Webinaires

Disponible en anglais seulement

Previous stops:

First stop: Toronto

CCRM and UHN will be showcasing the Center for Cell and Vector Production (CCVP) which opened just over a year ago. 

December 17, 2020

Speakers: 

• Jana Machan, VP Commercialization, CCRM
• Steven Keizer, Director Quality, CCRM
• Jose Mangles, Sr. Manager, Business Innovation, UHN
• Dwayne Barber, Professor, University of Toronto, UHN member

Second stop: Montreal

Meet the McGill Regenerative Medicine Network - a new partner in the Canadian cell therapy landscape 

January 21, 2020

 

Speakers:

• Prof. Corinne Hoesli, head of the Stem Cell Bioprocessing Laboratory at McGill University.
• Michel L. Tremblay, (Ph.D., F.R.S.C., C.Q.) (KANYR INC., CSO) Full Professor in the Departments of Biochemistry and Oncology, as well as a James McGill Professor and holder of the Jeanne and Jean-Louis Lévesque Chair in Cancer Research, at McGill University.

Third stop: Vancouver

Technology Development Tailored to Address Cell Therapy Manufacturing Challenges

February 18,2020

  

Speaker: Prof. James Piret

Fourth stop: Edmonton

Journey to the Clinic with ACTM

March 18, 2020

Speaker: Gayle Piat RQAP-GLP, RAC, ACTM Manager at University of Alberta

Cellular Immuno-Therapy for COVID-19 ARDS (CIRCA-19)

June 29, 2020

Join Dr. Duncan Stewart as he walks us through the recently-approved clinical trial that is being launched at the Ottawa Hospital’s Research Institute. Following his Stem Cell Network webinar, this talk will delve into the mechanics of translation, including proving comparability. The therapy is based on an MSC treatment that has already been through stage I clinical trials for treating septic shock (funded by OIRM), which can also lead to ARDS. The Ontario COVID-19 Rapid Research Fund has committed $1.2M, which has been bolstered by a further $300 000 from the Stem Cell Network. Listen in on our webinar to hear the details of this important Canadian work.

CIRCA19-CellCAN-v1_compressed_1pdf.io.pdf

Bioprinting at the nexus of medical device, biologic and cell therapy regulation, Sam Wadsworth, Aspect Biosystems

March 19, 2020

Now available online! Missed it? Here is your chance to catch up! Don't hesitate to engage with us if you have questions for our expert or would like to submit comments. 

Aspect Biosystems uses a unique 3D bioprinting technology to fabricate cellularized tissues and devices for therapeutic applications and for pre-clinical research. Therapeutic areas of particular focus include orthopaedics, with the development of a knee meniscus replacement, and metabolic disease, where the team is developing an implantable pancreatic beta cell-containing tissue to cure patients with type-1-diabetes. Sam will discuss the various components that need to come together to successfully develop these therapeutics including, the 3D printing hardware, tissue design and printer control software, the biomaterials and the cells. Regulatory considerations for the two tissue programs will be discussed; the need for quality control systems, clinical and non-clinical studies, location of manufacturing sites, and supply chain are a few of the issues that will be addressed.

Engineered Cell Therapies & Environmental Assessments: CTA Is Just The Start.

How To Navigate The New Substance Notification Regulations for Organisms, Sowmya Viswanathan, UHN

February 20, 2020

When it comes time to file a Clinical Trial Application for new cell or gene therapy products, a New Substance Notification Regulation (Organism) Schedule 1 form may also need to be filed with Environment and Climate Control Canada (ECCC). This is often true for products touched by biotech, including vector-modified or gene edited cells, such as CAR-T. But what necessitates the submission of this extra form? Why does it need to go to ECCC, where other forms are sent to Health Canada? And what’s being done to make the CTA process smoother for innovators? Tune in to hear Dr. Sowmya Viswanathan explain her work on clarifying the NSNR(O) process.

More than a Cord Blood Bank: Canadian Blood Services Supports Research and Clinical Trials, Jason Weiss, CBS

January 16, 2020

 

Now available online! Missed it? Here is your chance to catch up! Don't hesitate to engage with us if you have questions for our expert or would like to submit comments.

Did you know that Canadian Blood Services (CBS) supplies cord blood units for research as well as for the clinic? Unbankable cord blood is offered to the research community to support their studies and CBS has also recently expanded their program to support clinical trials. Listen in on this talk by Dr. Jason Weiss to hear more about how Canadian Blood Services can help advance your research.

The Training and Development Challenge with Craig Hasilo, CellCAN & Emily Hopewell, ISCT

December 12, 2019

Now available online! Missed it? Here is your chance to catch up! Don't hesitate to engage with us if you have questions for our expert or would like to submit comments. 

A well identified gap impeding the advancement of the cell and gene therapy ecosystem is the dearth of highly qualified personnel (HQP) throughout North America. CellCAN partnered with the Early Stage Professionals Sub-Committee at ISCT to address this issue and garner feedback from the stakeholders at large. An impressive discussion resulted at the ISCT North American Regional Meeting in Madison, WI, during an interactive polling presentation focused on HQP and employers’ perspectives on training programs offered and the hiring and onboarding process. Tune in to gain insights from these stakeholders and determine how you can contribute to revolutionizing the training and employment processes.

Extraneous Considerations for Manufacturing with Dr. David Courtman, OHRI

November 21, 2019

Now available online! Missed it? Here is your chance to catch up! Don't hesitate to engage with us if you have questions for our expert or would like to submit comments. 

The translation of cell therapies from basic research to clinical trials requires the development of standard operating processes that are both regulatory compliant and of relatively low risk to the quality of the final product. This often requires the careful external sourcing of ancillary materials and services. An appropriate risk analysis needs to be performed to identify and mitigate the risks involved from external suppliers. In early phase trials this may simply involve document review, development of contractual/reporting arrangements, and implementation of an incoming product qualification strategy. As trials progress to later phases external site visits and complete audits may need to be performed to assure the continuous supply of high quality goods and services. I will draw on examples from past academic trials to highlight our experience in implementing these strategies from first in man safety trials to larger efficacy-based studies.

Mastermind session: How to translate your research into a clinical application with Dr. Denis Claude Roy, CETC

October 17, 2019

Now available online! Missed it? Here is your chance to catch up! Don't hesitate to engage with us if you have questions for our expert or would like to submit comments. 

Dr. Denis Claude Roy of the Centre d'Excellence en Thérapie Cellulaire (CETC) will give advice on writing clinical trial applications. The CETC produces cellular therapy products for a variety of clinical trials that are currently underway. However, in order for these trials to proceed, they must first be approved by Health Canada. Dr. Denis Claude Roy will give a lunchtime webinar on tips and tricks for writing a clinical trial application, including common sticking points and how to take your research from the lab to the clinic.