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The University of North Carolina at Chapel Hill, a leading global public research university with significant expertise in HIV basic and clinical research, and GSK, a global, research-based pharmaceutical and healthcare company with a legacy of success in developing treatments for HIV, announced the creation of the dedicated HIV Cure center and a jointly owned new company that will focus on discovering a cure for HIV/AIDS. This unique public-private partnership will redefine the traditional way of conducting research and create a new model to seek the breakthroughs needed to tackle an extraordinarily challenging global health issue.
The HIV Cure center will be located on the UNC-Chapel Hill campus and will focus exclusively on finding a cure for HIV/AIDS. The new company, Qura Therapeutics, will handle the business side of the partnership, including intellectual property, commercialization, manufacturing and governance. Together, the HIV Cure center and Qura Therapeutics will serve as a catalyst for additional partners and public funding that will likely be needed to eradicate HIV worldwide. The collaboration is also expected to recruit and attract top talent from around the world.
“The excitement of this public-private partnership lies in its vast potential,” said UNC-Chapel Hill Chancellor Carol L. Folt. “Carolina has been at the forefront of HIV/AIDS research for the last 30 years. This first of its kind, joint-ownership model is a novel approach toward finding a cure, and we hope it serves as an invitation to the world’s best researchers and scientists. Today, Carolina’s best are taking another major step in the global fight against HIV/AIDS.”
“Like UNC, GSK has a long legacy of HIV research success. From the development of the world’s first breakthrough medicine for HIV patients in the 1980s, to our leadership in the market today through ViiV Healthcare, we’re continuously challenging ourselves to meet the needs of patients,” GSK CEO Sir Andrew Witty said. “This partnership is a testament to our past and present leadership, innovation and commitment to this field. We are inspired by the confidence that with the right resources and research teams, we will be able to make a meaningful impact towards a cure for HIV.”
UNC-Chapel Hill and GSK will focus on the latest scientific approaches to curing HIV, including a leading research approach toward an HIV cure, sometimes called “shock and kill.” This approach seeks to reveal the hidden virus that persists in people with HIV infection despite successful drug therapy, and augment the patient’s immune system to clear these last traces of the virus and infected cells. Part of this new paradigm was first tested at UNC-Chapel Hill and in 2012 a team led by UNC-Chapel Hill researchers demonstrated that latent HIV might be unmasked by new therapies. Recently, researchers at the university received Food and Drug Administration approval for a study in HIV-positive volunteers to combine this technique and an immune-boosting strategy.
“After 30 years of developing treatments that successfully manage HIV/AIDS without finding a cure, we need both new research approaches to this difficult medical problem and durable alliances of many partners to sustain the effort that will be needed to reach this goal,” said Dr. David Margolis, Carolina professor of medicine and leader of the Collaboratory of AIDS Researchers for Eradication (CARE). “The ‘shock and kill’ approach has shown significant promise in early translational research on humans and has been the focus of research for the last several years.”
“Although today’s treatments for HIV mean that millions of lives have been saved, people still have to take a lifetime of treatments, which takes an emotional toll and places an economic burden on society that is particularly challenging in countries with limited resources,” said Zhi Hong, senior vice president and head of the Infectious Diseases Therapy Area Unit at GSK. “This is why we must dedicate the next 30 years to finding a cure and scaling it up so that one day we will end the HIV/AIDS epidemic.”
Through the new company, GSK will invest $4 million per year for five years to fund the initial HIV Cure center research plan, and a small research team from GSK will move to Chapel Hill to be co-located with UNC researchers. The University will provide world-class laboratory space on its medical campus for the HIV Cure center and the new company. GSK will be contributing its expertise and know-how in medicines discovery, development and manufacturing, and UNC-Chapel Hill will bring to the table its research and translational medicine capabilities, talent, as well as access to patients and funding.
