Announcements

Human Vaccines Project [to 15 April 2017]
http://www.humanvaccinesproject.org/media/press-releases/
Apr 11, 2017, 09:00 ET
The Human Vaccines Project, Vanderbilt And Illumina Join Forces To Decode The Human Immunome
NEW YORK, April 11, 2017 /PRNewswire-USNewswire/ — The Human Vaccines Project and Vanderbilt University Medical Center today announced that they joined forces with Illumina, Inc., to decipher the human immunome, the genetic underpinnings of the immune system. Illumina will provide the genetic sequencing technologies and expertise required to process the massive amounts of data required to decode the human immunome.

The Human Vaccines Project is a public-private partnership of academic research centers, industry, non-profits and government agencies that aims to decode the human immune system to accelerate development of next-generation vaccines and immunotherapies. A core initiative of the Project is the Human Immunome Program, an internationally led effort by Vanderbilt University Medical Center to determine key principles of how the human immune system prevents and controls disease by illuminating the complete set of genes and molecular structures known as the human immunome.

“By decoding the human immune system, we have the potential to uncover novel diagnostic biomarkers for a wide range of diseases,” said James Crowe Jr., M.D., director of the Vanderbilt Vaccine Center and lead investigator of the Human Immunome Program. “This will enable the development of highly targeted vaccines and immunotherapies against infectious and non-communicable diseases like AIDS, Alzheimer’s, multiple sclerosis and cancer.”

Due to its scale and complexity, the human immunome is estimated to be billions of times larger than the human genome. With recent technological advances from biomedical and computational sciences, it is now possible to undertake such a mammoth genetic sequencing and data analysis program.

“We are very pleased to collaborate with the Human Vaccines Project, Vanderbilt and its partners, by bringing Illumina’s state of the art genetic sequencing and bioinformatics technologies to help solve this major challenge,” said Gary Schroth, Ph.D., distinguished scientist and vice president for product development at Illumina. “Successfully defining the human immunome will provide the foundational knowledge to usher in a new era of vaccine, diagnostic and therapeutic development.”…

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PATH [to 15 April 2017]
http://www.path.org/news/index.php
Announcement | April 12, 2017
Vietnam launches National Immunization Information System
The government-led scale-up of PATH’s ImmReg and VaxTrak systems aims to track the immunization of every individual in Vietnam, from birth until the end of their life
On March 24, Vietnam’s Deputy Prime Minister, Vu Duc Dam, officially launched the National Immunization Information System (NIIS) in Hanoi. This system evolved from ImmReg, a digital immunization registry, and VaxTrak, a vaccine tracking tool, both developed and tested by PATH beginning in 2012.

ImmReg allows health workers to use computers, smartphones, and tablets to enter and search for immunization records, and send short message service (SMS) reminders to those due for vaccination. It has shown to increase the on-time vaccination rates for essential vaccines for children, as well as reduce the time and costs associated with local routine immunization programs. VaxTrak tracks vaccine supply chain, thus decreasing the likelihood of stock-outs and reducing waste. Since 2016, PATH has supported the Ministry of Health (MOH) and Viettel, the largest telecom company in Vietnam, to integrate ImmReg and VaxTrak into a national system. They aim to track immunization records of the entire Vietnamese population, from birth to death, and make the vaccine supply chain more efficient.

The NIIS is an ambitious system that positions Vietnam as a global leader in digital health. Health centers throughout the world, in both developed and developing countries, have relied on paper-based records to record patient and vaccine information by hand. Paper-based records make it challenging to track which children are due for vaccination and can be prone to error. Inaccurate data leads to poor management of vaccine stocks, resulting in vaccines delivery delays. A paper-based system also makes it more difficult for health workers to develop reports for health officials to use in developing immunization plans and strategies.

Through initiatives such as ImmReg, VaxTrak, and the Better Immunization Data Initiative, PATH is helping countries adopt digital solutions that allow health workers to better record and access data, ultimately leading to better health service delivery…

Press release | April 12, 2017
Viet Nam’s first human milk bank to serve as model for learning and replication across the country
Human milk banks fill a vital nutritional gap for at-risk newborns without access to their own mother’s milk, but few exist across Southeast Asia. Viet Nam’s first human milk bank demonstrates the feasibility of establishing a facility of international standards in the region, and will serve as a model across the country and Southeast Asia.

