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Research!America, a GHTC member, recently hosted an event on global health research and development (R&D) in New York. In this guest post, Mandy Goldberg, MPH, shares highlights from the event. Research!America, in partnership with the AIDS Vaccine Advocacy Coalition (AVAC), Drugs for Neglected Diseases initiative North America (DNDi), Global Alliance for TB Drug Development (TB Alliance), International AIDS Vaccine Initiative (IAVI), SUNY Downstate Medical Center, and Treatment Action Group (TAG), hosted a forum, Global Health Research and Development in New York: Fueling Innovation and Saving Lives, on Monday, April 9, at the New York Academy of Sciences. Mary Woolley, president and CEO of Research!America, opened the forum by acknowledging the remarkable progress made in the growing field of global health research in New York in the past decade. She also released the results of a new state poll commissioned by Research!America that shows that 64 percent of New Yorkers are concerned about global health, and 63 percent believe that global health research is important to New York’s economy. Congresswoman Nita Lowey (D-NY-18) then took the stage and explained the significance of global health R&D as an economic driver that creates jobs for New Yorkers. She stated that “despite the critical importance and significant economic impact of these programs, funding for global health is threatened again this year” in regard to the proposed fiscal year (FY) 2013 budget, and pledged to continue fighting for “robust funding for all our global health programs, including critical research and development.” Renowned global health commentator Laurie Garrett, senior fellow for global health at the Council on Foreign Relations, moderated a discussion between panelists Rachel Cohen, regional executive director, DNDi North America; Jack DeHovitz, MD, MPH, distinguished service professor and director, SUNY Downstate AIDS International Training and Research Program; Margaret McGlynn, president and CEO, IAVI; Mel Spigelman, MD, president and CEO, TB Alliance; and Pol Vandenbroucke, MD, vice president of development, emerging markets, Pfizer. In her opening remarks, Garrett emphasized the importance of the US commitment to global health funding, especially after the 2008 financial crisis, when “the United States stepped up to the plate” after the community saw “a huge number of players disappear” from the field. She stated that “if we cannot protect the US commitment to global heath spending, every single program in global health is going to have to chop, chop, chop its budget.” Laurie Garrett moderated a panel including Mel Spigelman, Pol Vanderbroucke, Rachel Cohen, Margaret McGlynn, and Jack DeHovitz. Panelists then discussed how innovative partnerships among public, private, and academic sectors are transforming the way that research is conducted and yielding promising developments for the future of global health. Spigelman highlighted that the TB Alliance is “on the verge” of technological breakthroughs, which require an increased commitment to research due to the costly final stages of testing and clinical trials. Partnerships in global health R&D are cost-effective, he argued, citing the TB Alliance’s NC-002 clinical trial conducted in partnership with the US Agency for International Development, Bayer, and Novartis. This trial has the potential to produce a drug regimen that could reduce the TB treatment to 4 months, potentially saving as much as 90 percent of current costs. Vandenbroucke emphasized that the private sector has unique resources and capabilities to contribute to partnerships that are essential for the development of health technologies. He stated that cuts to the federal budget would affect the work of the pharmaceutical industry “in the long term, as less funds are available to do the basic groundwork to study diseases” that Pfizer then applies during its advanced drug development process. Cohen expressed concern over the fact that neglected tropical diseases (NTDs) received the single largest percentage funding cut of the global health programs in the President’s FY 2013 budget request and the impact this would have on DNDi’s work. She noted that there is currently no federal funding available for late-stage product development for NTDs, and the current FY 2013 budget request “totally eviscerates the possibility of future investments, at least for the coming 2 years,” if passed, which threatens the continued progress of DNDi’s efforts. McGlynn spoke about the evolution of IAVI from an advocacy organization to a product development partnership, with the support of Mayor Bloomberg and New York City. IAVI’s Vaccine Design and Development Laboratory, established in Brooklyn in 2006, plays a pivotal role in the Mayor’s New York City Bioscience Initiative and is a key component of IAVI’s global AIDS vaccine R&D network. McGlynn stressed that the scientific expertise of New York City’s “globally educated and raised” workforce has been essential to IAVI’s work, and to the growth of global health R&D in the area. DeHovitz reinforced that multisectoral collaborations have yielded major advancements in the field of HIV and AIDS. He cited the federal contribution to international HIV and AIDS through the work of the Fogarty International Center at the National Institutes of Health, which funds advanced research training in public health at five New York City universities. He also spoke of “the huge upsurge of interest among our health care students in global health,” stating that 45 percent of medical school entrants are interested in global health and 30 percent of medical school graduates have had a global health experience in school. “They’re committed, they’re interested and they want to help,” he said, noting the potential impact of this group to the future of global health. New York—home to seven of the top 50 US research universities, the largest bioscience workforce and second-largest life sciences workforce of any US city, and three global health product development partnerships (PDPs)—is clearly a world leader in global health R&D, and this growing industry is a promising economic engine for the state. There was a general consensus in the room that the community needs to work together to ensure that global health R&D remains a priority. Great progress has been made in the development of new technologies to fight TB, HIV and AIDS, and NTDs, and increased funding is needed to sustain this momentum and build upon previous successes. Spigelman noted that the current “slash and burn” Congress could have a devastating effect on global health efforts, and argued that the US will get “the most bang for that buck” by investing in global health technologies that will reduce the foreign aid budget in the long term. Woolley concluded the forum with a call to action, asking the global health community to share with others, including their members of Congress, the importance of the work that they do. A video of the event is available here. For more information on global health R&D in New York, check out the New York edition of Research!America’s economic impact state fact sheet and public opinion poll series.

