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DTSTART;TZID=America/Toronto:20260428T120000
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SUMMARY:Unlocking the Promise of Cell and Gene Therapies in Canada Through Translational Research: Making Evidence Where It Matters
DESCRIPTION:Register HereCanada stands at a critical juncture in the development and adoption of cell and gene therapies (CGTs)\, transformative treatments that hold potential for curing or significantly improving the course of life-threatening and chronic diseases. Innovation is progressing rapidly; however\, Canada’s life sciences and healthcare ecosystem is not in a state of readiness to bring these advanced therapies to our patients.  \nRecent reports and discussions have focused on accelerated patient access to CGTs through system integration efforts such as aligning regulatory and reimbursement processes and bolstering healthcare infrastructure and coordination. This panel positions translational research as the lynchpin for converting scientific promise into clinical\, regulatory\, and payer confidence—providing the high-quality\, decision-ready evidence needed to reduce uncertainty and move therapies from discovery into clinical development and\, ultimately\, patient care.  \nUnlike most sectors\, advancing a technology in the life sciences requires repeated engagement with regulators across the full development continuum\, from preclinical programs\, to first-in-human studies\, to pivotal trials\, post-market evidence generation\, and back again as new questions emerge. For CGTs in particular\, this iterative pathway demands a laser focus on clinical translation: generating robust\, credible evidence that satisfies regulators\, payers\, clinicians\, and patients. Importantly\, this focus represents a shared metric of success for both academia and industry.   \nAnchoring this translational work in Canada points to important questions about where evidence should be generated\, how domestic clinical development shapes learning\, and what advantages may emerge when regulators\, researchers\, and developers evolve together through ongoing evidence generation. Drawing on international experts from Europe and the United States alongside Canadian leadership\, panelists with diverse experiences in the research\, healthcare\, industry\, and regulatory sectors will explore:  \n\nWhat evidence unlocks translation of CGTs\, and how does that differ for regulators\, health technology assessment (HTA) bodies\, clinicians\, patients and investors?\nHow do regulators act as partners in CGT translation\, not just gatekeepers?\nHow do we anchor translational research domestically and why does it matter?\nWhat can Canada learn from other countries seeking to enable safe\, timely\, and equitable access to CGTs through product and policy innovation grounded in high-quality evidence?\n\nSpeaker information coming soon!Stéphanie Michaud\, PhDPresident and CEO\, BioCanRx See Bio×Dr. Stéphanie Michaud\nStéphanie Michaud\, PhD is the President and CEO of BioCanRx\, a not-for-profit in Canada that seeks to accelerate the delivery of innovative immunotherapies from the bench to the bedside. In this position\, Dr. Michaud is responsible for running all facets of the organization. She brings more than 20 years of public\, government and private sector experience in research and Science & Technology innovation policy. She strives to create partnerships between government\, not-for-profits\, academia and industry to maximize the impact of research funded by the BioCanRx network on the lives of those affected by cancer. \nPrior to joining BioCanRx\, Dr. Michaud was Deputy Director of the flagship Government of Canada Networks Centres of Excellence (NCE) program. In addition to responsibility for its performance\, management and delivery\, she led the implementation of high profile bilateral international initiatives and provided strategic advice to government and stakeholders. She is a strong contributor to S&T policy\, most notably in intellectual property. Dr. Michaud earned a PhD in Organic Chemistry from McGill University. She is involved with a number of not-for-profit organizations and is a member of the Board of Directors of Research Canada and CQDM and also\, the Advisory Board of the Canadian Cancer Research Alliance.  \nPeter Marks\, MD\, PhDSenior Vice President\, Molecule Discovery & Head of Infectious Disease\, Eli Lilly See Bio×Peter Marks\, MD\, PhD\nPeter Marks\, MD\, PhD received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. In 2012\, he joined the Food and Drug Administration and served as Director of the Center for Biologics Evaluation and Research from 2016 to 2025. He is currently Senior Vice President for Molecule Development and Head of Infectious Disease at Eli Lilly and Company\, has published extensively\, and is a member of the National Academy of Medicine. \nNatasha Kekre\, MD\, MPH\, FRCPCHematologist\, Transplantation and Cellular Therapy Program\, The Ottawa Hospital See Bio×Dr. Natasha Kekre\nNatasha Kekre\, MD\, MPH\, FRCPC is a Transplant Physician/Hematologist within the Transplant and Cellular Therapy Program at The Ottawa Hospital (TOH)\, Scientist and Program Director of the Cancer Research Program within the Ottawa Hospital Research Institute (OHRI)\, and Associate Professor of Medicine at the University of Ottawa. She holds the Research Chair in Advanced Stem Cell Therapy at TOH. She obtained her medical degree from the University of Ottawa\, where she also trained in Internal Medicine and Hematology. She went on to do a fellowship in stem cell transplantation at Dana Farber Cancer Institute in Boston with a Masters in Public Health from Harvard University. \nDr. Kekre’s research focuses on translating home-grown therapeutic strategies into early phase clinical trials for patients with hematologic malignancies. She collaborated with scientists and physicians across Canada to build the internationally recognized Canadian-Led Immunotherapies Collaborative (CLIC) program and initiate the first clinical trial of a made-in-Canada CAR-T therapy. Building on these transformational achievements\, she is now working to expand this platform to other made-in-Canada CAR-T products. Other research interests include clinical research focused on blood and marrow transplant and CAR-T therapy recipients\, and projects with an epidemiologic focus. \nPatrick Bedford\, MBA\, MBHL\, BHScVice President\, Regulatory & Strategic Operations\, Morphocell Technologies See Bio×Patrick Bedford\nPatrick Bedford\, MBA\, MBHL\, BHSc is the Vice President of Regulatory & Strategic Operations at Morphocell Technologies\, Inc and Founder of weCANreg Consulting Group\, Inc. He brings deep expertise in translational\, regulatory\, and compliance strategies for emerging biotechnologies\, having led policy development for biosimilars\, transplant materials\, and cell & gene therapies during his career at Health Canada\, where he also represented Canada internationally on classification and harmonization committees. Since 2016\, Patrick has been a prominent Canadian advocate in the global cell & gene therapy community\, supporting dozens of early-stage programs and multiple commercial cell and gene therapy products. In addition to his industry leadership\, he continues to shape regulatory policy in North America and actively contributes to Canada’s innovation ecosystem as a guest lecturer at universities and an advisor through accelerators such as Creative Destruction Labs and Lab2Market. \n \nCarmen Sanges\, PhDEU Initiatives Scientific & Strategic Project Lead\, Cellular Immunotherapy Program\, University Hospital Würzburg See Bio×Dr. Carmen Sanges\nCarmen Sanges\, PhD is a medical biotechnologist with a PhD in Molecular Biology and Medical Biotechnology and over seven years of industry experience in clinical operations and translational research. She is EU Initiatives Scientific & Strategic Project Lead at the Cellular Immunotherapy Program of the University Hospital Würzburg (UKW) and Executive Director of the T2EVOLVE Association. Carmen coordinates and contributes to multiple European initiatives in advanced therapies\, with a strong focus on CAR-T and TCR cell therapies\, regulatory science\, manufacturing innovation\, and patient access\, and is committed to building sustainable\, cross-stakeholder ecosystems across Europe.
URL:https://sciencepolicy.ca/event/unlocking-cgts/
LOCATION:Zoom
CATEGORIES:Virtual Session
ATTACH;FMTTYPE=image/png:https://sciencepolicy.ca/wp-content/uploads/2026/03/BioCanRx-April28-Panel-en.png
ORGANIZER;CN="Canadian Science Policy Centre":MAILTO:info@sciencepolicy.ca
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