[Article series] The experts behind Luxembourg’s Covid-19 fight

• Department of Infection and Immunity
• Clinical and Epidemiological Investigation Center (CIEC)

Interview with Dr Manon Gantenbein

Dr Manon Gantenbein is the current Director of the Clinical and Epidemiological Investigation Centre (CIEC) of the LIH Department of Population Health. She is currently playing a crucial role in the implementation of five new projects on Covid-19, launched in Luxembourg since the beginning of the pandemic. In this short interview, she talks about her expertise and her involvement, as well as the role of her team and her main partners in these ongoing Covid-19 initiatives.

Could you tell us more about your background and expertise?

MG: My expertise and background are in clinical research. I have an MSc in biochemistry and a PhD in fundamental and experimental pharmacokinetics and the effects of drugs. I have worked in clinical research since 1997,first in France, then in Germany and finally in Luxembourg. In France, I coordinated my first multi-center “pharma” trial at a clinical trial unit in a hospital setting. In Germany, I worked as a clinical research associate in a Contract Research Organisation (CRO) followed by an experience as Lead Monitor in a pharmaceutical industry, where I coordinated several multi-center registration trials on Multiple Sclerosis, among others, as well as early development phase I studies on Parkinson’s Disease. Through these experiences, I have developed a solid knowledge of clinical research performed not only by pharmaceutical industry and academia, but also by CROs, three areas that have very different interests. My knowledge and understanding of these three worlds has been a great asset to develop clinical research in Luxembourg.

In 2009, I joined the Clinical and Epidemiological Investigation Centre (CIEC) of the LIH, first as Coordinator, where I contributed to the development of the CIEC by interacting with local healthcare professionals, researchers and scientists, and then as Director. The CIEC is a national unit that aims to promote clinical research in Luxembourg. This was a challenge at that time, as clinical research in Luxembourg was not well known or developed and it lacked a specific framework. Today, in the current context of the pandemic, the CIEC is recognised as a valuable partner for the development of new investigator-driven clinical research projects. More than ever, we are being solicited to contribute to the setup of new clinical studies on Covid-19 aiming, on one hand, to better understand the disease and, on the other hand, to provide treatment options for affected patients or offer prophylaxis to health care workers.

Could you tell us more about how your expertise is being used in the current Covid-19 context?

MG: Currently no drug has been proven effective in the treatment of Covid-19 and doctors as well as scientists still know little about this disease. Thus, from the early stages of the pandemic, physicians from the Centre Hospitalier de Luxembourg (CHL), as well as LIH researchers, asked me to contribute to setting up several studies on Covid-19 in Luxembourg.

My expertise, but also that of my entire team, enabled me to respond very rapidly to these multiple requests. During periods of crisis, time is crucial. We have to move quickly, stay close to the field, while taking into account regulatory constraints. Even if timing is of the essence, it is important not to overlook any steps and comply with the the legal, regulatory and above all ethical frameworks. Owing to our longstanding experience in this field, we are familiar with all the regulatory and ethical steps to obtain the necessary authorisations before launching studies. Thus, for the past 4 weeks, our job has been to follow each of these new Covid-19 projects daily and rigorously and to ensure that the legal and ethical framework is scrupulously respected.

In this context, we have almost daily contacts with the Ministry of Health, and more particularly with the Health Directorate and the Ethics Committee. This excellent relationship, based on mutual trust, allows us to collaborate and to obtain the necessary authorisations in an exceptionally short period of time. This race against time is crucial for the launch of these new Covid-19 studies in the clinical setting.

What is the role of your team in these new Covid-19 projects?

MG: I am lucky to have a very strong, multi-disciplinary and efficient team to be able to respond to all the current requests. They adapt easily to emergencies to accomplish the various tasks in the limited time available. Without this good collaboration within the team, the implementation of all these new projects would not be possible. The support of all LIH administrative departments is also very important and is a key factor in this respect.

In terms of study design, we have to draft protocols as well as informed consents for participants, in accordance with legal and ethical requirements, gather scientific documentation and obtain regulatory authorisations, among others. All these tasks, which have to be performed for each individual project, are compulsory steps before these studies can enter the clinical setting. Without the knowledge and invaluable help of my collaborators, such as Myriam Alexandre, Charlotte Lieunard, Aurélie Fisher, Jonathan Cimino, Lamia Skhiri, Lucile Pernot, Nassera Aouali, Myriam Menster, Christelle Bahlawane and our new joiner Laetitia Garcia, the design of these new projects and their submission to the regulatory authorities could never have been possible.

Once the authorisations have been obtained, the projects will gradually enter the field phase. Jean-Yves Ferrand, our clinical research nurse coordinator, will manage the implementation of these studies at the hospital or homes of Covid-19 patients. Everything will be carefully thought through, from sampling procedures and preparation of materials, to the organisation of transport and coordination with the Integrated Biobank of Luxembourg (IBBL).

The team of highly motivated and flexible research nurses, including Jérôme Graas, Guilherme Marques, Victoria Lorenz and Sandie Boly, will go to the field to collect samples and data from Covid-19 patients. Maura Minelli, Tania Zamboni and Graziella Ambroset will help prepare for the visits by calling patients, answering their questions and filling out questionnaires over the phone.

On top of all these new projects, we are continuing our usual activities on our portfolio of ongoing studies. It is a particularly intense period for us!

Who are your partners in these Covid-19 projects within the LIH and at the national level?

MG: To deal with Covid-19, CIEC collaborates with several researchers and scientists within the LIH, but also with a multitude of partners at the national level. Within the LIH, I work mainly with Prof. Laetitia Huiart, Director of the Department of Population Health (DoPH), Dr. Guy Berchem, Director of Research at the Centre Hospitalier de Luxembourg (CHL) and Associate Medical Director at LIH, as well as Prof. Rejko Krüger, Director of Transversal Translational Medicine (TTM) at LIH and Dr. Michel Vaillant, Head of the Competence Center for Methodology and Statistics (CCMS).

At the national level, I collaborate with the Health Directorate and Luxembourg hospitals, especially with the CHL and its research cell but also with the Hôpitaux Robert Schuman and the Centre Hospitalier du Nord.

Thanks to all the valuable collaborations we have developed over the last few years, we can today react quickly and work effectively together in this pandemic context. The national collaboration between physicians, researchers, policy makers and regulators is our greatest strength in fighting Covid-19 together.