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Center for Global Development (CGD), a Washington DC-based think-tank that works to reduce global poverty and inequality through research, officially released its newest report on global health earlier this week. The launch brought together donors, academics, public health officials, and representatives from the pharmaceutical industry to continue an important conversation about improving one of the biggest challenges in global health: bringing the best health tools that research has to offer to the people who need them most through improved regulatory pathways. The report, called Safer, Faster, Cheaper: Improving Clinical Trials and Regulatory Pathways to Fight Neglected Disease, outlines a two-pronged approach—establishing regional regulatory pathways for the oversight of clinical trials, and building quality and cost-efficiency into trial planning and design. The report was the product of a working group that included representatives from donor groups, philanthropy groups, product development partnerships (PDPs), consulting firms, the pharmaceutical industry, government, researchers, and developing and developed country regulators. New report from Center for Global Development highlights need to improve regulatory pathways to help deliver health tools to the people who need them the most. Photo Credit: Satvir Malhotra Working group chair Tom Bollyky from the Center on Foreign Relations noted that navigating through even a single regulatory pathway can often be the most challenging part of bringing new products to market. Yet, many global health product developers find themselves needing to navigate not one but several regulatory pathways, often overseen by authorities with severely limited capacity, making the process seem insurmountable. According to the working group, a unified approach to approving and overseeing clinical trials could dramatically speed up product development and delivery. CGD’s report proposes “a centralized procedure model in which participating regulatory bodies and ethics committees jointly approve and oversee clinical trials for neglected disease technologies.” Additionally, the working group proposed that changes be made with clinical trials themselves—specifically the way they are organized and financed. Clinical trials are often modeled off of previous, successful clinical trials, most of which occur in wealthy countries. As a result, trial protocols have become extremely complex and expensive to carry out, putting them out of reach for developing countries where, too often, resources are sparse. Further, the working group recommends more input from local investigators and independent stakeholders early on in the clinical trial design. Food and Drug Administration (FDA) Commissioner Margaret Hamburg highlighted the need for new ideas and processes to advance global health technologies and regulatory pathways in her keynote address. In speaking of the FDA’s interest in the new report, she told that audience that failing to address the needs of the developing world’s health concerns undermines the health, security, and wellbeing of us all. She added that now, more than ever, global diseases need global solutions.

Jeff Meer is special advisor for global health policy and development at the Public Health Institute (PHI), a GHTC member. Based in Washington, DC, he provides strategic guidance to the organization on global health advocacy and develops new business proposals for global health projects. On Nov. 3-4, the Coalition Advancing Multipurpose Innovations (CAMI), a project of PHI, convened a symposium in Washington, DC, on “Multipurpose Prevention Technologies (MPTs) for Reproductive Health.” The gathering was attended by more than 100 product developers, researchers, academics, funding organizations, nongovernmental organization leaders, policymakers, and reproductive health practitioners. Participants discussed how best to advance emerging MPT science, with the goal of providing women around the world with safe, effective, low cost, and user-friendly means of protecting themselves simultaneously from HIV, other sexually transmitted and reproductive tract infections, and/or unintended pregnancy. The conference, funded primarily by the US Agency for International Development (USAID)’s Global Health Bureau and held at the Henry J. Kaiser Family Foundation’s Barbara Jordan Conference Center, follows a think tank convened earlier this year under the auspices of the Initiative for Multipurpose Prevention Technologies (IMPT), which is led by Bethany Young Holt of PHI. Other funders for the symposium include the National Institute of Health’s Office of AIDS Research, Gilead, and the Mary Wohlford Foundation. Dr. Young Holt directs CAMI, which serves as secretariat to the IMPT at PHI. Conference held to discuss Multipurpose Prevention Technologies (MPTs) and how they can help improve reproductive health to help women around the world . Photo Credit: Nguyen Ba Quang/PATH There are technologies already available to prevent unintended pregnancy and also block sexually transmitted infections. These include the male and female condom. However, newer MPTs are based on other technologies that may be more useable in some geographic and cultural contexts. These include impregnated vaginal rings, barrier devices, gels, and vaccines. The MPT field is developing a range of options for women, some of which may be more appropriate for different points in the life cycle. There are more than one dozen important MPTs now in development and testing, and some are much closer to commercial introduction than others. Among the topics covered at the symposium were: the state of the scientific field in developing MPTs; pressing issues like the effect of hormonal contraception on acquisition of HIV; the perspective of product developers; and regulatory pathways for MPTs in the United States and abroad. Other topics covered include: lessons learned from introduction of other reproductive health technologies; integrating end-user needs in product development; donor perspectives; public-private partnerships for MPT development; and political leadership on MPTs. Many experts consider MPTs to be a key global health technology area. Technologies such as MPTs that address multiple global health challenges—similar to vaccines that address more than one illness—can be both efficient and cost-effective interventions. And the twin challenges of preventing unintended pregnancy in order to reduce maternal mortality and reducing the transmission of HIV and AIDS are certainly high on the global agenda: they are the subject of United Nations Millennium Development Goals 5 and 6. Also, making inroads in these areas could offer substantial cost savings to governments and consumers alike. For example, in the United States alone, the estimated direct medical cost of unintended pregnancies in 2002 was $5 billion. Direct medical costs associated with treatment and care of sexually-transmitted infections in the United States in 2006 were even higher—approximately $14.6 billion. Despite this encouraging landscape, the MPT field is also fraught with challenges. Collaboration across scientific disciplines is never simple, and the worlds of research on contraception and sexually-transmitted infections do not necessarily regularly intersect. There are also significant regulatory hurdles to the introduction of technologies that deal with multiple health issues, and these can be daunting in trying to introduce even helpful and potentially life-saving technologies on a global scale. And any global health technology must pass the ultimate test of user acceptability. This symposium is meant to ask and answer some of these vexing questions, so that MPTs can be introduced successfully the first and every time. More information about the rationale for MPTs can be reviewed here.

