At GenSight Biologics, we have been working to accelerate cycle times and manage regulatory compliance from early development (preclinical to first- in- man) to commercial to provide to the patients beneficial solutions for counteracting the effect of rare and irreversible vision loss that can lead to legal blindness in very short time after the onset of the disease.
This presentation highlights the CMC strategy we have developed in the context of operational outsourcing to key suppliers including analytical, process development, manufacturing, and supply chain.
The execution part of a strategy is the critical and requires not only manufacturing capacities but also a successful integration of the process and analytical development sciences, the quality systems that apply to all aspects of GMP manufacturing and an acute understanding of the regulators expectations. All along our Pharmaceutical Development, we have been focusing on supplying in due time the clinical grade material for trials, demonstrating the product comparability and providing process consistency assurance for marketing application. Building a collaborative partnership in this context is a key success factor.
Catherine currently leads the Pharmaceutical Operations from preclinical to Phase III clinical studies and commercialization at GenSight Biologics. She has over 20 years’ experience in manufacturing operations and bioprocesses improvement in biotechnology companies. Prior to join GenSight in 2017, Catherine served at various positions at Sanofi Pasteur, including management level responsibilities in Manufacturing, Quality & CMC compliance, and Project Management, leading multifunctional project teams in Process Transfer, Manufacturing readiness and documentation for regulatory submissions.
Catherine received a master’s degree in Neurosciences from Pierre & Marie Curie University (Paris), an Engineering Degree in Biotechnologies from UTC and a master’s degree in Business and Management of Strategic Units from HEC (Paris).
GenSight Biologics (Euronext: SIGHT) is a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, such as the Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults.
Using its gene therapy-based approach, GenSight Biologics’ product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery.
The company has completed the data collection from two pivotal trials (REVERSE and RESCUE) in Europe in 2019 for its lead product candidate GS010, brand name LUMEVOQ™ (lenadogene nolparvovec) and expects to apply for marketing approval in Europe in the third quarter of 2020.