GSK’s investment in the HIV Cure center is separate from its investment in the discovery of novel antiretroviral (ARV) therapies in support of ViiV Healthcare, a global specialist HIV company dedicated to delivering advances in treatment and care for people living with HIV and owned by GSK, Pfizer and Shionogi. GSK’s HIV Discovery Performance Unit will continue its work on new ARVs in the Research Triangle Park area of North Carolina. ViiV has significant clinical expertise and will play an advisory role to the HIV Cure center and Qura Therapeutics.
Links to media coverage of the announcement from around the world include:
The New York Times
Bandages, anesthesia and syringes. These are common medical supplies hospitals in the United States always stock. But in Malawi, drug shortages occur frequently, says Innocent Mofolo, MSc, Associate Country Director of UNC Project Malawi. That’s why he decided to look for ways to combat this problem.
Mofolo and physician Jeff Wilkinson applied for and received a donation of supplies worth $1 million from Direct Relief International, a non-profit that “supports existing health providers over the long term, delivering aid without regard to race, ethnicity, political or religious affiliations, or ability to pay.”
“We have seen people suffering in the hospital because there is no medicine,” says Mofolo. “This donation will help those in need get medications for free.”
The 20 pallets of medications and supplies included antibiotics, catheters and post childbirth maternity pads. The donation will serve the patients of Kamuzu Central Hospital, Bwaila Hospital, Kasunga District Hospital and Child Legacy International. Mofolo enjoys knowing his fellow countrymen and women will now have access to these medications and supplies when they visit any of hospitals.
“I’m happy to help my fellow Malawians,” he says.
As a young boy growing up in Malawi, Gift Kamanga dreamed of overcoming his challenging circumstances and making a meaningful impact on the lives of his fellow Malawians. Inspired by Scottish missionary doctor David Livingstone and Malawi’s first president Hastings Kamuzu Banda, Kamanga strove to follow their examples of creating successful careers from humble beginnings. On May 9, UNC will bestow a doctoral degree on Kamanga.
“Earning a doctoral degree is quite an achievement. My doctorate is historic because I am the first one in my family to take this lead,” says Kamanga. “My strong determination and zeal even amazed my parents, who only did up to eight years of school. I made it a point to use every opportunity at my disposal. I adopted the motto: ‘Making the best of what I am.’”
Kamanga began his career at UNC-Project Malawi in 2000 as a clinical consultant for the HIV Prevention Trials Network (HPTN) study 024. This trial assessed the use of antibiotics to reduce chorioamnionitis-related perinatal HIV transmission. Chorioamnionitis is an inflammation of the fetal membranes due to a bacterial infection. HIV infected white bloods cells from the mother can then infect the baby. Six years later, Kamanga joined UNC-Project Malawi full time to lead another HIV study. The trial, Acute HIV-1 Infection Prospective Cohort Study, studied the immune system in detail to inform HIV vaccine development. His passion for research inspired UNC-Project Malawi leadership to invest in Kamanga’s education.
“After my clinical medicine training in Malawi, UNC-Project Malawi supported my public health training in the United Kingdom and the United States,” Kamanga says. “They introduced me to the prestigious University of North Carolina at Chapel Hill to fulfill my dream of reaching my full potential through the doctoral training. I feel very good about receiving such great, quality training at UNC.”
Kamanaga credits Myron Cohen, MD, Director of UNC’s Institute for Global Health & Infectious Diseases, which supports the Malawi site, and Irving Hoffman, PA, MPH, U.S. Director of UNC-Project Malawi, with recognizing his interest in global health and connecting him with resources to expand his training.
“We met Gift Kamanga shortly after he finished his training as a Clinical Officer in Malawi. He quickly demonstrated his energy, motivation and creativity. Most importantly, he got things done,” says Cohen. “Many, many successful research projects represent Gift’s hard work. Gift’s growth as a leader and a scholar were all about his talent, ability and commitment. It was a privilege to help along the way.”
