Announcements
Paul G. Allen Frontiers Group [to 16 Feb 2019]
https://www.alleninstitute.org/news-press/
No new digest content identified.
BMGF – Gates Foundation [to 16 Feb 2019]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.
Bill & Melinda Gates Medical Research Institute [to 16 Feb 2019]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.
CARB-X [to 16 Feb 2019]
https://carb-x.org/
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
No new digest content identified.
CEPI – Coalition for Epidemic Preparedness Innovations [to 16 Feb 2019]
http://cepi.net/
No new digest content identified.
EDCTP [to 16 Feb 2019]
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
No new digest content identified.
Emory Vaccine Center [to 16 Feb 2019]
http://www.vaccines.emory.edu/
No new digest content identified.
European Medicines Agency [to 16 Feb 2019]
http://www.ema.europa.eu/ema/
News and press releases
Role of big data for evaluation and supervision of medicines in the EU
15/02/2019
Recommendations for a path towards understanding the acceptability of evidence derived from ‘Big data’ in support of the evaluation and supervision of medicines by regulators were published today as part of a summary report of the Heads of Medicines Agencies (HMA) – EMA Joint Big Data task force . The recommendations and associated actions set out what needs to be addressed, but the mechanisms by which this may be achieved requires further focused work over the coming year. Stakeholders are invited to submit feedback and observations on the recommendations to inform the upcoming work of the group.
Massive amounts of data are generated on a daily basis through wearable devices, electronic health records, social media, clinical trials or spontaneous adverse reaction reports. There is no doubt that insights derived from this data will increasingly be used by regulators to assess the benefit-risk of medicines across their whole lifecycle. However, in order to benefit from and make prudent use of the data collected, regulators need a deeper understanding of the data landscape.
The HMA – EMA Joint Big Data task force is composed of experienced medicines regulators from 14 national competent authorities and EMA. In preparing the report, it assessed the generation of ‘big data’, their relevant sources and main formats, the methods for processing and analysing big data and the current state of expertise across the European medicines regulatory network.
A crucial step was defining ‘big data’ itself, a widely-used term that is lacking a commonly-accepted definition. The definition adopted by the task force reads as follows: “extremely large datasets which may be complex, multi-dimensional, unstructured and heterogeneous, which are accumulating rapidly and which may be analysed computationally to reveal patterns, trends and associations. In general, big data sets require advanced or specialised methods to provide an answer within reliable constraints.”
Six subgroups of data sources relevant to regulatory decision-making were considered by the taskforce: genomics, bioanalytical ‘omics (proteomics, etc.), clinical trials, observational data, spontaneous adverse drug reactions data and social media and mobile health data.
Stakeholders and members of the public are invited to submit their comments on the core recommendations in the summary report (not to exceed 1,000 words) to bigdatasec@dkma.dk
until 15 April 2019. In particular, views on prioritisation of future actions would be welcomed.
The feedback received will be taken into account in the next phase of the work of the task force. A newly-refined mandate for the group is in place for the next year to define next steps and prioritisation of actions.
European Vaccine Initiative [to 16 Feb 2019]
http://www.euvaccine.eu/news-events
Latest news
No new digest content identified.
FDA [to 16 Feb 2019]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
No new digest content identified.
Fondation Merieux [to 16 Feb 2019]
http://www.fondation-merieux.org/
No new digest content identified.
Gavi [to 16 Feb 2019]
https://www.gavi.org/
13 February 2019
UK to host Gavi replenishment in 2020
Geneva, 13 February 2019 – The UK government today announced that it will host Gavi’s replenishment pledging conference in mid-2020.
The event will follow the successful Gavi pledging conference in Berlin in January 2015, which raised US $7.5 billion for the 2016-2020 period. Next year’s event will raise funds to support Gavi’s programmes from 2021-2025, and will aim to bring together contributions from donors. These resources will be complemented by developing countries co-financing and the vaccine industry’s contributions. The investment case, which will set out the amount required, will be published later this year…
12 February 2019
Ethiopia introduces measles vaccine second dose with support from Gavi
Addis Ababa, 12 February 2019 – Ethiopia has introduced measles vaccine second dose (MCV2) vaccination into the routine immunization programme, with technical and financial support from Gavi, the Vaccine Alliance and the World Health Organisation. Around 3.3 million children throughout the country will receive measles vaccine second dose annually…
GHIT Fund [to 16 Feb 2019]
https://www.ghitfund.org/newsroom/press
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
No new digest content identified.
Global Fund [to 16 Feb 2019]
https://www.theglobalfund.org/en/news/
News
No new digest content identified.
Hilleman Laboratories [to 16 Feb 2019]
http://www.hillemanlabs.org/
No new digest content identified.
Human Vaccines Project [to 16 Feb 2019]
http://www.humanvaccinesproject.org/media/press-releases/
February 13, 2019
Decoding the Human Immune System
For the first time ever, researchers are comprehensively sequencing the human immune system, which is billions of times larger than the human genome. In a new study published in Nature from the Human Vaccines Project, scientists have sequenced a key part of this vast and mysterious system — the genes encoding the circulating B cell receptor repertoire.