In this regular feature on Breakthroughs, we’ll highlight some of the most interesting reads in global health research from the past week. A bipartisan group of former USAID administrators calls on Congress to preserve funding for USAID, saying that the stakes are too high to cut investments in an agency that conducts such critical work across the globe. Bill Gates pushes for a stronger focus on innovation and stresses the benefits of foreign aid in the Washington Post. Gates also urges the G20 to adopt a transaction tax to raise money to fight global poverty.. Medical research is benefiting from creative new methods of funding. A CNN opinion piece highlights the need to protect funding for the President’s Emergency Plan for AIDS Relief (PEPFAR) to keep saving millions of lives around the globe and fight the global AIDS crisis. Secretary of State Hillary Clinton will focus on HIV and AIDS and the need for research for new tools during a speech at the NIH next week. USAID celebrates 50 years of saving lives around the globe. The GHTC examined the agency’s impressive support for global health R&D. Report urges regional collaboration on clinical trials to improve regulatory pathways and deliver health tools faster to the people who need them most.

Today, the US Agency for International Development (USAID) celebrates 50 years of leadership and expertise in addressing development challenges to improve lives across the globe. Since it launched, USAID has had a rich history of supporting global health, including research and development (R&D). Some of the major breakthroughs in global health that USAID has supported include: Oral rehydration therapy (ORT). ORT, a treatment for diarrhea, is credited with saving tens of millions of children’s lives. USAID began supporting this effort in the 1960s. In 1979, USAID made the largest donor investment in the establishment of the International Centre for Diarrhoeal Disease Research, where scientists continue to conduct important R&D to improve ORT. Eradicating smallpox. In 1966, USAID joined the global effort to eradicate smallpox, a contagious disease that killed more than 300 million people in the 20th century. In the same decade that USAID began to fight the disease, 10 million to 15 million people contracted the disease a year, and more than 2 million people died from it. Through investing in research that adapted the mechanics of US military jet injectors for application of the smallpox vaccine, USAID played a critical role in achieving global eradication of the disease. Funding research for tools to help women. USAID funded research to develop the Uniject™ injection system, a tool that delivers the drug oxytocin to help reduce excessive bleeding during the third stage of childbirth. More recently, USAID has ramped up efforts to combat HIV by funding research for microbicide gels, a tool that has the potential to help women protect themselves from the virus. Through investing in a groundbreaking trial held at the Centre for the AIDS Programme Research in South Africa (CAPRISA), USAID played a critical role in supporting the first proof-of-concept trial that showed a microbicide can protect women against HIV and herpes. USAID has helped save lives across the world through its strong support for global health R&D Photo: Wendy Stone/PATH USAID’s commitment to global health R&D remains strong today. In fact, USAID is a vital partner to many GHTC members. USAID and the International AIDS Vaccine Initiative (IAVI) have been in a cooperative agreement since 2006 to accelerate the discovery of an AIDS vaccine. USAID also supports the Global Alliance for TB Drug Development (TB Alliance) in its effort to develop better drugs to treat tuberculosis (TB). The agency also contributed significant funding to the Meningitis Vaccine Project (MVP)—a partnership between PATH and the World Health Organization—for its efforts to discover and deliver a new meningitis vaccine. USAID supported a comprehensive analysis of the economic costs of meningitis epidemics, aided efforts to improve meningitis surveillance, and helped to address regulatory issues. With this strong commitment from USAID, the future of global health R&D will undoubtedly hold many breakthroughs that have the potential to save millions of lives worldwide.