Breakthroughs Blog: HIV/AIDS

Female condoms. Photo: PATH/Patrick McKernTake a stroll through any pharmacy and you’ll see shelves stacked with male condoms of many varieties, but look for a female condom and you aren't likely to find one for sale. Though first introduced more than 20 years ago, female condoms are remain an unknown or inaccessible option for many women. But thanks to the efforts of dedicated product developers, public health professionals, and female condom advocates, that’s changing, as a slew of new female condom products are emerging and expanding the market. Today, in celebration of Global Female Condom Day, we look back at the history of the female condom and look ahead at what’s next for this female-initiated prevention tool.A game changing product with a slow start When the first female condom—known as the FC1—was introduced on the US market in 1993 by Wisconsin Pharmaceuticals (now the Female Health Company), it was hailed as a game-changer in sexual health. It checked off all the requirements for what product developers had heard women wanted—it had comparable effectiveness to male condoms, it could be inserted prior to sex allowing for less disruptive love-making, it was less physically restrictive for male partners, and most importantly, it was female-initiated. FC2 female condom. Photo: Female Health Company In spite of these advantages, the female condom never really caught on among American consumers. Many women were hesitant to try it because of its unfamiliar size and shape—it is larger than a male condom and doesn’t come neatly rolled up in a small package. Among those women who did try a female condom, many found it was difficult to insert and uncomfortable or noisy during sex. The FC1 was also many times more expensive than a male condom, which deterred some women and couples from trying it out.While the product received a tepid reception in the United States, women’s health and rights groups in middle- and low-income countries—where rates of unplanned pregnancy and STIs/HIV are alarmingly high and women may have few options to negotiate protection—saw the female condom as an important new tool to save women’s lives. Pilot introduction programs took off in countries including Brazil, Ghana, South Africa, and Zimbabwe. In response, the Female Health Company optimized the product, changing the material from polyurethane to nitrile to reduce production costs, and introduced the world to FC1’s successor—you guessed it: the FC2. In 2007, the FC2 was prequalified by the World Health Organization (WHO) making it eligible for bulk procurement. Today, the FC2 is available in 144 nations. Expanding choice in the female condom market Cupid Female Condom. Photo: Female Condom Market IntelligenceSpurred by increased advocacy to expand options for female-initiated prevention, researchers and product developers went to work on new female condom designs. In recent years, consumers have begun to see the fruits of this labor, as several new female condoms, each with different design variations, have emerged on the market. In 2012, the Cupid female condom—which uses a foam sponge on one end rather than a ring to provide stability—joined the FC2 as the second female condom to receive WHO prequalification.The female condom market is on the cusp of further diversification, as additional female condoms are awaiting WHO prequalification decision or soon to be submitted for review. Phoenurse female condom. Photo: Female Condom Market Intelligence Each of these options offers a different approach to addressing the drawbacks of the FC1. For example, the Air female condom contains an air bubble to help keep the product stable during sex, while the Phoenurse comes packaged with an insertion stick for optional use when inserting the product. The Velvet condom is similar to the FC2 design but made of natural rubber latex, while the VA w.o.w, like the Cupid, contains a sponge for internal stability, but instead has a rounded triangular outer ring to keep it secure.Another second generation female condom in early introduction is the Woman’s Condom, developed by GHTC member PATH. As a nonprofit product developer focused on user-centered design, PATH set out in the late 1990s to create a female condom that would be easy to use and comfortable for both partners. The product development team began by examining acceptability studies of existing female condoms and hosting focus groups with men and woman in several countries to better understand what users wanted from a product. Their design objectives became clear: “create a product that would be easy to handle, easy to insert, stay stable in the vagina during sex…[and] provide good sensation for both the male and female partner,” explained Maggie Kilbourne-Brook, program officer at PATH, adding “and if possible, users wanted it be more aesthetically pleasing.” The Women's Condom. Photo: PATH/Glenn Austin  PATH developed and tested more than 50 prototypes before freezing design development. To increase the ease of insertion, the Women’s Condom’ main pouch is compressed into a narrow, rounded capsule which women insert like a tampon. Within 30-60 seconds, this capsule dissolves, allowing the condom to expand within the vagina. To provide stability, four small foam pieces are used which adhere gently to the interior of the vagina. And unlike other female condoms, the Woman’s Condom is not pre-lubricated; instead it is packaged with separate lubricant users can apply following insertion.New designs under development The Origami Condom. Photo: Female Condom Market IntelligenceAs these aforementioned female condoms are introduced and vie for market share, additional female condoms are advancing through the research and development (R&D) process. Next to market will likely be the Origami Condom, which is moving into phase 2 clinical trials. The Origami female condom is quite a dramatic reimagining