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 Executive Director’s Note News about EDCTP Governance
News about Calls and Grants
Focus on EDCTP grantees
Meetings and visits
Events
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| Executive Director’s Note | ||||||
As we enter the last quarter of 2007 I am glad to note the continuing relentless pace of the EDCTP programme. Following the stakeholder meetings held during the previous quarters, we launched 8 calls worth nearly €130 million in July and August. EDCTP will launch three more calls to support clinical trials in the fields of HIV vaccines, microbicides and treatment before the end of the year. In keeping with the increased pace of rolling out grants and therefore increased activities in Africa, Dr Pascoal Mocombi has been based at the EDCTP Africa Office in Cape Town since September 2007. He will continue his role as the High Representative, and will focus on more closely engaging African leadership. To cope with the increased grant activity, and the departure of some staff, I am glad to welcome Dr Nnemdi Kamanu Elias, Dr Montserrat Blázquez Domingo and Ms. Lara Pandya in the Projects team and Ms Patricia Sáez in the Administration section. They all have proven to be very valuable additions to the Partnership. EDCTP has continued with site visits to EDCTP funded projects. These visits collect information about ongoing EDCTP funded activities, identify capacity development requirements and provide an opportunity for the visiting team to meet with African leadership and policy makers. In the previous quarter, an EDCTP team visited institutions in Kenya and Uganda as reported in this current issue of the newsletter. In addition, there have also been several EDCTP supported networking meetings and training workshops. This includes a recent meeting for regional networks of excellence whose outcome we eagerly anticipate. |
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| News about EDCTP Governance | ||||||
EDCTP welcomes new staff members |
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 Dr Nnemdi Kamanu-Elias has joined the EDCTP Secretariat as Projects Manager. She is a medical doctor and a citizen of Nigeria and the United States. She studied medicine at Yale University and obtained a Masters in Public Health from the University of California, Berkeley. She gained considerable experience in the treatment of HIV/AIDS patients while practicing in the United States. Before joining EDCTP, she worked in Tanzania with the Centers for Disease Control (CDC) as Programme Director for HIV/AIDS Care and Treatment in Dar es Salaam, within the framework of the US President’s Emergency Plan for AIDS Relief (PEPFAR). |
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 Dr Montserrat Blázquez Domingo has joined as Project Officer to be part of the Projects team. Born in Barcelona, Montserrat carried out BSc and MSc studies in biochemistry and molecular biology, and holds a PhD degree in cell and molecular biology. Previously, she has worked as scientific copy-editor and journal administrator for two international journals (FEMS Immunology and Medical Microbiology and FEMS Reviews) at the Publications Division of the Federation of European Microbiology Societies in Delft (Netherlands). |
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 Lara Pandya was born in England and has joined EDCTP as Project Officer to be part of the Projects team. Lara studied Geography at the the University of Bristol and graduated with First Class (Hons) Master of Science. Following this, she worked at Kingston Hospital in Surrey where she was responsible for managing legal matters and handled clinical negligence claims made against the hospital. Lara moved to The Netherlands in September 2005 and worked for the Amsterdam office of Parexel firstly as Clinical Lead Assistant and later as Contracts Specialist, providing her experience of Clinical Trials management and contracts negotiation. |
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 Patricia Sáez was born in Spain, where she studied English Philology. After teaching English for several years, she moved to South Africa where she worked as a lecturer of Spanish at the University of South Africa and obtained a Diploma in Translation. Later on, she worked for different Diplomatic organizations as a secretary. She has recently arrived in The Netherlands to join EDCTP as an Administrative officer. |
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| News about Calls and Grants | ||||||
Calls open for application Malaria
Tuberculosis
Cross-cutting capacity building activities
For more information about these calls and how to apply, please visit our website at www.edctp.org. |
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| Funded projects | ||||||
