AERAS  [to 29 Sep 2018]
25 September 2018
GSK candidate vaccine helps prevent active pulmonary tuberculosis in HIV negative adults in phase II study
Today, GSK and Aeras reported that GSK’s M72/AS01E candidate vaccine significantly reduced the incidence of pulmonary tuberculosis disease in HIV-negative adults with latent tuberculosis infection in ongoing phase IIb clinical trial testing.
[See Milestones above for detail]
BMGF – Gates Foundation  [to 29 Sep 2018]
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Bill & Melinda Gates Medical Research Institute    [to 29 Sep 2018]
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
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CARB-X   [to 29 Sep 2018]
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
09.24.2018  |
CARB-X calls for new ‘open science’ era in antibacterial innovation: Sharing scientific data will help speed the delivery of new antibiotics and other life-saving products to fight superbugs
Achaogen will share valuable LpxC compounds and data with Forge Therapeutics, with both companies leading the ‘open science’ initiative among CARB-X-funded companies
CEPI – Coalition for Epidemic Preparedness Innovations  [to 29 Sep 2018]
Posted on 27TH SEP 2018 by Mario Christodoulou
CEPI Awards Contract Worth Up To USD$19 million to Oxford University and Janssen Vaccines to Develop MERS, Lassa, and Nipah Vaccines
OSLO (Norway), Oxford (UK)
CEPI (the Coalition for Epidemic Preparedness Innovations) today announced a collaboration with The Jenner Institute at the University of Oxford and Janssen Vaccines & Prevention B.V.—part of the Janssen Pharmaceutical Companies of Johnson & Johnson—through which they will receive funding to advance the development and manufacture of a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV). Preclinical development of novel vaccines against Lassa and Nipah viruses will also be undertaken as part of this collaboration.
Oxford has already initiated clinical development of the MERS-CoV vaccine, with funding from the UK Department of Health and Social Care, and a phase 1 clinical trial of the vaccine is underway in the UK. Under the terms of the Framework Partnering Agreement for the collaboration, Oxford and Janssen will receive $14.6 million from CEPI to support manufacturing of a phase 2 batch and preparation for stockpiling of a MERS-CoV vaccine candidate. Dependent on phase 1 results, CEPI will have the option to provide additional investment for a phase 2 trial and manufacture of an investigational vaccine stockpile that would be available for use in the event of an outbreak. Janssen’s proprietary vaccine-manufacturing platform will enable rapid and efficient production of large volumes of vaccines. Should CEPI exercise its option to provide support for further clinical development, Oxford will undertake phase 2 testing of the vaccine, in partnership with the King Abdullah International Medical Research Centre (KAIMRC) in Riyadh, Kingdom of Saudi Arabia, and the Kenya Medical Research Institute (KEMRI)-Wellcome Trust Research Programme at Kilifi, Kenya.
As part of the collaboration, CEPI will also provide funding of up to $2.1 million to support the preclinical development of a Lassa vaccine and up to $2.0 million to support the preclinical development of a Nipah vaccine…
EDCTP    [to 29 Sep 2018]
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
28 September 2018
EDCTP Prizes 2018 awarded at Ninth Forum
EDCTP awarded its 2018 prizes for research excellence and the Pascoal Mocumbi Prize at the opening ceremony of the Ninth Forum on Monday 17 September. Dr Leonardo Simão and Prof. Marcel Tanner, the EDCTP High Representatives for Africa and Europe, presented…
27 September 2018
EDCTP-funded R&D partnerships to tackle infectious disease in Sub-Saharan Africa, 2003-2018
On 17 September 2018 at the High-Level Meeting to discuss a third EDCTP programme in Lisbon, Portugal, Dr Michael Makanga, EDCTP’s Executive Director, presented a collection of success stories illustrating EDCTP’s contribution to the fight against poverty-related infectious diseases over…
Emory Vaccine Center    [to 29 Sep 2018]
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European Medicines Agency  [to 29 Sep 2018]
News and press releases

Harnessing the potential of real world data through a ‘learning healthcare system’
Real world data (RWD) hold the promise to substantially increase the effectiveness and efficiency of all processes in the development and utilisation of medicines, from research and development, to regulatory decision-making, pricing and reimbursement decisions to use in medical practice. However, to realise the full potential of RWD requires a ‘learning healthcare system’, write the European Medicines Agency’s (EMA) Executive Director and Senior Medical Officer, as well as heads of three national EU agencies, and academia, payer, and Organisation for Economic Co-operation and Development (OECD) representatives, in a paper published in Clinical Pharmacology and Therapeutics.