Developing new medical products is a global enterprise, with research and development (R&D) activities spanning national borders and products being introduced in many countries at the same time. A critical part of this global R&D effort is the regulation of new health tools to help ensure that these products are safe and effective before they reach the populations who need them. In countries around the world, regulatory agencies play a critical role in this process, much like the US Food and Drug Administration (FDA) does for health products for American consumers. When creating new tools for diseases of the developing world, product developers sometimes face overlapping and conflicting regulatory processes that can dramatically slow the development and delivery of vital new products to help combat global health scourges like malaria, tuberculosis, and neglected tropical diseases. Delays in the approval of clinical trials can add years to the product development process and can significantly increase costs. Meanwhile, delays in the final approval of a product can lead to unnecessary suffering and death for patients who are unable to access the best possible tools for prevention, diagnosis, and treatment. There has been a lot of talk recently about ways to streamline and harmonize regulatory processes to reduce the time and cost of delivering new products. One such effort is the new East African Community’s (EAC) Medicines Regulatory Harmonization initiative, launched at the end of March in Arusha, Tanzania. Through this program, regulators from six agencies in five East African countries—Burundi, Kenya, Rwanda, Tanzania, and Uganda—as well as Zanzibar will work together to: Establish harmonized procedures for medicines registration. Build regional capacity in regulatory science. Increase access to lifesaving solutions for patients and communities. Representatives from disease-endemic countries, regulatory authorities including the FDA, product development groups, donors and technical partners, and other key stakeholders participated in the launch activities, showcasing the excitement over the steps underway in the region. Participants also highlighted what is at stake in the EAC’s efforts, which are seen as establishing a path forward for other harmonization efforts in regions across Africa and around the world. Over the next several years, support for these efforts—in the form of technical assistance, training opportunities, and political backing—from the FDA and other experienced regulatory authorities will be crucial. The FDA has a vast amount of expertise that can be leveraged to benefit this new initiative, and supporting the EAC would add to recent efforts at the FDA to become increasingly involved in global health issues. By supporting the new EAC regulatory initiative, the FDA can help to make a real impact on the health of patients in East Africa through the delivery of better and safer medicines in the region.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) has released its final report. The report offers recommendations to close the funding gap in global health research and development. The Fogarty International Center and other programs at the National Institutes of Health are awarding about $20.3 million over the next five years to train the next generation of global health researchers and scientists. The US Agency for International Development (USAID) has released a new policy that aims to ensure the quality and integrity of the agency's scientific activities. The report recognizes that USAID is the US Government’s “lead international development agency, for which science and technology are critical means for improving the quality of peoples’ lives around the world.” A new study offers insight into promising new targets for future HIV vaccine efforts.

The Institute of Medicine (IOM) yesterday released a new report that stresses the importance of bolstering regulatory systems abroad in order to improve the safety and quality of medical products circulating around the globe. According to the report, many low- and middle-income countries do not have sufficient regulatory capacity, which limits their ability to oversee medical products such as drugs and vaccines. The report emphasizes that strengthening regulatory systems in these nations is critical for the health of Americans—indeed, more than 80 percent of active pharmaceutical ingredients and 40 percent of finished drugs in the United States actually come from overseas. US Food and Drug Administration (FDA) Commissioner Margaret Hamburg stressed this point recently when talking about why Americans should care about global health issues. In addition to securing the safety of the drugs and health products that Americans take, we at the GHTC believe that improving regulatory capacity overseas can have vast benefits for millions around the world. Strong regulatory systems can help guarantee that the safest and most appropriate products are available to populations in need, whether it be drugs to treat more well-known conditions like heart disease, or treatments for lesser-known but hugely devastating diseases like sleeping sickness and hookworm. Improved regulatory capacity in countries with neglected disease epidemics can also help monitor and oversee the safety of clinical trials for desperately needed new health tools. Improving regulatory capacity overseas can have vast benefits for millions around the world. Photo credit: PATH Fortunately, this new IOM report presents 13 steps that the FDA and other organizations can take over the next three to five years to bolster regulatory systems in developing nations. In addition to the FDA, other partners include other federal agencies, international stakeholders like the World Health Organization, private industry, and regulatory authorities in developing countries. For example, the report recommends that the FDA and other federal agencies—including the US Agency for International Development and Centers for Disease Control and Prevention—provide technical expertise, training, and tools to strengthen regulatory systems in developing countries. During the report launch event at the National Press Club, committee member Tom Bollyky from the Council on Foreign Relations said that the FDA and other regulatory stakeholders should build an international community to facilitate this capacity building in developing countries. According to Bollyky, this would include bringing international regulators to the United States, as well as sending FDA staff abroad, to facilitate the exchange of information and expertise. The report also calls on the US Government to work with Mexico, the host of the next meeting of the G20 nations, to add medical product safety to the G20 agenda. This will be an important and critical step to ensure that regulatory capacity building gets the buy-in and support from world governments, including the United States. As committee member Jim Riviere of North Carolina State University said, in order to have a “lasting and multiplier” effect on the safety of health products globally, we need to invest in capacity building and training for regulatory systems in all nations. This is one of the most important steps the FDA and others in the US Government can take to help ensure that new health products are safe and effective before they reach the people who need them most.