PARIS–(BUSINESS WIRE)–Regulatory News:
GenSight Biologics (“GenSight Biologics” or the “Company“) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced the strategic expansion of its Regulatory Affairs & Quality department with two senior appointments following recent regulatory milestones.
The company named Fang Li, Ph.D., RAC, as Chief Regulatory Affairs & Quality Officer, and Sabrina Chekroun, Pharm.D., as Senior Vice President, Regulatory Affairs and Quality. Sabrina Chekroun will report to Fang Li. Fang Li is based in the U.S., and Sabrina Chekroun is based in France. The appointments came as GenSight progressed in its early access program with individual patient authorizations in France and Israel and an individual IND approval in the United States. These appointments will support the company’s global regulatory strategy.
“We are excited to welcome Fang and Sabrina to the team as we enter a pivotal growth phase this year,” said Laurence Rodriguez, Chief Executive Officer of GenSight Biologics. “On behalf of the GenSight team, I take this opportunity to express our deepest gratitude to Magali Gibou, whose leadership, insights, and collegial support played an indispensable role in GenSight’s consolidation and transformation over the past two years.”
“As we prepare for a year of advances, marked by regulatory authorizations for early access across multiple markets and the planned launch of a new global Phase III trial, a strong, globally experienced regulatory leadership team will be essential to our success,” continued Rodriguez. “Fang and Sabrina bring deep and complementary expertise and experience that are critical to our mission of delivering innovative therapies to patients affected by conditions where unmet medical need is high.”
Fang Li brings more than 30 years of experience in drug development, including over 25 years in Regulatory Affairs, with extensive expertise in global product development and approvals across the United States and other regions. She held senior regulatory leadership roles across various pharmaceutical and biotechnology companies, including Opthea Ltd, Oculis SA, Graybug Vision, and Iveric Bio, as well as regulatory positions at organizations such as Novartis, Alcon, Bausch + Lomb, and Warner Chilcott. Her experience in regulatory strategy spans the areas of small molecules, biologics, gene therapies, and medical devices. Dr. Li holds a Ph.D. in Medicinal Chemistry from China Pharmaceutical University, a Master’s degree in Organic Chemistry from Wuhan University, and a Bachelor’s degree in Organic Chemistry from Xiamen University. She is RAC (US) certified.
“I am very excited to have an opportunity to work on the development of products that treat inherited retinal diseases,” said Li. “I hope to help advance our programs at GenSight to help patients affected by devastating ocular diseases such as LHON and retinitis pigmentosa.”
Sabrina Chekroun brings more than 23 years of experience in international Regulatory Affairs, with positions in leading pharmaceutical companies such as Sanofi-Genzyme and AstraZeneca, as well as biotechnology companies such as Abivax and Advicenne, where she held senior leadership positions in Global Regulatory Affairs. She has extensive experience in defining and leading global regulatory strategies across Europe, the United States, and other regions, from early development through post-marketing authorization, with a strong focus on orphan drugs and rare diseases. Ms. Chekroun holds a Doctor of Pharmacy degree from the University of Algiers, a Master’s degree in Industrial Pharmaceutics from the University of Tours, and a Master’s degree in Health Law and Management from the University of Paris XI.
“I am truly delighted to be joining GenSight Biologics, a dynamic and committed team with an exceptional project that brings real hope to patients suffering from rare and severe retinal neurodegenerative diseases,” said Chekroun.
About GenSight Biologics S.A.
GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics’ pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics’ lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. GS010 is currently in clinical development, has not to date been granted marketing authorization in France or any other jurisdiction, and is therefore not available commercially. 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.
Contacts
GenSight Biologics
Chief Financial Officer
Jan Eryk Umiastowski
[email protected]