A ‘learning healthcare system’, based on electronic health records and other routinely collected healthcare data, would allow RWD to be continuously fed into the system, ensuring that with every new patient treated, we know more overall about the practice of medicine.

Such judicious use of RWD would complement the traditional evidence from randomised clinical trials, for  the benefit of all stakeholders involved in the development and use of medicines, from patients and healthcare professionals to regulators, health-technology assessment bodies, payers, academic researchers and research-based pharmaceutical industry. The authors highlight the need to tear down the current barrier between the structured research setting and everyday medical practice, and instead use data gathered in everyday practice to generate new knowledge and answer research questions.

To achieve this, the healthcare systems must be ready in terms of technology to collect data, of a methodology to analyse information and governance in particular regarding aspects such as protection of personal data, consent, ethics and data access.
The authors therefore call for all stakeholders to join in a coordinated effort, at international level, to accelerate the implementation of such a model of a ‘learning healthcare system’.

Clinical Pharmacology and Therapeutics: Data rich, information poor; can we use electronic health records to create a learning healthcare system for pharmaceuticals?

EMA to launch new corporate website on 27 September 2018
European Vaccine Initiative  [to 29 Sep 2018]
25 September 2018
EVI Annual Report 2017 now available
We are pleased to share with you the EVI Annual Report 2017.
FDA [to 29 Sep 2018]
September 28, 2018
FDA in Brief: FDA modernizes clinical trial designs and approaches for drug development, proposing new guidance on the use of adaptive designs and master protocols
[See Milestones above for detail]

September 27, 2018 –
Statement by FDA Commissioner Scott Gottlieb, M.D., on preparations for the upcoming flu season and vaccinations
September 24, 2018 –
FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
The U.S. Food and Drug Administration today announced that it has awarded 12 new clinical trial research grants totaling more than $18 million over the next four years to enhance the development of medical products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry across the country…
   The FDA awarded the grants through the Orphan Products Clinical Trials Grants Program. This program is funded by Congressional appropriations and encourages clinical development of drugs, biologics, medical devices or medical foods for use in rare diseases. The grants are intended for clinical studies evaluating the safety and effectiveness of products that could either result in, or substantially contribute to, the FDA approval of products targeted to the treatment of rare diseases. Grant applications were reviewed and evaluated for scientific and technical merit by more than 100 rare disease experts, which included representatives from academia, the National Institutes of Health and the FDA…
Fondation Merieux  [to 29 Sep 2018]
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Gavi [to 29 Sep 2018]
28 September 2018
UBA Foundation and Gavi launch a new partnership for Africa
The UBA Foundation and Gavi will leverage the United Bank for Africa’s network and expertise to invest in Africa’s health system, starting with Nigeria.
Why hepatitis B vaccination should be Plan A in the fight against liver cancer
27 September 2018
Gavi at the UNGA: driving political leadership
27 September 2018
GHIT Fund   [to 29 Sep 2018]
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
September 27, 2018
GHIT Fund Invests in FIND and Fujifilm for Development of Innovative Rapid Diagnostic Tool for Tuberculosis.
TOKYO, JAPAN (September 27, 2018)—The Global Health Innovative Technology (GHIT) Fund announced today an investment of approximately 420 million yen (US$3.8 million) for a highly sensitive rapid diagnostic kit for tuberculosis (TB) known as TB-LAM, being developed by Japan’s Fujifilm Corporation and Switzerland’s Foundation for Innovative New Diagnostics (FIND)…

