CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that Dr. Sylvie Peltier (“Dr. Peltier”) has been appointed as Senior Vice President of Global Regulatory Affairs of the Company with effect from October 31st, 2022.
She will be responsible for developing global regulatory strategies, leading and driving the Company’s regulatory affairs activities, and initiatives in support of IND/CTA/BLA filing and approval of developmental products globally.
Dr Sylvie Peltier has extensive global leadership and hands-on experiences in clinical and CMC regulatory affairs across several multinational pharmaceutical and biopharmaceutical companies. Prior to joining CARsgen, Dr. Peltier served as Vice President, Head of US Regulatory Affairs at MorphoSys US Inc (NASDAQ: MOR) since 2020, and as Head of Regulatory Affairs at Servier Pharmaceuticals LLC from 2018. Before joining Servier Pharmaceuticals LLC, Dr. Peltier served at Cephalon since 2007, an international biopharmaceutical company which was acquired later by TEVA Pharmaceuticals Industries Ltd (NYSE: TEVA), holding various positions from Senior Director, Europe Regulatory Affairs, CNS/Pain and CMC, Senior Director, US Regulatory Affairs, to Senior Director, Clinical Search Evaluation and Due Diligence. Previously, Dr. Peltier worked at Pfizer Regulatory Affairs from 1995.
Dr. Peltier earned a Diploma of Pharmacy Doctorate and a Diploma of Graduated Specialized Studies (DESS) in Health Law from University of Paris XI in Paris, France.
Dr. Raffaele Baffa, Chief Medical Officer of CARsgen Therapeutics, said: “We are delighted to have Dr. Peltier join CARsgen. Dr. Peltier is a strong addition to our senior leadership team. Her extensive experience and knowledge in clinical and CMC regulatory will be critical assets for CARsgen as we continue to advance the pipeline products globally. Together with Dr. Peltier and the team, we will spare no efforts in developing our innovative cell therapy products to benefit cancer patients worldwide.”
Dr. Sylvie Peltier, Senior Vice President of Global Regulatory Affairs of CARsgen Therapeutics, said: “CARsgen is a leader in CAR T-cell therapies globally, with competitive product pipelines and technology platforms. I am very happy to join CARsgen in this exciting time when the company is developing several differentiated CAR T-cell products, including zevor-cel, a competitive anti-BCMA CAR-T and CT041, the first-in-class anti-CLDN18.2 CAR-T. I look forward to working together with the colleagues in CARsgen to bring the innovative products to market soon and ultimately help achieve the vision of ‘Making Cancer Curable.'”