This free webinar examines the nuances of successfully conducting hematological oncology clinical trials.
Hematological malignancies such as leukemia, multiple myeloma and lymphoma represent a subset of indications within oncology that are wholly different from solid tumors. The growing hematological oncology therapy market is fueling both large numbers of clinical studies and, more importantly, an enhanced and refined understanding of cancer pathologies. Conducting clinical trials in hematological malignancies requires an understanding of a rapidly evolving treatment paradigm that is increasingly nuanced, complex and patient-directed. Companies developing hematological oncology therapies must capitalize on the principles and infrastructures shared by solid tumor oncology trials while adapting endpoints, study designs and data management approaches as well as considering patients’ experiences to address the particular challenges related to investigating candidate treatments for blood-based cancers.
Join this webinar to gain an understanding of critical differences between solid tumor and hematological oncology and a discussion on the nuances of conducting successful hematological oncology clinical trials.
Learning Objectives
- Understand critical trial design considerations; including tumor type, standard of care vs. research interests, and overall data capture nuances
- Learn how to create meaningful, measurable endpoints and how they differ from solid tumor oncology studies
- Recognize how to effectively monitor and manage data and queries within hematology oncology studies
- Gain insight into selecting ideal trial sites for rare hematological malignancies and the importance of working with an oncology-experienced team
Speakers
Chris Smyth, PhD, MBA, Managing Director, European & Asian Operations, Novella Clinical
Based in Novella’s European headquarters in Stevenage, England, Dr. Chris Smyth oversees clinical research and operations in Europe and Asia. He also supports oncology delivery operations globally.
Dr. Smyth has more than 20 years’ research and development experience in the Pharmaceutical industry. He has led clinical research organisations and bioPharmaceutical companies in both Europe and the US, dealing exclusively in haematology and oncology drug development since 2003.
Dr. Smyth earned his PhD in Reproductive Biology from the University of Edinburgh and an MBA from Henley Management College, United Kingdom.
Message Presenter
Richard Gams, MD, Chief Scientific Officer, Novella Clinical
Dr. Richard Gams is a board-certified haematologist/oncologist with more than 40 years’ clinical research experience. As Novella’s chief scientific officer, he guides training, protocol design, medical monitoring and pharmcovigilance, and is focused primarily on haematologic malignancies including leukemias, lymphomas, myelodysplasia and multiple myeloma. Prior to joining Novella, he played an instrumental role at Adria Laboratories (now part of Pfizer) in moving three breast cancer drugs and a therapy for acute myelogenous leukemia to FDA approval and commercialization in the 1990s, and later founded Prologue Research International, a contract research organisation. Dr. Gams served as a Professor of Medicine in the Division of Haematology/Oncology at the University of Alabama at Birmingham and Chairman of the Lymphoma Committee of the Southeastern Cancer Study Group. Additionally, he was Professor of Medicine in Haematology/Oncology and Director, Developmental Therapeutics for the Comprehensive Cancer Center (CCC) at The Ohio State University.
Message PresenterWho Should Attend?
This webinar is intended for hematology oncology professionals who oversee hematological drug development and clinical research in North America. Attendees may include:
- VPs/Directors of Clinical Operations / Outsourcing / Procurement / Project Management / Study Management
- Hematology Oncology Division Leaders
- Data Managers
- Medical Monitors
- Medical Advisors
Xtalks Partner
Novella
Novella Clinical, a Quintiles company, is a global, full-service clinical research organisation (CRO) serving the unique needs of small to mid-sized oncology companies. Novella’s dedicated oncology division is comprised of more than 700 oncology clinical trial specialists across all functional areas. We have specific oncology teams and processes to support haematological studies that include board-certified haematologists/oncologists on staff and oncology experienced CRAs. We are proud that 30 percent of our oncology portfolio focuses specifically in haematological oncology and our experience includes AML, CML, multiple myeloma, myelodysplastic syndromes, NHL and many rare indications. Learn more at www.novellaclinical.com/oncology.
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