MOHAMAMD HANIF YAKUB SHAIKH

Home Institution: K.E.M. Hospital Research Centre (KEMHRC) - Pune, India

Host Institution: International Vaccine Institute (IVI) - South KOREA

Background Information: 

I have been working in clinical research field for more than ten years. After completion of masters in pharmacology, I started my career as a Research Associate working in Medical Affairs and Clinical Research department of Ranbaxy Research laboratories in India. I was mainly responsible for monitoring of clinical trials and training of site team. I also worked as a Project manager at KEM Hospital Research Centre (KEMHRC) Pune, India where I was mainly involved in conduct and implementation of study as per study protocol, ICH-GCP and NRA guidelines. During seven years work experience with KEMHRC, I got opportunities to work on various vaccine trials and disease burden studies.

Currently, I am placed at International Vaccine Institute (IVI) in Clinical Development and Regulatory department through WHO-TDR fellowship. At IVI, I am involved in scientific and operational activities of vaccine studies, like development of trial protocol and clinical study reports, writing paper manuscript, SOP writing, site monitoring and project management.

I enjoy overcoming challenges, and eager to learn new things. I have a genuine interest in research in infectious disease, vaccine development and management.

Debe Siaka

Home Institution: Centre national de Recherche de Formation sur le Paludisme (CNRFP) - Ouagadougou, Burkina Faso

Host Institution: European Vaccine Initiative (EVI) - Germany

Background Information: 

Currently I work as junior scientist at CNRFP. Our main missions are to conduct the clinical research on malaria and associated diseases and to contribute to training and retraining of researchers, students and other health workers.

During five (5) years, I have been involved in development of curative and preventive tools against malaria by clinical research: antimalarial drugs and malaria vaccine. We implemented several clinical trials of Phase I, II, III and IV. As responsibility, I am in charge to implement and conduct clinical trials and to manage research team.

Recently (15 November 2016), I have been placed at European Vaccine Initiative (EVI, Heidelberg) for a training period of 12 months. This training, supported by European and Developing Countries Clinical Trials Partnership (EDCTP) and WHO/TDR, aims to develop the career in clinical research.

As research topic, I am especially interested to clinical development of vaccines and drugs used to fight and control the tropical infectious diseases in Sub-Sahara population particularly among pregnant women and infants aged under five years: Malaria, Dengue disease, Zika disease, Leishmaniasis, tuberculosis and HIV infection. In addition, I envisage to teach in high school and university in research modules.

Castro Noriega, Maria del Mar

Home Institution: Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM) - Cali, Columbia

Host Institution: European Vaccine Initiative (EVI) - Germany

Background Information:

My research interests are oriented towards understanding the determinants of treatment response, and diagnostic and therapeutic product development for Neglected Tropical Diseases. Since 2012 I have participated in multiple projects, ranging from translational and epidemiological research to clinical trials, all aimed to improve management of patients with Cutaneous Leishmaniasis in Colombia. Additionally, I am a GCP and GHRP trainer in the TDR supported Regional Training Center in CIDEIM (Cali, Colombia), and have responsibility for the training of clinicians in endemic areas about the diagnosis and management of cutaneous leishmaniasis, as a capacity building strategy.

In 2017 I was granted with an EDCTP/TDR Research and Development Fellowship, to receive training in vaccine development focusing on diseases of poverty at the European Vaccine Initiative (EVI), a Product Development Partnership based in Germany.

Babatunde Ayodeji Adeagbo

Home Institution: Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Obafemi Awolowo University - Ile-Ife, Nigeria

Host Institution: Infectious Diseases Research Institute - USA

 

Background Information:

I am a lecturer in the Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Obafemi Awolowo University, Ile-Ife, Nigeria. I received my PhD in 2014, with the focus on population pharmacokinetics of imatinib mesylate.

Presently I am a WHO-TDR supported visiting scientist in Infectious Diseases Research Institute (IDRI), Seattle, USA. My research interest focus on development of bio-analytical assays and translational Pharmacokinetics, Pharmacogenomics and Pharmacometrics with emphasis on infectious diseases and cancer.

