12 - "Integration of in silico technologies in HealthTech product development"
ABSTRACT:
VCLS is a global product development consultancy firm, which guides Biotechnology, Pharmaceutical and MedTech manufacturers throughout product development and commercialization. From early stage to patients, VCLS assists innovators by designing product development strategies that optimize clinical development in order to drive commercial success, through an understanding of both regulators and payers.
VCLS’s team of HealthTech product specialists seamlessly supplement innovative life sciences companies’ resources with strategic advice and cross-functional operational capabilities. The firm offers integrated solutions to development planning, manufacturing, quality and controls, nonclinical and clinical testing, safety monitoring, and interactions with regulators and payers. With offices in Cambridge, and Somerville (MA & NJ, USA), London (UK), Paris and Rennes (France), Lausanne (Switzerland), Copenhagen (Denmark) and Bangalore (India). VCLS serves a broad range of developers and investors in Life Sciences.
BIOs:
Emmanuelle M. Voisin, PhD
Dr. Emmanuelle Voisin founded Voisin Consulting Life Sciences (VCLS) in 1997.
With 30+ years’ experience in drug development. Dr. Voisin’s expertise lies in non-conventional development strategies, maximizing the use of regulatory mechanisms and innovative approaches, to bring innovative technologies to patients. She has a particular interest in the in silico clinical development leading to expedited approval of drugs and biologics.
Cécile F. ROUSSEAU, PhD
As Director in the Regulatory Nonclinical / Clinical group at VCLS, Cécile is responsible for working closely with clients in the management of projects involving cell, gene and tissue-based medicinal products (“ATMPs”), medical devices, combination products, in vitro diagnostics and microbiome products, from nonclinical to clinical phases, in both Europe and the US. She plays an important role within VCLS as a team member in the Advanced Therapy Medicinal Products, Advanced Health Therapy and Microbiome groups.
