Session 3: When & How to Engage a CDMO
December 4, 2023
Speakers:
Cédric Héroux, General Director, Biodextris
Over 20 years of management experience in the pharmaceutical and consumer goods industries with an history of success in developing strategies to increase quality and operational efficiency for different product families and different product development stages from pre-clinical to commercial manufacturing.
His experience spans late product development stages, manufacturing, commercial production, and industrial strategy, with focus on operational excellence, quality and regulatory compliance as well as customer service.
His working experiences ranges from small start-up company to well established multinationals companies. Prior experience includes management and leadership positions with GSK Biologics, Jubilant Radiopharmaceutical, Essilor (consumer goods) Groupe Parima, Dals (consumer goods) and now Biodextris.
Gayle Piat, RQAP-GLP, RAC, Director, Alberta Cell Therapy Manufacturing, Faculty of Medicine and Dentistry, University of Alberta
Gayle Piat has a background in Medical Laboratory Technology and has over 30 years’ experience working in the life science field with 12 years spent specializing in Good Laboratory Practice (GLP) and 12 years in Good Manufacturing Practice (GMP). While working at the Alberta Research Council as a Quality Assurance Manager in a GLP toxicology facility, she earned her designation as Registered Quality Assurance Professional in GLP through the Society of Quality Assurance in 2003. In 2011 Gayle joined the University of Alberta as Project Manager for construction of a GMP cell and gene therapy manufacturing facility and is now Director of Alberta Cell Therapy Manufacturing (ACTM). In 2016 she earned Regulatory Affairs Certification through the Regulatory Affairs Professionals Society. Gayle is an active member of the Canadian biomanufacturing ecosystem including serving as a Board Member for International Society of Pharmaceutical Engineers (ISPE), Canadian affiliate and committee member in ISPE Canada's Women in Pharma Committee.
Jennifer Quizi, Ph.D., Director, Biotherapeutics Manufacturing Centre - Virus Manufacturing Facility, Ottawa Hospital Research Institute
Dr. Jennifer Quizi has a Doctorate in Cellular and Molecular Medicine from the University of Ottawa and has been working as part of a translational team in cancer therapy, providing strategic and scientific insight for more than 10 years. As Director of Manufacturing Operations at BioCanRx, Dr. Quizi is responsible for enabling the roll-out of point-of-care (POC) manufacturing at strategic sites across Canada as well as to facilitate building additional capacity in therapeutic virus manufacturing in Canada. To ensure the sustainability of these investments in biomanufacturing, Dr. Quizi has championed the establishment of a first-of-its kind training program that provides trainees with hands-on, real-world experience working in a GMP environment, called CanPRIME. Dr. Quizi is also an Investigator and the Director of BioCanRx Core Facility, the Biotherapeutics Manufacturing Centre- Virus Manufacturing Facility (BMC-VMF) at the Ottawa Hospital Research Institute. In her capacity as Director of the BMC-VMF, Dr. Quizi oversees the development and GMP production of therapeutic viruses that are used in early phase clinical trials in cancer and other disease indications.