Announcements

Announcements

EDCTP    [to 31 March 2018]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
29 March 2018
Call for applications: Workshop in French on EDCTP grant proposal writing
EDCTP is calling for applications from researchers interested in participating in a workshop on EDCTP Calls for Proposals and grant…

26 March 2018
EDCTP Alumni Network platform on line
To support the networking of African researchers, the European & Developing Countries Clinical Trials Partnership (EDCTP) has launched its Alumni Network platform. This online interactive platform makes the professional profiles of all current and past EDCTP fellows easily accessible. Moreover, it facilitates reflection and collaboration among the more than 100 EDCTP fellows from sub-Saharan Africa to date. Working groups on HIV, tuberculosis, malaria, and neglected or emerging infectious diseases have also been established.
Go to the EDCTP Alumni Network platform

 

European Medicines Agency  [to 31 March 2018]
http://www.ema.europa.eu/ema/
26/03/2018
EU recommendations for 2018/2019 seasonal flu vaccine composition
EU advice based on WHO recommendations
The European Medicines Agency (EMA) has issued the European Union (EU) recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2018…
 
 
FDA [to 31 March 2018]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
March 30, 2018 –
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to enhance the patient perspective and experience in drug development and review
Benefit-risk assessment is at the heart of what we do to ensure that Americans have access to medical products that are safe, effective and meet their needs.

But we’re also deeply aware that serious chronic illnesses aren’t monolithic. Patient perception of the benefits and risks of different treatment options can vary based on the stage of the disease, the age of onset, alternative therapies available to treat the disease (if any) and whether a novel therapy improves a patient’s ability to function normally, slows the rate of disease progression or impacts other aspects of a patient’s quality of life.

A 45-year-old father of two who is diagnosed with aggressive prostate cancer may have very different goals than an 80-year-old man diagnosed with the same disease.

To address these realities, we’ll continue working in close partnership with patients to incorporate their experience into our benefit-risk assessments. We know that first-hand knowledge of living with a serious illness – communicated in science-based terms that patients value and understand – is integral to facilitating the successful development of safe and effective products that can deliver meaningful benefits in each disease, or disease state.

Today we have many more tools to measure these patient benefits – including wearable devices, medical apps and even machine-learning programs. These tools can bring us a better understanding of how patients experience their illness, including how it affects their day-to-day feeling or functioning and how a given treatment may impact the course of that illness.

Tools for capturing the patient experience may be quantitative or qualitative, but they are transforming nearly every aspect of medical product development. Patients are teaching us about the benefits that matter most to them and the risks that they are most concerned about. Patients are, rightly so, becoming the driving force of the medical research enterprise.
Improving the science of medical product development – what we call translational science – is integral to improving the efficiency of medical research. Routinely reviewing and updating the tools we use to make benefit-risk assessments is one of the most important parts of that process…

I’m pleased to announce that today we’re issuing an update to our implementation plan, titled “Benefit-Risk Assessment in Drug Regulatory Decision-Making.” This document provides an overview of the steps the FDA has taken since 2013 to enhance benefit-risk assessment in human drug review, which included implementation of the FDA’s Benefit-Risk Framework into our drug regulatory review processes and documentation.

This document also provides a roadmap for enhancing the Benefit-Risk Framework, working toward a goal of providing guidance by June 2020 that articulates the FDA’s decision-making context and framework for benefit-risk assessment. This forthcoming guidance will also outline how patient experience data and related information can be used to inform benefit-risk assessment…
 
 
GHIT Fund   [to 31 March 2018]
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 ·
2018.03.30      Report
GHIT’s 5th Anniversary Special Report Published
GHIT’s 5th Anniversary Special Report (PDF) is now available online. The report highlights an interview of GHIT’s stakeholders and sponsors, GHIT’s past and future, as well as other activities for its first five years.
PDF Version : Click here  (20551kb)

2018.03.29      Press Room
As the GHIT Fund Closes Out First Five Years of R&D for Lifesaving Medical Breakthroughs, It Launches Next Phase, Focusing on Access and Delivery, Bringing Total Investment to 13.2 Billion Yen (US$123 Million)
The GHIT Fund’s new investments support work to accelerate schistosomiasis elimination; combat drug-resistant tuberculosis; deploy CRISPR gene-editing tools to fight Chagas disease; and develop a vaccine to stop malaria parasites from hijacking the human immune system

 

Global Fund [to 31 March 2018]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Global Fund Suspends Partnership with Heineken
29 March 2018
GENEVA – The Global Fund today suspended its partnership with Heineken based on recent reports of the company’s use of female beer promoters in ways that expose them to sexual exploitation and health risks.
“We take these allegations very seriously and have challenged Heineken to examine their operations and make changes to protect women from sexual exploitation and health risks,” said Peter Sands, Executive Director of the Global Fund. “We are suspending the partnership until such time as Heineken can take appropriate action to address these issues.”

 

IVAC  [to 31 March 2018]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
IVAC Blog
IVAC’s Newest Mission: Championing Adult Vaccination
Young children and older adults are both at higher risk for potentially devastating and debilitating diseases, many of which are vaccine-preventable. Countries prioritize and routinely immunize infants, yet the same cannot be said for older adults, variably defined as 50, 60, 65, or 70+ years of age, with or without risk factors. There is no simple explanation of why countries looking at very similar data come to very different conclusions. Even experts and the global health community are divided on the role of adult immunization. As a result, a large portion of countries have failed to address vaccine-preventable diseases like influenza, pneumococcal disease, and herpes zoster (shingles),  which affect this fast-growing demographic.
 
