EDCTP    [to 2 December 2017]
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
1 December 2017
Ethiopia and Angola join the EDCTP Association
EDCTP is pleased to welcome Ethiopia and Angola as member countries of the EDCTP Association.

1 December 2017
World AIDS Day 2017: EDCTP invests in clinical research to support health for all
Significant gains have been made in tackling the HIV epidemic: deaths from AIDS-related causes declined by 48% between 2005 and…

European Medicines Agency  [to 2 December 2017]
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2017
PRAC starts two safety referrals and reaches conclusion on re-examination
Revised strategy to measure the impact of pharmacovigilance is adopted
The PRAC adopted a revision to its strategy to measure the impact of pharmacovigilance activities. The strategy was launched in January 2016, with the aim to improve safety monitoring practices and determine which activities are most successful. The strategy has been revised to reflect, among others, how major regulatory interventions benefit patients’ health.
FDA [to 2 December 2017]
November 30, 2017 –
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Implementing the 21st Century Cures Act: An Update from FDA and NIH”

Gavi [to 2 December 2017]
30 November 2017
Millions of children set to be protected against typhoid fever
Gavi Board approves US$ 85 million funding window for 2019-2020 to support the introduction of typhoid conjugate vaccine in developing countries.
Vientiane, 30 November 2017 – Millions of children in the poorest countries could soon be protected against typhoid fever following the Gavi Board’s approval today of a support window for typhoid conjugate vaccines (TCVs).

“Typhoid fever imposes a dramatic burden on children in the poorest nations affecting countries, communities and families,” said Dr Ngozi Okonjo-Iweala, Gavi Board Chair. “This disease has long been eliminated from most industrialised nations, but it is still a serious threat in developing countries where the vast majority of deaths occur,” she said. “I lost my cousin and nearly lost my son because of typhoid. This vaccine will be a lifesaver for millions of children, especially those living without access to clean water or sanitation.”…

“This vaccine is safe, effective and can provide lasting protection,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. “The growing spread of drug resistant strains of typhoid is a major threat, not just to individuals but also to our efforts to control the disease, and requires us to prioritise prevention strategies. Strong coverage through routine immunisation together with efforts to improve access to clean water and hygiene will play a key role in dramatically reducing the disease.”

A new typhoid conjugate vaccine manufactured by Bharat Biotech International Limited and first licensed in India in 2013, is currently under review for prequalification by the World Health Organization (WHO).

This follows the recent recommendation by the WHO Strategic Advisory Group of Experts on Immunization (SAGE) that typhoid conjugate vaccines should be introduced in endemic countries to all children over six months of age. Vaccines from five additional manufacturers are also under development and are expected to be available between 2018 and 2022.

Gavi expects the first countries to apply in 2018 with introductions forecasted to begin the year after. The Gavi Board also noted that the use of this new vaccine will enable further studies on the impact of the disease, challenges with diagnosis and appropriate immunisation strategies.

Typhoid conjugate vaccines were first seen as a priority by the Gavi Board in the 2008 Vaccine Investment Strategy (VIS) although no financial commitment was made at that time in the absence of a suitable vaccine.

The Vaccine Investment Strategy is Gavi’s evidence-based process for assessing the suitability of new vaccines to further support countries. Developed every five years, the next VIS will be completed at the end of 2018.

Today, the Gavi Board approved the evaluation criteria that will be used for assessing potential new investments in vaccines and other immunisation products for endemic disease prevention.

Between 2016 and 2020, at least 20 Gavi-supported countries are expected to transition out of Gavi’s financial support. Most of these countries are on-track to fully finance their immunisation programmes and sustain the progress they have made since 2000, when Gavi was created. However, the Gavi Board recognised that a small number of countries are facing more significant challenges…
[See Milestones above for more detail].
GHIT Fund   [to 2 December 2017]
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 ·
2017.11.30      Events

2017.11.30      Events
Upcoming Event: UHC Forum Side Event: Linking R&D to Access & Delivery: Virtuous Systems Powered by UHC