of the female condom. It’s a conical shaped device that is folded during insertion and expands like an accordion during sex. It’s made of a durable, flexible silicon material designed for wash and reuse. The Bill & Melinda Gates Foundation is also giving a boost to female condom development. Last year as part of its initiative to develop “next generation condoms,” the Gates Foundation announced grant funding for three early-stage female condom development projects. Researchers from Indiana University received funding to advance their “female pleasure condom” which has ribbed siding to increase stimulation and enhance sexual experience, while another grantee is developing an “air-infused female condom” that is “inflated and positioned using air pressure” to enable easier and quicker insertion. The third grant recipient is approaching the insertion challenge in an entirely different way, designing a sliding, easy to use, re-usable applicator for female condoms that works like a tampon applicator.The many challenges of female condom development and access  A woman demonstrates use of a female condom at a community meeting in Kenya. Photo: PATH/Eric Becker Studies have shown that including female condoms in condom promotion programs leads to increased levels of protected sex, meaning certain men and women are using female condoms in circumstances where male condoms would have otherwise not been used. And qualitative studies have found that having female condoms available as an option can help some women negotiate condom use with their partners. “It can shift the conversation,” explains Kilbourne-Brook, “It’s not male condom or nothing—it’s male condom, female condom, or nothing.” Even though female condoms deliver improved health outcomes, they are still a challenging value proposition for global procurers who purchase over 90 percent of female condoms. While prices are expected to drop as new products come to market and production volumes increase, female condoms will always cost more because of their design. Today, at bulk procurement prices, a buyer can purchase roughly 17 male condoms for the price of one FC2 female condom. And the fact that demand is so driven by price-sensitive bulk procurers changes the nature of the market, discouraging developers and manufacturers from investing in R&D to enhance consumer-experience or spending on marketing to increase appeal. Instead, it encourages companies to focus on developing the lowest cost product possible that meets the health need.Developers hoping to bring a new female condom into the US market also face an additional hurdle. Because female condoms were a new product category at the time the FC1 underwent regulatory review, the US Food and Drug Administration (FDA) decided to regulate female condoms as Class III medical devices—a classification typically reserved for higher risk medical products (male condoms are classified as Class II devices). Because Class III devices require more data and evidence for approval, it creates a more costly and lengthy process for developers. Most other regulatory authorities classify female condoms as Class II devices, and female condom advocates are calling on the FDA to down classify female condoms to pave the way for expanded choice. The path forward  Many advocates argue that for female condoms to make the leap from niche product to a staple in the bedroom worldwide, concerted marketing, education, and awareness campaigns are needed to demystify and destigmatize female condoms and boost their consumer appeal. To build momentum, Global Female Condom Day was launched in 2012 as an international day of action focused on increasing knowledge, availability, and use of female condoms. And this year, advocates will Dance4Demand to urge policymakers, donors, and health providers to increase their support for female condoms. While the female condom may have been slow to catch on, its supporters believe it can make such a leap. After all, many people forget that male condoms were at one point stigmatized as products used only by people engaged in morally questionable activity. It took a concerted effort from public health professionals, governments, and the private sector to bring them into the mainstream and make them the ubiquitous, widely-used product they are today. If the hopes of female advocates are realized, pharmacies everywhere may soon have to make some extra room on their shelves. ReferencesHoke TH, Feldblum PJ, Van Damme K, et al. Temporal trends in sexually transmitted infection prevalence and condom use following introduction of the female condom to Madagascar sex workers. International Journal of STD and AIDS. 2007; 18(7):461–466. Latka M, Gollub E, French P, Stein Z. Male-condom and female-condom use among women after counseling in risk-reduction hierarchy for STD prevention. Sexually Transmitted Diseases. 2000;27(8):431–437. Barbosa RM, Berquo E, Kalckmann S. Acceptability of the Female Condom in Different Social Contexts: Final Research Report. Brasilia, Brazil: Ministry of Health, Secretariat for Health Policies, National STD/AIDS Coordinating Office; 2000. Artz L, Macaluso M, Brill I, et al. Effectiveness of an intervention promoting the female condom to patients at sexually transmitted disease clinics. American Journal of Public Health. 2000;90(2):237–244. Macaluso M, Demand M, Artz L, et al. Female condom use among women at high risk of sexually transmitted disease. Family Planning Perspectives. 2000;32(3):138–144. Musaba E, Morrison CS, Sunkutu MR, Wong EL. Long-term use of the female condom among couples at high risk of human immunodeficiency virus infection in Zambia. Sexually Transmitted Diseases. 1998;25(5):260–264. Gollub EL, French P, Latka M, Rogers C, Stein Z. Achieving safer sex with choice: studying a woman’s sexual risk reduction hierarchy in an STD clinic. Journal of Women’s Health & Gender-Based Medicine. 2001;10(8):771–783.

