BioCanRx Pre-Event Workshop


BioCanRx, in partnership with CellCAN, presents…
Working with Patients to Inform Early-phase Cancer Clinical Trial Design

Date: Wednesday, 8 March 2017
Time: 1:00 - 4:00 PM EST
Location: Westin Montreal, Montreal, Quebec


This workshop will outline what patient-oriented research is, how it is used to inform and impact clinical trials currently, how BioCanRx intends to conduct patient-oriented research to inform cancer clinical trial design, and provide ways for patients to get involved.

Specifically, BioCanRx network investigators will highlight how they will engage patients to inform early-phase clinical trial design of the first Made-in- Canada CAR-T therapy.


  • Manoj Lalu, BioCanRx Network Investigator
  • Justin Presseau, BioCanRx Network Investigator
  • Anne Lyddiatt, Patient on SPOR National Steering Committee
  • Zarah Monfaredi, Ottawa SPOR Program Facilitator 

Learning Objectives

By the end of this workshop, attendees will learn...

  • The importance of patient-oriented research and how it is done
  • The facilitators, barriers and preferences for implementation of trials
  • How evidence-informed clinical trial designs are developed
  • How patients have engaged in research in the past
  • How patients will be engaged in the first Made-in-Canada CAR-T early-phase clinical trial

Who Should Attend

  • Patients and caregivers
  • Other members of the public
  • Clinicians
  • Scientists
  • Research trainees
  • Non-government organizations focused on cancer research and representing cancer patients

How to Register to this FREE workshop

Registration is now closed. For information, contact Jovian Tsang.


About BioCanRx: Biotherapeutics for Cancer Treatment

BioCanRx’s vision is to cure patients and enhance the quality of life of those living with cancer. We will do this by supporting world-class research in the area of biotherapeutics for cancer treatment, and by accelerating to the clinic the most promising cancer biotherapeutics designed to save lives and enable a better quality of life. The Network consists of 42 founding investigators, 260 highly qualified personnel, 5 core facilities that specialize in GMP viral vectors and GLP immune-monitoring, and 43 partners in the academic, industrial and charity sectors. Through an innovative, collaborative funding process, which has funded 30 exciting projects to date, BioCanRx is becoming a world-leader in the translation, manufacture and adoption of innovative cancer biotherapeutics for the benefit of all cancer patients.

Learn more about BioCanRx at

SCN/CCRM Pre-Event Workshop


Stem Cell Network and CCRM are pleased to offer, in partnership with CellCAN...
Gaps in cell therapy regulation - Where to fit minimally-manipulated cell-based therapies and related processing devices?

Date: Wednesday, 8 March 2017
Time: 8:30 AM - 4:00 PM EST
Location: Westin Montreal, Montreal, Quebec

Workshop Leaders

  • Sowmya Viswanathan, University Health Network and University of Toronto
  • Julie Fradette, LOEX, CRCHU de Québec-Université Laval, Director of the ThéCell (cell and tissue therapy) FRQS network
  • Barbara von Tigerstrom, University of Saskatchewan


Minimally-manipulated autologous cell therapy products are inconsistently regulated in Canada. Currently, it is unclear what criteria shall be applied to determine whether they will be regulated as medical practice, in concordance with the federal Food and Drugs Act. Additional confusion arises because autologous cell therapies may be prepared and used under various circumstances – they may be processed at the bedside using devices, processed in hospital labs, or processed at highly specialized and centralized facilities. Regulatory uncertainty in this area prevents some from moving forward when they should, while it allows others to move forward when perhaps they should not. This workshop will explore these issues and participants will work to develop a set of recommendations for Health Canada’s consideration.

Workshop Purpose

The purpose of this event will be to discuss the current state of regulating minimally-manipulated autologous cell therapy products in Canada and, compare it to other jurisdictions, particularly the US and EU, with the intent of providing specific policy recommendations to Health Canada at the close of the workshop.

The workshop will include:

  • Summary of existing regulations (Canada and other jurisdictions) and developments
  • Questions for discussion (provided to attendees before the workshop)
  • Discussion leading to mutually agreed upon policy recommendations
  • Much of the day will consist of informal presentations guided by a moderator


  • Patrick Bedford – Manager, Clinical Trials & Regulatory Affairs, CCRM
  • Deborah Griffin – Chair, ISCT’s North America Legal and Regulatory Affairs Committee; consultant FACT Consulting Services, Omaha NE
  • Olive Sturtevant – Administrative Director for Cell Manipulation Core Facility, Dana Farber Cancer Institute; ISCT’s Designate for FDA’s Cellular Therapy Liaison Meeting and Health Canada’s Cell Therapy Stakeholders Group Bilateral Meeting
  • Dr. Maria Cristina Galli – Centre for drug control and evaluation, Istituto Superiore di Sanità, Roma, Italy 

Who’s Attending

Experts in

  • International cell therapy programs
  • Cell therapy (manufacture’s and clinicians)
  • Blood processing (eg. Canadian Blood Services and/or Hema-Quebec)
  • Umbilical cord blood processing
  • Processing stromal vascular fractions (eg. Stem Cell Clinics)
  • Bone marrow transplantation (Clinicians)
  • Cell therapy regulation (eg Health Canada, Academics in health policy)

How to Register to this FREE workshop

Registration is now closed. For information, contact Janetta Bijl.

About Stem Cell Network

Supporting and building Canada’s stem cell and regenerative medicine research sector has been the raison d’etre of the Stem Cell Network (SCN) since its inception in 2001. Its work has been supported by the Government of Canada from the beginning. SCN’s mandate is to act as a catalyst for enabling the translation of stem cell research into clinical applications, commercial products and public policy. In just over 15 years SCN has forged a national community that has transformed stem cell research in Canada, brought research to the point where regenerative medicine is changing clinical practice and established an outstanding international reputation. SCN has pushed the boundaries of what was a basic research area towards translational outcomes for the clinic and marketplace.

Learn more about Stem Cell Network at

About CCRM

CCRM, a Canadian not-for-profit organization funded by the Government of Canada, the Province of Ontario, and leading academic and industry partners, supports the development of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy. A network of researchers, leading companies, strategic investors and entrepreneurs, CCRM aims to accelerate the translation of scientific discovery into marketable products for patients with specialized teams, funding, and infrastructure. CCRM is the commercialization partner of the Ontario Institute for Regenerative Medicine and the University of Toronto’s Medicine by Design. CCRM is hosted by the University of Toronto.

Learn more about CCRM at