Clinical Pharmacology & Drug Candidates
Working group objective
Provide advice on clinical pharmacology, drug analysis, and clinical pharmacometrics relevant to COVID-19 clinical trials.
Working group members
Eleni Aklillu is a Professor of Tropical Pharmacology, senior research scientist, and research group leader at the Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden. She is a pioneer in leading major clinical pharmacology and pharmacogenetics research projects focusing on poverty-related infectious diseases including HIV, tuberculosis, Malaria, and various Neglected tropical diseases in low-middle income countries (https://staff.ki.se/people/eleakl). She has received several major external research grants in competition as principal investigators from various national and international research funding agencies. Currently, she is a principal investigator and coordinator of a 5-year multinational project entitled PROFORMA (https://proforma.ki.se) – focusing on pharmacovigilance, and medicine regulatory capacity-building in Ethiopia, Kenya, Tanzania, and Rwanda. Aklillu supervised > 17 completed PhDs and is currently supervising 10 PhD students from Africa working on various Global Health clinical pharmacology research projects (https://ki.se/en/labmed/research-group-eleni-aklillu). She is author of > 130 original peer-reviewed publications. Professor Aklillu is a board member of the Swedish research council’s scientific advisory committee for development research, a fellow of Royal College of Physicians Edinburgh (FRCPE), a fellow of African Academy of Science (FAAS), a former vice-chair and member of the Strategic Advisory Committee for European and Developing Countries Clinical Trials Partnership (EDCTP).
I am a pharmacist with an MPH and PhD in clinical pharmacology, who has worked in clinical research since 1995, initially within the pharmaceutical and contract research industries in the UK and South Africa, thereafter managing clinical research studies at investigator sites in South Africa and Mozambique. I currently head clinical research for the University of Cape Town’s Collaborating Centre for Optimising Antimalarial Therapy, where I am also a Scientific Coordinator for the Infectious Diseases Data Observatory (IDDO). Aside from trials, my focus is optimising data sharing for IPD safety analyses, and coordinating the WWARN Toolkit. I also lead The Global Health Network’s Global Pharmacovigilance platform and the Global Health Working group for the UK MRC/NIHR Trials Methodology Research Partnership.
I am a Professor of Clinical Pharmacology at the University of Cape Town (UCT), with research interests focusing on improving the treatment of malaria – and now COVID-19. My research in malaria started when I was appointed as a member of the South African National Malaria Advisory Group in 1996, at the start of a malaria epidemic in South Africa that was fuelled by drug and insecticide resistance. With drug resistance being one of the greatest threats to malaria control and elimination, my focus has been on translational research on the clinical pharmacology of antimalarials that informs malaria treatment policy and practice – including the comprehensive evaluation of changes in malaria treatment policy. To prevent / delay antimalarial resistance, I also lead research on optimising dosing in vulnerable populations (young children, pregnant women and patients with prevalent comorbidities such as HIV/AIDS or malnutrition). I have been a long standing member of World Health Organization Technical Expert Groups on both Malaria Chemotherapy and Drug Resistance & Containment, Principal Investigator of a number of international multi-centre studies, and serve as head of Pharmacology for the WorldWide Antimalarial Resistance Network (WWARN).
Professor Philippe Guérin is Director of the Infectious Diseases Data Observatory (IDDO). He was appointed Director of the WorldWide Antimalarial Research Network (WWARN) – the prototypic model for IDDO – in January 2009. Philippe has extensive experience working in the field for Médecins Sans Frontières and as a researcher for a Wellcome Trust Research Unit in many countries in Africa and Asia. Following three years as a Senior Advisor to the Department of Infectious Disease Epidemiology at the Norwegian Institute of Public Health, Philippe joined Épicentre in Paris – a World Health Organization (WHO) Collaborating Centre for Research in epidemiology and response to emerging diseases. Philippe served as Scientific Director for six years at Épicentre before moving to WWARN.
Why Data Sharing is Crucial to the COVID-19 Response
COVID-19 Clinical Research Coalition: Priorities in Latin America
Graduated in Medicine at the Federal University of Minas Gerais, Brazil. Fellowship in Internal Medicine at IPSEMG Hospital, followed by a fellowship in Oncology at the Brazilian National Cancer Institute. Masters and PhD in Oncology. Experience in clinical research in oncology. Head of the Clinical Research Division at the Brazilian National Cancer Institute.
