Saturday, December 3, 2022

561.316.3330

Biotechnology News Magazine

Dr Sylvie Peltier Appointed Senior VP of Global Regulatory Affairs at CARsgen Therapeutics

Latest Posts

Imago BioSciences Announces First Participant Dosed in Investigator-Sponsored Phase 1 Study of Bomedemstat in Combination with Venetoclax in Relapsed/Refractory Acute Myeloid Leukemia

Venetoclax is a BCL-2 inhibitor approved by the U.S. Food and Drug Administration (FDA) for treatment of several hematologic cancers, including in combination with azacytidine for elderly patients with AML unable to tolerate the standard of care.

Acer Therapeutics Announces $1.5M Private Placement

The proceeds from the private placement will be used by Acer Therapeutics for working capital and general corporate purposes and, together with Acer’s existing cash and cash equivalents, are expected to be sufficient to fund the Company’s anticipated operating and capital requirements through the fourth quarter of 2022.

AC Immune’s Alzheimer’s Disease Vaccine-candidate ACI-35.030 Selected for Further Development

Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “The selection of ACI-35.030 for further development is a significant step for this collaboration. Early clinical testing showed that ACI-35.030 was generally well tolerated and induced specific activity against the pathological species of Tau, including the neurotoxic pTau and enriched paired helical filaments (ePHF) species, both of which are closely implicated in Alzheimer’s disease (AD).

TransCode Therapeutics Announces eIND Submission to US FDA for Planned First-in-Human Clinical Trial in Patients with Advanced Solid Tumors

The planned clinical trial is to evaluate TransCode’s lead therapeutic candidate, TTX-MC138, in cancer patients with advanced solid tumors. ​TTX-MC138 is designed to inhibit the pro-metastatic RNA, microRNA-10b, described as the master regulator of metastasis in a number of advanced solid tumors. TransCode Therapeutics believes that TTX-MC138 could be used as a treatment for many of these cancers.

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.'”

Latest Posts

Learn More

spot_img

Subscribe

spot_img

Our Sister Publication

Medical Device News Magazine