The road to strengthening clinical trials (WHA76 side event)
24 May 2023
08:30 - 10:00 CET
Restaurant Vieux Bois
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IFPMA hosted an event in the margins of 76th World Health Assembly to discuss the implementation of WHA75.8 Resolution on strengthening clinical trials. Where do key actors stand with regards to the implementation of the Resolution? What can be expected in terms of future activities and roles of various stakeholders?
Our distinguished panelists and speakers shared their expert insights and highlighted where they see the greatest potential for impact of the WHA75.8 resolution, both in pandemic and interpandemic settings. We explored potential challenges, identified opportunities, and facilitated dialogue on the actions necessary to ensure successful implementation of the resolution’s various elements.
If you missed the event, read the highlights here!
Dr Vasee Moorthy is a Senior Advisor at the World Health Organization headquarters in Geneva. He has a crosscutting role in WHO’s Research for Health Department coordinating the work of the secretariat related to research. This includes resolution WHA75.8 on clinical trials. He is an internal medicine physician with a PhD in malaria immunology and 25 years experience in research prioritization, trial design, and working on clinical trials in all 6 WHO regions. He has supervised WHO’s International Clinical Trial Registration Platform and R&D Observatory and served as Team Leader for Vaccine R&D. He has a 1st class degree in Natural Sciences from the University of Cambridge and a medical degree and PhD from Oxford. He spent 5 years in sub-saharan Africa designing and implementing clinical research studies as well as time in Washington DC overseeing clinical trials of malaria vaccines while working for an NGO called PATH.
Mary is the Deputy Chief Scientific Adviser for the Department of Health and Social Care (DHSC). Mary is an epidemiologist with expertise in a range of disciplines including clinical trials, implementation science, systems thinking and population-based data, in both the UK and in low- and middle-income countries.
Before joining DHSC, Mary was Head of Population Health at Wellcome where she led Wellcome’s funding of population health research in the UK and low- and middle-income countries and the development of a new priority area on mental health. Strategic areas included Wellcome’s Longitudinal Population Studies Strategy, catalysing advances in nutrition, health of the public and multi-morbidity research, and strengthening the pathways through which research evidence improves health.
Before joining Wellcome, Mary was Deputy Director of the Centre for Global Mental Health at LSHTM. Her research included the design and evaluation of complex interventions to improve mental health in low- and middle-income countries, implementation research to ensure that these interventions are scalable and sustainable, and policy influence work to encourage the translation of evidence into policy and practice.
M. Khair ElZarrad, PhD, MPH, is the director of the Office of Medical Policy at the FDA’s Center for Drug Evaluation and Research (CDER) where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple projects focused on exploring the potential utility of real-world evidence, innovative clinical trial designs, and the integration of technological advances in pharmaceutical development. Dr. ElZarrad is the rapporteur for the International Council for Harmonisation’s ongoing work to revise the Good Clinical Practice Guideline (ICH-E6(R2)).
Dr Nathalie Strub-Wourgaft joined Drugs for Neglected Diseases Initiative (DNDi) in 2009 and is member of the Global Executive Team as COVID 19 and preparedness Director. She holds over 30 years’ experience in R&D. As Director of NTDs since 2018, Dr Strub-Wourgaft provided strategic and technical oversight to a wide portfolio of R&D and access plans for therapeutic areas covering Sleeping Sickness, Chagas disease, Cutaneous and Visceral Leishmaniasis, Filaria, & Mycetoma. In 2018, through an international public and private partnership including scientific platform from Africa, DNDI developed Fexinidazole, its first new chemical entity registered from its portfolio. Since March 2020, Nathalie leads DNDi’s response to COVID-19, as Coordinator of the ANTICOV study Consortium and one of the initiators of the COVID 19 clinical research coalition. She is involved in several working groups dedicated to therapeutics for COVID, with a specific focus on LMIC needs and settings. She has been appointed as General Delegate for PANTHER (PANdemic preparedness plaTform for Health Emerging infections Response) since August 2022.
Prior to her current appointment, Dr Strub-Wourgaft created and held the Medical Director position at DNDi, where she notably developed the organisation’s quality, pharmacovigilance and regulatory activities. Prior to DNDi, Dr Strub-Wourgaft served as Clinical Development Director at Trophos, and held many related roles within Pfizer, Lundbeck and Aspreva. Dr Strub-Wourgaft graduated as Medical Doctor from Necker Hospital, Université René Descartes in Paris in 1983. She co-authored several scientific publications in peer review journals.
Wiweka Kaszubska is the Head of Product Development at Medicines for Malaria Venture (MMV) based in Geneva, Switzerland. MMV is a public-private partnership with a mission to develop new, effective and affordable medicines for malaria patients in endemic countries. Wiweka is responsible for late-stage development portfolio of anti-malarial drugs. Prior to joining MMV in 2012 and pursuing her interest in Global Health, she spent more than 15 years in pharmaceutical industry working across all phases of drug development. She started her career in Discovery Research at Abbott Laboratories in Chicago in Metabolic Disease area. She then held number of positions at Merck Serono in Geneva ultimately heading the Global Product Unit for Autoimmune and Inflammatory therapeutic area. She obtained a PhD degree in biochemistry from the University of Illinois, and a Bachelor’s degree in chemistry from the University of Chicago, USA.
Dr Jennifer Harris is the Director of Research Policy at the Association of the British Pharmaceutical Industry (ABPI), focussed on making the UK a world-leading destination for pharmaceutical R&D, to support the discovery, research and development of new medicines and vaccines. Previously, Jennifer worked at the UK Government’s Department of Health and Social Care on the Independent Review of the Mental Health Act, where she led on evidence generation and patient involvement. She has a PhD in cancer research from the University of Cambridge and a BSc Hons in Biomedical Sciences.