For 2015, the call for innovation is loud and clear

In this guest post, Claire Wingfield—product development policy officer at PATH—writes about a new paper she developed for the GHTC that outlines key issues surrounding access to global health products. In order to achieve impact, a health technology must be more than just safe and effective. It must also be affordable, available, and acceptable to ensure that it is accessible to those who need it most. The pipeline of products addressing public health needs in low- and middle-income countries (LMICs) has grown substantially over the past two decades. Much of that success can be traced back to the 1990s when a number of nonprofit product development organizations (NPPDs) were established to accelerate the development and accessibility of new health technologies targeting poverty-related diseases and conditions. Since that time, NPPDs and their partners have contributed to the development, evaluation, and/or introduction of 42 new health products. The GHTC has launched a new paper that outlines key issues surrounding access to global health products. Photo credit: PATH Because NPPDs were established to develop—not deliver—health technologies, they negotiate collaborations with partners from the public and private sectors that are designed to ensure access to the resulting products and knowledge. Today, the GHTC is launching a paper that explores how NPPDs approach access and how they manage partnerships and negotiate agreements to improve access – which they define as the affordability, availability, and acceptability of technologies targeting the health needs of LMICs. Although there is no “one size fits all” model for how NPPDs operate, they do employ some common strategies to ensure that the resulting products benefit those most in need: Spreading investment in research and development across a portfolio of technologies, thereby allowing NPPDs to select only the most promising products to advance through the pipeline. Prioritizing access to these technologies for poor populations. Planning for access from the beginning of the product development process. Working closely with manufacturing partners to guarantee that consistent supplies of high-quality, cost-effective products are available to target populations. Engaging end users and beneficiaries in the design and the development of the product. Negotiating collaborations with partners from the public and private sectors that create a framework for access in LMICs. NPPDs also shared lessons that they and their partners have learned in trying to improve the affordability, availability, and acceptability of new health technologies for those most in need: Defining the value of a technology must be driven by the local communities and countries that will use the product. Product developers must understand and address the needs and wants of those who will ultimately be implementing and benefiting from the product. Achieving global access does not guarantee local access. NPPDs and partners may achieve global access targets (such as receiving World Health Organization prequalification) but this does not guarantee that the technology will be accessible at the national or subnational level. Relying on national average income status can undermine access for the poorest populations. In many middle-income countries, the burden of disease is among poorer populations who have not benefitted from strengthening economies. Therefore, the poorest populations, often the most at risk, are unable to access new technologies. Securing donor recognition that access activities need to be initiated early is critical. In order to ensure there is not a lag between licensing a product and making it available in the health system, NPPDs and partners must start planning for access from the beginning of the development process. Support from donors for these activities is critical. Demonstrating a niche in the market for manufacturers is essential to incentivize their investment. Manufacturing partners must understand the value that they bring to a market to enable them to invest time, effort, and expense to developing products for poverty-related and neglected diseases and conditions. Any delays in planning and implementing an access strategy can result in significant lag time from licensure to actual delivery in country. A product that needs to be retrofitted for affordability, availability, and acceptability will result in a costly and time-consuming development process. Therefore, as the GHTC’s new paper reveals, it is critical that NPPDs and partners address these principles from the beginning of the product development process.

