Program
| 8:00 am | Introduction To The Opportunity | |||
Welcome and introduction |
||||
| Chand Khanna (10 minutes) | ||||
Obstacles in the cancer drug development path |
||||
| Lee Helman(15 minutes) | ||||
Framing the data to address expectations |
||||
| Steven Hirschfeld (15 minutes) | ||||
Questions(5 minutes) |
||||
| 8:45 am | Session I - Human Pre-Investigational New Drug Studies | |||
| Moderator: Laurence Baker, Southwest Oncology Group |
||||
| Targeted delivery of TNF-? to tumor associated vasculature through the RGD motif
concept and preclinical development in murine models(15 minutes) |
||||
| Steve Libutti MD, Surgery Branch, CCR - NCI | ||||
| Validation of safety, targeting and activity in dogs with solid tumors(15 minutes) |
||||
| Melissa Paoloni, DVM, Comparative Oncology Program, CCR - NCI | ||||
Questions(5 minutes) |
||||
| In what ways can dogs with cancer inform the development of agents that are first
in class?(15 minutes) |
||||
| Wendy Levin, Pfizer | ||||
| Establishing pharmacokinetic, pharmacodynamic, efficacy correlations in dogs
with cancer(15 minutes) |
||||
| Cheryl London, DVM, PhD, Ohio State University | ||||
Questions(5 minutes) |
||||
Discussion: Human Pre-Investigational New Drug Studies(10 minutes) |
||||
| 10:05 am | Break | |||
| 10:15 am | Session II - Human Post-Investigational New Drug Studies | |||
| Moderator: Claudina Stevenson, Novartis |
||||
| Rapamycin and rapalogs in patients with sarcoma(15 minutes) |
||||
| Laurence Baker DO, Southwest Oncology Group | ||||
| Translation and integration: Studies of rapamycin in dogs with osteosarcoma(15 minutes) |
||||
| Chand Khanna DVM, PhD National Cancer Institute Questions(5 minutes) |
||||
| Human development path(15 minutes) |
||||
| Daniel Tumas, Gilead Pharmaceuticals Inc. | ||||
| Correlation of PK, PD, efficacy and imaging in dogs with lymphoma(15 minutes) |
||||
| David Vail, DVM, University of Wisconsin-Madison Questions(5 minutes) Discussion: Human Post-Investigational New Drug Studies(10 minutes) |
||||
| 11:35 am | Session III - Early Device Evaluation | |||
| Moderator: David Vail, University of Wisconsin |
||||
| Tomotherapy treatment plan evaluation and validation in dogs with head and neck cancer(15 minutes) |
||||
| Lisa Forrest DVM, University of Wisconsin-Madison | ||||
| Imaging as a biomarker: Importance of image quality in translational research(15 minutes) |
||||
| Robert Jeraj PhD, University of Wisconsin-Madison Questions(5 minutes) Discussion: Early Device Evaluation(10 minutes) |
||||
| 12:20 pm | Lunch | |||
| 1:00 pm | Session IV - Preclinical Biomarker Evaluation | |||
| Moderator: Carolyn Buser-Doepner, Merck |
||||
| The benefits and challenges in using circulating endothelial precursor cells as a
cellular biomarker to determine the optimal biological dose of antiangiogenic
drugs(15 minutes) |
||||
| Yuval Shaked PhD, University of Toronto | ||||
| Studies of angiogenesis inhibitors in dogs with naturally occurring cancers(15 minutes) |
||||
| Anthony Mutsaers DVM, University of Toronto Questions(5 minutes) Discussion: Preclinical Biomarker Evaluation(10 minutes) |
||||
| 1:45 pm | Session V - Before and Beyond Phase I and Future Trial Designs | |||
| Moderator: Dan Theodorescu, University of Virginia |
||||
| Phase 0 trials in cancer drug development(15 minutes) |
||||
| Joseph Tomaszewski, NCI, DCTD | ||||
| Informing human clinical trials beyond Phase I ((15 minutes) |
||||
| Doug Thamm, DVM, Colorado State University Questions(5 minutes) Discussion: Beyond Phase I and Future Trial Designs(10 minutes) |
||||
| 2:30 pm | Session VI - A Path Forward Setting an Agenda-Open Discussion | |||
| Moderators: Joseph Tomaszewski, Steven Hirschfeld, Chand Khanna |
||||
