SCN – An Introduction to Biologic GMP Manufacturing
Stem Cell Network, BioCanRx, and the National Research Council Canada are pleased to launch a three-part virtual training series: “An Introduction to Biologic GMP Manufacturing: Preparing for Early-Phase Clinical Trials.”
Held over three sessions, this virtual event is designed to give biomedical research teams a comprehensive understanding of the key topics in clinical translation, particularly progressing a therapeutic to GMP manufacturing for an early-phase clinical trial. The three sessions will cover crucial topics such as: critical decision-making points for bringing a product from an academic lab into GMP manufacturing/early phase clinical trials; preparing a preclinical data package for regulatory approvals; and engaging with contract development and manufacturing organizations (CDMOs).
Whether you are a seasoned researcher or just starting out, this event is an excellent opportunity to gain practical GMP manufacturing insights and knowledge to advance your research program and transition a new therapeutic to a GMP environment. The series will focus on early-phase clinical trials for biologics. This webinar series is a precursor to a larger in-person workshop-style event that is scheduled to take place in 2024.
Who should attend?
We invite research groups and Canadian start-up biotech companies who want to learn about clinical translation and making the academic bench to clinical trial transition. The event will be most relevant to research groups who have a strong preclinical program with therapeutics that have a clear clinical path on a short-medium term timeline.
Workshop Learning Objectives
By the end of this webinar series, participating project groups will:
- Understand the critical steps for assessing biologic readiness for manufacturing.
- Learn about preparing preclinical data packages and strategies for successful technology transfer.
- Acquire strategies for working with CDMOs to successfully manufacture a biotherapeutic.
Speakers & Sessions
| Date | Session | Speakers |
| November 20, 2023, 12 p.m.-1:30 p.m. ET |
Session 1: Lost in Translation – Are You Ready to Bring your Biological Product to Manufacture | Sanjana Fridman, Ms.C., Regulatory Compliance and Enforcement Advisor, Health Canada Brian Lichty, Ph.D., Associate Professor, Medicine, McMaster University, CTO, Co-founder, Turnstone Biologics Gayle Piat, RQAP-GLP, RAC, Director, Alberta Cell Therapy Manufacturing, Faculty of Medicine and Dentistry, University of Alberta Jennifer Quizi, Ph.D., Director, Biotherapeutics Manufacturing Centre – Virus Manufacturing Facility, Ottawa Hospital Research Institute |
| November 27, 2023, 12 p.m.-1:30 p.m. ET |
Session 2: CMC Strategy Supporting Cell & Gene Therapy Translation From Concept to Clinical Products and Beyond | Patrick Bedford, M.Sc., RA, Managing Director, weCANreg Consulting Group Inc. Panos Chrysanthopoulos, Ph.D., Co-Founder and Director, weCANdev Consulting Group Inc., Chief Development Officer, Morphocell Technologies Calley Hirsch, Ph.D., Principal Consultant, weCANdev Consulting Group Inc. |
| December 4, 2023, 12 p.m.-1:30 p.m. ET |
Session 3: When & How to Engage a CDMO | Cédric Héroux, General Director, Biodextris Gayle Piat, RQAP-GLP, RAC, Director, Alberta Cell Therapy Manufacturing, Faculty of Medicine and Dentistry, University of Alberta Jennifer Quizi, Ph.D., Director, Biotherapeutics Manufacturing Centre – Virus Manufacturing Facility, Ottawa Hospital Research Institute |
Learn more about the program and register on the SCN website.
Questions
For further information on this seminar series or for registration related enquiries, please contact Ellie Arnold at trainingSCN@stemcellnetwork.ca.