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ASH-FDA Joint Symposium I: Accelerating Drug Development for Hematologic Malignancies

Program: Special-Interest Sessions
Hematology Disease Topics & Pathways:
Research, Clinical trials, Lymphoid Leukemias, ALL, Acute Myeloid Malignancies, AML, Lymphomas, APL, Drug development, Clinical Research, Plasma Cell Disorders, Diseases, Treatment Considerations, Lymphoid Malignancies, Myeloid Malignancies, Measurable Residual Disease
Monday, December 9, 2024: 10:30 AM-12:00 PM
Room 11 (San Diego Convention Center)
Chair:
Cara Rabik, MD, PhD, Food and Drug Administration
Disclosures:
No relevant conflicts of interest to declare.
Introduction

Cara Rabik, MD, PhD

DHM1/CDER, Food and Drug Administration, Silver Spring, MD
From Detection to Development: A Regulatory Perspective on Measurable Residual Disease

Maryam Sarraf Yazdy, MD

(DHM2/CDER), Food and Drug Administration, Silver Spring
Development of Residual Disease as a Biomarker in Acute Leukemia

Emily Jen, MD, PhD

US Food and Drug Administration, Silver Spring, MD
Measurable Residual Disease Testing in AML: Challenges and Progress

Christopher S. Hourigan, DM DPhil

Fralin Biomedical Research Institute, Virginia Tech FBRI Cancer Research Center, Washington, DC
Recent Approvals of CAR T Therapy for Hematologic Malignancies

'Lola Fashoyin-Aje, MD, MPH

Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Obecabtagene Autoleucel for Treatment of Adults with Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia

Najat Bouchkouj, MD

Division of Clinical Evaluation Hematology, Office of Therapeutic Products (OTP), Center for Biologics Evaluation and Research (CBER), US Food and Drug Administration, Silver Spring, MD
Clinical Discussant for Acute Lymphoblastic Leukemia

Hetty E. Carraway, MD, MBA

Department of Hematology and Medical Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH
Panel Discussion

Cara Rabik, MD, PhD

DHM1/CDER, Food and Drug Administration, Silver Spring, MD
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