Evaezi Okpokoro

Home Institution: Institute of Human Virology Nigeria (IVHN)/International Research Centre of Excellence - Abuja, Nigeria

Host Institution: AERAS - South Africa

Background Information:

As a WHO/TDR fellow, I am presently under going mentoring in setting up and monitoring clinical trial sites for TB vaccine trials at international standards as well as other epidemiological studies in compliance with GCP at AERAS. I am being trained in clinical vaccine research and immunology; additionally being exposed to advance Biostatistics and Data Management for vaccine trial, Biorepository, Project Management, Medical writing, Regulatory Affairs, Vaccine Platform Technologies, and Safety with a view of implementing skills gain at my home institution. I am particularly interested in Infectious disease research or clinical trials with a focus on TB and HIV.

Ouattara San Maurice

Home Institution: Centre National de Recherche et de Formation sur le Paludisme (CNRFP) – Ouagadougou, Burkina Faso

Host Institution: Luxembourg Institute of Health (LIH) - Luxembourg 

Background Information:

I am a Medical Doctor, junior scientist in early career. I have around five years’ experience in conducting clinical trials. In the five-last year, I was engaged at the Centre National de Recherche et de Formation sur le Paludisme, as study physician, in several clinical trials on malaria drugs and vaccines. I was in charge of trial patients’ selection, enrolment, follow up, safety reporting and patients’ health care.

From January 2017, I am a Fellow of the EDCTP-WHO/TDR Clinical Research and Development Fellowships and I am placed at Luxembourg Institute of Health (LIH) for a capacity building in biostatistics and data management.

My fields of interest are Biostatistics, Epidemiology, Malaria and Infectious diseases.

Anne Abio

Home Institution: Gulu University - Gulu, Uganda

Host Institution: Luxembourg Institute of Health (LIH) - Luxembourg

Background Information:

I work as a Statistician in Gulu University, where I have been involved in data management and analysis in specific epidemiological studies conducted in the Faculty of Medicine, Gulu University.

My interest is in data management, and currently, I am on a WHO/TDR Clinical Research and Development Fellowship, placed at the Luxembourg Institute of Health, Luxembourg. The fellowship will enable me to gain additional skills and experience in data management, especially in the context of clinical trials. The skills and experience that I will acquire will go a long way in building my capacity and confidence towards contributing to high quality research in epidemiology.

Clifford George Banda

Host Institution: WorldWide Antimalarial Resistance Network (WWARN) - United Kingdom 

Home Institution: Malawi Liverpool Wellcome Trust Clinical Research Programme -Blantyre, Malawi

Background Information:

I am a member of the Malaria group at Malawi Liverpool Wellcome Trust Clinical Research Programme where I work as a Clinical Research Associate within the malaria pharmaco-epidemiology team. My main research interest is in clinical pharmacology, with focus on use of pharmaco-epidemiological techniques to optimize malaria case-management and dosing regimens. I aim to expand this interest to include other poverty related diseases (HIV, TB) and neglected tropical infections. In my current role as a Clinical Research and Development Fellow at WWARN, I am leading the development of a malaria specific clinical trials toolkit to aid malaria trialists in low and middle income countries in setting up and conducting clinical trials that yield standardised and quality data which can be easily shared to inform policy and practice at a wider scale. I am also gaining skills in pooled individual patient data analyses by employing data from the Haematology study group within WWARN to understand factors that can influence the relationship between haematocrit and haemoglobin when assessing the degree of anaemia in malaria endemic settings. 

Didier NZOLO BOMENE

Home Institution: University of Kinshasa - Kinshasa, Democratic Republic of the Congo

Host Institution: Glaxo Smith Kline (GSK) - Belgium 

Background information:

I am Medical Doctor from the University of Kinshasa with an MSc in Clinical Trials from the University of Ghana. I work in the National Pharmacovigilance Center in the Unit of Clinical Pharmacology and Pharmacovigilance in the University of Kinshasa, Democratic Republic of Congo. I am also an expert of the WHO Global Vaccine Safety. My particular domain of interest is vaccine safety in clinical development and post-marketing surveillance. I am actually a WHO/TDR fellow placed in GSK in the Vaccine Clinical Safety and Pharmacovigilance (VCSP) Department where I work as a Safety Evaluation and Risk Management (SERM) Physician for twelve months. I am also a PhD student whose topic is ‘A community based strategy to improve vaccine pharmacovigilance in Low income countries: a Congolese perspective’. 

