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

Date: 
Tuesday, January 22, 2019 - 8:00 am to 4:45 pm
Location: 
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.

Program

Opening remarks

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

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 

  • Cancer Immunotherapy
    Stephan Grupp, MD PhD, Director of the Cancer Immunotherapy Program, Director of Translational Research, Center for Childhood Cancer Research and Medical Director, Stem Cell Laboratory, Children's Hospital of Philadelphia

  • Adoptively Transferred T-cell Therapy for Viral Infections
    Ann M. Leen, PhD, Associate Professor, Department of Pediatrics, Section of Hematology-Oncology, Baylor College of Medicine

  • Panel Discussion
    Speakers above

Session 2: Regulatory Realities

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

  • Regulatory Considerations for Cell-Based Immunotherapies
    Peter Marks, MD PhD, Center for Biologics Evaluation and Research (CBER), US Food and Drug Administration (FDA)

  • Preclinical Considerations for Cell-Based Immunotherapies
    Allen Wensky, PhD, Biologist, Office of Tissues and Advanced Therapies (OTAT), CBER, US FDA

  • Approval of Kymriah (tisagenlecleucel) & Yescarta (axicabtagene ciloleucel)
    Roger J. Kurlander, MD, Medical Officer, CBER, US FDA

  • Panel Discussion
    Speakers above

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

  • Challenges in Process and Analytical Development of Cell Therapies: An Academic Perspective
    David DiGiusto, PhD, Chief Technical Officer, Semma Therapeutics

  • Early Stage Considerations for Source Material and Manufacturing
    Jaikumar Duraiswamy, DVM MS PhD, CMC Reviewer, Cell Therapy Branch. Division of Cellular and Gene Therapies, OTAT, CBER, US FDA

  • Industry Perspective on Large Scale Manufacture of Autologous Cell-Based Immunotherapies
    Thomas Fellner, PhD MBA, Head of Commercial and Business Development, Cell and Gene Therapy, Lonza Pharma & Biotech

  • Panel Discussion
    Speakers above

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

  • Clinical Trial Design and Adaptive Approaches in Cell Therapy
    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

  • 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

How to register

Register

If you are an NIH employee, your registration fee is waived. Please contact [email protected] to register and do not use the link above. Advance registration required.

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

Questions?

See NIH visitor information. Main workshop contact: [email protected].