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2019-2020 Webinar Series

CellCAN is proud to present its 2019-2020 Webinar Calendar. 

To attend one or all of these events, please fill the short form below and you will receive the information to access the webinar by email. 

October 17, 2019 - noon (Eastern Standard Time) 
Mastermind session: How to translate your research into a clinical application with Dr. Denis Claude Roy, CETC

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.

November 21, 2019 - noon (Eastern Standard Time)
Extraneous Considerations for Manufacturing with Dr. David Courtman, OHRI

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.

December 12, 2019 - noon (Eastern Standard Time)
The Training and Development Challenge with Craig Hasilo, CellCAN

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.

January 16, 2020 - noon (Eastern Standard Time)
Clinical Grade Cords - A new resource with Jason Weiss, Canadian Blood Services

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.

February 20, 2020 - noon (Eastern Standard Time)
Engineered Cell Therapies & Environmental Assessments: CTA Is Just The Start. How To Navigate The New Substance Notification Regulations for Organisms

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.

March 19, 2020 - noon (Eastern Standard Time)
Bioprinting at the nexus of medical device, biologic and cell therapy regulation, Sam Wadsworth, Aspect Biosystems

Aspect Biosystems develops 3D-printed structures that incorporate biomaterials, cells, and software. Sam Wadsworth will discuss the various factors that go into regulations of two of their research products: meniscus tissues for knee injury, and pancreatic islet tissue for type I diabetes. Quality control, clinical and non-clinical studies, manufacturing sites, risk mitigation, and supply chain are a few of the issues that will be addressed.

 

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