Senior Director Scientific Affairs & Digital Innovation

ICON PLC

Biography

Alexandre Malouvier, PhD, MS, Senior Director Scientific Affairs & Digital Innovation, has 25 years of clinical research experience, the majority of which focused on real-world research and digital health.  Dr. Malouvier holds a Ph.D. in Human Physiology, a Diploma of Statistics Applied to Clinical Research, and a Diploma in Bone Pathology from the University Paris VII-Denis Diderot, Paris, France. He also holds a Master in Bioengineering from the Universities of Rheims, France.

Dr. Malouvier initially worked as a Research Scientist for the American and European Space agencies and then moved into the pharmaceutical industry, working as an international CRA in a small pharmaceutical company specializing in oncology, where he gained experience coordinating study activities. He was promoted to Project Manager and then Senior Director, positions he held at both CROs and major pharmaceutical companies.

In the past 20 years, Dr. Malouvier has specialized in late stage/real world research, spending the last 19 years in departments or companies fully dedicated to peri- and post-approval programs. These included Compassionate-Use Programs (Expanded Access Programs, Named-Patient Programs), Post-Marketing Authorization Safety Studies (PASS), Post-Authorization Efficacy Studies (PAES), Drug-Utilization Studies (DUS) an many other observational research programs. Alexandre managed different types of registries, including drug registries and natural history of disease registries. He finally moved in his current position 7 year ago where he works collaboratively with clients and internal ICON stakeholders to provide strategic direction for patient service innovation across the company, focusing on Decentralized Clinical Trials (DCT), CRAACO, digital endpoints, and access to patient data.

His previous roles leading project management offices in late phase research organizations has given him wide exposure to real world research from both the CRO and large pharma perspective and has cultivated his in-depth expertise. Dr Malouvier frequently authors white papers, makes presentations in professional forums and is part of organizing committees of multiple conferences.

Dr Malouvier is an active member of the Real-World Evidence Working Group of AFCROs (French association of CROs), the leader of AFCROs’s Global Resourcing Working Group, the leader of EUCROF’s Real World Data and Digital Health Working Group, and a former member of the Decentralized Clinical Trails Working Group of the ACRO.

Dr Malouvier is a member of the Scientific Board of the University of Paris’s Fundamental Sciences and Biomedicine Faculty where he teaches clinical research. He is the co-creator of four courses, one for Clinical Research Associates, another for Medical Science Liaisons, a Master Degree in Clinical Research and Translational Medicine and another Master