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WEBINAR DESCRIPTION: While an increasing number of regulatory approvals in the Cell and Gene Therapy (CGT) field has fueled optimism for potential treatments and cures for debilitating and fatal conditions, constant challenges to US FDA oversight – by courts, federal and state legislatures, and rogue “stem cell clinics” - pose serious risks for individual patients and for the entire industry. This webinar begins with an overview of the U.S. legal landscape governing development and therapeutic usage of stem cell and gene therapies, including several recent, highly-consequential court rulings impacting the FDA and other federal agencies. The webinar then addresses recent state developments that have attracted little public attention, including new iterations of “Right-To-Try” and “Medical Freedom” laws, and their legal and practical impact on experimental stem cell and gene therapies. After exploring the wide-spread availability of unproven stem cell and regenerative interventions currently being offered by stem cell clinics and in other unregulated settings, the webinar will highlight existing risks for individual patients and the entire CGT sector, and ways these may be further exacerbated in the near future. The area of unproven stem cell and regenerative medicine clinics will be discussed in more depth as an exemplar of complex legal, policy and ethical challenges to federal and state regulators. The webinar will conclude with an interactive panel discussion and an open Q&A for attendees to raise issues and contribute to the discussion.
Presented by the ISCT Gastro-Intestinal Committee
September 13, 2024
Webinar Description:
While an increasing number of regulatory approvals in the Cell and Gene Therapy (CGT) field has fueled optimism for potential treatments and cures for debilitating and fatal conditions, constant challenges to US FDA oversight – by courts, federal and state legislatures, and rogue “stem cell clinics” - pose serious risks for individual patients and for the entire industry. This webinar begins with an overview of the U.S. legal landscape governing development and therapeutic usage of stem cell and gene therapies, including several recent, highly-consequential court rulings impacting the FDA and other federal agencies. The webinar then addresses recent state developments that have attracted little public attention, including new iterations of “Right-To-Try” and “Medical Freedom” laws, and their legal and practical impact on experimental stem cell and gene therapies. After exploring the wide-spread availability of unproven stem cell and regenerative interventions currently being offered by stem cell clinics and in other unregulated settings, the webinar will highlight existing risks for individual patients and the entire CGT sector, and ways these may be further exacerbated in the near future. The area of unproven stem cell and regenerative medicine clinics will be discussed in more depth as an exemplar of complex legal, policy and ethical challenges to federal and state regulators. The webinar will conclude with an interactive panel discussion and an open Q&A for attendees to raise issues and contribute to the discussion. -
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In Conversation with Asia CGT Startups
In Conversation with Asia CGT Startups
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In Conversation with CGT Leaders
In Conversation with CGT Leaders
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Hemophilia is an inherited bleeding disorder characterized by the deficiency or absence of clotting factors VIII (Hemophilia A) or IX (Hemophilia B). This lack of clotting factors leads to uncontrolled bleeding, which can result in severe health issues, particularly in the joints and brain. Despite significant advances in preventing bleeding episodes and managing the disease through prophylaxis and non-factor products, several needs remain unmet. One critical issue is the lack of a cure for the disease. This challenge is being strategically addressed through the development of innovative cell and gene therapies. The objective of this webinar, led by two eminent researchers, Dr. Edward Tuddenham (UK) and Dr. Blair Gage (Canada), is to discuss the latest advances and challenges associated with the use use of both therapies in treating Hemophilia A and B. Their goal is to achieve a durable reduction in both bleeding risks and the need for exogenous factor administrations.
Presented by the ISCT Gastro-Intestinal Committee
September 13, 2024
Webinar Description:
Hemophilia is an inherited bleeding disorder characterized by the deficiency or absence of clotting factors VIII (Hemophilia A) or IX (Hemophilia B). This lack of clotting factors leads to uncontrolled bleeding, which can result in severe health issues, particularly in the joints and brain. Despite significant advances in preventing bleeding episodes and managing the disease through prophylaxis and non-factor products, several needs remain unmet. One critical issue is the lack of a cure for the disease. This challenge is being strategically addressed through the development of innovative cell and gene therapies. The objective of this webinar, led by two eminent researchers, Dr. Edward Tuddenham (UK) and Dr. Blair Gage (Canada), is to discuss the latest advances and challenges associated with the use use of both therapies in treating Hemophilia A and B. Their goal is to achieve a durable reduction in both bleeding risks and the need for exogenous factor administrations.
