Safety Assessment Support
From complete IND-enabling programs to stand-alone assessments, our Safety Assessment team provides a full range of in vivo and in vitro testing services and regulatory support to comply with worldwide regulatory requirements for the nonclinical development of pharmaceuticals and animal health products as well as chemicals, agrochemicals, and biocides. Our scientific and regulatory staff work with clients to develop and execute individual studies or customized testing programs to ensure that drug safety and efficacy assessments are conducted in the most efficient manner.
It is critical that you choose a partner you can trust to keep you on the path to success, every step of the way. At Charles River, we immerse ourselves in niche markets, stay abreast of regulatory changes and keep up with new technologies so we can support the specific testing and manufacturing requirements of regulated industries.
Meet the Team
The scientists joining from Citoxlab bring new perspectives and years of experience to our growing safety assessment team.
Philippe Ancian, PhD
Director of Biomarkers
Dr. Ancian graduated as an engineer in chemistry from the National School of Chemistry in Montpellier, France before obtaining a PhD in molecular and cellular biology from Nice University. He has spent the last 20 years in the pharma, biotech and CRO industries where he has implemented and monitored biomarker analyses at the discovery, preclinical and clinical stages. Philippe is passionate about advanced therapies, including immunotherapies gene, and cell therapies.
Michel Assad, PhD
Executive Director of Orthopedics and Biomaterials
Dr. Assad is an accomplished biomaterials scientist with over 25 years of experience in preclinical research and product development. He received a bachelor’s degree in biological sciences from McGill University, a master’s degree in biomedical engineering, and a PhD in biomedical sciences from the University of Montreal, and then completed a fellowship in materials science at the Catholic University of Leuven in Belgium.
Dr. Assad joined Charles River with the acquisition of AccelLAB. He currently oversees all orthopedic, hard and soft musculoskeletal research activities and is the vice-chair of the site’s IACUC committee. He is an expert in biocompatibility, soft and hard tissue integration, and safety, efficacy and performance evaluation of various orthopedic biomaterials and biologics. Dr. Assad is an active member of the US Orthopedic Research Society (ORS) and Society for Biomaterials (SFB). He has authored more than 120 publications and scientific presentations in the biomaterials field.
Simon Authier, DVM, MBA, PhD, DSP
Deputy Chief Scientific Officer
Joining Charles River with the acquisition of Citoxlab, Dr. Authier has decades of experience investigating methodologies in nonclinical regulatory safety pharmacology studies to improve study designs for optimal sensitivity and decision making. He has participated in face-to-face FDA pre-IND meetings and overseen the conduct of preclinical studies for numerous small and large molecules. He currently oversees team of scientists and veterinarians specialized preclinical research for IND, BLA and NDA filing with a focus on pharmacology. He is a frequently invited speaker for scientific conferences including the Food and Drug Administration (FDA), NIAID, the Safety Pharmacology Society, American College of Toxicologists, Japanese Society of Safety Pharmacology, and the American Association of Laboratory Animal Science.
Dr. Authier is Associate Professor at University of Montreal, Canada where he is involved with clinical immunology and pharmacology and he has authored more than 70 peer reviewed articles and book chapters. To date, he has provided scientific overview for more than 800 preclinical studies. He holds DVM from the University of Montreal with a specialization in nonclinical studies, a PhD in preclinical pharmacology and an MBA in corporate finances and management.
Louis-Georges Guy, PhD
Director of Science, Boisbriand
After receiving a PhD in molecular biology form Université de Montréal, Dr. Guy became project leader during an industrial postdoctoral fellowship at Angiogene. He later invented and developed a cell and gene therapy approach to treat heart failure, a technology that was patented and licensed. He received a graduate diploma in management from HEC Montréal.
He comes to Charles River with the acquisition of AccelLAB, where he established the scientific program for the preclinical evaluation of medical devices in the fields of cardiology, ENT, orthopedics, and others. As an expert in bioabsorbable scaffolds, he has authored many articles in this field, presented for sponsors in scientific meetings, and was invited as preclinical expert at a workshop at the FDA and a biodegradable metal symposium. Dr. Guy is an active member of the Society of Toxicology. He holds a graduate diploma in management from HEC Montréal.
Christian Li, BSc
Director of Toxicology, Laval
After a BSc in biology, Chris earned a postgraduate diploma in ecotoxicology from Concordia University. He began as an auditor with Charles River Montreal’s Quality Assurance unit, working with both the validation and production QAU groups. Later as a study director, he completed more than 200 GLP and NGLP studies involving acute and chronic studies for general toxicology, inhalation, infusion, pharmacology and neurotoxicology, ocular and neuroscience, immunotoxicology, and teratology with all administration routes and species. During this period, also served as a member of Charles River’s IACUC committee, Global In-Life Subcommittee, and harmonization projects. As the current Director of Toxicology in Laval, he oversees the site’s team of study directors, and manages sponsor interactions, study director training, study plan/amendment, data and report review, validation/method development projects, and conduct/evaluation of preclinical studies.
John Stamatopoulos, BSc
Director of Bioanalytical and Analytical Chemistry
John has over 21 years of extensive LC-MS/MS experience in preclinical and clinical contract research organizations. He currently leads a team of scientists and analysts in Bioanalytical and Analytical Chemistry, ensuring that all work is performed in compliance with general scientific/regulatory standards and in full compliance with GLP. John obtained his bachelor’s degree in biotchemistry from Concordia University.
Robert Tavcar, BSc, DABT
Senior Director, Toxicology
Robert Tavcar, BSc, DABT is a board-certified toxicologist with over 25 years of nonclinical safety experience and presently serves as the Senior Director of the Toxicology Group in Laval, Canada. He oversees the Toxicology Study Director Group (General, Infusion, Dermal and DART), Pharmacology (including PK/PD and DMPK) and Statistical Services groups. He has experience in both large and small molecule drug development covering multiple therapeutic areas and targets. He performs scientific and regulatory peer review of study plans, critical data, amendments and reports and provides training and guidance to scientific staff (study directors) as well as support and help guide Sponsors on study/program designs and regulatory challenges. He is well-versed in OECD, ICH and FDA Guidelines and GLPs, resource allocation, and operational logistical issues key to the success of nonclinical safety programs. He has roughly 5 years of clinical drug development experience in support of Phase I and bioequivalence studies. He is also a member of multiple Toxicology organisations (ACT, SOT, STC and Teratology Society). Robert Tavcar obtained his Bachelor’s degree from Concordia University in biology and Toxicology Board Certification from the American Board of Toxicology.
Want to Meet?
Visit with us at the following conferences:
- European Society for Gene & Cell Therapy (ESGCT) 27th Annual Congress – Barcelona, Spain – October 22-25
- AAPS 2019 PharmSci 360 – San Antonio, TX – November 3-6
- American College of Toxicology (ACT) Annual Meeting – Phoenix, AZ – November 17-20
- 12th European Bioanalysis Forum (EBF) Open Symposium – Barcelona, Spain – November 20-22
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