Forum 11, Beijing, 29 October - 2 November 2007, Equitable access: research challenges for health in developing countries

The annual Global Forum brings together decision-makers, funders and leaders in research and development to focus on reducing the massive underinvestment in health research for the needs of developing countries. Equitable access, the overarching theme of Forum 11, will examine several questions in health research. How can research improve understanding of and equitable access to basic preconditions for health? What innovations in products, policies and processes can improve equity of access? What are the needs for research resources (human, institutional, financial, informational)? How can research facilitate good governance? What role does communications play?

Abstracts are now being accepted until 31 January.

For more information and online submission, see the website: www.globalforumhealth.org

 This is not an EDCTP Call for Abstracts

The Bill & Melinda Gates Foundation (BMGF) and the European and Developing Countries Clinical Trials Partnership (EDCTP) and its member states are pleased to announce the launch of a joint call, on World AIDS Day the 1 December 2006, for proposals to support capacity building in African countries. The main objective of the call is to establish or strengthen long-term capacity to conduct clinical trials of preventive HIV vaccines in African countries in order to ensure that novel candidate vaccines are expeditiously evaluated with the highest scientific and ethical standards.

The initial focus of this call is the preparation for and, if appropriate, the conduct of phase II trials of HIV candidate vaccines, as part of the collaborative effort proposed by the Global HIV Vaccine Enterprise.  >> More

The world has promised to stop AIDS by 2015. Although it is 25 years now since the description of the early cases, the AIDS global epidemic continues to grow and the vision of a world without AIDS in the near future is in jeopardy. This year alone there were 4.3 million new HIV infected persons (2.8 million from the sub-Saharan Africa) adding up to the total number of people living with AIDS to 39.5 million. It is therefore appropriate and timely that the World Aids Day theme for 2006 is ACCOUNTABILITY. This falls under the broader decade (2001-2010) slogan of STOP AIDS. KEEP THE PROMISE. The accountability is about keeping this promise, especially by the world political leaders, decision and policy makers, development partners, the private industry, the scientific community and civil society at large.

These promises which we have all made, include the milestone decision of 2001 by the United Nations General Assembly Special Session (UNGASS) on AIDS that declared support of the development of vaccines and other prevention technologies and encouraged private-public partnerships to effectively respond to the epidemic, a stand which has been reaffirmed this year (UNGASS +5). This year the Group of Eight (G8) have also pledged to promote the development of vaccines and microbicides against HIV, and to support efforts of the Global HIV Vaccine Enterprise. Promises have also been made in Africa, the continent that suffers most from the epidemic. In 2001 the African Heads of States in a summit held in Abuja, committed themselves through the Abuja Declaration to lead from the front in the battle against HIV/AIDS, tuberculosis and other related infections. In that declaration the leaders promised that they would take all necessary measures needed to ensure that resources would be made available, and effectively and efficiently utilised. The leaders also committed themselves to step up the improvement of their health care systems by allocating at least 15% of their annual national budgets and pledged to support the development of HIV vaccines that were suitable and affordable for Africa. This position was reaffirmed in May this year through the Abuja call which in addition, took a further step by calling for accelerated action towards universal access to HIV/AIDS, tuberculosis and malaria services in Africa. This, among other strategies called for the adoption and implementation of 2006 as the Year of Acceleration of HIV Prevention naming prevention of mother to child transmission (PMTCT) of HIV and promotion and support of research and development of vaccines, diagnostics and treatment for HIV/AIDS, tuberculosis and malaria as key strategies.

To respond to this, the European and Developing Countries Clinical Trials Partnership (EDCTP) has in 2006 launched two calls for grant applications to support the prevention of HIV/AIDS in Africa. These include grants to conduct research on the prevention of maternal to child transmission of HIV and on capacity development for conducting vaccine trials. The 6.1 million euro grant for the prevention of mother to child transmission of HIV was launched in July this year and co-funded by France, Ireland, the Netherlands, Spain and the United Kingdom. Today, as we commemorate the World AIDS day, EDCTP, together with European member states and the Bill & Melinda Gates Foundation, is launching a 20 million euro grant to support capacity development to conduct phase II clinical trials of HIV preventive vaccines in Africa. Where appropriate, the grant would also support the conduct of such clinical trials. This is in addition to the already ongoing projects and contracts under negotiation totalling around 11 million euros covering clinical trials on safe anti-tuberculosis treatment in individual who are co-infected with HIV, simple anti-retroviral regimens in children, prevention of per-partum acquisition of HIV and capacity building for conducting phase I/II and phase III clinical trials of microbicides for the prevention of HIV.

