-Author name in bold denotes the presenting author
-Asterisk * with author name denotes a Non-ASH member
Clinically Relevant Abstract denotes an abstract that is clinically relevant.

PhD Trainee denotes that this is a recommended PHD Trainee Session.

Ticketed Session denotes that this is a ticketed session.

ASH-FDA Joint Symposium on New Drug Approvals in Non-Malignant Hematology

Program: Special-Interest Sessions
Hematology Disease Topics & Pathways:
Diseases, Therapies
Monday, December 3, 2018: 4:30 PM-6:00 PM
Hall AB (San Diego Convention Center)
Chair:
Ann T. Farrell, MD., U.S. Food and Drug Administration
Disclosures:
No relevant conflicts of interest to declare.
This joint session, one of two co-sponsored by the U.S. Food and Drug Administration (FDA), will feature drugs recently approved to treat hematological disorders. FDA product-reviewers will discuss the safety and efficacy issues for the products' clinical trials and toxicity studies. The program will also include clinicians who will discuss their perspectives on the use of the products in the real-world setting. There will be ample time for questions from the audience.

Angelo De Claro, MD

U.S. Food and Drug Administration, Silver Spring, MD

Franco Locatelli1, Michael B. Jordan, MD2, Carl E. Allen, MD, PhD3, Simone Cesaro, MD4*, Carmelo Rizzari, MD5*, Anupama Rao, MD6*, Barbara Degar, MD7*, Timothy Garrington8*, Julian Sevilla, MD, PhD9*, Maria Caterina Putti, MD10*, Franca Fagioli, MD11*, Martina Ahlmann, MD12*, Jose-Luis Dapena, MD13*, Alexei A. Grom, MD14*, Fabrizio De Benedetti, MD15*, Walter Giovanni Ferlin, PhD16*, Maria Ballabio, MD16* and Cristina De Min, MD16*

1Department of Onco-hematology, Bambino Gesù Children’s Hospital IRCCS, Rome, Italy
2Division of Immunobiology, Department of Pediatrics, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH
3Department of Pediatrics, Texas Children's Cancer Center, Texas Children's Hospital, Houston, TX
4Department of Pediatric Onco-hematology, University Hospital Verona, Verona, Italy
5Department of Pediatrics, San Gerardo Hospital, University of Milano-Bicocca, Monza, Italy
6Department of Haematology, Great Ormond Street Hospital, London, United Kingdom
7Division of Pediatric Hematology/Oncology, Dana-Farber Cancer Institute, Boston, MA
8Center for Cancer and Blood Disorders, Children's Hospital Colorado, Aurora, CO
9Department of Pediatric Onco-hematology, University Children Hospital Niño Jesús, Madrid, Spain
10Division of Pediatric Hematology and Oncology, Department of Pediatrics, University of Padova, Padova, Italy
11Division of Pediatric Onco-hematology, Regina Margherita-S. Anna Hospital, Turin, Italy
12Department of Pediatric Hematology and Oncology, University Children's Hospital Muenster, Muenster, Germany
13Department of Pediatric Hematology and Oncology, University Hospital Vall d’Hebron, Barcelona, Spain
14Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH
15Division of Rheumatology, Bambino Gesù Children's Hospital IRCCS, Rome, Italy
16Novimmune SA, Geneva, Switzerland

Margret Merino, MD

CDER/OCE/DHP, U.S. Food and Drug Administration, Silver Spring, MD

Leslie Kean, MD, PhD

Boston Children's Hospital, Boston, MA

Nicole Gormley, MD

U.S. Food and Drug Administration, Bethesda, MD

Cynthia E. Dunbar, MD

Hematology Branch, NIH, Bethesda, MD

Laurel A Menapace, MD

Division of Hematology Products (DHP), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD

Barbara A Konkle, MD

Bloodworks Northwest, Seattle, WA

Ann T. Farrell, MD.

U.S. Food and Drug Administration, Silver Spring, MD