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

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 

• CAR T Cell Immunotherapy for All 
  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

• T Cell Stemness_An Emerging Principle of Successful Adoptive Cell Therapy
  Nicholas Restifo

• 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 CD19-Directed CAR T Cells: FDA Licensure of New Cell-Based Gene Therapy Products With a Challenging Safety Profile
  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

• Academic Cell and Gene Therapy Development and Manufacturing
  David DiGiusto, PhD, Chief Technical Officer, Semma Therapeutics

• Early Stage CMC Considerations for Source Materials and Manufacturing in Cellular Therapy
  Jaikumar Duraiswamy, PhD, Biologist, Cell Therapies Branch 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

• 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

• 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

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

• Pediatric Drug Development
• Substantial Evidence in 21st Century Regulatory Science: Borrowing Strength from Accumulating Data

Questions?

• See NIH visitor information.

• See NIH security information.

• See NIH campus map.

• Video: How to prepare for the security check at the entrance of the campus.

• [Directions for getting to the NIH Clinical Center from a variety of transportation modes][link defunct].

• “NIH CC Take Me There” app for navigating within the Clinical Center is available at Apple Store or Google Play.

• Main workshop contact: [email protected].