Sequencing these receptors in both adults and infants, the scientists found surprising overlaps that could provide potential new antibody targets for vaccines and therapeutics that work across populations. As part of a large multi-year initiative, this work seeks to define the genetic underpinnings of people’s ability to respond and adapt to an immense range of disease.
Led by scientists at Vanderbilt University Medical Center and the San Diego Supercomputer Center, this advancement is possible due to the merging of biological research with high-powered frontier supercomputing. While the Human Genome Project sequenced the human genome and led to the development of novel genomics tools, it did not tackle the size and complexity of the human immune system…
IAVI [to 16 Feb 2019]
https://www.iavi.org/newsroom
No new digest content identified.
IFFIm
http://www.iffim.org/library/news/press-releases/
No new digest content identified.
IVAC [to 16 Feb 2019]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
No new digest content identified.
IVI [to 16 Feb 2019]
http://www.ivi.int/
IVI News & Announcements
IVI and Yonsei University College of Medicine’s IIID to collaborate in vaccine R&D
On February 12 IVI exchanged a memorandum of understanding with the Institute of Immunology and Immunological Diseases (IIID), part of Yonsei University’s College of Medicine [Korea]. With this agreement, the two organizations are establishing a collaborative relationship in research and development of vaccines in order to help achieve the common goal of accelerating safe, effective, and affordable vaccines for people in developing countries and global health….
JEE Alliance [to 16 Feb 2019]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.
MSF/Médecins Sans Frontières [to 16 Feb 2019]
http://www.msf.org/
Selected News; Project Updates, Reports [as presented on website]
Cameroon
Nothing to drink and nowhere to sleep for thousands who’ve fl…
Press Release 14 Feb 2019
Democratic Republic of Congo
Even during a widespread measles epidemic, we can sa…
Interview 14 Feb 2019
Yemen
MSF opens new emergency room in Ad Dahi hospital
Project Update 14 Feb 2019
DRC 2018 Ebola outbreaks
Potential new Ebola drugs being trialled in MSF treatment centres
Statement 12 Feb 2019
[See Emergencies above for detail]
El Salvador
Breaking the invisible barriers that divide neighbourhoods con…
Project Update 11 Feb 2019
Colombia
Buenaventura: “MSF fills a huge vacuum in helping victims of vio…
Interview 11 Feb 2019
NIH [to 16 Feb 2019]
http://www.nih.gov/news-events/news-releases
February 14, 2019
NIH names Dr. Noni H. Byrnes director of the Center for Scientific Review
— National Institutes of Health Director Francis S. Collins M.D., Ph.D., announced today the selection of Noni H. Byrnes, Ph.D., as director of the NIH Center for Scientific Review (CSR), effective Feb. 17, 2019.
Patients to share personal journeys at NIH Rare Disease Day events
February 11, 2019 — Connect with patients about navigating life with a rare disease.
PATH [to 16 Feb 2019]
https://www.path.org/media-center/
No new digest content identified.
Sabin Vaccine Institute [to 16 Feb 2019]
http://www.sabin.org/updates/pressreleases
Monday, February 11, 2019
The Bill & Melinda Gates Foundation and the Sabin Vaccine Institute Partner to Improve Vaccine Access by Strengthening Immunization Programs
WASHINGTON, DC – With the mutual goal of improving access to life-saving vaccines, the Bill & Melinda Gates Foundation recommitted its support to the Sabin Vaccine Institute (Sabin) to relaunch a global network for immunization managers. The success of immunization programs to reach populations with vaccines depends on excellent program management. Sabin will use the three-year, U.S. $3.5 million grant to provide national and sub-national immunization managers with training, education and networking opportunities, with an emphasis on strengthening management and leadership skills.
This initiative builds on the IAIM Network (International Association of Immunization Managers), established five years ago with support from the Bill & Melinda Gates Foundation to help immunization managers connect, share best practices and learn from trusted peers. The IAIM Network has become the world’s largest network for immunization managers, with more than 400 managers from over 120 countries engaging in virtual or in-person activities.
