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Canadian Strategy Track Session 1: Cell & gene therapy manufacturing infrastructure
“Infrastructure that allows for the development of Canadian regenerative medicine therapies and enables the design and execution of clinical trials” (CCA Report, p. 24)
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Overview
Session Chair: Armand Keating, MD, Director, Division of Hematology, Epstein Chair in Cell Therapy and Transplantation, University of Toronto, Toronto, Canada
Coordinating clinical needs with manufacturing capabilities requires a vast knowledge of existing infrastructure and a clear vision of the direction for future expansion. In this session, the current cell and gene therapy manufacturing facilities landscape will be reviewed, contrasting academic vs. private centers, production capacity for multicenter clinical trials, centralized vs. decentralized manufacturing, sustainability of current infrastructure and maximizing output will be discussed. The landscape in Canada, France, Australia and the United States will be compared to identify strengths and opportunities.
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Presentations & Speakers
Current state of GMP Manufacturing in Canada, Denis Claude Roy, MD, PhD, CEO, CellCAN, Montreal, QC, Canada
Current state of GMP Manufacturing in France – BioRegate perspective, Oumeya Adjali, MD, PhD, Directrice du laboratoire de thérapie génique de Nantes, Unité de thérapie cellulaire et génique du CHU de Nantes, France
Current state of GMP Manufacturing in Australia, John Rasko, MD, PhD, ISCT President-Elect, Professor of Medicine, Central Clinical School, Centenary Institute of Cancer Medicine& Cell Biology, Sydney, Australia
Manufacturing requirements for CAR-Tcell therapies and engineered cells, Isabelle Rivière, PhD, Director, Cell Therapy and Cell Engineering Facility, Memorial Sloan Kettering Cancer Centre, New York, United States
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Canadian Strategy Track Session 2: Investment in Canada - the global advantage
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“Incentives for companies to build GMP facilities in Canada, and provide strategic investments to scale up the operations of existing facilities” (CCA Report, p. 23)
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Overview
Session Chair: Michael May, PhD, President & Chief Executive Officer, Centre for Commercialization of Regenerative Medicine, Toronto, Canada
In this session, strategic opportunities that exist for industry to invest in cell & gene therapy infrastructure in Canada will be discussed. How industry investment in Canadian GMP manufacturing facilities strengthens marketing and visibility, the impact of industry-driven later-phase clinical trial and commercialization will be reviewed.
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Presentations & Speakers
Leveraging funding for GMP manufacturing infrastructure – Federal support of industry investment: what more bang for your buck gets you, Aaron Dulgar-Tulloch, PhD, Director, BridGE, GE Healthcare, Toronto, ON, Canada
Doing business in Canada – Developing best in class iPSC therapies as an industry leader, Robert Deans, PhD, Chief Technology Officer, BlueRock Therapeutics, Toronto, Canada
Biomanufacturing for cell and gene therapy production in Canada, Frank Van Lier, PhD, Director R&D, Bioprocess Engineering, Life Sciences, Human Health Therapeutics, National Research Council Canada, Montreal, Canada
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Canadian Strategy Track Session 3: Making frontline life-saving therapies accessible & economically feasible
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| “Forum for policy development with a focus on the coordination of regulatory and reimbursement frameworks” (CCA Report, p. 27) |
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Overview
Session Chair: Lambert Busque, MD, Chief Medical Officer, Center for the Commercialisation of Cancer Immunotherapy, Montreal, Canada
Innovative cellular therapies are disruptive technologies to healthcare and require adequate foresight in drafting novel reimbursement policies. In this session, cell & gene therapies, such as viral vector-based gene therapies involving cells, hematopoietic stem cell transplantation, CAR-Tcell therapy, and cancer immunotherapy will be discussed in the context of regulatory policy, patient access and novel reimbursement strategies. Should private or public insurance pay?
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Presentations & Speakers
Health Canada’s NOC/c: requirements for accessing novel front-line life-saving cell & cell-based-gene therapies, Kelly Robinson, MSc, Director, Centre for Evaluation of Radiopharmaceuticals & Biotherapeutics, Biologics and Genetic Therapies Directorate, Health Canada, Ottawa, Canada
The challenges to HTA agencies of expedited regulatory approvals and approaches to managing the consequent risk, 2. Nick Crabb, PhD, Programme Director, Scientific Affairs, National Institute for Health and Care Excellence, London, United Kingdom
Risk sharing models for reimbursement, Richard Maziarz, MD, Professor of Medicine, Oregon Health & Science University, Chair, Interest Group for ASBMT on Value and Health Economics, Portland, United States
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Canadian Strategy Track Session 4: Strengthening the Canadian RMCT Ecosystem
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“Engage and support the regenerative medicine industry in Canada” (CCA Report, p. 24)
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Overview
Session Chair: TBC
Stem Cell research was pioneered in Canada in the early 60s and ever since Canada’s contribution to regenerative medicine has been unwavering. Today, this emerging Canadian sector has taken hold. In partnership with government, industry and others, Canada is well positioned to realize a robust and globally competitive sector. This session will look at Canada’s regenerative medicine ecosystem in an effort to better understand where the opportunities lie.
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Presentations & Speakers
The Regenerative Medicine Alliance of Canada, Michael Rudnicki, PhD, Chair, Regenerative Medicine Alliance of Canada, Scientific Director, Stem Cell Network, Ottawa, Canada
Examining Canada’s clinical trials environment, Erika Kleiderman, BSc, LLB, Academic Associate, Centre of Genomics and Policy, McGill University, Montreal, Canada
Successful Canadian therapeutics manufacturing: challenges of scale-up and expansion, Dina Iezzi, Director, Marketing & Special Projects Therapure Biopharma Inc, Toronto, Canada
Building successful international collaborations, Duncan Stewart, MD, President and Scientific Director, Ontario Institute for Regenerative Medicine, Ottawa, Canada
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