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The Global Health Technologies Coalition (GHTC) is excited to announce that the UPMC Center for Health Security has joined the coalition as its 26th member. The Center is an independent nonprofit organization that works to protect people’s health from the consequences of epidemics and disasters and to ensure that communities are resilient to major challenges. “At the UPMC Center for Health Security, we examine how scientific and technological innovation can strengthen health security,” said Anita Cicero, chief operating officer and deputy director at the Center. “Our goal is to contribute independent research and analysis that will impact both policy and practice over a range of health challenges, including emerging infectious diseases, pandemic flu, and the potential for biological accidents or threats. An important part of our mission is connecting diverse communities of health and science experts, industry representatives, and government officials to strengthen collective efforts to improve health security. Therefore, we are thrilled to join the Global Health Technologies Coalition and look forward to working with GHTC and its members to advance innovations and policies that strengthen our ability to prevent and respond to existing and emerging health challenges.” Based in Baltimore, Maryland, the Center was originally founded in 1998 as an organization dedicated to diminishing the public health consequences of biological threats. In 2003, the Center was recruited to join the University of Pittsburgh Medical Center (UPMC) and became the Center for Biosecurity of UPMC. Over the next decade, the Center expanded its work to address a broader range of issues in the health security field, including the global rise in emerging infectious diseases, a continued risk of pandemic flu, major natural disasters, dependence on vulnerable infrastructure, outbreaks of foodborne illness, and the potential for biological, chemical, or nuclear accidents or intentional threats. In 2013, the Center changed its name to the UPMC Center for Health Security to reflect these expanded priorities. “GHTC welcomes the UPMC Center for Health Security to our community of nonprofit product developers, think tanks, academic institutions, and advocacy organizations working to advance innovations that save lives,” said Erin Will Morton, Coalition Director of GHTC. “The Center’s independent research, analysis, and policy recommendations are highly valued by decision makers in the health and security fields, and the Center’s perspective will add tremendous value as GHTC educates policymakers and advocates for research and development of new tools to prevent, diagnose, and treat global diseases. For more information about the UPMC Center for Health Security, visit www.upmchealthsecurity.org.

This Monday, May 18 was HIV Vaccine Awareness Day (HVAD), and GHTC members AVAC, the International AIDS Vaccine Initiative (IAVI), and the Bill & Melinda Gates Foundation convened leaders in the field to discuss the state of HIV and AIDS vaccine research and development (R&D). The discussion—which was hosted as both a briefing for congressional staffers and a dialogue among partners—included Dr. Gaudensia Mutua of the Kenya AIDS Vaccine Initiative, Dr. Yegor Voronin of the Global HIV Vaccine Enterprise, and Michelle Dees of IAVI. With worldwide investment in HIV and AIDS vaccine research on the decline since 2007 and some members of Congress calling for further cuts to US investment in this area, the discussion illustrated four key reasons why now is the time to ramp up—rather than scale down—investment in HIV and AIDS vaccine R&D. (1) We are closer than ever to developing an HIV and AIDS vaccine Despite the complexity and mutability of the HIV virus and the difficulty of producing a vaccine, there are currently thirty different HIV and AIDS vaccine candidates in the research pipeline. To ensure that the best candidates advance, strong investments are needed to support this diverse portfolio of vaccines. While most of these candidates are still being tested for safety and for evidence of an immune response, one candidate has already demonstrated partial efficacy. The evidence from that clinical trial has since been used to adjust the vaccine regimen, and the new regimen is currently being tested in another round of clinical trials. (2) We cannot eradicate HIV and AIDS without a vaccine While we have made immense progress in combatting HIV and AIDS with AIDS-related deaths falling by 35 percent since the peak in 2005, eradication will not be possible without a vaccine. For every one person who starts treatment, two more are infected, resulting in 2.1 million new infections and 1.5 million AIDS-related deaths each year. The stigma surrounding the disease continues to impede diagnosis and treatment efforts globally. While existing tools—from antiretroviral treatment to voluntary male circumcision—have had a