Global Fund [to 2 December 2017];&country=
WHO and Global Fund Sign Cooperation Agreements
01 December 2017
WHO and the Global Fund signed cooperation and financing agreements amounting to an estimated US$50 million today, with the aim of providing vital technical support to countries to fight HIV, TB and malaria, and securing additional progress toward universal health coverage.
Spain, Three African Countries and the Global Fund Launch New Debt2Health Initiative
29 November 2017
The government of Spain today announced an agreement to waive debts owed by Cameroon, the Democratic Republic of Congo and Ethiopia in exchange for investments in domestic health programs supported by the Global Fund.
Human Vaccines Project   [to 2 December 2017]
December 01, 2017
Human Vaccines Project Presents Initial Findings from First Clinical Trials
Scientists leading the clinical programs for the Human Vaccines Project reported today high-level outcomes from two concurrent clinical studies aimed at deciphering the components and mechanisms used by the human immune system to prevent and control disease at the World Vaccine and Immunotherapy Congress in San Diego, Calif. The findings from the studies may provide important new insights on human immunity that the Human Vaccines Project – a public-private partnership aimed at decoding the immune system to advance human health – will leverage to launch expanded studies in 2018.
The Project’s first program, the Human Immunome Program, aims to identify the core components that exist across everyone’s immune systems and utilize this information to enable development of new and improved vaccines. The team is sequencing millions of recombined and expressed B and T cell genes in healthy adults and cord blood samples at an unprecedented depth, seeking to identify shared elements of the human immune system not previously recognized. The team is led by James E. Crowe, Jr., MD, Director of Vanderbilt University Medical Center’s Vaccine Center, the scientific hub of the Human Immunome Program…
Early findings from a second and complementary clinical research program of the Human Vaccines Project, aimed at revealing the key principles or rules that the human immune system follows when it comes to the prevention and control of disease, will be shared in two separate presentations by Manish Sadarangani, MD, PhD, Director of the Vaccine Evaluation Center of the University of British Columbia and BC Children’s Hospital Research Institute and Richard Scheuermann, PhD, Director, J. Craig Venter Institute, La Jolla Campus. The long-term goal of this program is to understand the rules of the human immune system that will enable one-shot vaccines to provide long term protective immunity in all populations. The aim of this study is to understand why some people respond effectively to a single immunization of a licensed Hepatitis B vaccine, while others require up to three immunizations for generating protective immunity…
IAVI  [to 2 December 2017]
November 30, 2017
Research Roundup: IAVI & Partner Discoveries 2017
The road toward an effective HIV is marked by fresh findings, promising new pathways for development, and the occasional breakthrough. This year offered a mix of all three, and as always with scientific progress – more questions to answer…

IVAC  [to 2 December 2017]
IVAC Blog  28 Nov 2017
SAGE Wisdom: What’s it like to sit on WHO’s expert immunization advisory group?
…From October 17-19, three faculty members from the International Vaccine Access Center (IVAC), of the Johns Hopkins Bloomberg School of Public Health (JHSPH), provided technical expertise and leadership at the annual SAGE meeting, an advisory body formed in 1999 to provide guidance on immunizations to the WHO.
IVAC’s delegation included Director of Epidemiology Bill Moss, Director of Science Maria Deloria Knoll, and IVAC Executive Director Kate O’Brien. The meeting, held in the August Room where WHO’s 34-member Executive Board meets, was attended by about 200 people and included presentations from nine Working Groups. SAGE Working Groups delve in to key immunization-related questions of interest to policymakers around the world…
MSF/Médecins Sans Frontières  [to 2 December 2017]
Press release
Syria: Bombing and Shelling in East Ghouta Overwhelm Medical Services
November 27, 2017
Doctors Without Borders/Médecins Sans Frontières (MSF) calls for urgent medical supplies and respect for International Humanitarian Law protecting medical facilities
NIH  [to 2 December 2017]
December 1, 2017
NIH Statement on World AIDS Day 2017
— After 30 years of marking progress against HIV, we are closer than ever to the beginning of the end of the HIV/AIDS pandemic.
…The ultimate goal for HIV prevention is development of a safe and effective vaccine. The National Institutes of Health announced yesterday that a new Phase 2b, proof-of-concept trial of an HIV vaccine has been launched in southern Africa. The study, called Imbokodo (HVTN 705), aims to enroll 2,600 HIV-negative women in sub-Saharan Africa. This new trial joins HVTN 702, a Phase 2b/3 vaccine efficacy trial being conducted in South Africa, aiming to build on the modest results of the RV144 vaccine trial in Thailand…

