Last Updated: 07/07/08
Phase 0 Trials in Oncologic Drug Development
September 5, 2007
Natcher Conference Center, NIH
Bethesda, MD
| Title/Presenter | Video |
Power |
|
|---|---|---|---|
| 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 | |
|
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| From Regulations to Reality: Obtaining and Holding an IND at Your Institution | |||
| Dr. Karen Kurdziel, Virginia Commonwealth University, NCI | |
|
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| Think Tank, Moderated Discussion | |||
| Dr. Joseph Tomaszewski, NCI, Moderator | |
— |
|
| Pharmacodynamic Paradigms in Early-Phase Cancer Clinical Trials | |||
| Dr. Hilary Calvert, Newcastle University, UK | |
|
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| Closing Summary | |||
| Dr. James H. Doroshow, NCI | |
|
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