- Learn on strategies forecasting the development and clinical application of CGT
- Increase the knowledge and education on the clinical development of CGT
- Showcase hemophilia as significant case example for the evaluation of emerging CGT
- Understand the science of CGT development for hemophilia
Adriana Migliorini, PhD (Moderator)
Senior Post Doctoral Research Fellow
McEwen Stem Cell Institute, University Health Network
Dr. Adriana Migliorini is a senior postdoctoral research fellow in Dr. Maria Cristina Nostro’s laboratory, at the McEwen Stem Cell Institute, University Health Network, Toronto, Canada. She studied medical biotechnology at the University of Florence (Italy) and completed her Ph.D. in human biology, at the Ludwig Maximilian University in Munich, Germany. Her research primarily revolves around the field of human pluripotent stem cells (hPSCs) and developmental biology, with a specific focus on the pancreas. Her current work involves investigating the composition and phenotype of the fetal pancreatic immune niche to gain a deeper understanding of its role during endocrine development and to explore novel applications for the treatment of Type 1 Diabetes (T1D).
Mustapha Najimi, PhD (Moderator)
Director of Research
UCLouvain
Mustapha Najimi is director of research at the institute of Experimental and Clinical Research (IREC) of the Faculty of Medicine and Pharmacy-UCLouvain in Brussels. He holds a PhD in cell and molecular biology from the Pierre & Marie Curie University, Paris in 1999. He joined the team of Pr Etienne Sokal in 2003 to set up a platform of liver cells’ culture dedicated to the development of a clinical cell therapy program. Since then, he led the stem cell group and coordinated the cell culture technology platform of the laboratory of pediatric hepatology and cell therapy. Thanks to an accumulated know-how and significant knowledge of human liver cells’ biology as well as the strategies to isolate them, his research activity led to the discovery of a population of liver mesenchymal progenitor cells. Those cells were the subject of more than 40 international publications, more than 200 citations and the attribution of 7 related patents. Mustapha NAJIMI has actively been/is involved in i) the design and supervision of the large-scale production of the first batches of these progenitor cells, that have been infused to patients with liver diseases at Saint-Luc hospital- Brussels, ii) the technology transfer of this cell therapy product to a spinoff company, iii) the supervision of R&D activities related to those cells with an industrial vision. Thanks to an active network of international collaborations, he continues conducting his research investigations with the major objectives of better understanding the mechanisms governing liver regeneration and improving the use of cell therapy for liver defects.
Blair Gage, PhD
Scientist, Assistant Professor
Ottawa Hospital Research Institute, University of Ottawa
hPSC-derived Liver Endothelium: A potential Cell Therapy for Hemophilia A
Blair K. Gage (PhD) is a Scientist at the Ottawa Hospital Research Institute in the Regenerative Medicine Program and an Assistant Professor in the Department of Cellular and Molecular Medicine at the University of Ottawa. After a BSc in Biotechnology from UBC and BCIT, he completed a PhD in Cell and Developmental Biology exploring how transcription factors regulated pancreatic endocrine subtype specification from human pluripotent stem cells. His postdoctoral work shifted to generate organ-specific endothelial cells of the liver from human pluripotent stem cells to create potential cell-based and cell-informed therapeutics for liver disease and Hemophilia A. Dr. Gage started his lab in December 2023 and focuses on understanding how endothelial cells gain and maintain organ specific functions to build new therapies for human liver diseases where these functions are lost. The Gage lab’s primary research model is human pluripotent stem cells which are differentiated to become endothelial cells that can be transplanted in mice where they durably engraft and become functional. This research model and approach has potential therapeutic value as delivery of stem cell-derived endothelial cells to mouse models of Hemophilia A resulted in correction of the severe bleeding disorder by sustained production of bioactive coagulation factors. Building on this cell-based therapy leverages many computational, genetic, and molecular approaches to identify and apply new therapies aimed at controlling endothelial function to fight disease.
