As part of the Imagine2030 campaign we want to show that innovation is not just something for the future – it is making a difference in the world today. In a guest post originally published on their own site here, the Global Health Technology Coalition’s (GHTC) Jamie Bay Nishi and Marissa Chmiola talk about the ways in which science is already transforming global health and saving lives. Find our more about GHTC here.
As part of the Imagine2030 campaign we want to show that innovation is not just something for the future. Medical advances being made right now will shape how we fight diseases of poverty in the future, and are delivering changes every day. It will be these advances, and the organisations behind them, that will bring us closer to our goal: an end of diseases of poverty by 2030.
As we shift our focus ahead of World Malaria Day on April 25, we’re delighted to be able to showcase the work of people at the frontline of the fight against malaria – where our partners at PATH are working together with community health workers to stop the spread of the disease.
As part of the Imagine2030 campaign we want to show that innovation is not just something for the future. Biomedical advances being made right now will shape how we fight diseases of poverty in the future, and are delivering changes every day. We’re also not just focused on new medicines or tools, but also on innovative ideas about how to shape the global fight against infectious diseases. To get a an understanding of the latest international initiative set up to combat disease, we spoke with the interim CEO of the Coalition for Epidemic Preparedness Innovations (CEPI), John-Arne Røttingen.
Can you tell us a little bit about why CEPI was set up, and what makes it unique?
Repeated outbreaks, most recently Ebola and Zika, have forged a global consensus that current models for developing vaccines for sporadic epidemic are not working, and that a new system is urgently needed. Four expert reports on the Ebola outbreak response reached the same conclusion: a new system is needed to drive product innovation to prevent and contain future infectious disease epidemics.
CEPI will provide that new system. It will tackle the barriers to epidemic vaccine development, advancing safe, effective and affordable vaccines that can help to contain outbreaks at the earliest possible stage. It will give us the joint global insurance policy we need.
How will it differentiate itself or integrate itself with other, existing initiatives – like Gavi or the EDCTP, for example?
CEPI is very focused on not duplicating ongoing research or other global health efforts. We will stimulate, finance and coordinate vaccine development against priority threats through phase 2 trials, particularly when this development is unlikely to occur through market incentives alone.
CEPI will engage with a range of stakeholders that operate outside of CEPI’s financing scope, including the discovery phase and the manufacturing, procurement and stockpiling side. CEPI is thereby filling a gap between the normative functions of the WHO and the delivery mandate of GAVI. CEPI is founded on the idea of the partners bringing their capabilities to the table, in order to be able to build on existing capabilities to get the best possible preparedness against epidemic threats.
There are lots of organisations working in this field. Who is CEPI partnering with, and who would you like to bring into the coalition?
CEPI’s mission requires close partnerships with a wide range of stakeholders. We have signed a memorandum of understanding with the World Health Organization (WHO), and we have established a partners forum and a Joint Coordination Group, in order to engage with our partners. CEPI’s partners include governments, industry partners, upstream R&D funders, other vaccine development funders, academic institutions and civil society organisations among others. Coordination also has to be tight with agencies and organisations that may take responsibility for stockpiling and deploying eventual vaccines during an emergency response.
What role do you see for research and innovation in the efforts to achieve the SDGs?
Research and innovation have to be key elements in order to make the best possible informed decisions on how to achieve the SDGs. Policies must be founded on knowledge, not on beliefs. Research contributing to meeting the SDGs will span many fields from scientific contributions to developing new insights and technologies to social science contributes that help us understand socioeconomic barriers and facilitators for implementation.
CEPI has picked a number of diseases that it wishes to focus on from the beginning. How and why were these particular diseases selected?
CEPI has chosen to start developing vaccines against MERS, Nipah virus and Lassa fever. We took as starting point the WHO’s R&D Blueprint for Action to Prevent Epidemics. This contains a list of priority pathogens against which the development of medical countermeasures are urgently needed. CEPI’s Scientific Advisory Committee chose these three diseases based on a set of criteria including the risk of an outbreak occurring, transmissibility of the pathogen, burden of disease, feasibility of vaccine development and the current pipeline candidates.
Since there always will be an unknown or a not selected pathogen that we will not be able to predict, CEPI will also fund development of rapid and adaptable vaccine technology platforms, where antigens from a new pathogen can substitute or be added to an existing vaccine.
Do you expect that you will expand the focus of the organisation as it matures?