“We know that improving management capabilities and skills has a direct effect on program performance,” said Dr. Bruce Gellin, president of Global Immunization at Sabin. “This network will empower immunization managers to get answers, grow in their role and raise their collective voice.”…
UNAIDS [to 16 Feb 2019]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
15 February 2019
Healthy populations for healthy economies in Africa
15 February 2019
Ethiopia demonstrates that communities deliver
14 February 2019
OAFLA to broaden its scope of work
14 February 2019
Taking action against HIV medicine stock-outs in the Bolivarian Republic of Venezuela
12 February 2019
AIDS care in the Californian desert
12 February 2019
UNAIDS is awarded the Science and Medicine Award at the 25th Annual Steve Chase Awards
UNICEF [to 16 Feb 2019]
https://www.unicef.org/media/press-releases
Selected Press Releases/Reports/Statements
Press release
Thousands of children vaccinated in remote Rukban settlement amid severe lack of access to medical care
UNICEF, UN and Syrian Arab Red Crescent reach more than 40,000 people with life-saving supplies in largest-ever humanitarian convoy since the start of the Syria crisis
15/02/2019
Press release
UNHCR and UNICEF urge action in Europe to end childhood statelessness
14/02/2019
Press release
More than 3,000 children released from armed groups in South Sudan since conflict began, but thousands more continue to be used
12/02/2019
News note
Fast Facts: 10 facts illustrating why we must #EndChildMarriage
11/02/2019
Press release
Dubai Cares and UNICEF announce the Dubai Declaration on Early Childhood Development at the World Government Summit
Declaration is a follow-up to the official MENA launch of the Lancet Series Advancing Early Childhood Development
10/02/2019
Press release
13.5 million children now uprooted in Africa – including those displaced by conflict, poverty and climate change
On eve of African Union Summit, UNICEF urges African States to lead in the protection and empowerment of uprooted children
Vaccine Confidence Project [to 16 Feb 2019]
http://www.vaccineconfidence.org/
No new digest content identified.
Vaccine Education Center – Children’s Hospital of Philadelphia [to 16 Feb 2019]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.
Wellcome Trust [to 16 Feb 2019]
https://wellcome.ac.uk/news
Opinion | 15 February 2019
This is a pivotal moment for clinical trial regulations
by Beth Thompson
Globally, clinical research is governed by guidelines established almost three decades ago. And Brexit is a looming issue for trials that take place in the UK. Wellcome’s Policy team is working to address both problems.
The Wistar Institute [to 16 Feb 2019]
https://www.wistar.org/news/press-releases
Press Release Feb. 15, 2019
Wistar’s David B. Weiner, Ph.D., Awarded Prestigious Scientific Achievement Award from Life Sciences Pennsylvania
PHILADELPHIA — (Feb. 15, 2019) — David B. Weiner, Ph.D., executive vice president, director of the Vaccine & Immunotherapy Center, and the W.W. Smith Charitable Trust Professor in Cancer Research at The Wistar Institute, has been named the recipient of this year’s Scientific Achievement Award from Life Sciences Pennsylvania. The organization, with its more than 800-member companies, has a single mission to make Pennsylvania a hub of innovation by creating a business and public policy environment that fosters life sciences growth and success.
“Our Scientific Achievement Award recognizes a scientist in the Pennsylvania life sciences community who has demonstrated outstanding achievement by advancing scientific knowledge, innovation, and/or patient care,” said Christopher P. Molineaux, president & CEO of Life Sciences PA. “We can’t think of a better honoree this year than David – considered a founder of the field of synthetic DNA vaccines with more than 30 years of research contributions and scientific influence.”…
World Organisation for Animal Health (OIE) [to 16 Feb 2019]
http://www.oie.int/en/for-the-media/press-releases/2018/
14/02/19
New report shows global shift in use of antibiotics in animals
[See Milestones above for detail]
::::::
BIO [to 16 Feb 2019]
https://www.bio.org/insights/press-release
Feb 15 2019
BIO Statement on CMS Proposed Decision Memo for the CAR-T National Coverage Determination
Washington, DC (February 15, 2019) – Today, Biotechnology Innovation Organization (BIO) Executive Vice President for Health Policy, Dan Durham, issued the following statement r regarding the CMS proposed decision memo for the CAR-T National Coverage Determination:
“We are further analyzing CMS’ released proposed decision memo for the National Coverage Determination for CAR T-cell therapy and look forward to providing the Agency with detailed comments in the coming weeks. It is critical that CMS coverage policies balance timely access to FDA-approved therapies across all potential appropriate settings of care, particularly when making determinations around innovations that represent significant advances in the delivery of treatment, such as CAR T. Further, such policy requirements should not be overly burdensome for providers, should be well aligned with FDA REMS requirements, and should provide enough flexibility as the class of medicines evolves.”
DCVMN – Developing Country Vaccine Manufacturers Network [to 16 Feb 2019]
http://www.dcvmn.org/
No new digest content identified.
IFPMA [to 16 Feb 2019]
http://www.ifpma.org/resources/news-releases/
No new digest content identified.
PhRMA [to 16 Feb 2019]
http://www.phrma.org/press-room
No new digest content identified.
Industry Watch [to 16 Feb 2019]
:: Moderna Announces Positive Interim Phase 1 Data for First Combination Vaccine Against the Respiratory Viruses hMPV and PIV3 February 12, 2019
Interim data show vaccination with mRNA-1653 boosted serum neutralization titers against hMPV and PIV3 at all dose levels tested and was generally well tolerated
Company plans to advance mRNA-1653 into a Phase 1b study in seropositive pediatric subjects