• Medical_Professionals
• Medical_students
• Nurses

John L. Allinson, FIBMS, Head, Biomarker Strategy, Drug Development Services, LGC Group
Viswanath Devanarayan, Ph.D., Global Head & Senior Research Fellow, Exploratory Statistics & Bioinformatics, AbbVie, Inc.

This tutorial will provide recommendations on the “fit-for-purpose” best practices in the development and validation of biomarker assays for exploratory or advanced biomarker applications. Strategies for different applications at various phases of biomarker development will be described. Key elements in the method of development and validation will be illustrated with examples, including reference to standard material, sample stability and collection integrity, validation and QC samples, validity of reference standards, calibration curve fitting methods, method optimization and feasibility studies. Special challenges in protein biomarker assays will be discussed, including strategies for moving from biomarker panels in the exploratory phase to the few markers chosen to support clinical trials, cross-validation of biomarker assays, etc.

Outline:

• Introduction: Nomenclature, types of biomarker methods/assays, method development and validation road-map, fundamental validity, similarity and differences from PK assays and diagnostic applications
• Pre-analytical and bioanalytical elements: Target range, standards, validation and QC samples, stability, matrix effect, specificity and relative selectivity
• Calibration curve model selection, evaluation and weighting
• Method feasibility and optimization with precision profiles
• Evaluation of some pre-study validation characteristics such as precision, bias, sensitivity and quantification limits
• Use of sample controls for in-study performance monitoring and conformance testing among laboratories
• Special considerations for multiplex assays, cross-validation of assays, etc.
• Method comparisons

John L. Allinson, FIBMS, Head, Biomarker Strategy, Drug Development Services, LGC Group

Jiri Aubrecht, Pharm.D., Ph.D., Senior Director and Safety Biomarker Group Lead, Drug Safety Research & Development, Pfizer

Nazneen Aziz, Ph.D., Chief Research Officer & Senior Vice President, Phoenix Children’s Hospital

Mark S. Boguski, M.D., Ph.D., Associate Professor, Center for Biomedical Informatics, Harvard Medical School

Darrell R. Borger, Ph.D., Director, Biomarker Laboratory, Massachusetts General Hospital and Harvard Medical School

Carrie Brodmerkel, Ph.D., Director, Immunology Biomarkers, Johnson & Johnson

Catherine Brownstein, Ph.D., Instructor, Pediatrics, Harvard Medical School and Boston Children’s Hospital

Kenneth Buetow, Ph.D., Director, Computational Sciences and Informatics Program for Complex Adaptive Systems; Professor, School of Life Sciences, Arizona State University

Michael E. (Ransom) Burczynski, Ph.D., Executive Director, Biomarker Technologies, Exploratory Clinical and Translational Research, Bristol-Myers Squibb

James Cai, Ph.D., Head, Data Science, Roche

Ken Chang, Ph.D., Clinical Assay Development & Outsourcing Lead, Merck

Clark Chen, M.D., Ph.D., Associate Professor and Chief, Stereotactic and Radiosurgery; Vice-Chairman, Academic Affairs, Neurosurgery, University of California, San Diego

Rong Chen, Ph.D., Director, Clinical Genome Informatics, Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai

Rajesh Chopra, M.D., Ph.D., Corporate Vice President, Translational Integration, Celgene

Seth Crosby, M.D., Director, Partnerships & Alliances, Washington University School of Medicine

Leticia De Mattos-Arruda, M. D., MSc, Research Fellow, Pathology, Memorial Sloan-Kettering Cancer Center

Viswanath Devanarayan, Ph.D., Global Head & Senior Research Fellow, Exploratory Statistics & Bioinformatics, AbbVie, Inc.