major impact on reducing the spread of the disease, a vaccine is needed to completely protect against infection. (3) Investments in HIV and AIDS vaccine R&D are producing broader impacts on global health The HIV virus is highly mutable, and is constantly adapting to better fight the immune system. Consequently, many of the standard approaches to vaccine R&D have not proved fruitful. One of the most common types of vaccines—a live attenuated vaccine—involves the use of a weakened, but live version of the pathogen to stimulate the immune system to develop antibodies. The mutability of the virus has made this approach impossible and unsafe. Alternately, scientists often examine the immune response of a survivor to develop a vaccine that will imitate or enhance that process. As no one has ever rid their body of the HIV virus once infected, researchers started the search without a roadmap for what might work. While developing a vaccine that can defend against an ever-changing virus has been a major challenge for scientists, the search has led to invaluable insights into the immune system and progress in vaccinology writ large. Additionally, investments in strengthening HIV and AIDS vaccine R&D capacity in endemic countries have produced broader research and health benefits. For example, the Kenya AIDS Vaccine Institute (KAVI) in Nairobi, Kenya, was established primarily to gather data and conduct clinical trials. However, in addition to the 11 vaccine candidates it has tested in the past 14 years, the institute trained more than 1,500 people between 2010 and 2014. These trainees have been educated in everything from laboratory management and clinical practice to grant writing and vaccine literacy. Additionally, the KAVI facility has been used to test vaccines and drugs for other infectious diseases including Ebola, has helped provide trial participants access to treatment options they may otherwise not have received, and has played a role in combating the stigma of HIV and AIDS in the local community. (4) A vaccine for HIV and AIDS would have enormous financial benefits While the human impact of HIV and AIDS is more than enough reason to invest in vaccine R&D, the continued financial cost of treatment should also be noted. The President’s Emergency Plan for AIDS Relief, which reaches nearly 5 million people each year, spends US$338 per patient per year on HIV and AIDS treatment, and that’s down from an initial $1,100. A vaccine could prevent between 5.2 and 10.7 million new infections and could consequently save $46 to $95 billion over ten years—just in treatment costs. For more information, check out these key messages from AVAC or this video featuring researchers and clinicians across the HIV vaccine field.

How can we get Big Pharma to invest in low-cost antibiotic research and development (R&D)? The Review of Antimicrobial Resistance—a research group led by economist Jim O’Neill and established by United Kingdom Prime Minister David Cameron—proposed innovative answers to this question in its recently released third report, focused on the R&D pipeline for antibiotics. The report calls for the creation of a fund worth US$16 to 37 per decade to provide cash incentives of $2 to 3 billion for pharmaceutical companies that develop new antibiotics and agree to sell them on a not-for-profit basis. Additionally, the report calls for the creation of a Global Antimicrobial Resistance Innovation Fund, worth $2 billion, to support basic research into antibiotics and diagnostics that would enable the strategic use of antibiotics by primary care physicians. O’Neill reiterated that the cost of inaction around antimicrobial resistance could be as high as $100 trillion and 10 million lives by 2050, as detailed in the first report. A group of experts, including Executive Director Bernard Pécoul of the Drugs for Neglected Disease initiative—a member of the GHTC—are calling on governments and other donors to establish a pooled fund to address R&D gaps for antimicrobial resistance, emerging infectious diseases, and neglected diseases. The experts address the aforementioned proposal to incentivize R&D for antibiotics, warning against a fragmented approach, and calling for coordination in not only financing, but throughout the R&D process. Liberia is now considered free from Ebola, after 42 days—twice the maximum incubation period—without a new case, and Guinea and Sierra Leone reported only seven and two cases last week, respectively. As the West African epidemic comes to a close, clinical trials for experimental Ebola vaccines and drugs are underway. The World Health Organization (WHO) hopes that it will be able to test the efficacy of the two drugs, Zmapp and sIRNA, but realizes that it may be challenging to determine the efficacy of the two vaccine candidates, developed by GlaxoSmithKline and a partnership between Merck and NewLink Genetics. Marie-Paule Kieny, assistant director-general for health systems and innovation at the