Biological Reseources Branch (BRB)

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.

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
• Patricia Keegan, M.D.: Critical Path Initiatives
• Eda T. Bloom, Ph.D.: RAID Training for Investigators: Product and Regulatory Overview

Practical and Organizational Issues for PI-Initiated Projects
• Stephen Creekmore, M.D., Ph.D.: Factors in the Development of Academic GMP Projects: Looking Beyond the FDA
• Donna L. Bialozor: NCI Technology Transfer Branch: RAID, Intellectual Property, and Technology Transfer Agreements

Regulatory Requirements and Recommendations
• Keith Wonnacott, Ph.D.: What is an IND?
• Karen D. Jones, Ph.D.: IND Regulatory Requirements and Recommendations

Major Clinical and Scientific Components of the IND

Preclinical and Nonclinical Testing
• Anne M. Pilaro, Ph.D.: Nonclinical Safety Testing for Biological Therapeutics for Cancer Treatment
• Ying Huang, Ph.D.: Perspective on Pharm/Tox Assessment for Cell and Gene Therapy Products

Clinical Trials
• An Introduction to FDA’s Clinical Trial Review
• Hong Zhao, Ph.D.: RAID Investigator Training – Clinical Trial Section II May 2007

Manufacturing
• Dan Takefman, Ph.D.: Manufacturing of Cellular & Gene Therapies: Ensuring Product Safety and Quality
• Ingrid Markovic, Ph.D.: Chemistry, Manufacturing and Control Issues in Production of Therapeutic Biologic Protein Products

Case Studies: The Good, the Bad, and the Ugly
• Deborah Lavoie, J.D., RAC: IND Case Studies
• Karen D. Jones: IND Case Studies

National Cancer Institute

National Institutes of Health

Health and Human Services

USA.gov

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