Brian Dougherty, Ph.D., Translational Genomics Lead, Oncology, AstraZeneca

Nicholas C. Dracopoli, Ph.D., Vice President, Janssen R&D, Johnson & Johnson

Paula Eason, Ph.D., Scientific Program Manager, Cancer Division of Research Partnerships, Foundation for the National Institutes of Health

Daniel Edelman, Ph.D., Core Manager, Clinical Molecular Profiling Core, National Cancer Institute, NIH

Kenneth Emancipator, M.D., Executive Medical Director, Molecular Biomarkers and Diagnostics, Merck Research Laboratories

Helen Fernandes, Ph.D., Associate Professor, Pathology and Laboratory Medicine, Weill Cornell Medical College

Andrea Ferreira-Gonzalez, Ph.D., Professor and Chair, Division of Molecular Diagnostics; Director, Molecular Diagnostics Laboratory, Department of Pathology, Virginia Commonwealth University

James M. Ford, M.D., Associate Professor, Medicine (Oncology) and Genetics; Director, Stanford Clinical Cancer Genomics Program, Stanford University School of Medicine

Yasuhiro Funahashi, Ph.D., Senior Director, Biomarkers and Personalized Medicine, Eisai

Birgit Funke, Ph.D., Assistant Professor, Pathology, MGH/Harvard Medical School; Director, Clinical Research and Development, Laboratory for Molecular Medicine, Partners HealthCare

Stephen T. Furlong, Ph.D., Safety Science Lead, AstraZeneca

Peter S. Gargalovic, Ph.D., Principal Scientist, Cardiovascular Drug Discovery Biology, Bristol-Myers Squibb

Jaya Goyal, Ph.D., Director, Translational Sciences, Value-Based Medicine, Biogen Idec

George A. Green IV, Ph.D., Group Director, Pharmacodiagnostic Center of Excellence, Bristol-Myers Squibb

Steven Gutman, M.D., Myraqa Strategic Advisor, Illumina, Inc.

Christos Hatzis, Ph.D., Assistant Professor, Medicine, and Director, Bioinformatics, Breast Medical Oncology, Yale University School of Medicine

Xiaolan Hu, Ph.D., Head, Clinical Genetics, Bristol-Myers Squibb

Chris Huang, Ph.D., Principal Scientist, Systems Pharmacology & Biomarkers, Immunology TA, Janssen R&D

Usman Iqbal, M.D., Senior Medical Affairs Leader, AstraZeneca

Shidong Jia, Ph.D., Scientist, Oncology Biomarker Development, Genentech

Bing-Hua Jiang, Ph.D., Professor, Pathology, Anatomy and Cell Biology, Thomas Jefferson University

Raghu Kalluri, M.D., Ph.D., Professor & Chair, Cancer Biology, MD Anderson Cancer Center

Ann Kapoun, Ph.D., Vice President, Translational Medicine, OncoMed Pharmaceuticals

Marc Ladanyi, M.D., William Ruane Chair in Molecular Oncology, Molecular Diagnostics Service and Human Oncology & Pathogenesis Program, Memorial Sloan-Kettering Cancer Center

Andrea H. Lauber, Ph.D., Executive Director, Business Development, Clinical Biomarkers and Pharmacodiagnostics, Bristol-Myers Squibb

USD

Group registrations not allowed

Accompanying persons not allowed

We don’t accept Online Abstracts

Loews Philadelphia Hotel

1200 Market Street, Philadelphia, PA 19107, USA

Submission Info

Cambridge Healthtech Institute encourages attendees to gain further exposure by presenting their work in the poster sessions. To secure a poster board and inclusion in the conference materials, your abstract must be submitted, approved and your registration paid in full by March 27, 2015. 

Register online, or by phone, fax or mail.  Please indicate that you would like to present a poster.  Once your registration has been fully processed, we will send an email with a unique link and instructions for submitting your abstract using our online abstract submission tool.  Please see below for more information. 

Reasons you should present your research poster at this conference: 

• Your poster will be presented to our international delegation 
• Receive $50 off your registration 
• Your poster abstract will be published in our conference materials 
• Your research will be seen by leaders from top pharmaceutical, biotech, academic and government institutes 

Note: Posters should be portrait orientation, with maximum dimensions of
36 inches wide (3 feet) x 48 inches high (4 feet). 

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