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PRE-CONFERENCE EVENTS - Tuesday, March 25

Overview   |   Full Day   |   Morning   |   Afternoon

AFTERNOON SHORT COURSES

(SC6) CIRCULATING TUMOR CELLS
Moderator: Minetta C. Liu, M.D., Assistant Professor of Medicine and Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Hospital

Insights into the Biology of Circulating Tumor Cells
John W. Park, M.D., Associate Professor, Medicine, University of California, San Francisco

Circulating Tumor Cell Applications in the Pre-Clinical Phase of Drug Development
Gerald V. Doyle, DDS, MS, Senior Director, Clinical Research, Immunicon Corp.

CTCs: A Reliable Assessment of Treatment Efficacy in Metastatic Breast Cancer
Minetta C. Liu, M.D., Assistant Professor of Medicine and Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Hospital

Clinical Utility of CTCs for Prostate Cancer
Howard I. Scher, M.D., D. Wayne Calloway Chair in Urologic Oncology, Chief, Genitourinary Oncology Service, Department of Medicine, Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan-Kettering Cancer Center

(SC7) CANCER STEM CELLS
Chairperson:
Craig T. Jordan, Ph.D., Director, Hematologic Malignancies Translational Research Program, James P. Wilmot Cancer Center and Associate Professor of Medicine, University of Rochester School of Medicine

  • Techniques for isolating cancer stem cells

  • Methods to characterize cancer stem cells

  • Approaches for developing anti-cancer stem cells compounds

2:30 Characterization and Targeting of Leukemia Stem Cells
Craig T. Jordan
Malignant stem cells have recently emerged as a major factor in the genesis and perpetuation of several types of cancer. This phenomenon is particularly well characterized for the blood cancer leukemia. This presentation will provide a general overview of leukemia stem cell biology with a particular emphasis on features relevant to therapy. Strategies for selective targeting of leukemia stem cells will be discussed and future objectives/directions will be proposed.

3:05 “Cancer Stem Cells” in solid epithelial tumors: working definition and implications for patient prognosis
Piero Dalerba, Ph.D., Stanford Institute for Stem Cell Biology and Regenerative Medicine, Stanford University
A growing body of evidence is increasingly lending support to the concept that cancer can be studied and modeled as a stem-cell disease. This hypothesis is supported by the observation that only a phenotypic subset of cancer cells, usually termed “cancer stem cells” (CSC), is capable of initiating tumor growth when transplanted into immunodeficient mice. Research in our laboratory focuses on the study of human CSC in solid epithelial tumors and recently led to two major advancements: 1) we were able to extend the CSC model to the study of human colorectal cancer, developing a very robust protocol for isolation of human colorectal CSC (Co-CSC), based on a novel set of three independent surface markers (EpCAM/CD44/CD166); 2) by analysis of the gene-expression profile of human “breast cancer stem cells” (Br-CSC), we were able to identify a gene-expression signature that could be used to stratify breast cancer patients into different prognostic categories, thus providing the first evidence of the potential clinical implications of human CSC isolation.

3:40 Break

3:55 Identification of Stem Like Cells in Bone Sarcomas
Dr. C. Parker Gibbs, Associate Professor, Orthopaedics, University of Florida
Cancer stem cells have been implicated in the pathogenesis of several malignancies including leukemia and epithelial cancers. However, their role in mesenchymal solid tumors is much less understood. This presentation will focus on the identification and role of cells in bone sarcomas that appear to utilize the machinery of mesenchymal and embryonic stem cells to facilitate their malignant potential. Possible therapeutic intervention relative to this concept will be discussed.

4:30 Characterizing Brain Tumor Stem Cells in Man and Mouse
Peter B. Dirks, Ph.D., Scientist & Principal Investigator, Neurosurgery, Hospital for Sick Children
Brain tumors, in humans and in some mouse models, are organized as a functional hierarchy with growth dependent on relatively rare cells that have stem cell properties. These brain tumor stem cells can be prospectively enriched by sorting for cell surface markers. Recently, we have used chemical biological screens to identify agents that suppress normal and brain tumor stem cell proliferation. These agents reveal
possible new drugs for human brain tumors and also suggest additional pathways that may regulate neural stem cells.

5:00 Panel Discussion: Is there Proof of Cancer Stem Cells in all Cancers?

(SC8) Models for Evaluating Drug-Drug Interaction Potential in PreClinical Development
Joseph Ware, Ph.D., Senior. Scientist, Late Stage PK/PD, Genentech, Inc.
James McKim, Ph.D., DABT, President & Chief Scientific Officer, CeeTox, Inc.
Philip S. Burton, Ph.D., Chief Executive & Scientific Officer, ADMETRx, Inc.
This course will cover:

  • An overview of drug-drug interactions from the clinical perspective, withdrawn drugs and the overall impact on development

  • CYP inhibition and induction methods and in vitro/ in vivo correlations

  • Transporter models and in vitro/in vivo correlations

(SC10) BEST PRACTICES FOR COMPILING A REGULATORY DOSSIER FOR REGULATORY BODIES IN INDIA: A HANDS-ON WORKSHOP
Brijesh Regal, C.E.O., Apothecaries Clinical Research, New Delhi, India (Former WHO Consultant to Drugs Controller General of India, and coordinated the development of Schedule Y)

  • In-depth understanding of regulations in general, and Schedule Y in particular, that prescribe documents for regulatory dossiers

  • Inventory and depth level of documents that need to go into the regulatory dossiers for various phases of clinical trials or for products registrations

  • Prescribed ICDs for clinical trials

  • Preparing documents to be submitted to ethics committees

  • Import and export regulations for clinical trial material

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