NIH and partners launch HIV vaccine efficacy study
November 30, 2017 — Public-private partnership begins clinical trial in sub-Saharan Africa.
The National Institutes of Health and partners have launched a large clinical trial to assess whether an experimental HIV vaccine regimen is safe and able to prevent HIV infection. The new Phase 2b proof-of-concept study, called Imbokodo, aims to enroll 2,600 HIV-negative women in sub-Saharan Africa. Of 1.8 million new HIV infections worldwide in 2016, 43 percent occurred in eastern and southern Africa, with women and girls disproportionately affected.
“Imbokodo,” the Zulu word for rock, is part of a well-known proverb in South Africa that refers to the strength of women and their importance in the community. The study is sponsored by Janssen Vaccines & Prevention, B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, with co-funding from two primary partners, the Bill & Melinda Gates Foundation (BMGF) and NIH’s National Institute of Allergy and Infectious Diseases (NIAID).

The vaccine regimen being tested in Imbokodo is based on “mosaic” immunogens — vaccine components designed to induce immune responses against a wide variety of global HIV strains. This regimen differs from the one being tested in the Phase 2b/3 HVTN 702 study, an ongoing HIV vaccine efficacy trial sponsored by NIAID that launched late last year in South Africa with major co-funding from NIAID and BMGF. HVTN 702 is evaluating a newer version of the vaccine regimen tested in the RV144 Thai trial — the only candidate HIV vaccine regimen ever shown to provide some protection against the virus.

“Together with the implementation of existing HIV prevention and treatment strategies, the development and delivery of a preventive HIV vaccine that is safe and at least moderately effective would help bring about a durable end to the HIV/AIDS pandemic,” said NIAID Director Anthony S. Fauci, M.D. “We are committed to pursuing multiple vaccine development strategies to achieve this goal.”

The first Imbokodo participants have received vaccinations at clinical research sites in South Africa. Regulatory approvals are being sought to conduct the study at additional sites in Malawi, Mozambique, Zambia and Zimbabwe. With the start of Imbokodo, two HIV vaccine efficacy trials now are taking place in sub-Saharan Africa. Results from HVTN 702, which is enrolling HIV-negative men and women in South Africa, are expected in late 2020. Results from Imbokodo are expected in 2021…

The NIAID-funded HIV Vaccine Trials Network (HVTN), headquartered at Fred Hutchinson Cancer Research Center in Seattle, is implementing Imbokodo. The South African Medical Research Council (SAMRC) is helping implement the study in South Africa. Additional partners providing support include the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research, the U.S. Army Medical Materiel Development Activity, and the Ragon Institute of MGH, MIT and Harvard…

NIH launches HIV prevention trial of long-acting injectable medication in sexually active women
November 30, 2017 — Study to test efficacy, safety of injectable cabotegravir compared with daily oral PrEP.
The first large-scale clinical trial of a long-acting injectable medication for HIV prevention in sexually active women has begun. The study in southern and eastern Africa will examine whether a long-acting form of the investigational anti-HIV drug cabotegravir injected once every eight weeks can safely protect women at risk for HIV infection. The only drug regimen currently licensed for HIV pre-exposure prophylaxis, or PrEP, is the anti-HIV medication Truvada taken daily as an oral tablet. The U.S. National Institutes of Health (NIH) is sponsoring the trial, and the NIH-funded HIV Prevention Trials Network (HPTN) is conducting the study, called HPTN 084…

Combination HIV prevention reduces new infections by 42 percent in Ugandan district
November 29, 2017 — NIH-supported study provides evidence for implementing approach broadly.
A study published today in the New England Journal of Medicine provides real-world evidence that implementing a combination of proven HIV prevention measures across communities can substantially reduce new HIV infections in a population.
Investigators found that HIV incidence dropped by 42 percent among nearly 18,000 people in Rakai District, Uganda, during a seven-year period in which the rates of HIV treatment and voluntary medical male circumcision increased significantly…
PATH  [to 2 December 2017]
Press release | November 30, 2017
Novel drug delivery system has game-changing potential to reduce rates of HIV infection
An international collaboration announces preclinical development of a microarray patch delivery system for HIV pre-exposure prophylaxis
Seattle, WA, December 1, 2017—The United States Agency for International Development (USAID), through the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), awarded PATH a three-year, $9.4 million grant to advance a needle-free microarray patch for delivery of HIV pre-exposure prophylaxis (PrEP). Microarray patches are a discreet, easy-to-use technology that contains an array of tiny projections that painlessly penetrate the top layer of skin to deliver a drug.
PATH, ViiV Healthcare, Queen’s University Belfast, the Population Council, and LTS Lohmann Therapie-Systeme AG will combine their complementary expertise to develop a novel microarray patch for HIV PrEP in preparation for future clinical trials. The collaborators will engage with women and health care workers in Kenya, South Africa, and Uganda to design a microarray patch product that meets their needs…
Announcement | November 28, 2017
PATH statement on the World Health Organization’s World Malaria Report, 2017
Regaining progress against malaria requires new tools
A statement from PATH’s Vice President for Essential Medicines, Dr. David C. Kaslow, follows:
This week, the World Health Organization (WHO) released the 2017 World Malaria Report on the state of malaria control and elimination across the globe and, worryingly, emphasized that although more countries have accelerated toward malaria elimination, the global progress to prevent malaria disease and death has stalled after a period of unprecedented positive impact.
The new data find that malaria killed an estimated 445,000 people in 2016, a number essentially unchanged in the last three years. The report also finds that there were an estimated 216 million cases of malaria globally in 2016, a consistent figure for the past five years.