“Gift came from a very humble beginning and for him to have received a PhD from one of the greatest universities in the world is a true testament to his personal vision, perseverance, sacrifice and intelligence,” says Hoffman. “Gift is a born leader and I have always believed in his potential. UNC is lucky to have Gift on our team.”
Kamanga currently provides leadership to several HIV prevention initiatives at UNC-Project Malawi, including an upcoming HIV vaccine trial. He is grateful that his educational training has prepared him to not only work at the UNC site in Malawi, but with any organization or government entity with a public health focus.
“I have worked in areas of HIV prevention, maternal and neonatal health and other sexual reproductive health areas,” Kamanga says. “My wish is to continue my expertise and leadership in these areas. The health of people is paramount. My satisfaction in promoting the health of the public is because healthy people are the ‘engine’ for social economic development.”
It is difficult to choose one event in Doug McAllister’s life to make the focus of a profile. He served five years in the Navy, but only spent 10 days on a ship. He married his second grade classmate after the two reconnected in Florida. He knew Michael Bloomberg before he was famous. He was working five blocks from the World Trade Center on September 11th. He earned his undergraduate degree at UNC and after 10 years of retirement decided to apply for a job at his alma mater.
“I flunked retirement,” McAllister says with a laugh. “My friends were shocked when I told them I was applying for jobs and interviewing at UNC. At first I thought UNC contacted me because they had to reach out to all applicants. But by the second interview, I realized they were serious. I used to be on the other side of the table when I worked in New York City, so I wasn’t sure if my age would make me an unattractive candidate.”
In December 2014, McAllister became UNC’s Institute for Global Health & Infectious Diseases receptionist. He is the first person staff, students and visitors meet when they enter the Institute’s headquarters on Mason Farm Road. He enjoys interacting with all of the people who work at the Institute – from physicians to accountants – on a daily basis.
“IGHID was intimidating at first because before I worked here, I didn’t fully appreciate its wide scope and how recognized it is globally,” McAllister says. “I am so pleased to work here. Everyone has been generous with their time and support.”
This is a complete career change for McAllister who majored in European history at UNC, worked in air intelligence in the Navy and then spent three decades in the bond business in New York City.
“Most people who work in bonds work on the trading floor, buying and selling bonds for their clients. After an initial training period, they move on to a junior trading sales research position. The turnover is high, so I interviewed a lot of people. Although the firm I was with was bought by others companies a few times, I was with the same company for my entire career, which doesn’t happen often,” McAllister says. “There are similarities about my career in bonds and my work at UNC. In both jobs, no two days are alike and I enjoy that.”
Eric Schneider, Assistant Director of the Institute for Global Health & Infectious Diseases, hired McAllister. He said a certain moment during McAllister’s interview left him with no doubt that McAllister was the right person for the position.
“During the interview, Doug conveyed that his vision for the position was lined up with mine, when he said, ‘I believe I can be the face of the Institute.’ I had previously described the high visibility aspect of the receptionist position as being ‘the face of the Institute.’ After that, it did not take much more for Doug to convince the committee that we should select him as our candidate,” says Schneider. “Working with Doug has been great. He is friendly, engaging, humble and sincere. The feedback I hear from faculty and staff alike is that Doug is well liked and respected.”
Before working at UNC, McAllister volunteered at UNC’s Kenan-Flagler Business School. Since he had a strong background as a hiring manager, he helped business school students hone their communications skills through mock job interviews. A native North Carolinian, McAllister is also enjoying becoming reacquainted with his home state.
“When you grow up in an area as a young person, you don’t appreciate it until you leave,” McAllister says. “When I attended UNC, there were only 4-5,000 students and now there are close to 30,000. A lot has changed, but many things are still the same. My wife and I had forgotten how delightful the weather is here.”
He and his wife have one son and a grandson who is nine. McAllister enjoys cheering on the sidelines of his grandson’s basketball and soccer games. He also brings his grandson to UNC football and basketball games with the hopes that he will someday be a Tarheel, too.
