Session Details

Quality & Operations Track Session 4 - Current Clinical Development Regulatory Guidance – Context and Implications
Saturday, September 14, 2019 07:30 AM - 08:30 AM
Ballroom B
The goals of this session include:
•      Understand current FDA guidance for cell and gene therapies
•      Understand the differences between cell therapy products regulated solely under PHS Act Section 361 and those requiring full BLA approval, and provide some clinical examples
•      Review implications of relevant FDA draft guidance for cell and gene therapies
•      Review future considerations for clinical development of cell and gene therapies

Chair: Kurt Gunter, MD, Cell Medica Inc., USA

Speakers:
Regulatory consideratins for more than minimally manipulated cell-based therapies: a clinical perspective
Peiman Hematti, MD, University of Wisconsin-Madison School of Medicine and Public Health, USA
Learning objectives:
•      To provide an an overview of FDA Guidance: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use
•      To provide an overview of regulatory definitions of minimal manipulation and homologous use
•      To provide examples of implications of these regulatory considerations in practice of cell therapy

Clinical Regulatory Guidance for Genetically-Modified Cell Therapies: An Industry Perspective
Cynthia Molina, Triumvira Immunologics, Inc., USA
Learning objectives:
•      Understand current FDA guidances for genetically-modified cell therapies
•      Review implications of draft guidances
•      Future considerations for clinical development