AIXIAL AN ALTEN COMPANY #TogetherWeCreateValue Retour INTERVIEW OF COLLABORATORS: DR. JACQUES MASSOL | P R O J E C T S | LinkedIn Facebook Twitter Share We regularly conduct interviews with employees so that they share their experiences within AIXIAL. Hello Jacques, can you introduce yourself? My name is Jacques MASSOL, I am a doctor formerly working in a university hospital and I used to be a teacher of medical therapeutics. I have spent my life teaching, doing research and healing in different medical specialties (cardiology, diabetes-endocrinology, and, more recently, oncology). In parallel, I have been involved in evaluation, Public Health and epidemiology for many years within French health authorities, then creating an Institute of Real World Evidence called PHISQUARE (Public Health Impact Institute) that I ran during more than 10 years before joining AIXIAL. When did you join AIXIAL and what were your motivations? I had joined AIXIAL more than two years ago now, my motivations were diverse. First, we realized at PHISQUARE that we would have more interest in joining a bigger research laboratory, with dynamic and qualified teams and an international dimension to be able to carry out large-scale studies to international standards. On its side, AIXIAL was thinking that I could have a real added value as an experienced M.D., Ph.D., especially in Real World Evidence Can you explain in a few words what Real World Evidence is? These are the bundles of evidence acquired in real life, i.e. with “Real World data”. Knowing what happens in the real world, distinguishing theoretical knowledge from empirical knowledge, has been a concern since Antiquity and has become a major issue in health care, especially in the last twenty years. For health products, it is possible to define with Food Drug Administration or European Medicines Agency, in a schematic way and by elimination, Real World Data as any health data collected other than by an experimental interventional method such as a clinical trial. Knowing the real world dictates its own research method: Observe rather than intervene. RWE could be defined as, “the clinical evidence regarding the usage, and potential benefits or risks of a medical product derived from analysis of RWD” (FDA, 2016). But this RWE definition is far too limiting. Very schematically, RWE includes evidence acquired specifically to answer a question, after a hypothesis has been generated: Hypothesis-driven research and real-life data collected without prior hypothesis generation, but which may be used secondarily to acquire it. RWE can be either ad hoc studies or studies based on public or private databases. Among the evidence to answer questions, there are those requested by the authorities: Mandatory regulatory studies, that are used for registration and/or Health Technology Assessment (as part of Risk Management Plans, Post Authorization Safety Studies, Post Authorization Efficacy Studies, early access or compassionate follow-up, registries, post-registration studies, data collection as part of performance contracts, etc.) and non-mandatory studies, which answer questions asked by industry or researchers. But the scope of the RWE is far from being limited to the three questions defined by the FDA, even if we focus on health products alone. It also feeds into data that may or may not require prior assumptions and must be conducted pre- or post-market: Quantifying medical needs, defining target populations, the conditions under which a particular health system is capable of receiving a particular type of health product, quantifying the medical and economic burden of a particular condition, describing and identifying the obstacles faced by patients in their chronic disease care pathway, quantifying the medical and/or economic impact of the use of a particular product on the health of the population, on the use and organization of the health care system, and on real-life efficiency…. What role do you play in the industry? My main role is to advise the industry to conduct studies of the highest possible scientific quality, useful for the health of the population, and in line with the expectations of the health authorities. I work closely with Dr. Jean-Hugues MASGNAUX, a former pharmaceutical industry executive, with whom I am used to advising manufacturers on market access, as well as with the AIXIAL teams. Within the group, our mission is to provide medical advice and to develop the RWE activity of the group. What matters is the research scientist question. AIXIAL’s strength lies in its ability to answer this question by conducting all types of studies: Clinical trials, observational field or database studies, national/international studies. I can provide a medical and methodological dimension and anticipate the needs of health authorities, but the quality of AIXIAL’s projects lies in the exchange that takes place right from the construction of the project with the internal teams and with a network of external partners. It is a collective effort. The expansion of the AIXIAL group will lead us to extend our role, particularly internationally. What is AIXIAL Lab? AIXIAL Lab is an innovation laboratory that works on research activities related to methodological issues. AIXIAL participates in the development of methodologies that are directly related to its business and that allow us to support our clients in disruptive areas. Can you talk about the scientific news “AIXIAL reviews” that are regularly published? The news demonstrates our advisory role to the industry and are a means of communication between AIXIAL and its partners. They also allow us to share AIXIAL’s medical expertise. In addition to our skills and experience, we want to showcase our mindset, our dynamics, our international projects, our positioning as a consultant, our proposals, and our differentiating factors. This is an opportunity to demonstrate our openness to advancing science and supporting our clients in an innovative way. They are also an opportunity to demonstrate AIXIAL’s ability to adapt. The current social, economic, and political environment is changing rapidly, and a CRO must be able to adapt to these changes and communicate with its partners. All these capabilities have allowed us to become one of the top 5 mid-size Contract Research Organizations in the world and to keep our clients loyal for many years! Interview conducted by Angélique LAQUET – Communication Officer – April 27, 2021 POST NAVIGATION AIXIAL Review #8 Course des Héros 2021 – A message from Petit Cœur de Beurre | LET’S TALK ABOUT | AIXIAL Review #10 17.11.2021 Interview of employees: Galia 18.10.2021 ‹ › AIXIAL 4 rue Danjou – Bâtiment B 92513 Boulogne-Billancourt Cedex FRANCE T: +33 1 46 08 89 00 DISCOVER AIXIAL Discover AIXIAL ALTEN group Data protection policy AREAS OF EXPERTISE Vigilance Regulatory Affairs Clinical Data Science Clinical Operations WORK AT AIXIAL Offers Career page FOLLOW US linkedin Youtube Copyright © www.aixial.com - All Rights Reserved - Legal disclaimer SPONTANEOUS APPLICATION