Recognising that research capacity and the necessary enabling environment to conduct clinical trials, including ethics review and an effective regulatory framework are important limiting factors in carrying out clinical trials of new drugs and vaccines in Africa, EDCTP together with other partners including the World Health Organization (WHO), African AIDS Vaccine Programme (AAVP) and Internationals AIDS Vaccine Initiative (IAVI) is working to address these deficiencies. In partnership with WHO, EDCTP has in 2006 supported strengthening of National Regulatory Authorities in Africa, including conducting the First African Vaccines Regulators’ Forum in Accra, Ghana. Together with WHO, AAVP, AIVI and other partners, EDCTP has been working with the African Union to develop a common advocacy and strategy for HIV vaccine development in Africa. Nevertheless, for all this to bear fruit the world needs steadfast commitment and accountability from all leaders at all levels. Political leaders, scientists, members of civil society and all in a position to influence or make decisions and policies must take responsibility for keeping the promise to stop AIDS and be accountable. A world without AIDS will be possible, only when this promise is fulfilled.

The Developing Countries Coordination Committee (DCCC) of the European and Developing Countries Clinical Trials Partnership (EDCTP) is seeking four new members for a two-year tenure starting 1 January 2007.

Please visit our Vacancies section for more information.

EDCTP wishes to announce that the current serving Executive Director, Dr. Odile Leroy, will be leaving the organisation to take up a new Chief Executive role at EMVI (European Malaria Vaccine Initiative) with effect from 01/10/2006.

Dr. Leroy joined EDCTP in July 2005 and during her time with the organisation worked tirelessly to bring a new momentum to developing the EDCTP, achieving considerable success in the process.

Dr. Diana Dunstan (Chair of EEIG – GA) would like to express her thanks on behalf of all of the EDCTP constituencies to Dr. Leroy for all of her efforts and wishes her the best of success in her new venture.

The General Assembly will start immediately to recruit a successor to Dr. Leroy and a formal vacancy announcement will be posted in the relevant media in the near future. As an interim measure Dr. Dunstan will be supporting the secretariat directly by spending up to 2 days per week at the Hague office. Mr Simon Belcher (Financial Manager and Vice Executive Director) will be Acting Executive Director when Dr. Dunstan is out of the office.

EDCTP wishes to reassure all parties involved with the initiative that it is well placed to maintain continuity of operations over this period and the launching of future calls will progress as previously planned.

The EDCTP 3rd Annual Forum is being held in Stockholm, Sweden between the 9-11 October 2006. For further information on the forum, or to go to the newly updated website please click here. Please note that all African participants need to have a visa in order to enter Sweden. There is detailed instructions on how to get a visa on our website, please check it to make sure that you are fully informed.

EDCTP is pleased to announce that it has extended its contract with the European Commission until 2010. In view of this, EDCTP is encouraging scientists to create larger networking consortiums and is welcoming brokering initiatives. The new strategy will focus on larger clinical trial grants that will still include all other components that are important to EDCTP such as networking and capacity building to enable the conduct of good quality trials, enhance the partnership and encourage sustainability. For this reason, EDCTP will no longer launch the smaller calls that have been launched in the past.

EDCTP is pleased to announce the launch of a call for proposals in support of studies for the Prevention of Mother To Child Transmission (PMTCT) of HIV, including prevention of transmission during breast feeding.

This is a Joint call between five European Member States (France, The Netherlands, UK, Spain and Ireland) & EDCTP. However, the call is open to researchers from all EDCTP partner countries.

The prevention of mother to child transmission of HIV is one of the most cost-effective interventions against the spread of HIV. Therefore, it is essential to develop studies on strategies to prevent mother-to-child transmission. >>More

The Dutch Ministry of Foreign Affairs, the European & Developing Countries Clinical Trials Partnership (EDCTP) and the Netherlands-African partnership for capacity development and clinical interventions against poverty-related diseases (NACCAP) are organising a Stakeholder Forum - 28 June 2006 IN Brussels bringing together representatives from academia, industry, governments and non-governmental organisations to debate: “ Connecting the Chain”, Towards a comprehensive approach to delivering affordable medicines against poverty-related diseases.
 
