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In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. GHTC’s Senior Policy and Advocacy Associate Jenny Howell assesses how tomorrow’s congressional election results could impact global health research and development (R&D). With Republicans expected to gain seats in the House and take control of the Senate, shifts in the makeup and leadership of key committees with oversight over global health R&D are expected. Senators Tom Harkin (D-IA) and Lamar Alexander (R-TN) announced their intention to introduce a new bill to accelerate the development of treatments and vaccines for Ebola. The bill would add Ebola to the list of qualifying tropical diseases for the Food and Drug Administration’s priority review voucher program—which is designed to incentivize the development of drugs, vaccines, and other health tools for neglected tropical diseases. Emily Donaldson, program coordinator at AVAC, and Tom Harmon, senior policy analyst at the International AIDS Vaccine Initiative (IAVI), discussed the state of HIV prevention research funding while the first-ever conference devoted solely to HIV prevention R&D took place last week in Cape Town, South Africa. During his speech at the annual meeting of the American Society of Tropical Medicine and Hygiene, Bill Gates said he believes it is possible to eradicate malaria within a generation. To reach that goal, Gates pledged that the Bill & Melinda Gates Foundation would increase its malaria program budget by 30 percent—to more than $200 million per year. A group of European universities and medical groups plan to give experimental drugs to Ebola patients in West Africa without assigning any trial participants to a placebo group. These groups say it would be unethical to withhold potentially lifesaving treatment, but US officials argue that without a control group, it is impossible to assess whether the drugs are effective. The Wall Street Journal takes a deeper look at this debate.

As candidates make their final pitches, volunteers canvas like crazy, and pollsters make their predictions, GHTC is taking a look at what the outcomes of next week’s election could mean for global health research and development (R&D). With every member of the House of Representatives and a third of the Senate up for re-election, there will undoubtedly be some big changes ahead. Here are the potential changes we’re tracking: The House will remain red, but changes expected in key committee membership While Republicans are expected to retain their House leadership, there will still be changes in membership on key committees. Photo: Slack12 There’s no question that Republicans will retain their leadership in the House. While the House will likely see less drastic changes than the Senate, there will be changes to membership and leadership of a number of the Committees that have jurisdiction over both policy and funding for global health R&D. Foreign Affairs Committee: Although the House Foreign Affairs Committee (HFAC) won’t see major changes in leadership, we already know that Representatives Tom Cotton (R-AR)—currently in a tight run with incumbent Senator Mark Pryor for a seat in the Senate—and Steve Stockman (R-TX)—who lost his primary in a bid to replace Senator Cornyn (R-TX)—won’t be returning. HFAC members facing tough races include Representatives Brad Schneider (D-IL) and Ami Bera (D-CA). Bera—who sits on the Subcommittee on Africa, Global Health, and Human Rights and is a trained physician—has been an outspoken advocate for global health. Appropriations Committee: Similar to the HFAC, the Appropriations Committee isn’t likely to see significant changes in leadership, although there will be some notable faces missing from the 2015 roster. Representative Jack Kingston (R-GA)—current chairman of the Subcommittee on Labor, Health and Human Services, and Education, which appropriates funds for the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA)—gave up his seat in a failed bid for the Senate and will not be returning to the 115th Congress. Representatives Tom Womack (R-AZ)—current committee vice chair—or Tom Cole (R-OK) are rumored to be the top candidates to take over the chairmanship. Also missing due to retirement will be Representatives Frank Wolf (R-VA), Tom Latham (R-IA), Jim Moran (D-VA), Ed Pastor (D-AZ), and Bill Owens (D-NY). Energy and Commerce Committee: With jurisdiction over the NIH, CDC, and FDA, the Energy and Commerce Committee (E&C) plays an important role in issues relating to global health R&D, particularly as the Ebola crisis has thrust the CDC into the global spotlight. After twenty terms in Congress, E&C Ranking Member Henry Waxman (D-CA) will be retiring. Representatives Frank Pallone (D-NJ) and Anna Eshoo (D-CA) are both vying for the role, with the loser likely taking the role of ranking member on the Health Subcommittee—a position currently held by Rep. Pallone. Of course there’s no knowing until Election Day how things will actually shake-up in the House. After that, it’s up to members to make the case to House leadership for their desired and priority committee assignments. With a possibility for run-off races continuing after November 4, it’s likely that committee rosters won’t be finalized until February 2015. The Senate is leaning red; could mean major shift in key committee leadership Recent polls indicate the odds are in