NCI BRB Workshops

NCI Immunotherapy Workshop

The workshop developed a ranked list of immunotherapeutic agents that are currently unavailable but have high potential for use in treating cancer. The proceedings (click here for presentation slides) were intended to inform other governmental agencies, nongovernmental funding agencies, industry, and individual investigators that these agents have broad appeal to the immunotherapy community. A report on the Proceedings of the Immunotherapy Workshop July 2007 is available here.

Working with FDA: Biological Products and Clinical Development

This workshop provides specialized training and information to investigators who plan to undertake clinical development of novel concepts such as cellular and gene therapies, therapeutic proteins, and vaccines. Documents and presentations contained herein provide education on scientific, technical, and regulatory requirements for product development and approval. The workshop is also part of the FDA’s “Critical Path Initiative,” the goal of which is to translate new concepts more rapidly and safely into clinical utility.


Practical and Organizational Issues for PI-Initiated Projects

Regulatory Requirements and Recommendations

Major Clinical and Scientific Components of the IND

Preclinical and Nonclinical Testing

Clinical Trials


Case Studies: The Good, the Bad, and the Ugly