Monday, June 4
12:00 pm Conference Registration
1:25 Chairperson’s Opening Remarks
Hartmut Koeppen, M.D., Ph.D., Staff Pathologist, Genentech
» 1:30 Keynote Presentation: Pathology Contributions to Pharma R&D: Enabling Key Intersections between Scientific Discovery and Tissue Diagnostics
 John Lowe, M.D., Senior Director of Pathology, Genentech
Physicians increasing depend on biomarkers to prospectively treat patients with specific therapeutics most likely to yield a response. An overview will be presented of how pathologists, and the infrastructure they manage, contribute to the development of tissue-based biomarkers by integrating scientific efforts in early drug discovery with the design and execution of clinical trials where new drug candidates are tested.
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2:00 Characterization and Clinical Validation of an Immunohistochemical Assay for MET in NSCLC
Hartmut Koeppen, M.D., Ph.D., Staff Pathologist, Genentech
We developed and validated an immunohistochemical assay to detect MET in paraffin-embedded tissue sections. This assay was used to analyze a phase II clinical trial evaluating onartuzumab, a one-armed anti-Met antibody, plus erlotinib vs erlotinib alone in advanced NSCLC patients. Scoring criteria for MET expression were pre-specified prior to unblinding of clinical data. A statistically significant benefit in progression-free (Hazard ratio=0.53, 95% CI=0.28-0.99, p=0.04) and overall (Hazard ratio=0.37, 95% CI=0.19-0.72, p=0.002) survival was observed for patients with Met-positive tumors treated with onartuzumab.
2:30 Chasing the Holy Grail - Towards Pathway Analysis of Circulating Tumor Cells
Arndt Schmitz, Ph.D., Senior Scientist, Global Biomarker Research, Bayer Pharma AG
Circulating tumor cells (CTC) promise to enable less invasive and longitudinal determination of the current status of the systemic disease. Biomarker research on CTC requires compliant access to relevant, high quality clinical specimens. Currently, 2nd generation CTC isolation techniques with increased yield and purity are emerging. Bayer is working with Prometheus to use their CEER chip technology for functional pathway analysis in tumor tissues. This presentation will provide an update regarding our ongoing efforts to combine these two approaches into a powerful tool for personalized medicine.
3:00 Integrating Data Mining with Image Analysis to Accelerate Tissue-based Biomarker Research
Alan Jerusalmi, Ph.D., Senior Consultant, Definiens, Inc.
In many applications Definiens image analysis has proven to deliver unsurpassed detection of target structures in histology resulting in detailed cell-by-cell readouts of morphology and molecular expression profiles. Tightly integrating data mining with image analysis and maintaining the linkage between data points and target structures in digital slides allows to significantly accelerate the development and the validation of biomarkers, opens up completely new research approaches, supports new assay types and can be used for predictive modeling. The talk will give an overview about workflows, technology and use cases.
3:30 Refreshment Break with Exhibit & Poster Viewing
4:00 Nuclear Heat-Shock Factor 1 (HSF1) as a Predictor of Poor Prognosis in Breast Cancer.
Tan A. Ince, M.D., Ph.D., Associate Professor, Pathology; Director, Tumor Stem Cell Division; Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine
We found that HSF1 is associated with reduced breast cancer survival. The findings indicate that HSF1 should be evaluated prospectively as an independent prognostic indicator in ER-positive breast cancer. HSF1 may ultimately be a useful therapeutic target in cancer.
4:30 mTOR Pathway in Urologic Malignancies: A Therapeutic Target and a Potential Progonsticator
George Netto, M.D., Associate Professor,Pathology, Urology and Oncology, Johns Hopkins University School of Medicine
The role of mTOR pathway members in solid tumors development has come into focus. Urologic malignancies including prostate, bladder and renal carcinomas account for approximately one third of human malignancies. A promising prognostic role for some of the pathway members such as PTEN has been proposed in prostate cancer and potentially bladder cancer. The pathway is now successfully used as a target of therapy in clear cell renal cell carcinoma and being evaluated in other urologic malignancies.
5:00 Welcome Reception with Exhibit & Poster Viewing
6:00 CLOSE OF DAY ONE