favor of a Republic-controlled Senate. Photo: Joe Shlabotnik The Senate is where things get interesting and where we’ll likely see the greatest change. Recent polls are consistent in their predictions that the odds are in favor of a Republican-controlled Senate; currently Democrats have 55 seats and Republicans have 45. If Republicans do take the majority, we will see a huge shift in committee leadership as Republicans take hold of coveted chairmanship positions. Senate Foreign Relations Committee: With six committee members up for reelection—one Republican and five Democrats—five are expected to hold on to their seats with the only toss-up race being Senator Jeanne Shaheen’s (D-NH) seat. If Republicans take the Senate, current Ranking Member Bob Corker (R-TN) will likely become the chairman. Otherwise, the chairmanship will likely be kept by Senator Bob Menendez (D-NJ). Senate Appropriations Committee: Of the 14 members of this committee that are up for re-election, 5 of them are currently toss-up races. An additional three—Senators Mike Johanns (R-NE), Tim Johnson (D-SD), and Tom Harkin (D-IA)—previously announced their retirement and won’t be returning for the new session of Congress. As the chairman of the Labor, Health, and Human Services Subcommittee, Senator Harkin’s departure is notable. His role will likely be filled by current Ranking Member Jerry Moran (R-KS), or if Democrats hold their seats, by Senator Patty Murray (D-WA)—a huge champion for global health R&D and the lead Senate sponsor of the 21st Century Global Health Technology Act. If Republicans win, other notable changes in leadership would likely include Senators Lindsay Graham (R-SC) chairing the Foreign Operations and Related Programs Subcommittee, Thad Cochran (R-MS) chairing the Defense Subcommittee, and Richard Shelby (R-AL) chairing the full committee. If there is a change in Senate leadership as expected, committee breakdowns will change to reflect the balance between Republicans and Democrats. For the Appropriations Committee, this could result in junior members—like staunch global health advocate Senator Chris Coons (D-DE)—losing their seats on the committee. Senate Health, Education, Labor, and Pensions Committee: With current committee Chairman Tom Harkin retiring, the Health, Education, Labor, and Pensions Committee will see new leadership regardless of the election outcome. Current Ranking Member Lamar Alexander (R-TN) is likely to take the role if Republicans gain critical mass. If not, Senator Murray is rumored to be the top choice for chairman—otherwise she will likely become ranking member. What’s next? What does all this mean for the future of global health R&D? While it’s impossible to fully predict election outcomes, the future will become much clearer in the coming days (unless of course run-offs or recounts keep us waiting). As the new Congress convenes in January, it will be critical for global health R&D advocates to educate new members and their staff on the importance of continued funding and strong polices to support the development of new health tools to meet the needs of the developing world. For real-time election analysis, check out Nate Silver’s FiveThirtyEightPolitics, Politico’s Election Central, or The Washington Post’s Election Lab.

In this guest post, Emily Donaldson—program coordinator at AVAC—and Tom Harmon—senior policy analyst at the International AIDS Vaccine Initiative (IAVI)—write about the state of HIV prevention research funding as the first-ever conference devoted solely to HIV prevention research and development (R&D) takes place in Cape Town, South Africa, this week. Progress toward new tools to prevent HIV infection—including vaccines, microbicides, the use of antiretroviral treatment as HIV prevention, pre-exposure prophylaxis (PrEP), and a host of other options—is being presented and discussed at the inaugural HIV Research for Prevention Conference (HIVR4P) in Cape Town this week. While much progress has been made over the last few years, a four percent decline in funding between 2012 and 2013 speaks to the uncertain nature of the global environment in which that research is taking place. Such cuts hinder the ability of the researchers in Cape Town and across the globe to continue their work and could delay progress toward efficacy trials and eventual rollout of new prevention options. Investment data for almost every technology being discussed in Cape Town can be found in HIV Prevention Research & Development Investment in 2013: In a changing global development, economic, and human rights landscape—the most recent annual report by the HIV Vaccines and Microbicides Resource Tracking Working Group. The data show that the US government continued to fund more than 70 percent of HIV prevention R&D efforts in 2013. The combination of recent funding cuts across all US government budgets and declines in European investment in HIV prevention R&D led to the overall decline in funding from the previous year. Relying on such a small number of very committed donors is problematic when one or more of those donors is forced to reduce their support.The report also highlights funding declines in nearly every category of HIV prevention R&D, underscoring an urgent need to sustain and diversify funding sources through partnerships between governments, philanthropies, and the biopharmaceutical industry. The 2013 data provoke