Prof. Edward Tuddenham
Emeritus Professor of Haemophilia
University College London
Gene therapy for haemophilia B widely adopted but problems remain for haemophilia A
Professor Edward (Ted) Tuddenham's journey into haemophilia began in 1969 at the Royal Victoria Infirmary in Liverpool, where he treated haemophilic patients. His interest deepened in Cardiff under Arthur Bloom, where he investigated the relationship between Von Willebrand Disease and Haemophilia A. Tuddenham dedicated seven years to purifying factor VIII, first at the University of Connecticut and then at the Royal Free Hospital Haemophilia Centre. His work led to the complete purification of factor VIII, enabling its amino acid sequencing and the cloning of its gene. These breakthroughs facilitated accurate carrier testing, antenatal diagnosis, and the discovery of mutations causing haemophilia A.
In 1987, Tuddenham established the Haemostasis Research Group for the Medical Research Council, focusing on rare bleeding disorders. In 2006, he returned to the Royal Free Hospital to pursue gene therapy for haemophilia. His team demonstrated the safety and efficacy of gene therapy for haemophilia B, using a vector that allowed high levels of factor IX expression. This resulted in most patients discontinuing replacement therapy and remaining free of spontaneous bleeding for up to 13 years. This vector was later modified by Uniqure, leading to the marketing approval of Hemgenix in 2023.
Collaborating with Amit Nathwani's laboratory, Tuddenham also helped develop a vector for transferring the factor VIII gene to treat Haemophilia A, culminating in market approval in the EU in 2022. He continues his work on gene therapy trials for haemophilia and other rare bleeding disorders, with 350 publications, an H-index of 74, and over 21,000 citations.
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Join us for an interactive workshop and Q&A led by global CGT recruiters who will provide insights on how to land your dream job and craft a path to elevate your career.
Presented by the ISCT ESP Mentoring Working Group
March 11, 2024
Webinar Description:
Join us for an interactive workshop and Q&A led by global CGT recruiters who will provide insights on how to land your dream job and craft a path to elevate your career.
Jen Metivier, MS
Associate Director, Talent Acquisition
Obsidian Therapeutics
Emily Thurley
Principal Consultant, Tech Ops & Quality
Skills Alliance
Alice Sandall
Consultant, Tech Ops & Quality
Skills Alliance
Maurice Thorton
Managing Director
Headcount Recruitment
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This webinar is an informed discussion around the current realities and challenges of cell and gene therapies for sickle cell disease with panelists from various roles/viewpoints in the field.
Presented by the ISCT ESP Mentoring Program
April 11, 2024
Webinar Description:
This webinar is an informed discussion around the current realities and challenges of cell and gene therapies for sickle cell disease with panelists from various roles/viewpoints in the field.
Kevin Bosse, PhD, RAC-US
Director of Research Regulatory Affairs
Nationwide Children's Hospital, United States
Director of the Office of Research Regulatory Affairs at Nationwide Children’s Hospital. As a RAC-certified regulatory professional, he advises the development and regulatory strategy of novel drugs, biologics and devices with extensive focus on cell and gene therapy.
Ms Victoria Gray
First sickle cell disease patient, who volunteered in 2019 for the exa-cel therapy trial, sponsored by Vertex Pharmaceuticals and CRISPR Therapeutics. Mother of four from Forest, Mississippi, she is a sickle cell warrior having received a CRISPR-based therapy for SCD.
Ms Michele Salter
Chair of the Sickle Cell Society (UK). Michele was formerly the Vice-Chair & Treasurer and has been working for the Sickle Cell Society since 2014, contributing to its goal to support and represent people affected by sickle cell, to improve their overall quality of life.
Akshay Sharma, MD
Clinician-Scientist
Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children’s Research Hospital
Clinician-scientist in the Department of Bone Marrow Transplantation and Cellular Therapy at St. Jude Children’s Research Hospital. He is an expert in development of novel gene editing therapeutics, and his research includes transplant and gene therapy clinical trials for patients with SCD.
