NCI BRB Workshops
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.
Introductions
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
Manufacturing
Case Studies: The Good, the Bad, and the Ugly