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IAVI – International AIDS Vaccine Initiative [to 15 April 2017]
https://www.iavi.org/
April 13, 2017
IAVI Mourns the Passing of Major Force in HIV Science Dr. Mark Wainberg
The world lost a leader in the fight against AIDS this week with the passing of Dr. Mark Wainberg. The pioneering Canadian researcher is widely recognized for his involvement in the 1989 identification of antiviral drug Lamivudine, which is now one of the most extensively used drugs in treating  HIV  and its co-infections.

“Dr. Wainberg’s passing is a tremendous loss for the scientific community,” said IAVI President and CEO Mark Feinberg. “His extraordinary contributions to the field of HIV research and development continue to be an inspiration to me and to all who knew him.  Discoveries stemming from his investigations and collaborations have significantly advanced treatment, prevention and cure research.”

Among these contributions was the identification of several mutations in the HIV genome that are responsible for drug resistance.  In recent years, he also turned his attention to researching a potential HIV cure based on the possibility that HIV may be unable to form resistance to compounds called integrase inhibitors that block viral replication…

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UNAIDS [to 15 April 2017]
http://www.unaids.org/
Selected Press Releases & Updates
Press statement
UNAIDS saddened by the death of HIV researcher Mark Wainberg
GENEVA, 13 April 2017—UNAIDS is deeply saddened by the tragic death of pioneering HIV researcher Mark Wainberg. An internationally renowned scientist, Dr Wainberg was a leading HIV researcher from the start of the AIDS epidemic.

“Mark Wainberg was a giant in HIV science. His work contributed to saving millions of lives,” said Michel Sidibé, Executive Director of UNAIDS.

Dr Wainberg and colleagues identified one of the main antiretroviral medicines used to treat HIV infection, lamivudine. He contributed to the understanding of HIV drug resistance and more recently was working towards a cure for HIV. Dr Wainberg was the head of AIDS research at the Lady Davis Institute for Medical Research at the Jewish General Hospital and Director of the McGill University AIDS Centre, Canada, at the time of his death…

Update
UNAIDS Scientific and Technical Advisory Committee calls for HIV testing revolution
13 April 2017
The participants of a meeting of the UNAIDS Scientific and Technical Advisory Committee (STAC) have called on UNAIDS to lead global efforts to galvanize an HIV testing revolution. The target is to achieve 90% of people living with HIV knowing their HIV status by 2020. In 2015, only 60% of people living with HIV knew their HIV status.

In a mid-term review of progress towards the 90–90–90 targets, held on 9 and 10 April in Geneva, Switzerland, the participants heard that late HIV diagnosis represents the single greatest barrier to increasing rates of HIV viral suppression globally. New testing technologies have emerged, but programmes must reach the people who need HIV testing services.

Key barriers to HIV testing uptake include lack of individual awareness of risk, stigma, legal and structural barriers, associated costs such as travel to facilities and the perception that there is little benefit from diagnosing HIV infection if no symptoms are present. The participants heard that many people avoid seeking HIV testing services at health facilities, since both travel and waiting times can often be long. Barriers to testing are often experienced by young people, men and members of key populations.

The participants agreed that political and financial support for HIV testing must be significantly increased and that the central focus of HIV testing services should be moved from the health facility to the community. Community workers have a critical role in scaling up these community-centred strategies. The STAC recommended that UNAIDS develop a road map for the HIV testing revolution, for review and comment by the STAC at its next meeting in July…

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European Medicines Agency [to 15 April 2017]
http://www.ema.europa.eu/ema/
12/04/2017
Update of EMA recommendations for 2017/2018 seasonal flu vaccine composition
Update completes previous recommendations issued in March 2017