Later this year, French pharmaceutical company Sanofi plans to launch a vaccine for dengue fever, the first on the market for an infection for which nearly half of the world’s population is at risk. Sanofi has spent more than US$1.5 billion over 20 years on the research and development (R&D) of this dengue vaccine and expects it to be not only lifesaving, but also highly profitable. Dengue fever is endemic in a number of low- and middle-income countries in Asia and Latin America and is spreading into high-income countries in southern Europe as well as Japan and the United States. In preparation for the launch, Sanofi has invested more than $300 million in a manufacturing facility for the vaccine with the capacity to produce 100 million vaccines each year. Pharmaceutical companies Takeda, Merck & Co., Inc., and GlaxoSmithKline are also developing vaccines for dengue fever, and Takeda’s candidate could be on the market by 2020. The US Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation to pharmaceutical company Bristol-Myers Squibb for its HIV treatment BMS-663068, based on the results of phase 2 clinical trials. The designation expedites FDA review in order to accelerate the availability of drugs for serious or life-threatening conditions and in cases where preliminary evidence suggests that the new product would offer significant advantages over current treatments. BMS-663068 is the first antiretroviral drug that actually prevents the HIV virus from attaching to and entering human immune cells. The designation is limited to use of the drug for “treatment-experienced” HIV patients who are developing resistance to other antiretroviral treatments. A new study suggests that the appearance of a pill can impact a patient’s perception of its efficacy. The study asked more than 100 participants each from the United States, China, and Colombia to rate images of pills on anticipated bitterness, ability to fight off headaches, and how hard it is to swallow, based solely on the shape and color of the pill. Across all three countries, participants perceived white pills as the most effective, and diamond-shaped pills—in contrast to round or oval pills—as the most difficult to swallow. A majority of US participants considered green pills to be the least effective and believed that red pills would lead to greater mental alertness. Past research has also suggested that a pill’s appearance can impact use; a study from 2014 indicates that when generic manufacturers change the shape or color of a pill, nearly one-third of patients will stop using the medication. On Monday, July 20, the Center for Global Development published The White House and the World, a report with concrete policy recommendations for the next US president on everything from energy and climate to migration and trade. The report notes that the United States often serves as the “first responder” in outbreaks and is a leader in global health, but calls for clear leadership—including the appointment of a global health coordinator—and pathways for coordination across US agencies. The report highlights the needs for reform at major multilateral organizations such as the World Health Organization and suggests that the United States should spearhead reform efforts and use those platforms to advance US priorities. The report identifies ways for the United States to provide technical assistance—through an office of Global Health Trade, Economics, and Knowledge Exchange—with partners in low- and middle-income countries, ultimately calling for a shift from the “aid-based status quo” and positioning the United States as a “forward-looking and strategic investor” in global health. The Guardian took an in-depth look at the status of antimicrobial R&D, including antibiotic drug discovery, alternative treatments for drug-resistant bacteria, and improved diagnostics. In the 1950s through the 1970s, researchers were discovering around twelve new antibiotics each year just by examining soil samples and identifying compounds—generated by the one percent of micro-organisms that can grow in normal laboratory settings—that could fight off bacteria. A new device known as iChip allows scientists to cultivate microbes while still in soil, enabling them to work with the other 99 percent of micro-organisms. Researchers at Northeastern University have identified 25 potential compounds using iChip, including one that demonstrates promise against drug-resistant tuberculosis and that the team believes could be available for use in humans within five years. According to Dr. Kim Lewis, the project’s lead researcher, “the rule of thumb is you need 50 promising leads for one drug, [so] we will keep searching for more.” Dr. Matt Cooper, a professor of chemistry at the University of Queensland, is also searching for new antimicrobial compounds. Earlier this year, he established the Community for Open Antimicrobial Drug Discovery, which will collect thousands of chemicals and test them for antibiotic potential. While Lewis and Cooper search for new compounds, others look for alternative or supplemental treatments for drug-resistant bacteria. The London-based biotech company Helperby Therapeutics has developed a “resistance breaker,” which Chief Scientific Officer Anthony Coates describes as “punching holes in the membrane of bacteria” to enhance the ability of existing antibiotics to combat the bacteria. David Livermore, a professor of medical microbiology at the University of East Anglia, is calling for rapid diagnostics to improve the diagnosis and treatment of drug-resistant infections. Livermore compares the current use of antibiotics to “carpet bombing in the second world war,” killing off all bacteria in patients, including protective bacteria in the human gut, and leaving a vacuum in which harmful bacteria can develop resistance. Because antibiotics are cheap and used by patients for a short amount of time, however, large pharmaceutical companies can be hesitant to invest in their R&D. As Cooper explains, the “low-hanging fruit[s]” have been discovered, and government investment is now needed to return to the “golden era” of antibiotic drug discovery.