The challenge
Despite many efforts, the goal of bringing much-needed drugs and vaccines to communities in sub-Saharan Africa remains elusive.
One important reason is that the world is not yet allocating the funds needed to decisively tackle poverty-related diseases like HIV/AIDS, malaria and tuberculosis.
At the same time, however, working together concertedly to deliver effective and affordable medicines is also proving to be a daunting task.
The product development chain, from early-stage scientific research all the way to delivery, is owned or affected by many players, all with their own background, jargon, priorities and interests. As a result, links of the chain are often not properly interconnected or even missing.
This Stakeholder Forum aims to identify gaps in the product development chain and to come up with an agenda for bridging them.
 
Some Key questions:

• How should Europe organize and fund its support for vaccine and drug development, taking into account all parts of the chain?
• How can we improve co-ordination and co-operation within the entire development chain, as well as amongst donors and the growing number of product development partnerships?
• How can we make sure new drugs, vaccines and diagnostics fit in with national policies and health systems in Africa? How to ensure that local governments are equipped to handle market approval?
• How can we improve current and planned funding programs so as to make sure that new medicines are not only effective but also affordable?
• Do health care and research & development capacity deserve greater attention from national and international development agencies? How can these agencies get more involved in building research capacity in Africa?
• How can we make push and pull support mechanisms work better together? How to increase investments in early-stage product development?
• And will advanced market commitments bring pharmaceutical industries back into the action?

 The Netherlands-African Partnership for Capacity Development and Clinical Interventions against Poverty-related Diseases (NACCAP), is the Netherlands National Programme, contributing to the objectives of EDCTP. Apart from co-funding of EDCTP awarded research proposals and commissioned projects for capacity strengthening, NACCAP favours participation in joint calls but also announces its own calls for proposals, to be executed by partnerships between African, Dutch and other European research groups.
The specific objective of the second NACCAP call is to strengthen capacity of African owned (pharmaceutical or biotechnological) R&D institutes by technology transfer between African and European private and public institutes. The call will focus on translational research, in which science is translated into clinical application by partnerships between private partners and academic institutes in order to enhance the development of new products. In addition, small scale production of clinical products (against HIV/AIDS, malaria and tuberculosis) according to international accepted standards may be financed. In doing so, sustainable strengthening of African R&D capacity e.g. by technology transfer of partnerships between private and public partners is a prerequisite.
Deadline Letters of Intent: 7th June 2006 17:00h CET.

For more detailed information please visit our website www.nwo.nl/naccap or contact Judith de Kroon, Programme Coordinator NACCAP (steentjes(at)nwo.nl).

For the application form and instructions please see http://www.nwo.nl/subsidiewijzer.nsf/pages/NWOP_692LSS_Eng?opendocument.

In 2006, malaria remains a major weapon of mass destruction in the world affecting 300-500 million people and causing over 1 million deaths every year, principally in Africa (90% of deaths) and mostly in children. More resources are needed to combat this preventable and treatable disease and the 25th of April; the African Malaria Day reminds us of this responsibility.

The European and Developing countries Clinical Trials Partnership (EDCTP) is committed to contribute towards poverty reduction in developing countries by improving the health of the populations, through European research integration and in partnership with African countries to develop new clinical interventions to fight HIV/AIDS, malaria and tuberculosis. To this effect, the first EDCTP calls for proposals on Malaria were launched in 2004 and more are planned for 2006. To date an approximate total of € 23 million as shown in the table below has been committed towards site preparation of malaria vaccines trials, capacity building and the evaluation of both new drugs and drug combinations for the treatment of uncomplicated and severe malaria.

EDCTP Malaria activities (€m) 

2004	Uncomplicated malaria: Artemisinin based therapy	2.0
2006	Uncomplicated malaria: Combinations of registered products	2.0
2006	Uncomplicated malaria: Registration of a new drug	7.0
2006	Severe malaria: Intravenous artesunate	5.0
2006	Treatment of malaria in pregnant women	5.0
2006	Capacity building: Phase I-III trials of vaccines	2.0
	TOTAL	23.0

However, as we mark the Africa Malaria Day we need no reminder that despite it being a global health issue, malaria is largely an African problem that requires a strong African input in finding solutions. This calls for the African research community, policy makers and political leaders to spearhead in priority setting for finding appropriate sustainable interventions against this major killer disease in Africa.
EDCTP supports strong African leadership in the fight against malaria and other major poverty-related diseases including HIV/AIDS and tuberculosis.

Announcement of the First EDCTP Investigators Meeting
24 -25th July 2006, Cape Town, South Africa - Strictly by invitation

EDCTP invites all principal investigators and their collaborators from African study sites and Europe or USA where applicable to an Investigators' Meeting. This meeting is planned to take place at the Medical Research Council in Cape Town (South Africa) on 24 to 25 July 2006. More