“I would love to see him come to UNC,” McAllister says.
Dr. Nilu Goonetilleke & Team Jumpstart Immune System with Implications for HIV Cure & Vaccine Research
The Explorations in Global Health faculty research grants are designed to foster the development of research partnerships and projects in global health. Grants are made to UNC faculty for international travel or to bring international colleagues to campus to establish or maintain research relationships (with the aim of applying for external funding) or to undertake small-scale, discrete research projects with international collaborators.
This year, the IGHID is supporting six, diverse projects in Nicaragua, West Africa, Indonesia, Sri Lanka, Tanzania and Mexico.
Will you be next? The 2015-16 call for applications will be released in October or November.
Sylvia Becker-Dreps, MD, MPH, Assistant Professor, Department of Family Medicine, UNC School of Medicine, and Ralph Baric, PhD, Professor of Epidemiology, UNC Gillings School of Global Public Health
Gastroenteritis is one of the most common causes of child mortality worldwide. Following the global roll-out of rotavirus vaccines, norovirus is now the most commonly detected enteropathogen in children with gastroenteritis, both in the community and in health facilities in developing countries. In Nicaragua, norovirus was detected in over one in five cases of gastroenteritis. A better understanding of risk factors for norovirus diarrhea and norovirus transmission patterns is crucial to develop effective control strategies. In particular, candidate norovirus vaccines are now entering clinical trials, and our work may inform targeted immunization approaches to avoid spread of norovirus within households.
Ebola in West Africa
“Longitudinal study of Ebola survivor cohort to characterize the clinical sequelae of infection as well as create a biorepository of blood, semen, and vaginal secretions to determine the compartmental dynamics of virus replication and shedding”
William Fischer, MD, Assistant Professor of Medicine, Division of Pulmonary and Critical Care Medicine, UNC School of Medicine, and David Wohl, MD, Associate Professor of Medicine, Division of Infectious Diseases, UNC School of Medicine
The Ebola epidemic currently devastating West Africa has evolved into an unprecedented humanitarian crisis. As of January 14, 2015, 21,296 infections and 8,429 deaths have been reported by the World Health Organization (WHO) – a likely underestimate but already eclipsing the numbers of infections and deaths in all previous Ebola outbreaks combined. While the rate of confirmed cases of Ebola is declining in Liberia and Sierra Leone, it is certain that regardless of the short-term trends in the epidemiology of this outbreak, the social, economic and healthcare dynamics in West Africa will long be altered. The proposed studies will better characterize the viral dynamics in urogenital compartments in a large survivor cohort in order to inform public health policies. In addition to addressing many unknown questions about EVD, the proposed investigations will provide opportunities for Dr. Fischer to develop skills in clinical research design and implementation in outbreak settings that will complement his expertise in emerging viral pathogens.
Malaria in Indonesia
“Malaria Relapses in Indonesia – Detecting genetic signatures of Plasmodium vivax relapse in Indonesian soldiers”
Jessica Lin, MD, Assistant Professor of Medicine, Division of Infectious Diseases, UNC School of Medicine
Plasmodium vivax, the most widespread human malaria parasite, causes over 100 million malaria episodes each year. Those infected can suffer periodic relapses, yet few persons receive adequate antirelapse therapy with primaquine because of the long courses needed and the drug’s side effects. Hence, P. vivax relapses drive ongoing transmission and represent an important obstacle to malaria elimination.
In Southeast Asia, up to two-thirds of P. vivax infections lead to relapse. Relapse potential seems to be intrinsically determined by parasite genetics: historically, those inoculated with different vivax strains exhibited different patterns of relapse. Unfortunately, studies of vivax relapse in endemic settings have been hindered by an inability to distinguish relapses (arising from activation of hypnozoites) from re-infections (due to new mosquito bites). One way to overcome this is to study relapses in persons returning to malaria-free areas where re-infection is impossible. This project aims to achieve a better understanding of the genetic determinants of P. vivax relapse by detecting genetic signatures of relapse among a unique cohort of returning Indonesian soldiers using next generation sequencing methods.
