Webinar
Multiple Myeloma: Best Practices for Efficacy Endpoint Evaluation
The landscape of new therapies in multiple myeloma trials is rapidly evolving, with stringent global regulations around blinded independent central review (BICR) for efficacy endpoints.
This webinar will review the challenges of conducting BICR and highlight how clinical trial sponsors can optimize endpoint assessments to meet their development goals. The panel includes Perceptive scientists with expertise in myeloma clinical trials and a globally-renowned myeloma physician with a blended background as a clinician AND an independent reader.
Surabhi Bajpai, MD
Sr. Director of Scientific and Medical Services, Perceptive Imaging
Dr. Bajpai is a radiologist and currently heads the oncology therapeutic area of Perceptive Imaging in the USA. She has nearly 20 years of experience in medical imaging and clinical research. She has worked on several oncology trials both early and late phase trials including hematology. She has led several trials in Multiple Myeloma at perceptive and has established a harmonize approach for myeloma response evaluation in a central review paradigm with KOLs like Dr. Mikhael and Dr. Shaji Kumar.
Rudresh Jarecha, MD
Sr. Medical Director, Head of Haemato-Oncology, Perceptive Imaging
Dr. Jarecha’s has managed the imaging components of more than 300 oncology and haemato-oncology clinical trials, resulting in the submission and approval of more than 20 regional and global oncology indication treatments. Building strong teams in the USA and APAC, he manages the USA, China, and Japan markets’ unique drug development challenges. A board-certified Radiologist, Rudresh served as Co-Chair of a CT Coordinating Committee and CT Volumetry Biomarker Committee in QIBA, RSNA.
Joseph Mikhael, MD, MEd, FRCPC, FACP
Professor, Applied Cancer Research and Drug Discovery Division, Translational Genomics Research Institute (TGen)
In addition to his role at TGen, an affiliate of the City of Hope Cancer Center, Dr. Mikhael is also the Chief Medical Officer of the International Myeloma Foundation (IMF). He facilitates and promotes myeloma research worldwide. Joseph specializes clinically in plasma cell disorders, namely multiple myeloma, amyloidosis and Waldenstrom’s macroglobulinemia. He has served as a Scientific Advisor for Perceptive for various plasma cell disorder trials.
Join this engaging session and learn how to harmonize an approach for overcoming the common challenges in myeloma clinical trials, including:
– Imaging and its relevance in the context of response evaluation
– Relevance of PET and metabolic response for evaluation under IMWG criteria
– Incorporating lesions on physical examination
– Evaluating local and central lab datasets for efficacy with emphasis on the confirmation of progression
– Suppression of light chains with newer therapies and methods to interpret them for response