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Join us for an engaging webinar where we explore the art of crafting and delivering impactful elevator pitch presentations. Discover proven strategies and techniques to captivate your audience and leave a lasting impression when showcasing your innovative research. Our speakers, including previous elevator pitch judges and winners, will share invaluable insights on composing your pitch, refining your message, and mastering delivery techniques to confidently showcase your ideas. Plus, you'll have dedicated exercise time to practice and receive feedback on your pitch. Whether you're a seasoned professional or just starting out, this webinar will equip you with the skills and confidence to make every elevator pitch count. Don't miss out – register now and elevate your presentation game!
Co-organized by Cytotherapy and the ESP Committee Community Engagement Working Group
May 16, 2024
Webinar Description:
Join us for an engaging webinar where we explore the art of crafting and delivering impactful elevator pitch presentations. Discover proven strategies and techniques to captivate your audience and leave a lasting impression when showcasing your innovative research. Our speakers, including previous elevator pitch judges and winners, will share invaluable insights on composing your pitch, refining your message, and mastering delivery techniques to confidently showcase your ideas. Plus, you'll have dedicated exercise time to practice and receive feedback on your pitch. Whether you're a seasoned professional or just starting out, this webinar will equip you with the skills and confidence to make every elevator pitch count. Don't miss out – register now and elevate your presentation game!
Key Learning Objectives:
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To develop and demonstrate effective skills in delivering elevator pitch presentations.
Daniel J. Weiss, MD, PhD (Moderator)
Professor, ISCT 2024 Co-Chair
University of Vermont, US
Nikita Patel, MSci, PhD (Moderator)
Senior Scientist
INmune Bio
Rachel Burga, PhD (Moderator)
Principal Scientist, Early Stage Professionals Committee (ESP) Co-Chair
Obsidian Therapeutics
Kathryn Strange, MSc, PhD
Postdoctoral Research Associate
The Francis Crick Institute, Kings College London
Elani Wiest, PhD
Process Development Associate Staff Scientist
Mayo Clinic
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This webinar will feature updated definitions of point of care (POC) manufacturing and feature two leading innovators in POC manufacturing to offer real-world examples of – and insights from – successful POC programs. Real-life experts will speak about their experience of building a point-of-care manufacturing program at a clinical laboratory. They will discuss the challenges, the potential solutions, and the regulatory aspects of in-house manufacturing, and provide perspective from the different vantage points of their respective roles.
Presented by the ISCT North America Regional Executive Committee and Lab Practices Committee
March 12, 2024
Webinar Description:
This webinar will feature updated definitions of point of care (POC) manufacturing and feature two leading innovators in POC manufacturing to offer real-world examples of – and insights from – successful POC programs.
Real-life experts will speak about their experience of building a point-of-care manufacturing program at a clinical laboratory. They will discuss the challenges, the potential solutions, and the regulatory aspects of in-house manufacturing, and provide perspective from the different vantage points of their respective roles.
Key Learning Objectives:
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To discuss the regulatory landscape surrounding point-of-care manufacturing of cell and gene therapy products from the FDA perspective.
To delineate the process of establishing a point-of-care manufacturing program in an academic institution.
To highlight potential challenges and possible solutions from the experts who have built successful programs.
Ashley Krull, PhD (Moderator)
Associate Director, W.W. Williams Cellular Therapy Laboratory
The Ohio State University
Ashley Krull received her undergraduate degree in Biochemistry from the University of Iowa and her Ph.D. in Neuroscience from the University of Washington. After graduate school, Dr. Krull completed a postdoctoral fellowship in regenerative neurobiology within the Department of Neurology at Mayo Clinic in Rochester, Minnesota. In 2019, Dr. Krull became Mayo Clinic’s second-ever Cellular Therapy Fellow and was granted an extended two-year fellowship, which she completed in 2021. This fellowship program included didactic, experiential, and project-driven training with an emphasis on directorship of a clinical cell therapy laboratory. Subsequently, Dr. Krull held an appointment as Instructor within the Department of Laboratory Medicine and Pathology and served as a senior program coordinator within the Mayo Clinic cellular therapy lab and as a consultant for a joint venture biotechnology company spun out of the lab’s work at Mayo Clinic. In 2022, Dr. Krull moved to The Ohio State University where she currently serves as the Associate Director of Cell Therapy Manufacturing and Engineering. She also holds an appointment of Assistant Professor within the Department of Hematology. Her work focuses on the optimization of manufacturing processes for immune effector cells and the translation of novel cellular therapies into the clinic.
