, the Meningitis Vaccine Project , a partnership between PATH and the World Health Organization (WHO), was tasked with leading R&D for a new vaccine against group A meningococcal meningitis—a particularly deadly strain of meningitis that forms a belt across sub-Saharan Africa. The most significant ask was to deliver the vaccine at a price the countries could afford: less than 50 cents a dose. It was a daunting challenge, but one that Marc and his team did not shy away from. By working with a host of multi-sector partners, including multilateral institutions like the WHO and a well-established manufacturer in India, the Meningitis Vaccine Project succeeded in creating MenAfriVac™, the first vaccine designed specifically for Africa. In addition, the US Government played a critical role in the creation of this new vaccine. The Centers for Disease Control and Prevention, US Food and Drug Administration, National Institutes of Health, and US Agency for International Development all made scientific and research contributions to the development and delivery of MenAfriVac™. It should also be noted that the success of this project would not have happened without the cooperation and involvement of African governments, which identified the need for a vaccine, stressed the importance of a low price per dose, and finally helped orchestrate the immunization campaigns in country. Marc LaForce, retired director of the Meningitis Vaccine Project. Photo credit: PATH To date, MenAfriVac™ has reached almost 55 million people since its launch in Burkina Faso at the end of 2010. Even more impressive is that in all of those vaccinees, not a single case of meningitis A has been reported. The creation and roll-out of MenAfriVac™ represents one of the most exciting success stories in global health R&D, and demonstrates how a strong commitment to R&D from a range of partners can result in an amazing new tool that can make an impact of millions of lives. However, as Marc pointed out at the Global Health Technologies Coalition’s annual briefing on Capitol Hill last week, the battle against this disease is far from over. We need greater investment in R&D for an additional vaccine that would protect against other types of meningitis. Through Marc’s leadership and vision, we know that an effective, affordable, and accessible vaccine is not just possible, but achievable. February 28 was Marc’s last day at PATH before his official retirement, and he left us with quite the legacy. Leaders at PATH are fond of referring to the success of Meningitis Vaccine Project as the “beginning of the end” of meningitis A in Africa. In many ways, this phrase can be applied to Marc’s new chapter in life. Instead of hitting the links or working on his tan in Florida as other retirees might, Marc will return to his former life in academia, molding the minds of the next generation of public health professionals and scientific leaders. Who knows, there might just be a future Marc LaForce among them.

Research!America, a member of the GHTC, recently conducted analyses in target states to measure the health and economic impact of global health research and development (R&D), highlighting its benefits for states across the nation and strengthening the evidence base for Congress’ support of federal investments in global health R&D. Danielle Doughman, program manager for global health R&D advocacy, shares the organization’s findings in Maryland. This is the third post in a series. If it’s true that health is wealth, Maryland has both in abundance. Maryland is home to two federal health powerhouses, the Food and Drug Administration and the National Institutes of Health (NIH), the world’s largest medical research institute. Together, they employ 25,000 people. Silver Spring’s Walter Reed Army Institute of Research is engaged in global health research to protect our military personnel from infectious threats they may encounter in the field. And Marylanders see the direct benefits of that research: 82 percent recognize that American civilians benefit from the health research conducted by the military, according to a poll commissioned by Research!America. Maryland is home to two federal health powerhouses, the Food and Drug Administration and the National Institutes of Health (NIH), the world’s largest medical research institute. Photo credit:PATH What’s more, Maryland’s life sciences sector supported 71,600 jobs in 2010. Workers in the life sciences industry earned, on average, more than $91,000 annually—76 percent more than the state average. Of the nearly $52.7 million in extramural funding that flowed to Maryland from NIH in fiscal year 2012, over 70 percent, or $37.8 million, was awarded through contracts and grants to Johns Hopkins University. Hopkins is among Maryland’s largest employers, with 47,000 employees across the university and affiliated health system, and it contributes more than $10 billion per year to the state’s economy. Nonprofit global health “product development partnerships” use a unique business model to work across sectors to accelerate the creation of low-cost drugs, vaccines, and diagnostics to advance health for the most vulnerable populations. Two such nonprofits are headquartered in Maryland. Rockville’s Aeras, another GHTC member, engages in the development of new tuberculosis (TB) vaccines and other prevention technologies, capitalizing on the expertise of its partners to accelerate the development of the six vaccines in its R&D pipeline. Aeras’ 135 Maryland-based employees understand that the sooner effective products are available, the closer we are to dramatically reducing the 1.4 million lives lost to TB every year. Just last week, Aeras announced its partnership with NIH’s National Institute of Allergy and Infectious Diseases for a Phase II clinical trial of a TB vaccine. With the first cases of totally drug-resistant TB coming to international attention earlier this year, aggressive pursuit of vastly improved TB drugs, vaccines, and diagnostics has never been more crucial than it is now. With support from the US Agency for International Development and NIH, Maryland’s International Partnership for Microbicides (IPM) is helping to lead the charge to design products to protect women from HIV and AIDS, the leading cause of death for women ages 15-44 worldwide. In addition to the support of the US government, IPM works with partners around the world to develop antiretroviral-based microbicides to safely and effectively protect women against HIV. Later this year, IPM and the NIH-funded Microbicide Trials Network will move a promising product into late-stage clinical trials. The robust federal investment and presence in Maryland reflects the fact that more than three-quarters of Marylanders say Americans should be concerned about global diseases like malaria, cholera, and other infectious diseases that mostly affect poorer countries. More than ever before, America’s health—in both economic and medical terms—is global health.