In the first years CEPI will focus on vaccine development according to our business plan. We are also exploring how we in partnership with other organisations can foster development of diagnostics of relevance to epidemics, and at a later stage we will consider moving on to also fund development of diagnostics and therapeutics.
Will CEPI be involved in advocating for global health research on the international agenda, given its relative lack of prominence in high-level political debates?
CEPI will advocate for global health research. We will of course focus on our mission to increase preparedness against epidemic threats, but also demonstrate that there are similar needs for development of other global health relevant technologies where market incentives are not sufficient.
What do you hope the achievements of CEPI will be when we look back in ten years?
In ten years, I hope we can look back at having advanced 5-10 vaccines to the stage where there is proof of principle (up to and including phase II trials), ready for large scale efficacy trials or emergency use in the event of an epidemic, and that we for some of these also have efficacy data sufficient for some level of regulatory approval. In addition, I hope CEPI will advance 2-3 new vaccine technology platforms that will enable quick vaccine development in case of the emergence of new viruses with epidemic potential.
If you had one hope or wish for 2030, what would it be?
That we as a connected world will be able to advance substantially on all the SDGs. Avoiding deaths and ill health from preventable infectious diseases is one important step.
Learn more about CEPI here.
Go back to imagine2030.org
As part of the Imagine2030 campaign we want to show that innovation is not just something for the future. Biomedical advances being made right now will shape how we fight diseases of poverty in the future, and are delivering changes every day. It will be these advances, and the organisations behind them, that will bring us closer to our goal: an end of diseases of poverty by 2030.
For our focus on Tuberculosis in February 2017, our partners at Aeras share the latest developments in the field of TB vaccines – and why we urgently need innovation to fight the disease. Read on to find out more!
Tuberculosis (TB) has a persistent reputation for being a disease of the past. But in reality, TB kills more people than any other single infectious disease in the world. Today, a third of the global population – more than 2 billion people – are infected with the bacteria that cause TB, and some 10% will get sick and could infect others simply by coughing or sneezing. On average, a person with active TB will spread the disease to 10 to 15 people within a year. TB, especially drug-resistant TB, is a deadly disease and thousands of Europeans are already infected with the bacteria that cause it.
A Global Epidemic and Regional Burden
In 2015 there were 10,4 million cases and 1,8 million deaths from TB disease around the world—and Europe is not immune. In 2015, the European region had 323 000 new cases and 37 000 deaths from TB.
In addition to the health burden, the economic burden of TB is considerable, costing Europe more than €5 billion in treatment and lost productivity each year, much more than the amount it would take to develop a new, more effective vaccine to prevent TB. Although TB treatment success rates in Europe have improved, they were still below global average in 2014, at 76%.
Drug-Resistant TB: Global Threat
The rise in multidrug-resistant (MDR) and extensively drug-resistant (XDR) strains is making TB harder to fight and presents a grave threat to health and security in all countries. Drug resistance is especially prevalent in Eastern Europe, where there is a serious MDR-TB epidemic, with one of the highest levels of MDR-TB globally. Nine of 30 countries with a high burden of MDR-TB are in the European region. And the XDR-TB “superbug” strains have now been found in 117 countries.
New Vaccines Must Be Part of the Fight Against TB
The United Nations’ Sustainable Development Goals and the World Health Organization’s (WHO) End TB Strategy both state that a new TB vaccine is key to ending the TB epidemic. A cost-effective vaccine that prevents adolescents and adults from acquiring, developing and transmitting TB would also lead to less reliance on antibiotics—a critical step in fighting the rising threat of drug-resistance. But a successful vaccine will only be possible with continued innovation and investment from around the globe. So as World TB Day approaches, we ask that you put your support behind vaccine research and development, and stand with us in the fight to end TB.
Learn more about Aeras here.
Go back to imagine2030.org
As part of the Imagine2030 campaign we want to show that innovation is not just something for the future. Medical advances being made right now will shape how we fight diseases of poverty in the future, and are delivering changes every day. It will be these advances, and the organisations behind them, that will bring us closer to our goal: an end of diseases of poverty by 2030.
Focusing on World AIDS Day, and the fight against HIV & AIDS, we sat down to talk with Dr. Anatoli Kamali, PhD, the Regional Director – Africa for the International AIDS Vaccine Initiative, based in Nairobi, Kenya. Dr. Kamali talks about the work of IAVI, and the potential benefits an AIDS vaccine could bring.
DSW: Can you explain a little what IAVI Africa does, and how it is advancing the search for a HIV vaccine?
