CellCAN

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Pre-conference official program - March 13

Wednesday March 13
7:30 - 9:00	Registration – Vanity Fair Foyer 2^nd floor Breakfast – Pall Mall, Palm Court and Vanity Fair Ballroom B
9:00 - 9:10	Welcome from C3i – Centre for Commercialization of Cancer Immunotherapy Lambert Busque, Chief Medical Officer, C3i Vanity Fair Ballroom A
Theme 1: The role of biomarkers in supporting GMP manufacturing Moderator: Michel Rochon, Health and Science Journalist Chair: Denis Claude Roy, CEO, CellCAN, Chief Scientific Officer, C3i Vanity Fair Ballroom A
9:10 - 10:30	Characterizing products for GMP manufacturing: What, how and when? Donna Rill, Chief Technology Officer, Triumvira Immunologics Analytical testing: preparing for the jump from research lab to GMP manufacturing Martin Giroux, CETC, Montréal Raman spectroscopy analysis of cellular therapeutics for transplantation James Piret, Professor, Department of Chemical & Biological Engineering and the Michael Smith Laboratories, University of British Columbia
10:30 - 10:50	Health break and exhibitors visit
10:50 - 11:45	Regulatory expectations for cell therapy release criteria in Canada. Dino Petrin, Senior Biologist/Evaluation Officer, Health Canada Panelist discussion: Regulatory requirements for cell therapy release criteria Donna Rill, Chief Technology Officer, Triumvira Immunologics Martin Giroux, Director of operations, CETC Dino Petrin, Senior Biologist/Evaluation Officer, Health Canada
11:45 - 13:00	Lunch, networking and exhibitors visit Pall Mall, Palm Court and Vanity Fair Ballroom B
Theme 2: Clinical response to CAR Ts and other cellular therapies Moderator: Michel Rochon, Health and Science Journalist Chair: Jean-Sébastien Delisle, Hematologist and Principal Investigator, Hôpital Maisonneuve-Rosemont Vanity Fair Ballroom A
13:00 - 15:00	Characterizing the response to cellular therapies with immunophenotyping Jean-Sébastien Delisle, Hematologist and Principal Investigator, Hôpital Maisonneuve-Rosemont TAC technology, its unique and novel MoA, preclinical data and considerations for biomarker analysis in our Phase I/II trial Andreas Bader, Senior Vice President R&D, Triumvira Immunologics Determinants of response and resistance in CAR T cell therapy Joerg Krueger, Hematologist, Oncologist, SickKids Improving the anti-tumor efficacy of gene-engineered T cells for the treatment of cancers Jan Joseph Melenhorst, Adjunct Associate Professor, Pathology & Laboratory Medicine, University of Pennsylvania
15:00 - 15:20	Health break and exhibitors visit
Theme 3 - Companion tests and patient stratification in the era of personalized medicine Moderator: Michel Rochon, Health and Science Journalist Chair: David Courtman, Director, Cell Manufacturing, Biotherapeutics Manufacturing Centre, The Ottawa Hospital Vanity Fair Ballroom A
15:20 - 16:20	Biomarker development for immuno-oncology applications Raffi Tonikian, Associate Director, Immuno-oncology Biomarkers and Companion Diagnostics, Merck Integration of companion tests in the health care system Lambert Busque, Chief medical officer, C3i
16:20 - 16:30	Closing remarks of the pre-conference Lambert Busque, Chief Medical Officer, C3i
18:30 - 21:00	Welcome Reception (sponsored by CCRM) CC Lounge & Whisky Bar, 45 Front St E, Toronto, ON M5E 1B3 Food & beverages will be provided - bring your name badge! Exhibition Hall