Colin Pillai runs two social ventures that develop scientific capability in drug discovery and development in low- and middle-income countries. Previously, he worked as a pharmacometrician and a senior leader at Roche and Novartis in Switzerland. He acquired his clinical and research experience in hospital and community pharmacy, academia and at the South African Medical Research Council’s Tuberculosis Research programme running Phase 1 clinical trials. Colin is a Honorary Professor at UCT, a Honorary Fellow of the Royal College of Physicians and a Senior Advisor on capacity development for global health to the Bill and Melinda Gates Foundation.
Websites: www.cpplusassociates.org; www.pmxafrica.org
Email: email@example.com Twitter: @colpil
Dr Joel Tarning started his scientific research career in 2007 at the Mahidol-Oxford Tropical Medicine Research Unit (MORU) in Bangkok, Thailand. Since 2013, he has been leading the MORU department – Clinical Pharmacology, comprising a large and diverse team of 30 people. The main scientific directions within the department are pharmacometric data analysis, bioanalytical method development, drug quantification of clinical study samples, omics-based research, and medicine quality. His main research is focused on dose-optimisation in neglected tropical diseases, with a particular focus on vulnerable populations at risk of treatment failure and resistance development, such as children and pregnant women. His work on population pharmacokinetic-pharmacodynamic modelling of oral dihydroartemisinin-piperaquine in children with uncomplicated malaria, and intramuscular artesunate in children with severe malaria started the debate on new dose recommendations in young children, which resulted in revised WHO Guidelines for the treatment of malaria, 3rd edition (2015). He is a Professor of Clinical Pharmacology at the University of Oxford, UK (2016), and a visiting professor at the Faculty of Tropical Medicine, Mahidol University, Thailand (2016).
Professor Nick White is a Wellcome Trust Principal Research Fellow who chairs the Wellcome Trust Tropical Medicine Research Programmes in South East Asia. He has lived and worked in Thailand since 1980. His research focus is the pathophysiology and treatment of malaria. He has concentrated on characterising antimalarial pharmacokinetic-pharmacodynamic relationships to improve the treatment of malaria and reduce the emergence of resistance. This led to artemisinin-based combination treatment for falciparum malaria, and the change to artesunate for severe malaria. He has authored over 1000 scientific publications and 50 book chapters. He is on the Board of the WorldWide Antimalarial Resistance Network and Infectious Diseases Data Observatory, and he co-chairs the WHO GMP technical expert group on prevention and treatment of malaria and the WHO antimalarial treatment guidelines committee. He was appointed a Knight Commander of the Order of St Michael and St George (KCMG) for services to tropical medicine and global health in the 2017 New Year’s Honours.
Dr Getnet Yimer, a physician, scientist and consultant medical specialist, is the Regional Director for Global One Health Initiative of the Ohio State University in Eastern Africa. Prior to this, he served as a Director for Research and Technology Transfer at the College of Health Sciences, Addis Ababa University. For over 7 years, he has worked as consultant on TB-HIV clinical trials for WHO-TDR in charge of leading and coordinating activities in 6 African countries namely Tanzania, Zambia, Uganda, Nigeria, South Africa, and Ethiopia. Getnet is also a member of the National Health Research Ethics Review Committee at the Ministry of Science and Higher Education and the National Drug Advisory Committee at the Ethiopian Food, Medicines and Healthcare Administration and Control Authority. He is the current chair for the National TB advisory committee in Ethiopia. He has served as a PI for a number of projects funded by; CDC-PEPFAR (1U2GGH001477-01), Swiss National Foundation (R01 MH922731), USAID, EDCTP, Novartis and GSK and as a co-PI for NIH D43- TW010143-01 (MEPI), HRSA-T84HA21124-05-01 (iRIM), World Bank (CDT-Africa), EDCTP, and Astra Zeneca funded projects. He has had over 50 international peer reviewed articles and a book chapter published. Dr Getnet is part of the TARTARE steering committee and will also be serving on the Disease Burden team.
Traditional medicine and COVID-19 scientific research
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- IDDO guidance for blood pharmacokinetic sample collection, processing and transport in COVID-19 clinical trials
- IDDO guidance for collection of ECG data in COVID-19 clinical trials
- COVID-19 Pharmacology Resource Center: Conquering COVID-19 with clinical pharmacology, innovation, and collaboration. Includes an in silico workbench, outcomes database, and clinical trial tracker
- University of Liverpool Covid19 Drug Interactions website: A freely available drug interactions resource to provide information on the likelihood of interactions between the experimental agents used for the treatment of COVID-19 and commonly prescribed co-medication
- Webinar “Controlled Human Infection Challenge Studies: Lessons from Malaria towards COVID-19”
- Webinar “Model-informed Drug Repurposing – Applications for COVID-19”