Nathanial Moorman, PhD, Assistant Professor, UNC Department of Microbiology and Immunology
Dengue virus (DENV), transmitted by mosquitos, is the causative agent of dengue fever (DF) and dengue hemorrhagic fever (DHF). Once a public health problem in only a handful of countries in Southeast Asia, today DENV is endemic in over 100 countries worldwide, with over 400 million annual DENV infections resulting in more than 500,000 cases of severe DHF and 20,000 deaths. Dengue pathogenesis is strongly influenced by both host and viral factors. Amongst host factors, the role of pre-existing immunity is a topic of intense study. While it is well established that some dengue virus strains are more pathogenic than others, the viral genetic determinants of severe dengue remain to be defined. In 2009, a new strain of DENV1 emerged that caused more severe disease. This new DENV1 strain is responsible for the majority of current clinical dengue in Sri Lanka.
The project directly advances global public health by beginning to define the DENV genetic determinants underlying viral disease. This project also advances global public health by facilitating a nascent collaboration between Dr. Aruna Dharshan, Director of Genetech Research Institute (GRI) in Sri Lanka and UNC. Future collaborations will analyze samples from patients infected with the same DENV1 genotype that develop mild (DF) versus severe (DHF) disease, in order to determine how DENV1 genetic variation influences clinical outcome.
Christina Shay, PhD, Research Assistant Professor, Department of Nutrition, UNC Gillings School of Global Public Health
The incidence of type 1 diabetes (T1D) is growing around the world and these trends are also evident in Sub-Saharan Africa. Few population-based estimates exist for the prevalence, incidence, or clinical characteristics of T1D in Sub-Saharan Africa and the majority of available reports were published several decades ago. This lack of knowledge has contributed to limited resources for T1D detection and treatment in this region and has led to significantly higher rates of diabetes-related complications and premature mortality in individuals with T1D in Sub-Saharan Africa compared to Western regions. At this critical moment in history, trends in T1D are dynamic yet poorly understood from a global perspective. Understanding the epidemiology and natural history of T1D in Sub-Saharan Africa is essential to improve patient care in this region where T1D is rapidly emerging as an urgent health care need.
Lindsey P. Smith, PhD, Research Assistant Professor, Department of Nutrition, Gillings School of Global Public Health
Currently, the prevalence of obesity in Mexico is over 33 percent for children 1-18 years old and about 70 percent for adults; and in 2006, the prevalence of Type 2 diabetes (T2D) in adults was 14.4 percent. Concurrent with the rise in obesity and diabetes were large increases in a sugar-sweetened beverage (SSB) and nonessential food (often termed ‘junk food’) intake. In an effort to prevent continued increases in obesity and diabetes, in January 2014, the Mexican government implemented a 1 peso per liter excise tax on nonalcoholic beverages with added sugar, and an 8 percent ad valorem tax on nonessential foods with energy density ≥ 275kcal/100g, meant to target foods high in added sugars or solid fats (e.g. chips, snacks, candy, etc.). Together, these taxes cover about 20-25 percent of daily caloric intake in Mexico across age groups. Our team’s preliminary analysis of the SSB tax shows it reduced SSB purchases by 5 percent three months after the tax went into effect. Recently, a short-lived Danish saturated fat tax appeared to change food purchasing behavior. However, it is unclear how these taxes will impact purchases over the long-term, how they will impact the nutritional quality of what people buy, and whether these changes will be greater among low socio-economic subpopulations (SES). The overarching goal of this project is to examine how Mexico’s SSB and “junk food” taxes affect the nutritional profile of food and beverage purchases of the Mexican population.