In this post, Amie Batson, MBA—chief strategy officer at GHTC member PATH—discusses a new PATH-led initiative to identify and showcase lifesaving innovations with the promise to transform global health by 2030 and offers insights into what it will take to accelerate the impact of innovation. This post originally appeared in the Innovation Countdown 2030 Report: Reimagining Global Health. What if the solutions to the greatest health challenges of our time were within reach? Imagine if the world came together around those solutions and worked to accelerate the ones with the most potential to transform health. How might the world source, assess, finance, and coordinate investment in the highest-impact innovations and dismantle the barriers that keep them from reaching the very people who need them most? This is the intriguing premise behind the PATH-led Innovation Countdown 2030 (IC2030) initiative. With support from the Norwegian Agency for Development Cooperation, the Bill & Melinda Gates Foundation, and the US Agency for International Development, we set out to identify, evaluate, and showcase health technologies and interventions with great promise to accelerate progress toward solving the world’s most urgent health issues. We turned to experts and innovators all over the globe, crowdsourcing transformative ideas and innovations that could dramatically increase the affordability, accessibility, or effectiveness of health care compared to the current standard of care. Reimagining Global Health, the inaugural report of the IC2030 initiative, features 30 innovations that experts believe could quicken the pace of progress toward the health targets in the proposed UN Sustainable Development Goals (SDGs), along with commentaries from health, technology, and business leaders. These 30 innovations are presented in four categories mapped to the proposed health targets: maternal, newborn, and child health (MNCH); infectious diseases, including malaria, HIV and AIDS, and tuberculosis (TB); reproductive health; and noncommunicable diseases (NCDs), including diabetes, cancer, and chronic respiratory and cardiovascular disease. We cast a wide net in our search because innovation is truly diverse and global. Our call for nominations brought in more than 500 ideas submitted by people in nearly 50 countries across five platforms: devices; diagnostics; drugs and therapeutics; systems and services, including digital health; and vaccines. We then tapped more than 60 health experts to evaluate and rank those innovations, selecting the final set featured here. For a detailed look at our methodology, please see pages 37–41 of the Reimagining Global Health report. Four strategies to accelerate the impact of innovation Our list of 30 promising innovations and our dialogue with experts and innovators around the world offer important insights into what it will take to harness the power of innovation to save lives. 1. Tap and support innovation wherever it occurs. Innovators are everywhere, not just in well-funded labs and technology companies in wealthy nations. Today’s innovation ecosystem is diffuse, with smart ideas coming from every corner of the globe and across every sector and discipline. The world increasingly sees the importance of user-centric solutions that are demand-driven, relevant, and affordable. The opportunities for accelerating innovation—wherever it comes from—have never been greater, empowered by digital platforms where new ideas, data, and approaches can be shared, developed, and deployed. Our crowdsourcing approach for gathering innovations is one example of the new tools that are redefining health innovation. Nearly 30 percent of the 500-plus submissions received by IC2030 came from people in low- and middle-income countries, giving voice to their growing role in health innovation. There were many more promising ideas than we could feature in this report. Strengthening the capacity of low- and middle-income countries to identify, develop, adapt, produce, regulate, assess, and share innovations is critical for a robust innovation pipeline. Investments in countries’ innovation ecosystems will catalyze better overall global health while ensuring that innovations are appropriate for low-resource markets and local contexts and cultures. Innovators with direct experience working with limited resources may be the best source for frugal innovations—cost-effective solutions to address the needs of the poor, wherever they live. 2. Assess and advance innovations that deliver the most health for the money. Rigorous and transparent assessment of an innovation’s health impact, market size, and technological feasibility compared to alternatives in the pipeline is important for informing decisions about where to invest precious health resources. Low- and middle-income country governments are requesting assistance in evaluating the potential health and economic value of introducing one innovation versus another amid a burgeoning supply of new tools and interventions. Investors are also demanding more and better data on which to base investment decisions. However, comparing innovations across diseases and conditions is a challenge. Health experts frequently focus on specific