Vaccines, Blood & Biologics
Resources for You
Welcome to OCTGT Learn, the Center for Biologics, Evaluation and Research's (CBER) Office of Cellular, Tissue and Gene Therapies (OCTGT) web page for industry education. CBER ensures the safety, purity, potency, and effectiveness of biological products, including vaccines and allergenics, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions, or injuries. OCTGT-regulated products include gene therapy, tumor vaccines, xenotransplantation, stem cells, human tissue for transplantation, combination products, bioengineered tissues and certain medical devices.
The presenters are OCTGT staff and therefore, as employees, have claimed no interests, financial or otherwise, with products that may be shown in any of the presentations.
OCTGT Learn Course List:
Listed below are the courses OCTGT currently offers. Additional online courses may be developed and will be posted upon completion.
You may submit suggestions for future courses to OCTGTLearn@fda.hhs.gov.
- Regulatory Obligations for Investigator-Sponsored Research (New)
Pat Holobaugh discusses the regulatory requirements for an investigator who is also a sponsor of an IND or IDE.
- Early-Phase Trials of Cellular and Gene Therapies (New)
Steve Winitsky discusses the clinical risks of cellular and gene therapy products, and reviews some considerations for the design of early-phase trials of these products.
- Pediatric Clinical Trials (New)
Steve Winitsky discusses the regulation and design of pediatric clinical trials.
- The Target Product Profile (New)
Bindu George presents the Target Product Profile (TPP) and describes how the TPP can facilitate product development.
- Fast Track (FT) for Products Regulated in OCTGT (New)
Bindu George discusses Fast Track requests and designation for OCTGT products, including cellular and gene therapies.
- IND Safety Reporting (New)
Bindu George provides basic information regarding the FDA safety reporting requirements for INDs.
- Data Monitoring Committees (New)
Ke Liu describes the history, establishment, operation, and responsibilities of Data Monitoring Committees (DMCs).
- Endpoint Assessment and Adjudication Committees (EAACs) (New)
Ke Liu presents situations when an EAAC is useful, discusses potential bias in endpoint assessment, and describes the EAAC charter and operation.
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
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
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.