This appointment makes the Montreal site attractive to North American clients and boosts CiToxLAB’s expertise in preclinical development and regulatory affairs.
CiToxLAB, a leading CRO in the field of non-clinical research, announces today that John C. Kapeghian has joined the company as senior director of toxicology in North America (Montreal, Canada). His experience includes thirty years in preclinical drug safety at Ciba Pharmaceuticals (now Novartis) and Charles River Laboratories.
John is a renowned regulatory toxicologist. He brings outstanding expertise to the team at CiToxLAB. His skill set includes study design and implementation, data evaluation and report review, FDA pre-IND meeting representation and briefing document preparation, as well as Investigator Brochure and IND/NDA/BLA preparation.
John has a PhD in pharmacology/toxicology and is a diplomate of the American Board of Toxicology (DABT). He was formerly head of Experimental Toxicology at Ciba Pharmaceuticals (now Novartis) and then joined Charles River Laboratories where he established and led the Navigator Scientific and Regulatory Consulting Group and Program Management Team. As the president of Preclinical Safety Associates, he has recently collaborated with pharmaceutical and biotechnology companies worldwide to advise on programs, study design and to monitor non-clinical regulatory packages.
John is a member of the Society of Toxicology and the American College of Toxicology. He sat on the editorial board of the International Journal of Toxicology. Over the years, he has published dozens of peer-reviewed papers and continues to be active in his areas of specialty, including biotechnology-derived therapeutics development and drug-induced hepatotoxicity. John frequently presents his work at international scientific meetings and sponsors and organizes preclinical training workshops, including study director training.
“I am delighted that we are adding a colleague of this standing to our organization. John will make a valuable contribution to our customers’ development programs. John’s recruitment reflects the CiToxLAB policy of carefully listening to our customers’ needs,” said Dr Jean-Francois Le Bigot, chairman and CEO of the CiToxLAB Group.
“CiToxLAB will celebrate its 45th anniversary in 2014, just three years after CIT merged with LAB-Research. CiToxLAB continuously invests in new techniques to validate in vivo and in vitro models. New safety pharmacology models have been recently implemented in NHPs and minipigs. We also invested in new methods for biomarkers in genomics, flow cytometry and immunohistochemistry. The hiring of John C. Kapeghian will make our Montreal site even more attractive for our clients in North America and reflects our mission to make CiToxLAB a science-driven CRO that offers the best scientific expertise to customers,” said Dr. Le Bigot.
The CiToxLAB group offers a comprehensive range of pre-clinical services to meet the needs of pharmaceutical, biotechnology and chemical companies worldwide.
CiToxLAB carries out studies in general and reproductive toxicology, carcinogenicity, immunology, safety pharmacology, DMPK and bioanalysis. The group has particular expertise in areas such as toxicology and reprotoxicology in NHPs and minipigs, inhalation, genomics and radiation studies. Environmental studies (ecotoxicology and those related to REACH regulations) are a further specialty.
Atlanbio (Saint-Nazaire, France) joined the group to offer CiToxLAB extensive services in pre-clinical and clinical bioanalysis and biomarkers. A partnership with Stemina (Madison, USA) also allows it to offer metabolomic screening services for toxicity and teratogenicity using human embryonic stem cell models.
Through the five facilities located in France (Evreux/Paris, Saint-Nazaire), Canada (Montreal), Denmark (Copenhagen) and Hungary (Veszprem), CiToxLAB offers proximity to the clients, coupled with direct access to the scientists and to management with global expertise.
Created in 2011 through the merger of CIT and LAB-Research, CiToxLAB group has more than 850 employees working on the five sites representing 60,000 sq meters of state-of-the-art facilities.
The company has a world-class team of top-level management in scientific, financial and business activities.