EDCTP is pleased to announce funding of the following projects:  |
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EDCTP stakeholder meeting in HIV vaccines The EDCTP stakeholders’ meeting on HIV vaccines was the last in a series of such meetings focusing on specific disease topics within the EDCTP scope. The HIV vaccine stakeholder meeting was organised by EDCTP and the Prince Leopold Institute of Tropical Medicine, Belgium. The aim of this meeting was to help EDCTP to identify and prioritise potential products in the pipeline and suggest suitable sites to do the trials as well as make recommendations on the funding procedure for these projects. In addition, EDCTP wanted to have preliminary information about the financial commitment and participation of the Member States for clinical trials on HIV vaccines. Although there was no clear cut recommendations, bearing in mind the scope and merit of EDCTP as well as the current landscape, the majority of the opinion seemed to favour conducting a phase II preventive vaccine trial. The meeting was chaired by Dr José Esparza, Senior Advisor on HIV Vaccines at the Bill & Melinda Gates Foundation. The report of the meeting is available on the EDCTP website at www.edctp.org. |
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Networking meeting for establishment of regional Networks of Excellence EDCTP organised a meeting for potential institutional applicants for its call for proposals to establish regional networks of excellence. This call will support the development of networks of collaborating institutions or clinical trial sites to expedite the conduct of clinical trials on HIV/AIDS, tuberculosis and malaria in sub-Saharan Africa. These networks will enable less developed institutions participate in multicentre trials through mentorship and training programmes and will allow for facilitated planning of trials. The meeting was in response to the networks of excellence stakeholders’ meeting recommendations that suggested availing an opportunity for regional discussions between institutions to come up with joint proposals. It took place at the EDCTP Africa Office in Cape Town, South Africa. EDCTP, through the Developing Countries Coordinating Committee (DCCC), invited participating institutions from all regions of Africa. All regional networks are expected to submit their proposals to EDCTP before the 2 December 2007 deadline, after which the proposals will be subject to peer-review before selection for funding in the first quarter of 2008. The networks of excellence meeting was followed by a DCCC meeting held at the same venue.
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| Focus on EDCTP grantees | ||||||
Global Training Network (GTN) workshops The main goal of these workshops was to provide representatives of African National Regulatory Authorities (NRAs) and Ethics Review Committees with the necessary expertise and capacity to:
The first workshop on Authorisation of Clinical Trials was held in December 2006 in Ouidah, Benin. It targeted 11 French-speaking countries. The second course held in June in Harare was for English speaking countries that included Uganda, Ethiopia, Tanzania, Malawi, Mozambique, Botswana, Ghana, Nigeria, The Gambia and Zimbabwe. Participants from NRAs, Ethics Committees and Research Institutions from these countries attended the training. Another workshop focussed on Good Clinical Practice (GCP). This GCP inspection course was delivered for the first time in Africa as a result of a collaboration between Developing Countries Vaccine Regulatory Network (DCVRN) with the national Department of Health, Medicines Regulatory Affairs in South Africa, National Agency of Drug and Food Control of Indonesia, the Collaborative Centre on Cold Chain Management in South Africa, University of Cape Town and the Ministry of Health in Turkey. The training material is based fully on adult learning methodologies. Meetings and workshops from EDCTP networking grant A consensus paper on the role of clinical pharmacology in supporting the fight against HIV/AIDS, tuberculosis and malaria was drafted. As part of our ongoing commitment to capacity building, the workshop also provided a one-day training to staff and students at the Department of Medicine, Pharmacology and Pharmacy as well as at the Infectious Diseases Institute of Makerere University. Start of Phase II trial of intravenous artesunate for children with severe malaria The Press release is available on the EDCTP website at www.edctp.org HIV/AIDS infected children can now benefit from a European and Developing Countries Clinical Trials Partnership (EDCTP) funded trial The Press release is available on the EDCTP website at www.edctp.org |
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| Meetings and visits | ||||||
