Phase 0 Trials in Oncologic Drug Development

September 5, 2007
Natcher Conference Center, NIH
Bethesda, MD

Title/Presenter	Video	Power Point
Welcome
Dr. James H. Doroshow, NCI
The Exploratory IND Guidance
Dr. David Jacobson-Kram, FDA
Phase 0 Therapeutics Examples: Preclinical and Clinical Presentations
Dr. Joseph Tomaszewski, NCI
Dr. Shivaani Kummar, NCI
Herceptin as a Phase 0 Imaging Example
Dr. Steven Larson, Memorial Sloan-Kettering Cancer Institute
Panel: Clinical Trial Design/Biostatistics/Ethics/Recruitment
Phase 0 Trial Designs: How Do They Differ from First-in-Human Phase I Trials Dr. Anthony Murgo, NCI, Moderator
Biostatistics Dr. Larry Rubinstein, NCI
Phase 0 Trials: Ethical Considerations Dr. Holly Taylor, Berman Bioethics Institute
Dr. David Wendler, NIH		—
Phase 0 Trials from the Patient Side of the Desk Ms. Deborah Collyar, Patient Advocates in Research (PAIR)
Recruitment Experience in a Phase 0 Trial of ABT-888 in Patients with Advanced Malignancies Dr. Martin Gutierrez, NCI
Panel: Small Molecule Pharmacodynamics (PD) and Imaging —Models and Assay Development
Building Blocks of the DCTD Program in Clinical PD Dr. Ralph Parchment, SAIC, Moderator
Optimizing Tissue Collection for PD Assays Using Non-Clinical Models Dr. Melinda Hollingshead, NCI
Development of Assays for Use in Patient Response Measurement in Phase 0 Trials Dr. Robert Kinders, SAIC
Phase 0 Trials—Why Haven’t They Been Widely Adopted? Dr. Susan Galbraith, Bristol-Myers Squibb Company
Imaging to Guide Early Drug Trials Dr. David Mankoff, University of Washington
Panel: Regulatory Issues in Phase 0 Imaging
Introduction Dr. Jerry Collins, NCI, Moderator		—
Nuts and Bolts—You Too Can Prepare an IND Dr. Paula Jacobs, SAIC-Frederick, NCI
The Radioactive Drug Research Committee Approval Process for Tracer Use Dr. Anthony Shields, Karmanos Cancer Institute
From Regulations to Reality: Obtaining and Holding an IND at Your Institution Dr. Karen Kurdziel, Virginia Commonwealth University, NCI
Think Tank, Moderated Discussion
Dr. Joseph Tomaszewski, NCI, Moderator		—
Pharmacodynamic Paradigms in Early-Phase Cancer Clinical Trials
Dr. Hilary Calvert, Newcastle University, UK
Closing Summary
Dr. James H. Doroshow, NCI