Presenter: Keith Wonnacott
Keith Wonnacott discusses information that is needed to prepare an investigational new drug application for a cellular therapy product.
Presentation and Survey
Introduction and Scope of OCTGT
Presenter: Patrick Riggins. Patrick Riggins introduces the Office of Cellular, Tissue and Gene Therapies and provides a scope of what the office does.
IND Basics in OCTGT
Presenter: Patrick Riggins. This presentation looks at the basics of IND submission in OCTGT.
Sponsor Meetings with OCTGT
Presenter: Lori Tull. Lori Tull describes various sponsor meetings with OCTGT.
"361" Human Cells, Tissues, & Cellular and Tissue Based Products[ARCHIVED]
Presenter: Samuel Barone. In this presentation, Samuel Barone describes what HCT/Ps are and how they are regulated.
The Chemistry, Manufacturing and Controls (CMC) Section of a Gene Therapy IND[ARCHIVED]
Presenter: Andrew Byrnes. In this presentation, Andrew Byrnes explains the basics of how to put together the CMC section of a gene therapy IND, particularly for Phase 1 trials.
Advanced Topics: Successful Development of Quality Cell and Gene Therapy Products
Presenter: Denise Gavin. Denise Gavin aims to guide manufacturers toward successful development of quality cell and gene therapy products, in this presentation.
Cellular Therapy Products
Presenter: Keith Wonnacott. Keith Wonnacott discusses information that is needed to prepare an investigational new drug application for a cellular therapy product.
Preclinical Considerations for Products Regulated in OCTGT
Presenter: Allen Wensky. Allen Wensky provides a basic overview of preclinical considerations that make up one of the three key elements of an IND submission.