Dr. Kamali: The International AIDS Vaccine Initiative (IAVI) is a not-for-profit organization with the mission to ensure the development of safe, effective and accessible AIDS vaccines. IAVI’s Africa work is to examine and understand the extent of HIV epidemic in Africa, and to contribute to the development of an AIDS vaccine that can ultimately help to end the epidemic. Our work is conducting epidemiological studies to better understand how the virus is transmitted and how the disease progresses, and engaging communities at the epicenter of the epidemic to generate data that informs vaccine design; evaluating promising AIDS candidates through clinical trials among populations who most need it; capacity building initiatives that enable the conduct of HIV vaccine research in Africa, such as laboratory infrastructure and training the next generation of African scientists; and extensive work on advocacy, policy and communication to promote HIV vaccine research and development, with a special focus on donors, policymakers and political leaders.
The work in Africa is conducted in collaboration with a network of leading scientific institutions in East and Southern Africa (centers of excellence in Uganda, Rwanda and Zambia, Kenya and South Africa). To date we have a network of over 10 clinical facilities with fully equipped pharmacies and accredited laboratories with ability to conduct state of the art research. The facilities are run by highly trained African scientists. Together the clinical centers have capacity of recruiting 5000 volunteers per year in clinical trials. A total of 23 early (phase 1 and 2) AIDS vaccine trials, 25 non-vaccine efficacy trials (phase 2b/3, including for microbicides and treatment), and over 20 epidemiological and mucosal immunology studies have been conducted in collaboration with the research centers in Africa.
The IAVI Africa work is coordinated in the Nairobi Regional office with a hub in Johannesburg.
What kind of an impact would a HIV vaccine have on the fight against HIV & AIDS, in East Africa and beyond?
UNAIDS estimates indicate that by 2015, 36.7 million people were living with HIV/AIDS, of whom 25.5 million live in sub Saharan Africa and 19 million are from eastern and Southern Africa. There were approximately 2.1 million new HIV infections in 2015 and 46% of these were from east and Southern Africa. Since 2010 the number of new infections has remained static despite the current behavioral (ABC strategy) and biomedical interventions (such as PrEP, treatment as prevention, male medical circumcision), and HIV testing and counselling. Thus the current preventive efforts are unlikely to stop the epidemic. We also know that vaccination is the most effective public health strategy for controlling epidemic infectious disease. Therefore, a safe and efficacious AIDS vaccine could be the most cost effective tool to combat the HIV/AIDS epidemic. Modelling studies have indicated that a 70% efficacious and well-adopted vaccine could prevent the majority of annual new HIV infections within 25 years after introduction.
What is the one thing that you would want European politicians and donor governments to help the kind of research that you are doing?
We would ask European politicians and donor governments, as well as civil society and researchers, to keep the development of an AIDS vaccine a priority in health and development agendas, and to help advance the research with supportive policies and sustained funding. The partnership between Europe and Africa can help us achieve this important mission.
What, in your opinion, is the key obstacle standing in the way of global health research from fulfilling its potential?
Global Health research has already achieved the development of important new drugs, diagnostics and vaccines to combat infectious diseases and epidemics, saving millions of lives in our region and globally. Major advances have also been made in AIDS vaccine research – to bring this to the finish line we need more incentives for international collaborations across regions and sectors, and sufficient resources across the entire product development chain.
What is in the development pipeline from IAVI in the coming years?
Over the coming years, IAVI will design and test novel AIDS vaccine candidates based on promising results in early studies with new immunogens and delivery systems. We will also develop innovative preclinical and clinical models that facilitate the rapid prioritization of candidates, and conduct new clinical trials of the promising candidates. There are currently in IAVI’s portfolio 5 vaccine candidates in clinical trials and another 6 in early development / preclinical studies; we also support over 20 additional development efforts for AIDS vaccines and other HIV prevention and vaccine technologies.
What is your one hope for how the world will look in 2030?
My hope is that by 2030 considerable progress will have been made in the discovery of an AIDS vaccine and that ultimately a vaccine will be available to all those who need it globally. The world will hopefully be better prepared to manage global emerging and re-emerging epidemics, and that technology, infrastructure and resources will be available in the current low income countries to reverse the 10/90 gap, with substantially more resources devoted to health research in developing countries, where over 90% of all preventable deaths worldwide occur.
Learn more about IAVI here.
