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Session Details

Plenary Session: The Current Reality and Future of Point of Care Manufacturing
Saturday, September 9, 2023 09:15 AM - 10:45 AM  
Grand Ballroom J-K
Chairs
Sarah Nikiforow, MD, PhD, Dana-Farber Cancer Institute, USA
Jacques Galipeau, MD, FRCP(C), University of Wisconsin in Madison, USA

Speakers
Yongping Wang, MD, PhD, Children’s Hospital of Philadelphia, USA – P.O.C. Manufacturing – Yes You Can! (but do you want to?)
Nirav Shah, MD, Medical College of Wisconsin, USA – Point of Care Manufacturing at an Academic Center: Increasing Local, National and Global Accessibility to Cell Therapies
Kimberly Schultz, PhD, FDA, USA – CBER Perspectives on Point-of-Care Manufacturing


Session Objectives
  1. Discuss required infrastructure, pros and cons of point-of-care cell therapy manufacturing at academic centers
  2. Evaluate merits of current POC models in the clinical trial space.
  3. Explore future path of POC manufacturing as relates to FDA and potential BLA requirements

Jacques Galipeau MD FRCP(C)
Don and Marilyn Anderson Professor in Oncology, Associate Dean for Therapeutics Development
University of Wisconsin in Madison
Chair


Sarah Nikiforow MD, PhD
Asst Professor, Stem Cell Transplantation Program, Asst. Medical Director, Cell Manipulation Core Facility, Technical Director, Immune Effector Program
Dana-Farber Cancer Institute
Chair


Kimberly Schultz PhD
Chief, Gene Therapy Branch
FDA
Speaker


Nirav Shah MD
Associate Professor of Medicine Lymphoma/BMT program
Medical College of Wisconsin
Speaker


Yongping Wang
Associate Professor of Clinical Pathology and Laboratory Medicine
Children’s Hospital of Philadelphia
Speaker