Global Fund [to 29 Sep 2018];&country=
Global Fund Supports Brave Commitments to Ending TB
26 September 2018
The Global Fund is joining leaders who converge in New York today to commit to speeding up global collaboration in the fight against TB, a preventable disease that killed 1.6 million people in 2017.
Hilleman Laboratories   [to 29 Sep 2018]
Hilleman Labs announces publication of original research on Heat Stable Rotavirus Vaccines
Hilleman Laboratories today announced the publication of original research as well as expert commentary on development of Heat Stable Rotavirus Vaccine (HSRV).
Human Vaccines Project   [to 29 Sep 2018]
Towards a Universal Influenza Vaccine: Lessons from the Great Influenza Pandemic of 1918 to Now
November 15-16, 2018 I Nashville, TN
The Human Vaccines Project is hosting a scientific summit featuring prominent researchers and thought leaders to discuss cutting-edge influenza research. The 2-day meeting will bring together leading scientists, clinicians and public health specialists including: John Barry, James E. Crowe, Jr., Senator Bill Frist, and Laurie Garrett.  Find a full agenda at:
IAVI  [to 29 Sep 2018]
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IVAC  [to 29 Sep 2018]
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IVI   [to 29 Sep 2018]
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JEE Alliance  [to 29 Sep 2018]
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MSF/Médecins Sans Frontières  [to 29 Sep 2018]
Selected Press Releases/Statements
One of the world’s biggest paediatric intensive care units is full
Press Release 25 Sep 2018
:: Magaria hospital is the only health facility available in a region of 700,000 to one million people, around 20 per cent of whom are aged under five
:: Of the 730 children currently admitted, 208 are critically ill and mortality rates remain alarmingly high
:: It’s likely that hundreds more children are seriously ill in the community and not getting the care they need

Global leaders must make bold commitments at first-ever UN tuberculosis summit
Press Release 25 Sep 2018
:: World leaders are meeting in New York this week for the first-ever high-level summit on tuberculosis
:: TB is the world’s deadliest infectious disease, killing 1.6 million in 2017, but is drastically under-funded
:: MSF implores leaders at the summit to urgently scale up TB diagnosis and treatment, and commit more resources

NIH  [to 29 Sep 2018]
September 26, 2018
Combination HIV antibody infusions safely maintain viral suppression in select individuals
— HIV did not develop resistance to experimental treatment.

NIH releases strategic plan to address tuberculosis research
September 26, 2018 — TB is the leading infectious cause of death worldwide.
[See Milestones above for detail]

NIH-funded genome centers to accelerate precision medicine discoveries
September 25, 2018 — Part of the All of Us Research Program, centers will sequence 1 million genomes.
The All of Us Research Program awarded funds totaling $28.6 million to establish three genome centers around the country. These centers will begin to generate genomic data from biosamples contributed by the program’s participants. Ultimately, this information will become a critical component in the program’s precision medicine research platform, a national resource to support studies on a variety of important health questions. The All of Us Research Program is part of the National Institutes of Health…
The new All of Us Research Program Genome Centers will be led by:
:: Baylor College of Medicine, Houston, with Johns Hopkins University, Baltimore, and The University of Texas Health Science Center at Houston (UTHealth)
:: The Broad Institute, Cambridge, Massachusetts, with Color, Burlingame, California, and the Laboratory for Molecular Medicine at Partners HealthCare, Cambridge, Massachusetts
:: Northwest Genomics Center at the University of Washington, Seattle..

PATH  [to 29 Sep 2018]
Sept. 27, 2018
Global rotavirus vaccine options expand with World Health Organization prequalification of new vaccine from India
Thermostable rotavirus vaccine ROTASIIL® now available for procurement by UN and Gavi
SEATTLE, PATH welcomes the World Health Organization’s (WHO’s) prequalification of the thermostable rotavirus vaccine, ROTASIIL®, manufactured by Serum Institute of India. The vaccine, which prevents severe rotavirus-induced diarrhea in infants, provides an innovative and affordable option to the global market as it is the first rotavirus vaccine that does not require constant refrigeration and will help meet the critical public health goal of improving vaccine supply worldwide…