10/04/2017
Reporting irregularities that may affect medicines
EMA Board adopts new policy on handling information on alleged improprieties from external sourcesThe European Medicines Agency’s (EMA) Management Board has adopted a new policy on how EMA handles allegations of improprieties received from external parties. These improprieties may include allegations of departures from standards of good practices that could have an impact on the evaluation and supervision of medicines.
The goal is to create an environment where individuals from outside the Agency feel confident to raise their concerns on improprieties in their area of work. The policy helps EMA assess these reports and co-ordinate any further investigation in a structured way, while protecting the confidentiality of the reporter.
Since 2013, EMA has received a total of 43 reports that relate, for example, to the manufacturing of medicines or the conduct of clinical trials. Although no formal policy has existed until now, all reports were dealt with in line with the principles included in the new policy.
A dedicated email inbox, reporting@ema.europa.eu, has been created. Individuals external to EMA can raise their concerns by sending a message or providing information to this address. They can also send a letter to the Agency. Their identity will be kept confidential…

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NIH [to 15 April 2017]
http://www.nih.gov/news-events/news-releases
April 12, 2017
NIH study of Ebola patient traces disease progression and recovery
The patient was at the NIH Clinical Center for 26 days.
Excerpt
Analysis of daily gene activation in a patient with severe Ebola virus disease cared for at the National Institutes of Health in 2015 found changes in antiviral and immune response genes that pinpointed key transition points in the response to infection. The changes included a marked decline in antiviral responses that correlated with clearance of virus from white blood cells. The analysis also showed that the preponderance of host responses shifted rapidly from activation of genes involved in cell damage and inflammation toward those linked to promotion of cellular and organ repair. This pivot came before the first signs of clinical improvement in the patient, who was admitted to the NIH Clinical Center on day 7 of illness and remained at the hospital for 26 days. Researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) led the study…
… Although this study represents only a single case, it provides unprecedented detail on the host response to Ebola virus disease and may inform the development of therapeutics designed to boost or accelerate host factors that most effectively counter the virus and promote healing. It may also lead to better prognostic criteria to enable clinicians to tailor the treatment of patients with Ebola virus disease in ways that can best promote recovery…

NIH scientists advance understanding of herpesvirus infection
April 12, 2017
Protein complexes identified that control infection and reactivation.

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FDA [to 15 April 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
What’s New for Biologics
Complete List of Currently Approved NDA and ANDA Application Submissions (PDF – 17KB)
Posted: 4/10/2017; Updated as of 4/5/2017

Complete List of Currently Approved Premarket Approvals (PMAs) (PDF – 16KB)
Posted: 4/10/2017; Updated as of 4/6/2017

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Wellcome Trust [to 15 April 2017]
https://wellcome.ac.uk/news
News / Published: 12 April 2017
One of our researchers wins global health award
Professor César Victora, a Wellcome Investigator, has been awarded the prestigious John Dirks Canada Gairdner Global Health Award 2017 for his work on maternal and child health in low- and middle-income countries.
The award recognises Professor Victora’s (opens in a new tab) contributions to child health and nutrition, health programme monitoring and evaluation, and health equity.
His key achievement has been his work on cohort studies. He helped set up the 1982 Pelotas Birth Cohort, in Brazil, one of the world’s longest running birth cohort studies. It is still monitoring around 6,000 individuals, and has been followed by further cohort studies set up in 1993 and 2004.
Professor Victora’s research helped to demonstrate the impact of the first 1,000 days of life on influencing lifelong outcomes, in particular the importance of breastfeeding for preventing infant mortality…

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GHIT Fund [to 15 April 2017]
https://www.ghitfund.org/
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical companies, the Japanese Government and the Bill & Melinda Gates Foundation.
2017.04.10
GHIT Fund 5th Anniversary Website Launched
In celebration of our 5th anniversary we have launched a special site featuring substantive interviews with key global health leaders and GHIT partners. Interviews examine GHIT and Japan’s impact on global health R&D to date, and the potential for further impact in the years to come. The site also offers background on the history of our institution and staff, as well as our plans for our next 5 years. We invite you to visit the site and take a journey with us through our past and future.
:: GHIT 5th Anniversary Website   http://5th.ghitfund.org/top/en

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