Upcoming Learning Opportunities

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 Manufacture November 20, 2023, 12 p.m.-1:30 p.m. ET Learning objectives: Gain a general understanding of clinical translation pathway Learn some key elements for go/no-go decision-making for moving toward GMP biomanufacturing Learn the fundamentals of GMP requirements for Phase I/II clinical trials (later-phase trials will be very briefly touched on) Understand how and when to engage with Health Canada Attain strategies for meeting GMP requirements from each phase 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 Learning objectives: Learn how to effectively coordinate chemistry, manufacturing and controls (CMC) technical and preclinical operations to satisfy regulatory expectations Gain a better understanding of quality-centered development strategies for scalable processes and robust analytics Hear about important considerations for execution of preclinical studies Have a better understanding of core CMC milestones supporting successful regulatory filing Session 3: When & How to Engage a CDMO December 4, 2023, 12 p.m.-1:30 p.m. ET Learning objectives: How, when and what to expect when engaging a CDMO How to choose a CDMO Responsibilities of the researcher vs CDMO
How to Register	Register at this link.
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	By attending this webinar, participants agree to complete a short survey describing the value of the training opportunities made available through the webinar. This information will be used at SCN and BioCanRx’s discretion on their respective websites, newsletters, and for the purposes of reporting to their funding agencies. By attending this webinar, participants also accept to have their pictures taken during the three-part training series and used in materials as described above.

For further information on this series, please contact Sarah Ivanco at sivanco@biocanrx.com.

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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.

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Click here to learn more about SMRTS Seminars Program.

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