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Tuesday, March 8, 2016 Presentations

Quantitative Translational Approaches in Oncology Pre-conference

Chairs
Karen Rowland-Yeo, PhD, Certara, Waterford, CT
Karthik Venkatakrishnan, PhD, FCP, Takeda Pharmaceuticals, Cambridge, MA

Opening Slides
Closing Slides

Personalized Medicine
Razelle Kurzrock, MD, University of California San Francisco, San Diego, CA

PK/PD Efficacy Modeling of Combinations to Guide Scheduling and Sequencing
Sonya C. Tate, PhD, Eli Lilly and Company, Surrey, United Kingdom

Translational Safety Models in the Development of Oncology Compounds
Jay T. Mettetal, PhD, AstraZeneca, Waltham, MA

Dose Optimization by Safety Guided Titration Approaches: Axitinib as a Case Example
Yazdi K. Pithavala, PhD, Pfizer Global Research and Development, San Diego, CA

Therapeutic Drug Monitoring in Oncology Improves Patient Outcomes
Jeannine S. McCune, PharmD, University of Washington, Seattle, WA

Clinical Perspective: Immuno-Oncology
Suresh S. Ramalingam, MD, Emory University School of Medicine, Atlanta, GA

M&S Approaches for Immuno-Oncology
Amit Roy, PhD, Bristol-Myers Squibb, Plainsboro, NJ

Disease Models in Oncology: Optimizing Trial Designs to Maximize POS
Rene Bruno, PhD, Centara, Marseille, France

Special Considerations for Modeling Exposure-Response for Biologics
Yaning Wang, PhD, US Food and Drug Administration, Silver Spring, MD

PBPK-PD MODELING TO PROVIDE A TRANSLATIONAL RATIONALE BETWEEN DRUGS AND BETWEEN SPECIES: EXAMPLE OF TRAIL FUSION PROTEINS.
M. Block1, J. Jäger1, P. Mavroudis1, M. Hutt2, N. Pollak2, M. Siegemund2, O. Seifert2, R. Kontermann2, K. Pfizenmaier2, K. Dickschen1
1Bayer Technology Services GmbH, Leverkusen, Germany, 2Institute of Cell Biology and Immunology, University of Stuttgart, Stuttgart, Germany.

A JOINT MODEL RELATING CHANGES IN PROSTATE SPECIFIC ANTIGEN (PSA) TO SURVIVAL IN CASTRATE RESISTANT PROSTATE CANCER (CRPC).
T. H. Mai, E. Gray, M. R. Sharma; 
University of Chicago, Chicago, IL.

COMBINED POPULATION PK MODELING AND DISPROPORTIONALITY ANALYSES TO ASSESS THE ASSOCIATION BETWEEN KINASE INHIBITION AND ADVERSE EVENTS.
J. Liu1, G. Kim2, J. Xu2, A. McKee2, M. Hu3, T. Palmby2, L. Zhuang4, L. Zhao3
1Division of Clinical Pharmacology, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, 2Office of Hematology and Oncology Products, Office of New Drugs, CDER, US Food and Drug Administration, Silver Spring, MD, 3Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, CDER, US Food and Drug Administration, Silver Spring, MD, 4Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, US Food and Drug Administration, Silver Spring, MD.

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