conditions and make decisions with a single health outcome in mind. A key feature of IC2030 is the health and cost impact modeling process we developed to quantify lives saved, cases of disease averted, and costs for a subset of MNCH innovations. This model could provide a common framework to assess innovations with the greatest potential to address the SDG health targets. Our impact modeling results for select maternal, newborn, and child health innovations are featured on pages 13–19 of the Reimagining Global Health report. The data provide new insights into prioritizing global health investments for greatest impact. For example, we found that new tools for community-level water treatment to prevent diarrheal disease and the scale-up of a low-cost drug to prevent newborn infections could save more lives over the next 15 years compared to other innovations we modeled. Measuring the impact of crosscutting innovations is equally important. These health systems and platform innovations, including digital tools and broad diagnostics, have the potential to address multiple SDG health targets simultaneously. About one in five of the innovations submitted to IC2030 was crosscutting in nature. Yet assessing their impact is particularly challenging because of the complexity of linking multiple health outcomes to the foundational structure of the health system that supports them. In this first year of IC2030, we did not systematically evaluate crosscutting innovations, but they will be a focus going forward. New assessment tools and more comparable, comprehensive, and reliable financial and technical data are critical to help spotlight and advance innovations with particular promise that might otherwise be overlooked. A clear and rigorous framework to gauge the best value for money in a range of low- and middle-income settings is needed to inform national and subnational purchasing decisions and the decisions of those purchasing on behalf of countries. This will also help innovation investors more accurately assess potential impact, markets, and revenue flows. Zeroing in on health solutions that offer the greatest value for money is the essential next step in reaching the millions of people still waiting to share in the gains of our progress. 3. Develop new financing mechanisms for global health innovation. The pool of public and private funds to invest in health innovations is large and evolving. Funds from traditional R&D and development donors—typically dedicated public funds from wealthy countries—are being augmented by resources from philanthropies, social impact investors, private-sector mechanisms, and domestic sources. This new mix of innovation funding creates both opportunities and challenges. Domestic funding to introduce and scale up health innovations is becoming central to innovation funding. As low- and middle-income economies grow and countries graduate from aid, they are expected to finance their own health expenditures, creating new markets for affordable health tools and interventions. Sustainable financing of innovation will depend on the decisions of domestic stakeholders, including governments, insurance entities, corporations, and individuals. As more viable markets emerge, we will see a rebalancing of innovation from being primarily supply-side driven by donors and the R&D community to being more demand-side driven by countries and markets. Supporting country decision-makers to buy or, in the case of insurance mechanisms, cover or reimburse cost-effective health innovations must be at the heart of a new and improved financing model. Global funding mechanisms, including the Global Fund to Fight AIDS, Tuberculosis and Malaria and the new Global Financing Facility at the World Bank, may be well-positioned to act as intermediaries, as Gavi, the Vaccine Alliance, currently does for vaccines. These mechanisms can increase the certainty that funds will be readily available to purchase high-priority innovations if countries demand them. To play this role, they will need a window into the innovation pipeline and a means of engaging with eligible governments to identify high-impact innovations. The next generation of health financing mechanisms must also be responsive to the increasing requirements of social impact and private investors who base their investment decisions on not only the potential health impact of an innovation but also its probable market in low- and middle-income countries. While traditional funders have always understood the importance of having a clear “line-of-sight” to the market, it was often discounted. The assumption has been that if an innovation demonstrated significant public health value, a donor would eventually support it. New financing mechanisms must spotlight and bridge the critical links between R&D decisions, market uptake, and health impact. Innovators will respond to incentives that encourage them to maintain a focus on the market from the beginning of the development process to ensure the creation of sustainable and affordable innovations. New financing mechanisms must also provide more efficient and effective models for making and executing investment decisions. Over the past decade, the evolving spectrum of innovation funders has led to increasing fragmentation of investment decisions and growing transaction costs. Each investor—whether a public agency representative, a social impact investor, or a minister of health—brings a unique mix of risk tolerance, due diligence processes, data sources, expected returns, and interest in specific platforms, geographies, or health areas. For any investor, the difficulty and risk of investing alone is high, but today, the transaction cost of coordinating decisions and investment can be even higher. Global health investment funds try to address this challenge but require all investors to align on risk/reward preferences. The growing diversity of funders, while currently a challenge, has the potential to be a benefit if investors can leverage their different interests and risk tolerance. If actively coordinated, mixed sources of funding can be structured to finance different stages in the innovation cycle with a focus on the market. This means recognizing the growing role of purchasers in establishing a market, as well as finding new ways to align the decisions of investors and purchasers. All parties would make better decisions if they knew, and could count on, what others were doing. 