An Introduction to Biologic GMP Manufacturing: Preparing for Early-Phase Clinical Trials
Dates: November 20, 27, and December 4, 2023
Location: Ontario
Register Here
SCN, BioCanRx, and the National Research Council of 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
Session 1: Lost in Translation – Are You Ready to Bring your Biological Product to Manufacture
November 20, 2023, 12 p.m.-1:30 p.m. ET
- 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
Session 2: CMC Strategy Supporting Cell & Gene Therapy Translation From Concept to Clinical Products and Beyond
November 27, 2023, 12 p.m.-1:30 p.m. ET
- 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.
Session 3: When & How to Engage a CDMO
December 4, 2023, 12 p.m.-1:30 p.m. ET
- 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
Dates & Key Details (including location) |
Session 1: Lost in Translation – Are You Ready to Bring your Biological Product to ManufactureNovember 20, 2023, 12 p.m.-1:30 p.m. ET
Session 2: CMC Strategy Supporting Cell & Gene Therapy Translation From Concept to Clinical Products and BeyondNovember 27, 2023, 12 p.m.-1:30 p.m. ET
Session 3: When & How to Engage a CDMODecember 4, 2023, 12 p.m.-1:30 p.m. ET
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How to Register | |
Eligibility |
Anyone working in academia or industry who wants to learn about clinical translation and making the academic – clinical trial transition is welcome to register. The event is most relevant to research groups who have a strong pre-clinical program with therapeutics. |
Conditions |
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For further information on this series, please contact Sarah Ivanco at sivanco@biocanrx.com.
Sharing Multi-network Resources for Trainee Success (SMRTS) Seminars Program
Ongoing | Online
The SMRTS (Sharing Multi-network Resources for Trainee Success) Seminars Program is a professional development initiative between 9 national and provincial networks aimed at providing the best possible programming to our respective trainees.
Each month, we will offer our trainees access to a wide range of soft skills programming through a live-streamed webinar or event.
Past topics have included: grant writing strategy, media relations, patents and intellectual property, and communicating in plain language.
Click here to learn more about SMRTS Seminars Program.

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