 
MSF/Médecins Sans Frontières  [to 31 March 2018]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Northwest Syria: Two Airstrikes Cause Mass-Casualty Influx to MSF-Supported Hospital
March 23, 2018
Two airstrikes hit a densely populated neighborhood in the town of Harem in Syria’s Idlib Governorate yesterday afternoon, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières Friday. The nearest MSF-supported field hospital saw 63 injuries and 38 deaths—around half of which were children—in a town where medical staff are already overwhelmed and supplies are limited.

 
NIH  [to 31 March 2018]
http://www.nih.gov/news-events/news-releases
March 29, 2018
NIH study may help explain why iron can worsen malaria infection
— Researchers identify protective role of iron export protein and its mutation.

NIH-funded study shows sorafenib improves progression-free survival for patients with rare sarcomas
March 28, 2018 — Progression-free survival is the length of time patients lived before their disease worsened.

Study changes long-held concepts of cell decoding
March 28, 2018 — NIH scientists discover macromolecular complexes that could enable medication development.
 
 
PATH  [to 31 March 2018]
http://www.path.org/news/index.php
Announcement | March 26, 2018
PATH commends Congress for commitment to global health in FY18 spending bill
PATH welcomes the passage of the Fiscal Year 2018 Omnibus Appropriations bill by the US Congress, which expressed a clear commitment to sustaining US leadership in global health, including additional funding to further strengthen America’s ability to protect against infectious disease outbreaks—both abroad and within our own borders…
 

UNAIDS [to 31 March 2018]
http://www.unaids.org/en
26 March 2018
H6 commits to accelerate results for health
The H6 combines the strengths of six international organizations [UNAIDS, UNFPA, UNICEF, UN Women, WHO, World Bank] to help countries to realize the United Nations Secretary-General’s Every Woman Every Child strategy. The partnership mobilizes political commitment and resources to transform societies so that women, children and adolescents can realize their rights to the highest attainable standards of health and well-being.
High-level representatives of the six organizations met in New York, United States of America, to shape a shared vision for the H6. During the meeting, which took place on 21 March, health leaders committed to jointly deliver more and faster results in countries.
The Chair of the H6, Michel Sidibé, shared his vision for the partnership, including how it can evolve to meet the demands of the Sustainable Development Goals, including in humanitarian settings, and be a leading platform to advance United Nations reform.
“As a transformative platform, I see the H6 as an outstanding opportunity to rapidly bring United Nations reform to life and deliver results for every woman, child and adolescent on the ground,” said Michel Sidibé, Executive Director of UNAIDS.
The participants were united in their ambition to make the H6 a one-stop shop for countries for strategic policy advice, technical assistance and strategic information. Adolescent health, particularly for 10–18-year-olds, was discussed as a key focus area…
 
 
Vaccine Confidence Project  [to 31 March 2018]
http://www.vaccineconfidence.org/
Blog
Politics and public trust shape vaccine risk perceptions
Posted on 29 Mar, 2018 by Heidi Larson
There is something about vaccines, and getting vaccinated, that touches nerves — personal, political and cultural nerves. It’s not natural; it hurts (“just a little bit”), and sometimes has side effects. Although these are mostly minor issues, they still provoke
See full text of article from Nature Human Behaviour below in Research/Reports/ Commentary.

 

Wellcome Trust  [to 31 March 2018]
https://wellcome.ac.uk/news
News / Published: 27 March 2018
Wellcome to lead efforts to deliver fair access to healthcare interventions
For the first time, Wellcome is stating its position on equitable access to healthcare interventions in a single statement. This is because we want new and improved interventions to be accessible to the people who need them most.
[See Milestones/Perspectives above for full text]

News / Published: 27 March 2018
Azim Surani wins Gairdner award for discovery of genomic imprinting
Professor Azim Surani, a Wellcome Investigator, has been given a prestigious Canada Gairdner International Award. It recognises outstanding biomedical scientists who have made original contributions to medicine through increased understanding of human biology and disease.
Professor Surani discovered the phenomenon of genomic imprinting in 1984 and subsequently contributed to understanding of the developmental consequences and mechanistic basis of genomic imprinting.

 
The Wistar Institute   [to 31 March 2018]
https://www.wistar.org/news/press releases
Press Release   Mar. 27, 2018
Repurposing Existing FDA-Approved Inhibitors May Provide New Treatment Approach for Ovarian Cancer
Wistar researchers have found rationale for repurposing a class of antitumor compounds called HDAC inhibitors as a new therapeutic option for ovarian cancer with mutations in the ARID1A gene.

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DCVMN – Developing Country Vaccine Manufacturers Network  [to 31 March 2018]
5 April 2018
Webinar: The new Future Vaccine Manufacturing Hub, collaborating with DCVMN
Prof Robin Shattock, Professor of Mucosal Infection and Immunity, Imperial College, London
Thursday, April 5, 2018 9:00 am
Europe Summer Time (Paris, GMT+02:00)

 

Industry Watch   [to 31 March 2018]
:: Crown Prince Mohammed bin Salman’s Visit to Boston Extends Saudi-U.S. Collaboration
Collaborative Agreements Signed Between Private Sector and Higher Education
Excerpt
:: A collaborative agreement between KAUST, Research Products Development Company RPDC, and Saudi VAX. This agreement will establish the Saudi Vaccine and Bio-manufacturing Center at KAUST [King Abdullah University of Science and Technology].