Session 1: An Introduction to Biologic GMP Manufacturing Preparing for Early Phase Clinical Trials

Session 1: Lost in Translation – Are You Ready to Bring your Biological Product to Manufacture
November 20, 2023

Speakers:
Sanjana Fridman, Ms.C., Regulatory Compliance and Enforcement Advisor, Health Canada
Sanjana Fridman is a Regulatory Compliance and Enforcement Advisor with Drug GMP HQ Team 3 in the Health Product Inspection and Licensing Division. She joined Health Canada in 2018. Prior to that, Sanjana worked in industry in the area of sterile injectable products. She holds an M.Sc in radiation oncology.

Marie-Michelle Genois, Ph.D., A/Sr. Biotherapeutics Quality Reviewer, Biologic and Radiopharmaceutical Drugs Directorate, Health Canada
Marie-Michelle Genois is a A/Sr. Biotherapeutics Quality Reviewer at the Biologic and Radiopharmaceutical Drugs Directorate. She joined Health Canada in 2021.
Prior to that, Marie-Michelle completed a post-doctoral fellow at the Harvard Medical School in the area of cancer biology. She holds a Ph.D. in Cellular and Molecular Biology.

Brian Lichty, Ph.D., Associate Professor, Medicine, McMaster University, CTO, Co-founder, Turnstone Biologics
Dr. Brian Lichty has extensive expertise in oncolytic viruses and related immunotherapies. He has been a professor in the Department of Pathology & Molecular Medicine and the McMaster Immunology Research Centre (MIRC) at McMaster University since 2004. He is also a co-founder of Turnstone Biologics. Dr. Lichty’s expertise includes influence research in the identification of strategies to leverage oncolytic viruses to harness the patient’s immune system in a sustainable manner, including vaccine design and engineering to directly engage the adaptive immune system tumour-specific and/or to enhance combinations with other immunotherapies. He is also director of the Robert E. Fitzhenry vector lab at McMaster where clinical grade viral vaccines are manufactured for human clinical trials. Dr. Brian Lichty received his PhD from the University of Toronto and holds a BSc from the University of Guelph.

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.