Elena Maryamchik, MD, MBA (Moderator)
Director of Cell Therapy Laboratory
Memorial Sloan Kettering Cancer Center
After receiving a dual MD/MBA degree from the University of Miami in 2016, Elena completed her residency in Clinical Pathology at the Massachusetts General Hospital, Cell and Gene Therapy Fellowship at the University of Pennsylvania/Children’s Hospital of Philadelphia, and Transfusion Medicine Fellowship at Harvard. She is a Director of Cell Therapy Laboratory at Memorial Sloan Kettering Cancer Center, and an Assistant Attending in Transfusion Medicine. Her interests include Point-of-Care manufacturing of cell therapy products, exploring the role of stem cell graft characterization and post-thaw viability monitoring in guiding clinical decisions and improving patient outcomes, developing training programs to facilitate the entry of qualified technicians into the field of cell therapy, teaching the next generation of cell therapy leaders, and optimizing operations of a clinical laboratory to meet the rising demand. As an early-stage professional, she is a member of ISCT Lab Practices Committee, ISCT Expanded Access Working Group, ASTCT representative to the AABB COI for Cellular Therapies Task Force, and a member of the FACT-JACIE Standards HCT Processing Subcommittee.
Kimberly Schultz, PhD
Director of Division 2, Office of Gene Therapy
US Food and Drug Administration (FDA)
Kimberly Schultz is Director of Division 2 in the Office of Gene Therapy at FDA’s Office of Therapeutic Products in the Center for Biologics Evaluation. Kim joined the FDA in 2015 as a Commissioner’s Fellow to conduct a cross-study analysis of CAR T cell CMC data and contributes to FDA review, guidance, and policy. Prior to joining the FDA, she received her PhD from the University of Wisconsin and conducted postdoctoral studies at Johns Hopkins Bloomberg School of Public Health specializing in virology and immunology.
Yongping Wang, MD, PhD
Director, Cell and Gene Therapy Laboratory
Children’s Hospital of Philadelphia
Dr. Yongping Wang is a pathologist in Philadelphia, PA and currently working as the Director of Cell and Gene Therapy Laboratory at Children's Hospital of Philadelphia. He received his medical degree from Geisel School of Medicine at Dartmouth and has been in practice for more than 15 years. He is one of 39 doctors at Children's Hospital of Philadelphia who specialize in Pathology. He has more than 20 publications and over 500 citings.
Patrick Hanley, PhD
ISCT NA Regional VP 2022-2024
Chief & Director, Cellular Therapy Program, Associate Professor, Children’s National Hospital
Dr. Hanley is the Chief and Director of the Cellular Therapy Program and an associate professor of pediatrics at Children’s National Hospital and the George Washington University, respectively. He oversees processing for standard of care stem cell transplantation as well as the development, manufacture, quality, and testing of novel cell and gene therapies. Over the past 16 years he has helped to translate more than 550 products on over 25 cell therapy protocols – ranging from mesenchymal stromal cells to cord blood virus-specific T cells and tumor-associated antigen specific T cells – into the clinic.
Dr. Hanley was elected VP-North America of the International Society for Cell and Gene Therapy (ISCT) where he also serves on the board of directors, co-founded and served as the inaugural co-chair of the Early Stage Professionals committee which focuses on workforce development, and is the commissioning editor of the society’s journal, Cytotherapy. Representing ISCT, he serves on the Regenerative Medicine Forum of the National Academies where he co-leads the workforce working group. He also serves on the board of directors of the Foundation for the Accreditation of Cellular Therapy (FACT) and is a FACT representative at the Cell Therapy Liaison Meeting, serving as a thought leader in a forum with the FDA. Dr Hanley also serves as an advisor for a number of cell and gene therapy biotech companies. In his free time he enjoys tweeting with fellow scientists and Bills fans, playing soccer, cycling, cooking, and traveling.
