RAID CD MAIN MENU

Meeting Agenda (MS Word document)

Speaker Information (MS Word document)

SMIL and PowerPoint Presentations

Welcome

• Jerry M. Collins, Ph.D., Developmental Therapeutics Program, DCTD, NCI
  
• Raj K. Puri, M.D., Ph.D., Center for Biologics Evaluation and Research, FDA
  

Introductions

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

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
  (PPT document)
  
• Donna L. Bialozor: NCI Technology Transfer Branch: RAID, Intellectual Property, and Technology Transfer Agreements
  (PPT document)
  

Regulatory Requirements and Recommendations

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

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
  (PPT document)
  
• Ying Huang, Ph.D.: Perspective on Pharm/Tox Assessment for Cell and Gene Therapy Products
  (PPT document)
  

Clinical Trials

• Ke Liu, M.D., Ph.D.: An Introduction to FDA’s Clinical Trial Review
  (PPT document)
  
• Hong Zhao, Ph.D.: RAID Investigator Training – Clinical Trial Section II May 2007
  (PPT document)
  

Manufacturing

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

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

• Deborah Lavoie, J.D., RAC: IND Case Studies
  (PPT document)
  
• Karen D. Jones: IND Case Studies
  (PPT document)
  

Bibliography

Supplementary Materials

• NCI RAID Incoming Material Transfer Agreement (MS Word document)
• NCI RAID Outgoing Material Transfer Agreement (MS Word document)
• RAID Applicant Intellectual Property Report Form (PDF)