Research Roundup: What we’re reading this week

“I deeply believe in the importance, power, and influence of research,” said Senator Chris Coons (D-DE) at GHTC’s congressional briefing. He added, “We all need to ensure that basic science eventually translates into saving lives.” The briefing—GHTC’s fifth annual where we launched our 2014 policy report—brought together leading voices from the nonprofit, philanthropic, public, and private sectors to reinforce the importance of robust support for global health research and development (R&D). For generations, the US government has invested in the lifesaving potential of research and innovation, supporting discoveries that have improved public health around the world. These investments have led to breakthroughs in global health and contributed to the development of remarkable vaccines, drugs, diagnostics, devices, insecticides, and other health technologies. Sen. Chris Coons (D-DE) giving remarks at GHTC's annual briefing Moderator Steve Davis, president and CEO of PATH, opened the briefing by reminding attendees what’s really at stake if the US government does not continue to be a leader in global health R&D: “The United States now stands at a critical juncture. Although the recent budget agreement prevents a second round of sequestration cuts, stabilizing global health R&D will require Congress to preserve funding for global health R&D, and US agencies must protect global health research and programming within their own budgets.” He added, “Halting funding would mean that the world may never benefit from the tools that are so close to development and delivery.” Many US government agencies play a vital role in global health research and product development, including the Centers for Disease Control and Prevention, the Department of Defense, the Food and Drug Administration, the National Institutes of Health, and the US Agency for International Development (USAID). Specifically, USAID has announced several promising developments in global health innovation over the past year. In addition to releasing a report to Congress on its activities in global health R&D, the agency continues to support the critical work of the Center for Accelerating Innovation and Impact at USAID. Panelist Wendy Taylor, director of the Center for Accelerating Innovation and Impact, mentioned at the briefing that USAID is currently involved in about 100 of the technologies currently in the global health pipeline. “Science, technology, and innovation are driving progress in global health,” said Taylor. She added, “Innovation bends the curve of history and makes the impossible, possible.” Critical to the work of the Center for Accelerating Innovation and Impact, as well as global health R&D broadly, are public-private partnerships. The private sector plays an important role in providing expertise and know-how to develop new technologies. Adrian Thomas—vice president of Global Market Access, Commercial Strategy, and Global Public Health at Janssen Pharmaceuticals, Inc.—reinforced the importance of multi-sector engagement: “We have to have the right partnerships and programs…the right incentives in play” to develop tools for low-resource settings. Thomas explained to the audience that incentives are key to getting private-sector engagement. “Without co-financing from donors like the US government, the risk to develop some products would be too high,” Thomas explained at the briefing. Many of the public-private partnerships involved in global health product development are also funded in part by the Bill & Melinda Gates Foundation. While the importance of the Gates Foundation is unquestionable, they fully admit that they cannot be the only funder involved in the development of new technologies for low- and middle-income countries. “The US government is the world’s largest and most important funder in global health R&D,” said Dan Hartman, director of Integrated Development at the Gates Foundation. Hartman continued to explain that without steady funding from the US government, we risk losing the progress we’ve made in research over the last decade. Each of the panelists during this year’s briefing gave very compelling arguments to Congress and the Administration why we need continued and increased support for global health R&D. Yet none were more compelling than Winfred Amoako, a tuberculosis (TB) survivor originally from Ghana. Shortly after moving to the United States in 2010, Amoako was diagnosed with TB. When asked what he would say to US policymakers if given the chance, he said: “I would say…please continue the fight. Continue to be the leader in research so that someday we can eliminate TB and these diseases.” That important message reminds us about the lives that are affected by neglected diseases and global health challenges. As Steve Davis said in his concluding remarks, “We are at the brink of a remarkable time in global health…we can and we must do more.” The stakes have never been higher, which is why the US government must continue its leadership role in supporting global health research and innovation so that essential technologies reach all of the patients who need them.