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Unlock the pathway to successful cell therapy approval in Australia with our ISCT exclusive webinar, "Getting Your Cell Therapy Product Approved: Some Dos and Don'ts." Hosted by experts from the Therapeutic Goods Administration (TGA), this event is your guide to navigating the intricacies of regulatory processes. Learn firsthand the crucial dos and don'ts that can make or break your cell therapy product's approval journey. Our distinguished speakers will delve into the nuanced requirements of the TGA, providing invaluable insights into crafting robust submissions, avoiding common pitfalls, and streamlining your approval process. Stay ahead of the curve by gaining a comprehensive understanding of Australia's regulatory landscape for cell therapies. Whether you're a seasoned professional or new to the regulatory realm, this webinar equips you with practical knowledge to optimize your strategy and enhance your chances of a successful approval. Seize this opportunity to engage directly with TGA officials, ask questions, and network with fellow industry professionals. Don't miss out! Register now for a transformative experience in advancing your cell therapy product through the regulatory maze Down Under.
Presented by the ISCT ANZ Regional Executive Committee
February 9, 2024
Webinar Description:
Unlock the pathway to successful cell therapy approval in Australia with our ISCT exclusive webinar, "Getting Your Cell Therapy Product Approved: Some Dos and Don'ts." Hosted by experts from the Therapeutic Goods Administration (TGA), this event is your guide to navigating the intricacies of regulatory processes.
Learn firsthand the crucial dos and don'ts that can make or break your cell therapy product's approval journey. Our distinguished speakers will delve into the nuanced requirements of the TGA, providing invaluable insights into crafting robust submissions, avoiding common pitfalls, and streamlining your approval process.Stay ahead of the curve by gaining a comprehensive understanding of Australia's regulatory landscape for cell therapies. Whether you're a seasoned professional or new to the regulatory realm, this webinar equips you with practical knowledge to optimize your strategy and enhance your chances of a successful approval.
Seize this opportunity to engage directly with TGA officials, ask questions, and network with fellow industry professionals. Don't miss out! Register now for a transformative experience in advancing your cell therapy product through the regulatory maze Down Under.Key Learning Objectives:
• Understand pathways and provisions for Cell Therapy products in Australia.
• Learn what are the regulator expectations for compliance with relevant standards
• Understand which manufacturing principles apply to cell therapies
• Learn the dos and don’ts for cell therapy dossier developmentZlatibor Velickovic, PhD (Moderator)
ISCT ANZ Regional VP, A/Prof, Director
CTTWA, Royal Perth Hospital, Australia
Jessica Sue, MSc, MHSM (Moderator)
ISCT ANZ Regional ESP Subcommittee Co-Chair, Quality Manager
Sydney Cord Blood Bank
Mat Adams, MD, PhD
Senior Evaluator
Biological Science Section, Scientific Evaluation Branch, Therapeutic Goods Administration, Australia
Glenn Smith, MD, PhD
Director
Biological Science Section, Scientific Evaluation Branch, Therapeutic Goods Administration, Australia
Tony Gill, MD
Director
Blood, Biologicals and Infectious Diseases Unit, Therapeutic Goods Administration, Australia
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The Implementation of ISO Cell Counting Standards course is a partnership between ISCT and the Standards Coordinating Body (SCB). This course was developed by the Subject Matter Experts (SMEs), including NIST, FDA, and device manufacturers, who created the ISO 20391-1:2018 (Part 1) and ISO 20391-2:2019 (Part 2) Standards.
The course comprised ten modules for approximately 10 hours of learning. Each module consists of a training video and a knowledge check (quiz). The last module of the course is the final examination consisting of 50 multiple-choice questions.
Learners have one attempt to complete and pass the final examination in order to obtain the certificate.
Any learner who failed the final examination may pay $250 to retake the course and examination once more.
Please note that the re-examination fee must be paid within 30 days of the failed exam date.-
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