Join CellCAN on December 13, 12PM EST, for a presentation by new CellCAN Network Affiliate, the Canadian Blood Services (CBS).

A presentation by Nicholas Dibdin, BSc, MLT, PMP, Associate Director, Stem Cells Operations

Canadian Blood Services operates a stem cell program that supports better outcomes for patients living with diseases and disorders that can be treated with stem cell transplants. They collect, manufacture and distribute cord blood stem cells through their national, public cord blood bank and cord blood for research program. They manufacture and distribute autologous stem cells through their stem cell manufacturing facilities in Ottawa & Edmonton. They operate a robust national registry of cord blood units and potential adult stem cell donors, participating in an international network of registries. They provide HLA typing services to ensure the best possible matches between those willing to donate stem cells and those who need them.

This webinar will allow participants to learn more about:

• SOP portfolio development

• Issues implementing these SOPs at various sites

• Standardization of cold chain transport and other shipping-related issues

• Validating procedures/equipment

Lack of highly qualified personnel (HQP) is repeatedly cited as a bottleneck hindering the growth of the cell and gene therapy industry. In 2018, the ISCT Early Stage Professionals (ESP) Committee conducted a Job Market survey of early stage professionals (those within 10 years of their terminal degree) with the goal of gathering information from trainees on their experience entering the cell and gene therapy workforce. The ESP Committee has partnered with CellCAN to broaden the scope of the survey and gather and disseminate data on the training gaps identified by both employers and employees across academia and industry. Join ISCT and CellCAN for an interactive session featuring live polling, Q&A with expert panelists, and a robust discussion on how the ecosystem can collaborate to address the training challenges holding back the field of cell and gene therapy.

When?  September 13, 2019 from 5PM to 6PM

Where? Plenary Hall, ISCT North America Regional Meeting

Registration deadline:  N.A./For all ISCT attendees

More information on the ISCT Regional Meeting here. 

The Clinical Translation Education Group composed of BioCanRx, CCRM, CellCAN, Ontario Institute for Cancer Research (OICR), Ontario Institute for Regenerative Medicine (OIRM) and Stem Cell Network, will be hosting a one-day workshop on current trends and innovations in cell and gene therapy with an emphasis on disruptive technologies. It will be aimed at trainees and other professionals in the biotherapeutic space and will introduce new tools and strategies that are shaping where the biotherapeutic field is headed. Importantly, the Workshop will provide an opportunity to network and learn about careers in these areas.

When? September 27, 2019

Where? Downtown Toronto

Travel award deadline?  July 31, 2019

Registration deadline? September 13, 2019

More information here. 

Dr. Denis-Claude Roy of the 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.

Join us at 12PM. 

Register here.

November 4, 2019 at 11:50AM in the Montréal 2&3 Conference room, at the Till&McCulloch Meeting in Montréal.

This workshop will feature the critical quality attributes required for iPSC-based research projects to meet clinical grade specifications for cGMP manufacturing and lot release. Emphasis will be placed on process validation and standard operating procedure development needed to standardize quality control (QC) of iPSC production. These modifications can improve laboratory efficiency, increase experimental reproducibility, and optimize manufacturing scaleability.

Speakers will describe their ideal QC workflow based on real case studies. International consensus-built QC guidelines will be compared with those developed here in Canada. Canadian and international perspectives from the Montreal Neurological Institute and the Global Alliance for iPSC Therapies will be presented and discussed.

Speakers:
Dr. Thomas Durcan, Associate Director, Early Drug Discovery Unit (EDDU), Montreal Neurological Institute-Hospital (The Neuro), Assistant Professor, Department of Neurology and Neurosurgery, McGill University

Dr. Stephen Sullivan, International Liaison Officer, Global Alliance for iPSC Therapies (GAiT)

The number of good manufacturing practice (GMP) facilities is growing in Canada with the rapid progressions in cell therapy. This has created a need for well-trained highly qualified personnel (HQP), as working under GMP conditions and requirements for GMP manipulations are regulated and quite different than in standard research laboratories. In this course, the attendees will learn the essentials of GMP requirements from experts illustrated by several experiences from actual clinical trials. The workshop is a mixture of lectures and hands-on training. Participants will actually perform manipulations according to the GMP standards. Moreover, attendees will have the chance to experience the workflow in a GMP facility and learn how a GMP cell therapy facility is organized. The ongoing regulatory review and what to expect will also be presented and discussed.

When? November 17-18-19, 2019

Where? Centre d’Excellence en Thérapie Cellulaire (CETC) at Maisonneuve-Rosemont Hospital

Registration deadline: October 25, 2019

More information here.

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.

Join us at 12PM. 

Register here. 

ISCT Early Stage Professional (ESP) Committee and CellCAN hosted an impressive discussion around the training and hiring process at the ISCT Regional Meeting in Madison this September. The audience had many questions during the interactive session, and many interesting points were brought up by participants. This webinar session will address the unanswered questions from the live session, as well as the results of the polls answered by the participants during the live event. Tune in to see how established and early stage professionals answered the surveys.

Join us at 12PM. 

More details will be available soon.

Join us at 12PM.

Register here.

This free seminar will feature international experts and health care leaders discussing their experiences and solutions to supply chain an logistics challenges for the CGT industry, and sharing key considerations fore the first and last 100 metres to get a treatment to the clinic. Participants will gain an understanding of global issues, the regulatory environment, how product is received on the clinic floor, and the physician's experience. 

When? Monday, January 20, 2020, 8:30 AM to 12:30 PM

Location: Auditorium, Mezzanine Level, 700 University Ave., Toronto

For more information. 

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.

Join us at 12PM.

Register here.

 Workshop Summary: 

The translation of discoveries into new clinical therapies is a multi-step process that requires careful planning and rigor at all stages. The Stem Cell Network and BioCanRx are excited to host, in conjunction with our partner sponsoring organizations CellCAN, OIRM and ThéCell, a new 2-day training workshop that will provide attendees with foundational knowledge in two key areas that are critical to establishing the robust experimental evidence necessary for successful clinical or commercial translation: Quality Best Practices and Preclinical Experimental Design and Reporting, both of which are cornerstones in achieving reproducibility, reducing experimental waste and improving the translational prospects of a discovery.

When? February 25 & 26, 2020

Where? Chestnut Conference Centre, Toronto, Canada

For more information and travel award opportunities. 

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.

Join us at 12PM (EST).

Register here. 

CellCAN is proud to announce that it will be hosting a third edition of the Cell & Gene Therapy Revolution Strategic Forum in Ottawa, from September 19 to 21, 2022 (new dates)!

More information available here.

Event's Website