Modelling and simulation (M&S) has grown to become a reliable approach to better understand and optimise key decisions related to safety, efficacy, dosing, and special target populations. As both computing power and our understanding of human systems biology improve, the increased use of M&S motivates regulators to consider this new type of digital evidence to support medical device and medicinal drug product development and allow new approaches in clinical trials, in view of increasing the probability of success, reduce costs and accelerate time to patients.
Cécile F. Rousseau, PhD, Director
With 10+ years in nonclinical and translational research and histotechnology, Dr. Cécile F. Rousseau has considerable expertise in medical devices, engineered cellular therapies and companion diagnostics.
Emmanuelle M. Voisin, PhD, Founder and CEO
Dr. Emmanuelle Voisin founded Voisin Consulting Life Sciences (VCLS) in 1997. Dr. Emmanuelle Voisin has 30 years’ experience in drug development. Her expertise lies in non-conventional development strategies, maximizing the use of regulatory mechanisms and innovative approaches to drug development, to bring innovative technologies to patients.
Susan Carter, M.Sc., Director, Regulatory Science
As a Director, Regulatory Science, Susan provides scientific and regulatory advice to clients for the development of small molecules and biologics particularly with regards to rare diseases. The projects she manages are in various stages of development, from nonclinical through to marketing application.