Navigating FDA Expectations for Minimal Residual Disease (MRD) in Multiple Myeloma

Join IQVIA’s experts for an in-depth discussion on optimizing radiopharmaceutical trials from aligning with the FDA’s latest guidance on dosage optimization to ensuring radiation therapy quality assurance and overcoming logistical hurdles. Learn how IQVIA’s proven expertise and global capabilities can help accelerate your oncology pipeline and bring novel therapeutic modalities to market faster.

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/fda-mrd

Event overview:

In January 2026, the U.S. FDA issued draft guidance outlining how minimal residual disease (MRD) negativity in complete response may support accelerated approval in multiple myeloma. This guidance marks a meaningful shift for sponsors designing myeloma clinical programs.

This moderated panel discussion examines what the FDA guidance enables, what regulators can expect, and how MRD can be operationalized as a primary endpoint across trial design, assay validation, and regulatory strategy.

Key Learning Objectives:

• Understand what the FDA’s MRD guidance means for accelerated approval pathways in multiple myeloma
  
• Recognize how trial design, endpoint timing, and assay validation influence regulatory confidence
  
• Learn practical steps that sponsors can take now to prepare MRD‑based programs for regulatory review

Speakers:

Sari Heitner Enschede, MD
Head of Hematology, Senior Medical Strategy Lead, Hematology-Oncology Center of Excellence
IQVIA

Sari Heitner Enschede, MD, has worked in the pharmaceutical industry for 18 years, including six years at IQVIA, providing strategic guidance to customers for hematology studies and programs in addition to consultation and leveraging of professional networks for hematology-specific partnerships. Her previous experience at AbbVie/Abbott entailed leading global clinical trials in hematologic malignancies for Phases 1 through 4, with key roles in product safety, regulatory agency communications, and the launch of its BCL2 inhibitor Venetoclax. Prior to transitioning into the pharmaceutical industry, as an experienced hematologist, Enschede served as assistant professor in medicine in the Department of Hematology-Oncology at Rush University, Chicago.

Bradley Smith, PhD
Vice President Therapeutic Strategy, Drug Development and Regulatory Strategy
IQVIA

Brad Smith, PhD, is the vice president of therapeutic strategy, specializing in translational medicine. He is a recognized leader in biomarkers and companion diagnostics in clinical research, with expertise in technical, scientific, regulatory, legal, and business aspects. Previously, Smith led corporate development at Cell Signaling Technology and managed the translational medicine lab. His scientific background includes research at Stanford University and The University of California, San Francisco, focusing on disease mechanisms.

Franklin Sedarat, MD, MS
Global Director, Hematopathology,
IQVIA Laboratories

Dr. Franklin Sedarat is Global Director of Hematopathology at IQVIA Laboratories, where he leads the global Hematopathology Center of Excellence. A board-certified anatomic and clinical pathologist with subspecialty certification in hematopathology, he brings more than 20 years of diagnostic and clinical trial experience.

He specializes in lymphoma and leukemia diagnostics across flow cytometry, immunohistochemistry, cytogenetics and molecular pathology. His experience includes leadership roles in large reference laboratories, global laboratory harmonization efforts, and contributions to assay development and validation for clinical research.

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/fda-mrd