The brunt, by far, of the burden of disease and deaths is shouldered by sub-Saharan Africa (with the exception of India, which had the third highest number of malaria deaths in 2016).
The good news is that malaria control works when there is sufficient funding and political will behind the effort. But current malaria funding levels are insufficient, and while we wait for funding to keep pace with global need, the malaria parasite continues to kill, debilitate and evolve.

Regaining progress made in driving malaria to zero will require more than just maintaining the status quo. Though existing tools may be imperfect, when used at scale they are having an impact. However, in the end, current tools will only take us so far, and new tools are needed, particularly in geographies with the highest malaria burden.

This new report makes clear that to keep up with the parasite, malaria control efforts must make the best use of currently available bednets, diagnostic tests, drugs, and indoor residual spraying. It also makes abundantly clear that investment must be made in research and development of new tools—including drugs, diagnostics and surveillance tools, vaccines, and vector control—that build on the progress already made, and bring new approaches to preventing disease and death and stopping the spread of malaria parasites.

The increasing number of countries that have eliminated malaria, and all of those approaching elimination, provide clear evidence that the parasite can be controlled. At the same time, setbacks in countries with a high disease burden serve as a wake-up call that the global community needs to fund and scale existing control efforts, and invest in the research and development of new tools.
Posted November 28, 2017.

UNAIDS [to 2 December 2017]
1 December 2017
UNAIDS Congratulates French President Macron for his leadership on AIDS

30 November 2017
Geneva international community unites to end violence against women and girls
To galvanize joint action to end the epidemic of violence against women and girls, the African Women Ambassadors to the United Nations in Geneva and UNAIDS convened a special event on the eve of the International Day for the Elimination of Violence against Women and to kick off 16 Days of Activism.
The event, held on 24 November in UNAIDS’ headquarters in Geneva, Switzerland, was attended by more than 35 ambassadors to the United Nations in Geneva…

UNICEF  [to 2 December 2017]
Global complacency threatens the lives of children and adolescents as world set to miss global AIDS target – UNICEF
NEW YORK/JOHANNESBURG, 01 December 2017 – In 2016, 120,000 children under the age of 14 died of AIDS related causes, and 18 children were infected with HIV every single hour. If current trends persist, there will be 3.5 million new adolescent HIV infections by 2030, according to projections from the 2017 UNICEF Statistical Update on Children and AIDS released today.

Global agreements on migration and refugees should include commitments to protect children, UNICEF urges world leaders
MEXICO CITY/NEW YORK/GENEVA, 30 November 2017 – The rights, protection and wellbeing of uprooted children should be central commitments of global migration policies, UNICEF said today ahead of a meeting in Puerto Vallarta, Mexico, on safe, regular and orderly migration.