Official Program - March 14-15

Thursday March 14
7:30 - 8:50	Registration – Hall – 2^nd floor Breakfast – Pall Mall, Palm Court and Vanity Fair Ballroom B
8:50 - 9:00	Welcome from CellCAN – Regenerative Medicine and Cell Therapy Network Denis Claude Roy, CEO, CellCAN Vanity Fair Ballroom A
9:00 - 9:20	The patient to patient interview: a life changing therapy Moderator: William Brock, Survivor of acute myelogenous leukemia (AML), CellCAN Chairman of the Board Patient: Mai Duong, Survivor of leukemia, Founder, Swab the World Vanity Fair Ballroom A
Theme 1: Innovation in allogeneic cellular therapies: game changer in regenerative medicine Moderator: Michel Rochon, Health and Science Journalist Chair: Heidi Elmoazzen, Director, Stem Cells, Canadian Blood Services Vanity Fair Ballroom A
9:20 - 10:20	Engineering stem cells for islet cell replacement Tim Kieffer, Professor, Cellular & Physiological Sciences and Surgery, University of British Columbia Generating a FailSafe^TM kill switch for allogeneic cellular therapies Andras Nagy, Canada Research Chair in Stem Cells and Regeneration, Senior Scientific Investigator, Lunenfeld-Tanenbaum Research Institute, Sinai Health System
10:20 - 10:40	Health break and exhibitors visit
10:40 - 12:00	Preparing for first human trial of iPSC-derived cells for Parkinson’s disease Daisuke Doi, Research associate, Department of Clinical Application, Center for iPS Cell Research and Application, Kyoto University, Japan Panelist discussion: Allogeneic vs autologous sourced donor cells: the strategic advantages Duncan Stewart, President, OHRI, CEO, OIRM Lucie Germain, Professor Université Laval, CHU de Québec-Université Laval Andras Nagy, Canada Research Chair in Stem Cells and Regeneration, Senior Scientific Investigator, Lunenfeld-Tanenbaum Research Institute, Sinai Health System Daisuke Doi, Research associate, Department of Clinical Application, Center for iPS Cell Research and Application, Kyoto University, Japan
12:00 -14:00	Lunch, networking and exhibitors visit Pall Mall, Palm Court and Vanity Fair Ballroom B
14:00 - 14:15	The patient to patient interview: a life changing therapy Moderator: William Brock, Survivor of AML, CellCAN Chairman of the Board Patient: Kevin Bolusi, Self-Assembling Skin Substitute recipient, Survivor of 3rd degree burns Special guests: Lucie Germain, Professor, Université Laval, CHU de Québec-Université Laval Véronique Moulin, Researcher, LOEX, CHU de Québec Research Center-Université Laval Vanity Fair Ballroom A
Theme 2: The next generation of clinical trials Moderator: Michel Rochon, Health and Science Journalist Chair: Janet Dancey, Director, Canadian Cancer Trials Group, Scientific Director, Canadian Cancer Clinical Trials Network, Professor, Department of Oncology, Queen's University Vanity Fair Ballroom A
14:15 - 15:15	Gene therapy studies for thalassemia and sickle cell anemia Donna Wall, Blood and Marrow Transplant/Cellular Therapy Program, The Hospital for Sick Children/University of Toronto Canadian manufacturing and delivery of CAR-T therapy as health care implementation research Rob Holt, Co-Director and Distinguished Scientist, BC Cancer Immunotherapy Program, BC Cancer Genome Sciences Centre
15:15 - 15:45	Health break and exhibitors visit
15:45 - 16:45	Taking CAR-T from theory to reality - the Novartis experience Marta Majdan, Medical Advisor, Oncology, Novartis Canada Panel discussion: Vision of clinical trials for the next 5-10 years Denis Claude Roy, CEO, CellCAN Donna Wall, Blood and Marrow Transplant/Cellular Therapy Program, The Hospital for Sick Children/University of Toronto Marta Majdan, Medical Advisor, Oncology, Novartis Canada
16:45 - 17:00	Wrap-up of day 1 Denis Claude Roy, CEO, CellCAN Armand Keating, Director, Cell Therapy Program, University Health Network
18:00 - 21:00	Industry Networking Event (sponsored by STEMCELL Technologies) Vanity Fair Foyer, Palm Mall and Palm Court