Go back to imagine2030.org
Anatoli Kamali, PhD
He is currently the Regional Director – Africa for the International AIDS Vaccine Initiative, based in Nairobi, Kenya. He trained at Makerere University in Medicine and Surgery and also holds Master of Science at the London School of Hygiene and Tropical Medicine, UK, and PhD in Public Health from the City University, UK. Kamali is also an Honorary Professor, Department of Infectious Disease Epidemiology at the London School of Hygiene and Tropical Medicine. Previously he was the Deputy Director and Head of HIV Epidemiology and Prevention Programme, MRC/UVRI Uganda Research Unit on AIDS, and Head of Department of Epidemiology, Uganda Virus Research Institute, Entebbe.
He has been involved in HIV/AIDS research since 1989, and he has led several prevention studies including early HIV vaccine trials, Ebola vaccine trials, phase III microbicide trials; prophylactic trials among HIV infected individuals, HIV epidemiological studies in general populations and high risk cohorts (female sex workers and fishing communities). He participates in several international scientific collaborations with institutions in the UK, USA and Africa. He was a member of the UK Microbicides Development Programme (MDP) that conducted a large efficacy and safety phase III microbicide trial for vaginally acquired HIV infection.
He has served on several scientific boards for international organizations such as the WHO, UNAIDS, International Partnership for Microbicides, and Data and Safety Monitoring Board for the National Institute of Allergy and Infectious Diseases Division of AIDS (NIAID) Vaccine and Prevention. He has published over 100 scientific peer reviewed articles and book chapters.
As part of the Imagine2030 campaign we want to show that innovation is not just something for the future. Biomedical advances being made right now will shape how we fight diseases of poverty in the future, and are delivering changes every day. It will be these advances, and the organisations behind them, that will bring us closer to our goal: an end of diseases of poverty by 2030.
For our celebration of World AIDS Day, and the fight against HIV & AIDS, we profile an organisation that is working to produce innovative ways to help women protect themselves, and their sexual and reproductive health.
Fourteen years ago, the International Partnership for Microbicides (IPM) entered the HIV prevention field with a promise and a clear vision to create products that women in developing countries could use themselves to prevent HIV, and protect their sexual and reproductive health.
Since IPM was founded as a nonprofit organization in 2002, it has leveraged public, philanthropic and private sector resources to accelerate the development of safe and effective life-saving technologies for women. The organisation builds on partnerships — with governments, foundations, researchers, pharmaceutical companies, policy-makers, advocates and communities — to bring scientific ingenuity, political will and financial resources to bear on all phases of product development.
The dapivirine ring
IPM led the development and testing of the monthly dapivirine ring, the first long-acting HIV prevention method shown to safely help offer protection. The novel vaginal ring delivers the antiretroviral (ARV) drug dapivirine continuously over the course of one month, offering women a practical and discreet way to protect themselves against HIV. By marshalling scientific know-how and resources through partnerships with public, private, research and civil society stakeholders, IPM brought the ring from concept to Phase III efficacy trials just seven years after acquiring the license for dapivirine. In 2016, two parallel Phase III trials confirmed the safety and efficacy of IPM’s monthly dapivirine ring.
Strengthening medical research capacity in Africa
IPM has collaborated with in-country partners and research staff to build and strengthen capacity at more than 15 research centers across sub-Saharan Africa. They have trained more than 600 research center clinical staff, including community engagement teams on microbicide trial implementation. These staff are well-equipped to conduct high-quality HIV prevention and related clinical trials that contribute to the health of their communities.
Because HIV and unintended pregnancy are major causes of serious health complications and death for women worldwide, IPM is developing a multipurpose technology: a 90-day dapivirine-contraceptive ring designed to offer both HIV prevention and contraception. A Phase I trial is expected to begin in 2017.
Developing the first combination ARV ring
IPM developed the first combination ARV vaginal ring to reach clinical trials, the dapivirine-maraviroc ring, and is exploring formulations using potent new ARVs. Combining ARVs with different mechanisms of action may provide greater protection against HIV than a single drug alone and reduce the chance of acquiring drug-resistant HIV.
What’s next?
For IPM? The first long-acting, self-initiated HIV prevention product for women potentially approved for public use. The dapivirine ring is being made available to women who participated in both Phase III trials through two “open-label” studies now under way across Africa. IPM is also pursuing regulatory approval to license the ring, with the first regulatory submissions planned for mid-2017. The earliest potential product approvals could be received in late 2018 in some countries.
bit.ly/DPVringWAD
Learn more about IPM here.
Go back to imagine2030.org