EDCTP site visit to Kenya From 16 to 20 July, EDCTP visited EDCTP supported institutions in Kenya. The EDCTP team consisted of Dr Pascoal Mocumbi (High Representative), Mr Simon Belcher (Director of Finance and Administration) and Dr Michael Makanga (Capacity Development Manager). The team had meetings with the scientists and management of Kenya Medical Research Institute (KEMRI/Centre for Disease Control (CDC) Kisumu, The Kenya Medical Research Institute (KEMRI) headquarters, Pharmacy and Poisons Board, Ministry of Health, Kenya, and a number of high officials from various institutions. Kenya Medical Research Institute (KEMRI/Centre for Disease Control (CDC) Kisumu The Kenya Medical Research Institute (KEMRI) head quarters Pharmacy and Poisons Board, Ministry of Health The EDCTP visiting team together with the DCCC member Dr Walter Jaoko had separate meetings with several officials including the Permanent Secretary of the Ministry of Science and Technology, Professor Crispus M. Kiamba; the Chief Science Secretary, Dr Rispah N. Oduwo; the Head of the European Union delegation in Kenya, ambassador Eric van der Linden; the WHO Resident Representative to Kenya, Dr David O. Okello; the Vice Chancellor University of Nairobi, Professor G.A.O Magoha; Deputy Vice Chancellor University of Nairobi, Professor Jacob T. Kaimenyi; Director of the Office of International Programmes, Professor Kenneth Muema Mavuti; and the Chairperson of the University of Nairobi Institutional Ethics Committee, Professor Kirana Bhatt among others. |
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EDCTP site visit to Uganda From 13 to 17 August, EDCTP visited various institutions involved in EDCTP supported activities in Uganda. The EDCTP team consisted of Dr Pascoal Mocumbi, Mr Simon Belcher and Dr Michael Makanga. The team had meetings with the scientists and the management of the Uganda Virus Research Institute (UVRI), the Makerere University Medical School in Mulago, the Uganda Malaria Surveillance Project (UMSP), the Uganda National Council for Science and Technology (UNCST) and the Uganda National Regulatory Authority (UNRA). Uganda Virus Research Institute Makerere University Medical School in Mulago The Department of Pediatrics is involved in a multicentre phase III double blind placebo/controlled trial of the efficacy and safety of infant peri-exposure prophylaxis with lamivudine to prevent HIV-1 transmission by breastfeeding (PROMISE-PEP trial). |
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The Uganda Malaria Surveillance Project (UMSP) which involves academic researchers and Uganda ministry of health, is involved in various EDCTP supported projects including evaluation of 4 artemisinin-based combinations for treating uncomplicated malaria in African children; evaluation of the best approach to retreating recurrent malaria in Ugandan children; safety of artemisinin derivatives-based combination therapy in children with uncomplicated malaria; and population-based pharmacovigilance. Other projects at Makerere include the KIDS-ART-LINC, a network of clinical centres treating HIV-infected children in Africa; a network for European and sub-Saharan African research and capacity building in pharmacology; and support of institution review board. Authorities responsible for regulatory oversight of research projects in Uganda |
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| Events | ||||||
The Fourth Annual Forum Preparations for the upcoming EDCTP Fourth Annual Forum to take place in Ouagadougou, Burkina Faso, on 22-24 October 2007 are almost complete. The main objectives of the forum are to have an overview of ongoing clinical trials on the three main diseases of HIV/AIDS, malaria and tuberculosis in Africa and to promote networking. The forum that will be opened by a high ranking Burkinabe government officias will consist of keynote addresses by invited speakers, plenary sessions, breakaway sessions, group workshops, posters and electronic presentations. At least 165 people have registered for the forum. Participants are African researchers, European research collaborators, policy makers, and members of EDCTP constituencies. Some projects funded by EDCTP will present their on-going work. Sixty African scientists have been given bursaries to attend the forum and present their scientific work electronic poster presentations (pragsters). The European member states that have contributed money for the bursaries are Austria (1), Belgium (10), Ireland (10), Italy 2.5), Netherlands (7), Spain (3), Sweden 2.5), UK (10); while the rest have been funded by EDCTP. The programme of the forum can be accessed from the EDCTP website www.edctp.org. The website will carry daily updates during the forum and also the report that will be produced four weeks after the forum. |
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