Wellcome Trust  [to 2 December 2017]
News / Published: 27 November 2017
New Research Enrichment awards available for grantholders
Today, we’re pleased to launch new Research Enrichment awards. These extend our dedicated funding for public engagement to encompass open research, and diversity and inclusion.
We’re doing this because we believe this new funding will increase the impact of the work we fund and so benefit society.
Research Enrichment funding is available to support activities in:
:: public engagement – this replaces the Provision for Public Engagement scheme
:: open research
:: diversity and inclusion.
The new enrichment awards will allow our grantholders to widen participation in their research by:
:: inspiring, consulting or collaborating with the public
:: developing innovative ways to make research open, accessible and reusable
:: identifying and tackling barriers to diversity and inclusion…

IFPMA   [to 2 December 2017]
Published on: 28 November 2017
Press Release: 3rd Biennial Scientific Conference on Medical Products Regulation in Africa
PRESS RELEASE, 27 November 2017, Accra – Ghana
Significant strides have been made over the years to enhance and modernize the regulation of pharmaceutical manufacturing and product quality across the world. However, the drug registration system in Africa remains complex and varied, and separate national review processes currently in place impact patients’ access to medicines in Africa. Harmonisation of the processes for medicine registration is long overdue.
Under the African Medicines Regulatory Harmonization (AMRH) initiative, there are some ongoing pilot projects that are aimed at improving national registration processes, and these will go a long way towards meeting the goal of regulatory harmonization and convergence.
The proposed African Medicines Agency is at the centre of the 3rd Biennial Scientific Conference on Medical Products Regulation in Africa taking place at Alisa Hotel in Accra from 27-28th November.
Organised by international stakeholders with support from the West African Health Organisation, (WAHO), NEPAD, the Government of Ghana, the Federation of African Pharmaceutical Manufacturers Associations (FAPMA), and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the meeting brings together the key stakeholders including regulators, policymakers, academia, the scientific community, private sector and civil society from across Africa.
The theme for the conference is “Sustaining the Momentum for Regulatory Harmonisation in Africa”. This theme will enable participants to contribute towards the future of regulation and harmonisation in Africa, which affects both industrial and regulatory aspects, as well as the aspirations of civil society and its wish to benefit from best practice, and best medicine…

PhRMA    [to 2 December 2017]
December 1, 2017
World AIDS Day 2017: Scientific breakthroughs paving the way for an AIDS-free generation
On World AIDS Day, the hope for an AIDS-free generation is within reach.

November 29, 2017
EFPIA-PhRMA Principles successfully enable responsible clinical trial data sharing
In a new survey with EFPIA and PhRMA, considerable data sharing is taking place.
Stakeholders are gathering in London this week for a workshop entitled Data Anonymization – a Key Enabler for Clinical Data Sharing. The workshop, jointly organized by the European Medicines Agency (EMA) and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, is but one example of efforts by a broad range of stakeholders to enhance clinical trial data sharing. The workshop will seek to propose guiding principles to enable international data sharing – an area in which PhRMA and its member companies are leading the way.

Making research data available to qualified researchers has the great potential to advance medical research to benefit patients by accelerating the development of new medicines and improving patient care. The biopharmaceutical industry has been at the forefront of initiatives to improve access to clinical trial data and has led the way in sharing patient-level data. Industry details its commitments to sharing clinical trial data in the joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing (or Principles) which were adopted by the boards of both associations in July 2013. The Principles support enhanced data sharing while safeguarding patient privacy, respecting the integrity of national regulatory systems, and maintaining incentives for investment in biomedical research.

Today, EFPIA and PhRMA released the Report on the 2016 Member Company Survey which details the results of a joint survey conducted between July and September 2016, to assess the degree to which member companies had made progress in implementing the commitments under the Principles. The survey results show that 98 percent of EFPIA and PhRMA member companies share clinical trial data beyond any legal or regulatory requirements. In addition, EFPIA and PhRMA member companies collectively documented more than 1,000 requests for access to clinical trial data between January 1, 2014 (the date that the companies began to implement the Principles), and the close of the survey. Of the 935 requests on which a decision had been made, the vast majority, 80 percent, were approved, showing that considerable data sharing is now taking place…

Industry Watch    [to 2 December 2017]
:: Takeda Initiates Phase 1 Clinical Trial of Zika Vaccine Candidate
November 28, 2017
:: Takeda’s investigational Zika virus vaccine candidate (TAK-426) progresses into Phase 1 clinical trial
:: The clinical trial (ZIK-101) will evaluate safety and immunogenicity of TAK-426 in 240 subjects between the ages of 18 and 49 across the continental U.S. and U.S. territories
:: Takeda’s Zika program is funded with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201600015C

:: Sanofi updates information on dengue vaccine
New analysis of long-term Dengvaxia® data found differences in vaccine performance based on    
    prior dengue infection
Company will ask regulators to update product label to reflect new information
[See Milestones/Perspectives above for detail]