ACDRS-NIH Workshop: Cell-Based Immunotherapy: From Bench to Bedside and Beyond

Tuesday, January 22, 2019 - 8:00 am to 4:45 pm
Masur Auditorium, National Institutes of Health Clinical Center/Bldg 10, Bethesda MD

10 Center Dr, Bethesda, MD 20814

Regulatory and development experts will engage with participants at this special one-day ACDRS-NIH workshop dedicated to the memory of Professor Louis Cantilena.


Opening remarks

Carl C. Peck, MD, Adjunct Professor, University of California, San Francisco

PDF icon Keynote Address

ADM Brett P. Giroir, MD, Assistant Secretary for Health, US Department of Health and Human Services

Session 1: Harnessing the Immune System to Fight Disease

Chair: Nicholas R. Restifo, MD, Director, Center for Cell-Based Therapy and Head, Center of Excellence in Immunology, National Cancer Institute (NCI), NIH 

Session 2: Regulatory Realities

Chair: Ellen G. Feigal, MD, Partner, NDA Partners

Session 3: Challenges and Opportunities in Manufacturing of Cell-Based Immunotherapies

Chair: David Stroncek, MD, Chief, Cell Processing Section and Co-Director, HLA Laboratory, Department of Transfusion Medicine (DTM), NIH

Session 4: Challenges and Opportunities in Clinical Studies

Co-Chairs: Ellen G. Feigal, MD, Partner, NDA Partners and Nirali N. Shah, MD, MHSc, Associate Research Physician, Hematologic Malignancies Section, Pediatric Oncology Branch, NCI, NIH

  • PDF icon Issues in Clinical Trial Design for Cell Therapies 
    Telba Irony, PhD, Deputy Director, Office of Biostatistics and Epidemiology, CBER, FDA

  • Early Phase Trials of CAR T Cells: Lessons Learned
    Crystal Mackall, MD, Ernest and Amelia Gallo Family Professor of Pediatrics and Medicine, Founding Director Stanford Center for Cancer Cell Therapy, Stanford University

  • PDF icon CRISPR-Edited CAR T Cells
    Jorge Mansilla-Soto, PhD, Research Associate, Center for Cell Engineering and Immunology Program, Memorial Sloan-Kettering Cancer Center

  • New Cellular Immunotherapy for Solid Tumors
    Steven A. Rosenberg, MD PhD, Chief of Surgery Branch, Head of Tumor Immunology Section, NCI, NIH

  • Panel Discussion
    Speakers above and Greg Campbell, PhD, Principal Statistician, GCStat Consulting

Wrap-up and summary

Harvey Klein, MD, Chief, DTM, NIH

Program in PDF

PDF icon Program.pdf

Administrative details

Each year, in addition to its course, ACDRS also presents a workshop that is open to all interested parties.

  • The workshop topic changes from year to year. (To be notified of new workshops, email [email protected] with your request.)
  • It is scheduled so that it is convenient for current ACDRS participants to attend, but you don’t need to be enrolled in ACDRS to attend.

Previous workshops