Modernising haematological malignancy adverse event assessment and reporting

Dr Lan-Lan Smith is the founding Editor-in-Chief of The Lancet Haematology, launching the journal in 2014. She earned her PhD from Cancer Research UK/University College London, UK, in acute myeloid leukaemia genetics and held post-doctoral research posts in the Haemato-Oncology Section at the Institute of Cancer Research, UK, and in the Department of Haematology-Oncology at King's College London, London, UK, before joining The Lancet group as a Senior Editor at The Lancet Oncology in 2011.

Dr. Gita Thanarajasingam is an Associate Professor of Medicine and consultant in the Division of Hematology at Mayo Clinic in Rochester, MN, USA. Her clinical practice is focused on Hodgkin and non-Hodgkin lymphoma, and she performs health outcomes research in cancer.  Her research program focuses on improving the evaluation of adverse events of treatment and measuring their impact on treatment tolerability in cancer patients. She developed Toxicity over Time (ToxT), a longitudinal patient-focused approach to adverse event evaluation. She serves of as vice co-chair of the Alliance Health Outcomes Committee and is the recipient of K and U01 grants from the U.S. National Institutes of Health (NIH). Dr. Thanarajasingam is a graduate of Yale University, Mayo Clinic Alix School of Medicine and the Brigham and Women’s Hospital at Harvard Medical School.

Dr. Amylou Dueck is an Associate Professor of Biostatistics and Vice Chair of the Department of Quantitative Health Sciences at Mayo Clinic, Scottsdale, AZ, USA. She is an expert in the statistical analysis of patient-reported outcomes (PROs), adverse events, and tolerability endpoints in cancer clinical trials and has contributed to the development of PRO measures, including the PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF). Dr. Dueck is the Co-chair of the Health Outcomes Committee of the Alliance for Clinical Trials in Oncology and Chair of the National Cancer Institute Moonshot Tolerability Consortium.

Dr. Lori Minasian, a medical oncologist, is the Deputy Director for the Division of Cancer Prevention at the US National Cancer Institute (NCI).  She is a leader in the NCI clinical trials enterprise and has fostered the incorporation of patient reported outcomes (PRO) in cancer clinical trials.  Dr. Minasian is one of the senior leaders in the development of the NCI’s PRO version of the CTCAE. She initiated an NCI funded consortium to develop new methods for analyzing PRO to better define patient tolerability in cancer clinical trials. In addition, she has participated in the NCI’s Women’s Malignancy Clinic seeing patients. Dr. Minasian earned a Medical Degree from the George Washington University School of Medicine in Washington, D.C. She completed a fellowship in Medical Oncology at the Memorial Sloan-Kettering Cancer Center.

Dr. Surbhi Sidana is an Assistant Professor of Medicine at Stanford University, Stanford, CA, USA, and specializes in the treatment of multiple myeloma and related disorders. She leads the myeloma cellular therapy program and the myeloma disease focused group within the BMT and Cell Therapy Division at Stanford. Dr. Sidana has an active clinical research portfolio and leads clinical trials, especially those focusing on CAR-T cell therapy, immunotherapy, and transplantation in myeloma. Her work on CAR-T therapy focuses on clinical trials, as well as understanding the patient experience and side effects amongst patients receiving CAR-T therapy.

Dr. Karin Ekstrom-Smedby is a professor and research group leader in hematology/oncology at the Karolinska Institutet, Stockholm, Sweden, and a senior consultant in Hematology at the Karolinska University Hospital. Her research focuses on etiology, survival, and survivorship in mature B-cell and T-cell malignancies using both observational register-based, clinical, and translational approaches. She is the national register holder of the Swedish Lymphoma quality-of-care register, chair of the Blood Cancer register steering group in Sweden and the Hematology Research and Education group at the Karolinska hospital. She is also an editor of the scientific journals Journal of Internal Medicine and Acta Oncologica. In 2022, she became honorary doctor of Aalborg University in Denmark.

Nicole Gormley, MD, is the Division Director for the Division of Hematologic Malignancies II at the U.S. Food and Drug Administration (FDA). Dr. Gormley joined the FDA in 2011 and previously served as a clinical reviewer and the Multiple Myeloma Clinical Team Lead. While in these roles, Dr. Gormley has actively engaged with the multiple myeloma community on the development of novel endpoints, including minimal residual disease, and methods to address racial disparities. Dr. Gormley completed fellowship training in hematology and critical care at the National Institutes of Health and served as the Deputy Clinical Director at the National Heart, Lung and Blood Institute prior to joining the FDA.

Tarec Christoffer El-Galaly is an MD DMSc and full professor of hematology at Aalborg University Hospital, Denmark and adjunct professor at the University of Southern Denmark. His focus is lymphoma research with a particular interest in real world data and how to utilise this for better patient care. He has published over 120 papers, most of them focusing on lymphoma outcomes research, survivorship, and epidemiology. He is also leading a national medical ethics committee in Denmark and serves as vice-chair of the scientific advice committee for hematology/oncology at the European Medicines Agency.