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.
Upon completing a Ph.D. program in Medical and Biological Engineering at the University Claude Bernard – Lyon 1 in 2002, Cécile proceeded with postdoctoral research in tissue engineering (including but not limited to cartilage, soft organs), toxicology and pharmacology at the Laboratory of Cartilage Biology and Engineering and at the Laboratory of Molecular Assembly of Biological Interest, both located at the Institute for the Biology and Chemistry of Proteins.
In 2006, Cécile joined the pharmaceutical industry where she gained experience from both sides CRO/Client relationship. First, as Senior scientist manager of the Preclinical and Characterization group for Organogenesis Switzerland GmbH in Zug, Switzerland / Lyon, France, then for Organogenesis Inc., in Canton, MA – USA, and later as Principal Scientist for Leica Biosystems – Companion Diagnostics R&D in Danvers, MA – USA.
At Organogenesis, Cécile developed and implemented with her group new analytical tools to characterize specimens generated from in vitro and in vivo nonclinical and translational research studies using molecular biology and histo-technologies. Cécile’s responsibilities included but were not limited to management, design, and execution of nonclinical studies related to process validation, engineering runs, material analysis and to assess medical devices for oral and burn application, early-stages engineered cellular therapies for soft tissue regeneration; management of non-GLP and GLP studies with external CROs to conduct safety and efficacy studies in rodent and swine models.
She supported Clinical/Medical Affairs groups through nonclinical studies that support pre-market approval for new products, existing indications for approved products (e.g. mode-of-action studies), and new indications for approved products (e.g. proof-of-concept studies). Cécile partnered with the Oral Regeneration business unit by providing scientific information and imaging support to complete product monograph (Gintuit™).
In 2014, Cécile became responsible for the development and implementation of IHC and ISH in vitro diagnostic (IVD) strategies to enable and support the development and implementation of companion diagnostics for manual and automated staining platforms at Leica Biosystems – Companion Diagnostics R&D in collaboration with pharmaceutical company partners. As Principal Scientist, Cécile prepared design control plans and development protocols and ran design review. She devised and managed milestone-driven plans for product development, optimization, and verification of new class II/III diagnostic medical devices. She authored and reviewed R&D relevant portions of clinical study protocols. Cécile also performed histopathology analysis on various cancer indications, developed scoring guidelines for new IHC and ISH assays in collaboration with pathologists, and provided analytical scoring training on new IHC and ISH assays to pathologists during site initiation visits to support clinical studies.
At VCLS, the main projects in which Cécile is involved concern the nonclinical and clinical areas, including but not limited to medical devices, cellular therapy, gene therapy, and in vitro diagnostics.
Resources by Cécile F. Rousseau, PhD
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Advanced Therapy Medicinal Products: An Innovative and Collaborative Approach
Advanced therapy medicinal products (ATMPs) belong to a rapidly developing, state-of-the-art field of science and technology in the EU. Due…
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A Regulatory Landscape Shift for In Silico Clinical Trials
Modelling and simulation (M&S) has grown to become a reliable approach to better understand and optimize key decisions related to…
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Cell and Gene therapies: European View on Challenges in Translation and How to Address Them
Advanced therapy medicinal products (ATMPs), i.e., cell and gene therapy products, is a rapidly evolving field of therapeutic development. A…