4. Coordinate investments to ensure a strategic approach to health innovation. Coordinated investments in innovations across the continuum of care, including prevention, diagnosis, treatment, and disease management, have the potential to ensure a comprehensive suite of health tools and services designed for the greatest possible impact. The proposed SDGs provide the opportunity for investors to work toward shared health targets and better coordination in how they source, assess, and invest in innovations that achieve those targets. Yet we found potential inefficiencies in investment approaches that may underscore the current lack of coordination. In certain health areas, for example, we received nominations for multiple devices all taking a similar approach to address the same health condition. While competition might result in better tools at better prices, it also raises the question of whether donors are aware of what others are investing in and whether scarce resources could be more strategically targeted. In maternal health, we received many submissions for diagnostics to predict and detect preeclampsia/eclampsia—the second leading cause of maternal mortality—but few innovations for the treatment of these life-threatening conditions. In many low-resource settings, the existing treatment, magnesium sulfate, is underused, incorrectly administered, or unavailable. Diagnostics will have limited value unless innovations in new treatments and delivery systems are developed in parallel. A broader understanding of where investments in innovation are high—or very low—is also warranted. NCDs now account for about two-thirds of global deaths, yet we received very few innovation nominations. Donors may assume others are funding NCD innovations while they focus on infectious diseases. Will they be surprised when they pivot to NCDs and discover the lack of appropriate innovations for people in low-resource settings? Could investments in preventive innovations today allow countries to effectively leapfrog developed nations and avoid creating the huge treatment burdens associated with NCDs? Conclusion The robust and growing innovation pipeline presents an exciting opportunity to accelerate high-impact solutions that can create better health and opportunity for all. Ensuring the best ideas are surfaced—wherever they come from—is the first critical step we must take to deliver on the promise of the SDG health targets. This should include investing in the innovation ecosystem in low-resource countries to enable local entrepreneurs to develop, produce, and share their ideas. It also means using new crowdsourcing tools to gather ideas and data visualization to make the comprehensive pipeline more visible to national and global investors, policymakers, and innovators. Developing and adopting assessment methodologies that provide common, consistent, and comparable evaluations of innovations is the second step. Countries are in great need of health technology assessment tools that allow governments and insurance entities to decide which of the many innovations available today and in the future should be procured, covered, and reimbursed. These tools also will improve the quality of market estimates, one of the most critical and yet weakest components of innovation assessment for all investors. The third step is to develop innovative financing mechanisms that both recognize the growing importance of domestic finance in determining markets in low- and middle-income countries and benefit from the growing diversity of investors. Financiers have the potential to leverage their investments by aligning with other funders while maintaining a strategic focus on the market. Aligned investment across the different stages of the innovation cycle, from development to production, commercialization, purchase, and wide-scale use, has the potential to dramatically accelerate our progress. The fourth step may be the most essential—coordinating the resources and attention of investors, innovators, and policymakers on innovations with the greatest potential value for money. Our progress depends on decision-makers sharing information to ensure that collectively, the world is investing in the portfolio of innovations that will allow us to achieve our shared goals embodied in the SDGs. Innovation is the key to sustainable health impact. But innovation isn’t a random set of ideas and inventions. High-impact innovation is more likely to result from the kind of sourcing, assessment, financing, and coordination described above. It is our hope that one or more of the innovations highlighted in this report will become a game-changer for global health over the next 15 years. But beyond the success of any single innovation, we hope IC2030 will be a platform to catalyze discussion, collaboration, investment, and momentum toward the day when everyone has an equal chance for a healthy life. Photo: PATH/Gabe Bienczycki.