As more detailed information about the President’s fiscal year (FY) 2015 budget requests to Congress is released, the results continue to be a mixed bag for global health research and development (R&D). The Congressional Budget Justifications—annual presentations to Congress to justify requests for funding—help shed a light into the administration’s priorities for FY 2015. National Institutes of Health (NIH) While the President made a modest request for overall NIH funding, the release of the NIH congressional budget justifications gives us a better sense of how the President hopes to fund specific institutes and programs at the agency. The National Institute of Infectious Diseases (NIAID) did include increases of $5.76 million for Biodefense and Emerging Infectious Diseases, $6.95 million for infectious and immunologic diseases, and $23.4 million for HIV and AIDS research compared with funding for FY 2014. The President’s request for the Office of AIDS Research—which covers all HIV and AIDS activities within all of the centers at NIH—was $3.004 billion. While this is nearly a $20 million increase from 2014 enacted levels, this number is still below enacted numbers for 2011 and 2012. Within this request was a decrease of 0.4 percent from 2014 funding for microbicides, an increase of 0.8 percent for vaccine research and a decrease of 1.4 percent for therapeutics research. Centers for Disease Control and Prevention (CDC) Historically, research at the CDC has led to major advances against devastating diseases, including the eradication of smallpox and advances in AIDS research. With a disappointing funding request for NIH, we were glad to see a much stronger request for the global health budget within the CDC. The President’s request included $445.29 million for Emerging and Zoonotic Infectious diseases, a $54.85 million increase from FY 2014 levels. Included in this was the $30 million requested for the Advanced Molecular Detection Initiative. The $30 million will go towards investments in advanced molecular detection technologies to help speed up outbreak detection and increase response efficacy. We’re glad to see the Administration acknowledging the need for the CDC to be cutting-edge in an increasingly global arena. US Food and Drug Administration (FDA) Amongst the government agencies involved in various stages of the development pipeline, the FDA has a vital role to play in accelerating the review of new global health products and strengthening the global regulatory system. Despite the tough budgetary times we currently face, Congress has been asking the FDA to do more with less. That said, we were pleased to see the President acknowledge that increased authority should also mean increased funding, with a robust request of $4.7 billion for the FDA, an 8.1 percent increase from Congress’ appropriation for 2014. The FDA’s Congressional Budget Justification acknowledged the unique role of the agency as an important international collaborator for global health through research and information sharing. The language specifically highlights the Biologics Program and its work to promote research and information sharing to facilitate access to vaccines and other products, harmonize regulatory standards, and establish and maintain standards for biologics. Another highlight is the news that FDA is in the process of drafting a proposed rule to add to their current list of neglected diseases for which they can allow accelerated reviews, and is specifically considering adding Chagas disease. US Agency for International Development (USAID) As we reported in our first blog post, while funding for global health at USAID and the Department of State was fairly disappointing, we were pleased to see an increase in the President’s request for malaria. Notable in this request was acknowledgement of the need for continued funding for R&D to support “the development of new malaria vaccine candidates, antimalarial drugs, new insecticides, and other malaria related research with multilateral donors.” Also in the USAID request was $153 million in central funding to accelerate science, technology innovation, and partnership. USAID describes this aim to “develop and scale breakthrough solutions and accelerate the transformation of the United States’ development enterprise by leveraging outside resources and improving the sustainability of development programs by attracting private-sector, market driven resources.” Department of Defense (DoD) DoD is the only US agency that funds global health research and product development from discovery to introduction. While we’re still sifting through all of the details in the Defense budget justifications, R&D at the agency—including health R&D—increased overall by 1.7 percent over FY 2014 enacted levels. Much of the global health research at DoD is funded through the Army’s Research, Development Testing and Evaluation (RDT&E) division as well as the Defense Health Program—including research on HIV and AIDS, malaria, and leishmaniasis. While we’re grateful the administration is continuing to recognize the need for sustained, robust support for global health R&D across several agencies, the decline of global health research funding in some key accounts remains concerning. We’ll look to Congress to equip these agencies with the necessary resources to carry out their essential role in developing new global health tools.