a concern that HIV prevention R&D is increasingly becoming a lower priority for public agencies funding international development, as portfolios and priorities within those agencies shift. Global health and development negotiations such as those around developing successors to the United Nations’ Millennium Development Goals take place far from the context of most HIV prevention clinical trials, but such international commitment at the highest levels can keep HIV and AIDS a priority for development agencies that can bolster support for science, technology, and innovation in endemic countries to end the epidemic. The report also compiles the number of volunteers taking part in HIV prevention R&D trials, which totaled almost 670,000 people in 2013. Most of these individuals are based in sub-Saharan Africa where the epidemic has its most profound impact and where several large-scale treatment-as-prevention and voluntary medical male circumcision trials and projects are underway. However, that balance doesn’t cut across all new prevention technologies—80 percent of volunteers in vaccine and PrEP trials reside in the United States and Europe. Ensuring that new HIV prevention options are appropriate and acceptable means testing them in partnership with those regions and those communities that need them most. Such communities are represented here at HIVR4P, and we’re excited by the opportunity to see them mingling with the experts working tirelessly to improve the state of HIV prevention R&D science and in turn hasten an end to the AIDS epidemic. However, they can’t do it without a diverse, committed investment base. Funding data show signals of vulnerability in support for HIV prevention R&D and support the need for policymakers and advocates to ensure that the state of the field remains a healthy one. The HIV Vaccines and Microbicides Resource Tracking Working Group consists of AVAC, IAVI, and the Joint United Nations Programme on HIV and AIDS. The report and summary materials are available at www.hivresourcetracking.org.

[Editor's note 4/1/16:The Global Health Regulatory Requirements Database is no longer part of GHTC. The global health regulatory team's member site is now hosted on the Gates Foundation PDP forum.] Photo: FDA/Michael J. Ermarth Navigating global regulatory processes is a critical component to the development and introduction of global health technologies. New drugs, vaccines, medical devices, and diagnostics must be evaluated and registered by national regulatory authorities before they can reach patients who need them. These technologies are typically intended for use in low- and middle-income countries (LMICs) which often have limited regulatory capacity and evolving regulatory requirements. As a result, securing clinical trial and product registration approval from national regulatory authorities can be a considerable hurdle for product developers. The GHTC’s Global Health Regulatory Requirements Database, developed with support from the Bill & Melinda Gates Foundation, is a tool that helps product developers and global health advocates better understand and navigate regulatory requirements of LMICs. The database serves as a critical information tool to help facilitate the testing and launch of new, lifesaving global health technologies. Here are four reasons why you should check it out: 1. It’s easy to use. Organized by country and technology type, the database features high-level summaries of regulatory requirements for 25 countries in Africa, Asia, Europe, and Latin America. The database conveniently consolidates regulatory requirements for these countries in one place, so users don't have to spend as much time tracking down regulatory information for different countries. Think of it as Cliff Notes for global health regulatory processes. 2. It’s comprehensive, but still comprehensible. Users can access top-line information on regulatory authority structure, relevant harmonization initiatives, ethics review processes, clinical trial and product registration application requirements, and pharmacovigilance requirements. You can also find links to key guidances and other relevant resources. All the information is presented in an easy-to-scan format so you can find what you seek. 3. It’s regularly updated. In August 2014, the Global Health Technologies Coalition (GHTC) completed its annual verification of the database. All information in the database is systematically reviewed on an annual basis, and significant changes to country regulatory requirements also are added on an ad-hoc basis. 4. It’s constantly expanding. During the last year, the GHTC introduced eight new countries to the database—Bangladesh, Ghana, Malawi, Malaysia, Nepal, Peru, Russia, and Ukraine! The GHTC also recently added country-specific labeling requirements and expanded information on regulatory authority collaborations with the World Health Organization and stringent regulatory authorities like the US Food and Drug Administration and European Medicines Agency. Whether you are a global health product developer or an advocate, you’ll find the database to be a useful tool. It can help product developers access necessary information to formulate a regulatory strategy, and can help advocates identify areas to provide and champion technical assistance for capacity development, harmonization, and other ways to advance global regulatory processes.