| 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 |
|
|