Masuka Josiah Tatenda

Home Institution: Medicines Control Authority of Zimbabwe (MCAZ), Pharmacovigilance and Clinical Trials Division - Harare, Zimbabwe

Host Institution: GlaxoSmithKline (GSK) - Belgium 

Background Information:

I am a physician scientist working as a regulatory pharmacologist in the Pharmacovigilance and Clinical Trials Division of the Medicines Control Authority of Zimbabwe. My role in this capacity is to review clinical trial protocols, conduct medical reviews and causality assessments of adverse drug reactions/events and also in conducting trainings on pharmacovigilance amongst other duties. Currently I am attached to GlaxoSmithKline Biologicals in Wavre, Belgium as a trainee SERM (Safety Evaluation and Risk Management) physician.  I am involved in benefit-risk evaluation and management for some vaccine products including signal detection and interacting with the involved stakeholders in vaccine safety. Broadly, I am interested in pharmaceutical medicine and the clinical development of therapeutics for the management of HIV and TB amongst other medicines for diseases prevalent in Africa.

Olaleye Atinuke

Home Institution: Department of Obstetrics and Gynecology, Benjamin Carson (Sr) School of Medicine, Babcock University

Host Institution: GlaxoSmithKline (GSK) - Belgium 

Background Information:

As a researcher and Consultant Obstetrician Gynecologist in Benjamin Carson Sr School of Medicine, Babcock University, I carry out clinical management of patients, in addition to teaching and conduct of clinical research. I am also involved in training and mentoring of undergraduate and postgraduate medical personnel academically, as well as in basic research methods.

My research interests are diseases affecting maternal and child health, particularly HIV/AIDS, Hepatitis B, Malaria and TB. I am focused on clinical and laboratory research into the reduction and/or elimination of vertically transmitted infections. In addition, I am interested in the conduct of clinical trials, and intend to conduct some in the near future.

Jerry Liwono Yana

Home Institution: Clinical Pharmacology Unit, Schools of Medicine and Pharmaceutical Sciences, University of Kinshasa/ National Pharmacovigilance Centre

Host Institution: DNDi

Background Information:

As Medical Doctor, I'm Research Assistant in Clinical Pharmacology and Pharmacovigilance Unit /University of Kinshasa and Technical Staff Member in National Pharmacovigilance Centre; please note that National Pharmacovigilance Centre is placed within Clinical Pharmacology and Pharmacovigilance Unit.

I’m Supervisor and my roles and responsibilities are:

  • To frame trainees or beginners in Pharmacovigilance and clinical Pharmacology, 
  • To participate in clinical research studies (Investigator, Clinical Research Associate…), 
  • Elaboration of therapeutic guidelines, standards procedures,
  • Management of adverse events reporting (analysis, feed-back, causality assessment, reporting at Uppsala Monitoring Centre/WHO….)
  • Clinical management of adverse drugs reactions in jointly with health care providers

Present research interests are:

  • Pharmacovigilance/pharmacoepidemiology
  • Co-infection Malaria/HIV (safety/rational use of antiretroviral and antimalarial co administration)
  • Clinical evaluation of medicines 
  • Drug utilization studies

Melchias Mukendiilunga

Home Institution: PNLTHA / DRC (National program against Human African Trypanosomiasis)/ CRT/DIPUMBA.

Host Institution: DNDi

Background Information:

I am a treating physician and I have worked as a local investigator in the Fexinidazole project at the Dipumba site, my job is generally to take care of patients with sleeping sickness and with regard to clinical trials my tasks are as follows:

  • Conduct the trial according to the study protocol and the Good Clinical Practice (GCP)
  • Supervise daily procedures:
    • recruitment
    • inclusion of subjects,
    • administration of treatments and
    • data collection
  • Perform daily assessment of patients under treatment
  • Manage and document adverse effects
  • Report serious adverse effects (SAE) to sponsor and monitor
  • Complete the observation workbooks (FIUs) and other documents related to the FEXINIDAZOLE trial, update the investigator binder
  • Quality assurance at the first level (ensuring quality of data)
  • Coordinate the work of nurses and laboratory technicians
  • To be available during monitoring (monitoring)
  • Develop and implement a strategy for patient follow-up
  • Link with sponsor and instructors (communication, etc.)

Currently working at DNDi for training in clinical research and development funded by TDR.