The US Agency for International Development (USAID) is the nation’s lead foreign assistance agency. Throughout its 50-year history, USAID has worked with other government agencies, the private sector, and nongovernmental organizations to support the development and introduction of affordable health products appropriate for addressing the diseases and health issues in developing countries. Today, the GHTC is launching a new blog series to highlight the impact of USAID’s commitment to global health research and development (R&D). The series will showcase stories from individuals who have benefited from the agency’s support and investment in R&D—as well as people whose lives would vastly improve if USAID were to expand its support for health R&D into new areas. Our first post is by Ted Prusik, senior vice president of Temptime. Temptime is a New Jersey-based company that has made a huge impact in global health with support from USAID. Ted Prusik is a senior vice president at Temptime, a New Jersey-based company that has made a huge impact in global health with support from USAID. Credit: Temptime. Q: Temptime has a long history of working with USAID to improve global health. How did this partnership begin, and what have been some of the global health research successes you’ve achieved with USAID support? Temptime’s history is a wonderful case study on the effectiveness of US investments in efforts to solve critical global health problems. In the early 1980s Temptime, then called Lifelines, developed a unique technology that gradually changes color when exposed to time and temperature. The original idea was to use this unique chemistry for food spoilage applications. At the same time, the World Health Organization (WHO), USAID and the global health nonprofit PATH identified a pressing need to improve the effectiveness of immunization programs in the developing world. Vaccines are heat sensitive. Exposure to excessive heat can result in the loss of efficacy, leaving children who are vaccinated with heat damaged vaccines vulnerable to disease. But vaccines are stable enough to withstand some exposure to heat. Immunization program managers faced the following issues: How to better protect children from receiving a heat-damaged vaccine that was no longer efficacious? How to prevent the wastage that is common in immunization programs when health care workers presume that the vaccine is heat damaged even when it is not? USAID, WHO, and PATH recognized that the answer was a time-temperature indicator, put on each unit of vaccine, that would clearly signal when the vaccine had been exposed to a pre-determined heat load. The technology that Temptime was working to develop for the food industry was a potential solution for this application: scientifically based, predictable, easy to read, and cost effective. The application of the Temptime technology to the need identified by USAID, WHO, and PATH resulted in the development of the vaccine vial monitor, or VVM, specifically designed for oral polio vaccine. The VVM is a small circular indicator that is applied on each vial of vaccine and clearly indicates whether or not that specific vial has been exposed to excessive heat. Q: Temptime also has a notable track record of working with other partners to improve global public health. How have your partnerships with nonprofit organizations like PATH helped you to maximize investments from government agencies like USAID? The VVM is an illustration of how public-private partnerships are one of the most effective ways to deploy new technologies to support global health and how successful partnerships work. In the case of the VVM, each party brought something unique to the development. PATH, WHO, and USAID were able to clearly define the health need because of their on-the-ground presence in developing countries. From this knowledge, they were able to specify key technology requirements needed to successfully develop and deploy the VVM. Industry as a private partner could then focus its resources and capabilities on what it does best: developing and manufacturing scientifically proven, time-temperature monitoring devices. Often, while a technology exists to address the basic market need, adaptation of that technology is required to truly solve the specific global health problem. Having the knowledge of the product specifications from public sector experts on the ground—as well as the commitment to deploy the technology once it is developed—takes much of the risk away from the private sector investment. Q: Temptime products created with USAID support—like the VVM—have proven tremendously successful at saving lives and improving health worldwide. What have been some of the most notable public health benefits of the VVM? PATH estimates that between 2002 and 2012, VVMs allowed health workers to recognize and replace more than 860 million doses of overexposed vaccine and to deliver 1.45 billion more doses in remote settings—helping to save more than 150,000 lives and reduce illness for countless others. The original intent and benefit of the VVM was to ensure that vaccines overexposed to heat not be administered to children. But the introduction of this technology through the USAID/PATH/WHO/Temptime partnership has had a multiplier effect in public health programs. For example, because the VVM contributes to the effectiveness of vaccination programs, it also plays an important role in improving health outcomes and reducing health care costs. In India, for example, there are 366 million children under age 14. If 5 percent of these children received temperature-damaged vaccines that were no longer efficacious, the ongoing medical costs to treat these children for the contracted disease would exceed $1 billion annually. By contributing to the effectiveness of immunization programs, the VVM improves outcomes and frees up dollars that can be spent on other key health initiatives. Q: New tools developed for global health needs often help improve health right here at home. What have been some of the domestic health benefits of the VVM? In the case of the PATH/USAID/WHO/Temptime partnership, there were also multiple benefits to US public health. The original investment by USAID enabled Temptime to develop a technology platform that could be leveraged for other important applications. The same technology that protects children in immunization programs is used on ready-to-eat meals and rapid skin decontamination lotion for US troops. Temptime over the years has also developed new technologies that are used to support patient protection in the US. These include freeze monitoring technology used on the H1N1 vaccine in 2009, currently used in each shipment of vaccine to participating providers in the US Vaccine for Children program, as well as numerous pharmaceuticals and medical devices. Q: Temptime’s experience also demonstrates that investments in global health research and development not only help save lives around the world—they’re also a smart economic investment. What impact has USAID funding had on Temptime’s ability to create jobs, expand your business and contribute to the domestic economy? Beyond the public health benefits worldwide, new health tools and the partnerships that develop them bring benefits to US industry. In the case of Temptime, we have built a small but growing company that continues to hire and develop people. We also manufacture all of our technologies in the US and export them globally, so in our own humble way we are contributing to the improvement of the US trade deficit.