September 25, 2018 by PATH
Vietnam welcomes two locally produced vaccines for seasonal and pandemic influenza
International collaboration announces successful clinical trial results with licensure expected in 2019
Nha Trang, Vietnam, September 25, 2018—The Institute of Vaccines and Medical Biologicals (IVAC), World Health Organization (WHO), international global health organization PATH, and the Biomedical Advanced Research and Development Authority (BARDA) within the US Department of Health and Human Services, today joined leaders from the Ministry of Health (MOH), the National Institute of Hygiene and Epidemiology (NIHE), and the Pasteur Institute in Ho Chi Minh City (PIHCM) to announce results from two different Phase 2/3 clinical trials of locally produced seasonal and pandemic influenza vaccine candidates. Overall results showed both vaccine candidates to be acceptably safe and capable of prompting an immune response in healthy adults…

Sabin Vaccine Institute  [to 29 Sep 2018]
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UNAIDS [to 29 Sep 2018]
28 September 2018
Building faith-based partnerships to end AIDS and TB among children and adolescents
PEPFAR: the first 15 years
27 September 2018
Learning lessons from the AIDS response to control NCDs
26 September 2018
An opportunity to end two of the world’s deadliest infectious diseases: TB and HIV
Uniting for every woman and every child
25 September 2018
First ladies of Africa working to stop new HIV infections among children

UNICEF  [to 29 Sep 2018]
Selected Press Releases/Reports/Statements
Press release
UNICEF teams up with Ebola survivors to help stop spread of deadly outbreak in the Democratic Republic of the Congo
[See Milestones above for detail]

Press release
Remarks by Henrietta H. Fore, UNICEF Executive Director at the High-Level Meeting on Tuberculosis
As prepared for delivery
[See Milestones above for detail]

Press release
New roadmap to prevent and treat tuberculosis in children and adolescents
In 2017, almost one million children fell ill and over 200,000 children under 15 died of tuberculosis
[See Milestones above for detail]

Vaccine Confidence Project  [to 29 Sep 2018]
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Vaccine Education Center – Children’s Hospital of Philadelphia  [to 29 Sep 2018]
September 2018
Vaccine Update for Providers
This newsletter is meant to keep you up to date on issues related to vaccines quickly and easily.
Wellcome Trust  [to 29 Sep 2018]
Published: 27 September 2018
Collaboration was key to success in latest Public Engagement Fund awards
In August, we made the second set of awards under our new Public Engagement Fund scheme. Greer Roberts and Alexandra Parsons pull out some patterns we saw in the applications and have tips for future applicants.

Opinion / Published: 27 September 2018
This is TB’s moment and it must be seized
Two scientific breakthroughs and a global meeting on tuberculosis mean there is an opportunity to move TB from the doldrums, says Wellcome’s Director Jeremy Farrar. But great science needs to be matched by greater global commitment, ambition and political will.
… But now, thanks to the prodigious efforts of two international research teams, two critical milestones have been reached:
:: results of promising clinical trials of a new candidate vaccine (opens in a new tab)
:: a major study sequencing 10,000 TB genomes (opens in a new tab) from patients across 16 countries – work key to the rapid drug sensitivity testing needed to stop the rise and spread of drug-resistant strains of TB…
The Wistar Institute   [to 29 Sep 2018]
Press Release
Virion Therapeutics, LLC Raises $5 Million to Develop Checkpoint Inhibitor Powered Vaccine Therapies for Treatment of Virally Induced Infectious Diseases & Cancers
PHILADELPHIA — (Sept. 26, 2018) — A new Philadelphia-based start-up, Virion Therapeutics, LLC spun out of The Wistar Institute, will work to advance innovative, immune-based therapies for the treatment of chronic viral-associated cancers and viral infections utilizing the first genetically encoded checkpoint inhibitor that can be given via vaccination. Virion is co-founded by Hildegund C.J. Ertl, M.D., professor in the Vaccine & Immunotherapy Center at Wistar, along with life science entrepreneurs Andrew D. Luber, Pharm.D., and Bernard Rudnick, MBA…