Friday March 15
7:00- 8:00	Registration – Hall Breakfast – Pall Mall, Palm Court and Vanity Fair Ballroom B
8:00 - 8:05	Introduction to day 2 activities Denis Claude Roy, CEO, CellCAN Vanity Fair Ballroom A
8:05 - 8:35	NRC Health Challenge Program: Initiatives & collaboration models to improve affordability and accessibility of cell and gene therapies in Canada Bernard Massie, Director General (acting), Human Health Therapeutics Research Centre, National Research Council of Canada Vanity Fair Ballroom A
Theme 3: Regulatory Reform and Reimbursement Moderator: Michel Rochon, Health and Science Journalist Chair: Sowmya Viswanathan, University Health Network Vanity Fair Ballroom A
8:35 - 9:35	Regulatory reform in Canada: modernizing novel cell & gene therapy regulations Pierre Sabourin, Assistant Deputy Minister, Health Products and Food Branch, Health Canada represented by Celia Lourenco, Director General, Biologics and Genetic Therapies Directorate (BGTD), Health Products and Food Branch, Health Canada Drug review process alignment: Health Canada, CADTH & INESSS collaboration Alexandra Chambers, Director of the pan-Canadian Oncology Drug Review (pCODR) program, CADTH
9:35 - 10:00	Health break and exhibitors visit
10:00 - 12:00	Redefining outcome measures for efficacy and novel clinical trial design in gene therapy treatments - A value demonstration approach Kathy Reape, Chief Medical Officer, Spark Therapeutics Challenges of implementing new technologies in the healthcare system Lambert Busque, Hematologist, Hôpital Maisonneuve-Rosemont, Chief Medical Officer, C3i Panel Discussion – Regulatory & Reimbursement in Canada’s public payer system: is there value in regenerative medicine technologies? Lesley Dunfield, Director of HTA and Program Development for Medical Devices and Clinical Interventions portfolio, CADTH Siofradh McMahon, Senior Manager, Clinical Translation and Regulatory Affairs, CCRM Michèle de Guise, Directrice des services de santé et de l'évaluation des technologies, INESSS Lambert Busque, Hematologist, Hôpital Maisonneuve-Rosemont, Chief Medical Officer, C3i
12:00 - 14:00	Lunch, networking and exhibitors visit Pall Mall, Palm Court and Vanity Fair Ballroom B
14:00 - 14:15	The patient to patient interview: a life changing therapy Moderator: William Brock, Survivor of AML, CellCAN Chairman of the Board Patient: Marc Doucett, Survivor of multiple sclerosis Vanity Fair Ballroom A
Theme 4: Optimizing cell and gene therapy manufacturing Moderator: Michel Rochon, Health and Science Journalist Chair: Michael May, CEO, CCRM Vanity Fair Ballroom A
14:15 - 15:45	3D printing human tissue: where engineering meets biology Spiro Getsios, VP of Tissue Engineering, Aspect Biosystems Scale-up, cost reduction and data considerations for cell manufacturing Gary Pigeau, Director, Centre for Advanced Therapeutic Cell Technologies at CCRM, GE Healthcare Planning for Success - the path to commercialization Donna Rill, Chief Technology Officer, Triumvira
15:45 - 16:15	Health break and exhibitors visit
16:15 - 17:15	Panelist Discussion: Centralized vs. decentralized manufacturing - opportunities & challenges Behnam Baghbadernai, Global Head, Process Development & Emerging Technologies - Cell & Gene Therapy, Lonza Robert Preti, CEO and President, Hitachi Chemical Advanced Therapeutics Solutions Mayo Pujols, VP and Global Head of Cell & Gene Technical Development & Manufacturing, Novartis Nuala Trainor, Director of Biologics, Octane
17:15 - 17:30	Closing remarks Denis Claude Roy, CEO, CellCAN

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