WHO, noted that there are alternative forms of efficacy testing, such as the “Animal Rule,” under which the US Food and Drug Administration will approve a vaccine if it has proven safe for humans and effective in animals with similar immune systems as humans. This rule can be applied for rare diseases or in cases where testing on humans would be unethical. The WHO also hosted an experts meeting on Ebola R&D last week, with the goal of creating a framework for expediting R&D in future outbreaks. While Kieny highlighted recent progress, with drug and vaccine candidates for Ebola moving through the pipeline in months rather than years, an existing framework would allow the WHO to respond rapidly. TB Alliance, a member of GHTC, has initiated clinical trials of “Nix-TB,” the first, all-oral drug regimen for extensively drug-resistant tuberculosis (XDR-TB). TB Alliance is sponsoring the trial in partnership with Janssen Pharmaceutica—who provided a royalty-free license for one of the drugs in the regimen—and three hospitals in South Africa where Nix-TB is being tested. The regimen is comprised of three drugs, including one that is currently undergoing clinical trials independent of Nix-TB and a general antibiotic that has been used off-label to treat TB. There is currently no approved treatment for XDR-TB, and only 16 percent of patients receiving treatment are cured after two years. According to TB Alliance President and CEO Dr. Mel Spigelman, “The launch of Nix-TB is a critical step to achieve the vision of a truly short-course, simple, affordable, and well tolerated universal treatment regimen.”

United States Representatives Jim Cooper (D-TN) and Cynthia Loomis (R-WO) introduced the Research for All Act last week which calls for the inclusion of more women in clinical trials for products submitted for US Food and Drug Administration (FDA) approval. Drugs can have different effects on women and men, and as women are often underrepresented in clinical trials, there have been products on the market that are unsafe or less effective for women. While the FDA has made strides in recognizing and addressing this disparity and its potential consequences, this bill would require the FDA to “ensure that the design and size of clinical trials for products granted expedited approval … are sufficient to determine the safety and effectiveness of such products for men and women using subgroup analysis." Opponents fear that this legislation could increase the cost or length of clinical trials and consequently, product development. Mark Prausnitz, director of the Center for Drug Design, Development, and Delivery at the Georgia Institute of Technology, has created a small patch covered with 100 minute needles intended to administer vaccines without a syringe and needle. Not only would the vaccination be virtually painless, but it could be self-administered, and it would not need to be refrigerated, making it accessible in remote areas with a paucity of skilled health workers or unreliable electricity. The patch has been used successfully to administer the measles vaccine to animals, and clinical trials in humans are expected to start in 2017. Prausnitz will also be testing a flu vaccine patch on 100 volunteers this summer. While the vaccine’s cost will remain the same, Prausnitz hopes the patch will be cheaper than syringes and needles. Researchers at the University of Notre Dame have created simple, paper cards that can identify low-quality or counterfeit malaria medicines. The cards have 12 bars that change color when exposed to a crushed-up pill, and those bars indicate the presence and quantity of six different antimalarial agents. One third of antimalarials in sub-Saharan Africa are either entirely fake, diluted with different ingredients, or contain inadequate amounts of the antimalarial agents. These drugs can cause drug resistance and the additional ingredients can be harmful to patients. The cards, which currently cost US$0.50 each, are intended for use by pharmacists and customs offices, but only work for non-artemisinin-based antimalarials. The leading approach to treating river blindness—mass administration of the medicine ivermectin—can be deadly to patients co-infected with Loa loa worms. However, the detection of these worms can be a challenge, requiring a microscope and a health worker trained to identify the worms in the patient’s blood. Daniel Fletcher, a professor of bioengineering at the University of California, Berkeley, has developed a microscope that connects to a smartphone, takes a video of a blood sample, and detects the movement of Loa loa worms. The entire process takes about three minutes, a much shorter process than transporting a blood sample to a laboratory and counting the worms individually. While this device is an invaluable diagnostic tool, the article highlights the need for research and development of a drug that can combat both the Loa loa worms and the parasites responsible for river blindness.