World Organisation for Animal Health (OIE)   [to 29 Sep 2018]
The United Against Rabies collaboration builds skills and knowledge in rabies-endemic countries towards achievement of zero human rabies deaths
On the occasion of the 12th World Rabies Day, the United Against Rabies collaboration highlights the critical role that intersectoral collaboration must play if the world is to be rid of human rabies deaths by 2030.
Paris/Geneva/Rome/Manhattan, 28 September 2018 – The United Against Rabies collaboration, consisting of the World Health Organization (WHO), World Organisation for Animal Health (OIE), Food and Agriculture Organization of the United Nations (FAO), and Global Alliance for Rabies Control (GARC), has been taking action following the launch in June of Zero by 30: the global strategic plan to end human deaths from dog-mediated rabies by 2030. The plan provides a phased, all-inclusive, intersectoral approach to eliminate human deaths from dog-mediated rabies by 2030. It leverages the work of the four aforementioned organizations to facilitate coordination across the institutions. Its aim is to offer an integrated response to country needs through empowering, engaging and enabling them to lead and strengthen elimination efforts.  The approach limits duplication and improves efficiencies…

BIO    [to 29 Sep 2018]
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DCVMN – Developing Country Vaccine Manufacturers Network  [to 29 Sep 2018]
27 September 2018
DCVMN engaged in open dialogue with ICDRA about challenges and opportunities for alignment of procedures for vaccine registration
Dublin, September 4th 2018 – The organizers of the International Conference of Drug Regulatory Authorities (ICDRA) [1] 2018 invited the DCVMN regulatory expert working group to join the pre-ICDRA session on “Enabling access to innovative medical products in resource-limited settings” and present the recently published study, conducted in collaboration with IFPMA [2], on the challenges for the registration of vaccines in emerging countries [3]. A DCVMN representative, Ms. Iin Susanti, delivered the lecture and participated in a panel discussion, elaborating on opportunities and future options for regulatory convergence in addressing the challenges, while respecting regulatory requirements…

IFPMA   [to 29 Sep 2018]
27 September 2018
The R&D-based biopharmaceutical industry welcomes the UN Declaration on NCDs and calls for innovative financing
As an official UN interlocutor that shares knowledge and expertise to improve global health, IFPMA welcomes the strong re-affirmation of the commitment of governments to take steps to reduce premature mortality from chronic diseases by 2030 and strongly supports the declaration’s emphasis on orienting health systems towards the achievement of universal health coverage (UHC)…

R&D-based biopharmaceutical industry welcomes UN Declaration on TB Partnerships are key to foster innovation and
26 September 2018
The R&D-based biopharmaceutical industry welcomes the political declaration and reaffirms its commitment to the global fight against TB. To deliver on our common goal, industry stands ready to partner on the three pillars of the WHO End TB Strategy including integrated, patient-centred care and prevention; bold policies and supportive systems; and, in particular, intensified research and innovation…

WIPO and IFPMA Launch New Online Patent-Search Resource to Help Health Agencies Procure Medicines
GENEVA, September 25, 2018 – WIPO and the research-based pharmaceutical industry today launched a new online tool designed to help procurement agencies better understand the global patent status of medicines.
The Patent Information Initiative for Medicines (Pat-INFORMED) is a unique resource where patent holders provide information about patents covering approved medicines through a free, open access database.
This new public database became operational today, along with a platform where procurement agencies can make direct enquiries to companies.
Pat-INFORMED is a partnership between WIPO and the International Federation of Pharmaceutical Manufacturers and Associations, IFPMA, the global trade association representing the research-based pharmaceutical industry. Pat-INFORMED originated in the industry’s efforts to add clarity to patent information about medicines. WIPO’s globally recognized expertise in the organization and public dissemination of patent data will make an important contribution to the accessibility of patent information.
WIPO is hosting the database and providing the resources to ensure its continued development, while IFPMA is working closely with the 20 leading research-based biopharmaceutical companies that have backed this initiative to help ensure a consistent and coordinated approach…
PhRMA    [to 29 Sep 2018]
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