The zoonotic Middle East Respiratory Syndrome (MERS), which World Health Organization (WHO) Director-General Dr. Margaret Chan called “a threat to the entire world” has spread to South Korea. More than 100 cases and 10 deaths have been reported, making it the largest outbreak outside of the Arabian Peninsula. While there are currently no vaccines or treatments for MERS, researchers are confident that with adequate political will and funding, such products could be rapidly advanced. Photo: PATH/Nguyen Ba Quang Dr. Matthew Frieman, a professor and researcher at the University of Maryland School of Medicine, has developed an experimental vaccine in partnership with vaccine company Novavax Inc. that successfully protected mice against the MERS virus. Greffex, another vaccine company, has already worked with the US National Institute of Allergy and Infectious Diseases to develop a vaccine that triggers the production of antibodies—proteins that protect against the disease—in mice. Dr. Frieman and Greffex CEO John Price agree that funding and political will are the only barriers to the development of a MERS vaccine. According to Price, Greffex could develop a MERS vaccine candidate in less than a month with a sample of the virus, but they lack the funding to conduct clinical trials. Researchers have also struggled to obtain the needed information and materials—including samples of the virus—from scientists in Saudi Arabia. In the meantime, Frieman is working to test existing, approved drugs for the treatment of MERS, and has identified 27 drugs that have demonstrated potential in combatting MERS in a laboratory setting. At this year’s G7 summit, leaders of seven countries—including Canada, France, Germany, Italy, Japan, the United Kingdom, and the United States— pledged to advance research and development (R&D) for neglected tropical diseases and new antibiotics. The members of the G7 committed to supporting everything from basic research through the development of “easily usable and affordable drugs, vaccines and point-of-care [diagnostics].” The G7 Leaders' Declaration also endorses the WHO Global Action Plan on Antimicrobial Resistance and the WHO Global Observatory on Health Research and Development, highlighting the need for improved coordination of global health R&D. In a New York Times op-ed, Gregg Gonsalves and Mark Harrington, co-founders of the Treatment Action Group, reflected on lessons learned about the US Food and Drug Administration’s (FDA) drug approval process during the US HIV and AIDS epidemic. The article comes as Congress is considering the 21st Century Cures Act, a bill intended to advance medical breakthroughs, in part through FDA reform. The legislation includes several provisions to expedite the approval of drugs and medical devices based on what Gonsalves and Harrington consider to be “lower standards.” The authors assert that while innovative regulatory pathways—such as the Accelerated Approval Program—enabled early access to new HIV and AIDS drugs, pharmaceutical companies were still required to demonstrate the safety and efficacy of products before they entered the market. Additionally, in the case of preliminary approval, companies were expected to continue and complete clinical trials. To protect patient safety, Gonsalves and Harrington argue that such standards should be upheld, reminding Congress that those standards “paved the way for the development and approval of breakthrough drugs [that] have been proven to be effective and safe.” There are nearly 170 contraceptives products in the R&D pipeline, from discovery, through product development, to regulatory review. Researchers, advocates, funders, and procurement agencies can now find information about these products all in one place through Calliope, the Contraceptive Pipeline Database, a new resource developed by GHTC member FHI 360. Calliope includes information regarding the R&D stage, the partners, the active pharmaceutical ingredients, the delivery and duration, and the mechanism by which the technologies prevent pregnancy. The contraceptive pipeline is diverse, and includes vaccines, microbicides, implants intrauterine devices and balls, pills, and even microchips. The exchange was created to galvanize contraceptive R&D for low-resource settings through knowledge sharing and the facilitation of cross-sector partnerships.