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MONDAY, SEPTEMBER 17

7:30-8:00 Registration for Pre-Conference Workshop

8:00-3:00 Pre-Conference Workshop (separate registration required):

Biomarker Assay Development and Validation

8:00-12:00 Part I: Tutorial

FIT-FOR-PURPOSE BIOMARKER ASSAY DEVELOPMENT AND VALIDATION 

Instructors: Jean Lee, Ph.D., Scientific Director, PKDM, Amgen Inc.; and Viswanath Devanarayan, Ph.D., Director, Statistics, Biomarker Research, Abbott Laboratories
This tutorial will focus on the recommendations for the best practices in the development and validation of biomarker assay development, method validation and sample analysis, with special emphasis on assays where a reference standard material is available. First, an introduction to the concept of "Fit-for-Purpose" method validation, the different types of biomarker methods and data, and a broad roadmap to method development and validation will be provided. The key elements of fundamental validity to meet the objectives of exploratory biomarker studies will be discussed, including the basic requirements such as sample stability and collection integrity, validation and QC samples, calibration curve fitting methods, method optimization and method feasibility studies. The elements of more extensive assay validation ("advanced" validation) needed for the chosen biomarkers in pivotal studies will then be discussed. Finally, the recommendations for pre-study and in-study validation will be provided with case illustration.

Coverage Includes:

  • Introduction: Nomenclature, types of biomarker methods/assays, biomarker method development & validation roadmap, fundamental validity, similarity to PK assays and difference from diagnostic application 
  • Pre-analytical and Bioanalytical elements: Target range, standards, validation & QC samples, stability, matrix effect, 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 
  • Illustrations of pre-study validation and in-study validation (sample analysis) 

12:00-12:30 Lunch (provided)

12:30-3:00 Part II: Workshop

SELECTING THE BEST PLATFORM FOR BIOMARKER ASSAY

12:30-1:00 Comparison of Multiplex Platforms for the Analysis of Serum Biomarkers in Clinical Trials: In-house and Outsourced 
Carrie Brodmerkel, Ph.D., Assistant Director, Clinical Pharmacology and Experimental Medicine, Centocor R&D 
A variety of multiplex platforms are available for the measurement of serum biomarkers. We have compared platforms in-house (Mesoscale and Pierce Searchlight) and also assessed outsourcing of serum analyses using Rules Based Medicine and Pierce Searchlight. The validation process for these platforms is more complex than that required for single analyte ELISA. The validation processes and comparison of data across platforms will be used to illustrate how best to choose the platform to fit the analyses required rather than assuming a one platform fit for all analyses.

1:00-1:30 FDA Perspective on Development and Qualification of Biomarkers
Reena Philip, Ph.D., Scientific Reviewer, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, U.S. Food and Drug Administration
Qualification of biomarkers is a challenging issue that requires the development of correlative information that illustrates the biomarker's clinical meaning in a given situation. This process often begins with the development of standardized assay technology that is reproducible and accurate. This talk is intended to provide the current perspective of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA's Center for Devices and Radiological Health on the issues related to the qualification of biomarkers for use in clinical practice or medical product development.

1:30-2:00 Emerging Technology Platforms for Biomarker Assay Development in the Clinical Setting
Sunil Kadam, Ph.D, Research Advisor, Genomic Medicine, Eli Lilly and Co.
Circulating tumor and endothelial cell enumeration and characterization is rapidly becoming integrated into clinical protocols for the development of various oncolytic agents. Since the analysis of these rare cell-types must be conducted with 72 hours of sample collection, special analytical and logistical considerations are necessary for sample collection, handling and analysis. This talk will focus on the development and enablement challenges of such assays and provide guidance toward an approach to outsource the production of reagents and sample analysis.

2:00-2:30 Issues Related to Biomarker Analysis in Drug Development – the Laboratory Experience
John L. Allinson, FIBMS, Director, Veeda Clinical Research Ltd.
The talk will cover topics that have been experienced by the speaker over many years as a Laboratory Scientist and Manager working in Drug Development. It will focus on issues that have come to light in that time and which impact upon the drug development pathway – from safety and patient welfare, including potential misinterpretation of data, through to time and cost impact to the programme. These will demonstrate the impact of ensuring that all components from the laboratory perspective are important – not only choice of analytical platform, but staff knowledge and experience also. Case Studies will be used to show what effect the issues discussed can have – with both positive and negative outcomes. 

2:30-3:00 Panel Discussion With the Speakers: Biomarker Validation and Qualification
Discussion Questions Include:

  • What is "fit-for-purpose" validation? Biological vs. analytical validation? 
  • What is cost/benefit analysis of biomarker acceptance criteria? 
  • What are the best practices for validation of multiplex platforms? 
  • Do the same rules apply as for single analyte validations? 
  • Do biomarker assays need to be GLP or GLP-like? 
  • Can a multiplex approach used for development be translated to a diagnostic test? 
  • What is the current regulatory guidelines on validation of biomarker assays? 
  • What are the strategies to deal with normal variability? 
  • What are the differences in biomarker validation criteria for internal drug development decision making vs. diagnostic product?

11:30-12:00 Registration for Pre-Conference Workshop

12:00-3:00 Pre-Conference Workshop (separate registration required):

microRNA as Cancer Biomarkers

12:00-12:30 microRNAs: From Technology To Diagnostic and Therapeutic Applications
Dalia Cohen, Ph.D., Executive Vice President, Head, Research and Development, Rosetta Genomics

12:30-1:00 microRNAs and Other Non-coding RNAs as Diagnostic, Prognostic and Therapeutic Biomarkers in Human Cancers
George Calin, Ph.D., Assistant Professor, Molecular Virology, Immunology and Molecular Genetics, Ohio State University
MicroRNA and other non-codingRNAs alterations are involved in the initiation and progression of human cancer. The causes of the widespread differential expression of miRNA genes in malignant compared with normal cells can be explained by the location of these genes in cancer-associated genomic regions, by epigenetic mechanisms and by alterations in the microRNA processing machinery. microRNA and other non-codingRNAs expression profiling of human tumors has identified signatures associated with diagnosis, staging, progression, prognosis and response to treatment. In addition, profiling has been exploited to identify microRNAs genes that may represent downstream targets of activated oncogenic pathways or that are targeting protein coding genes involved in cancer.

1:00-1:30 Networking Refreshment Break

1:30-2:00 microRNAs as Cancer Biomarkers in Human Clinical Specimens
Emmanuel Labourier, Ph.D., Director of Development, Asuragen Inc.
microRNAs are small regulatory biomolecules involved in processes as diverse as early development, cell proliferation and differentiation, apoptosis, and oncogenesis. Their unique biology and biophysical properties have quickly made these small RNA molecules promising candidates for therapeutic and diagnostic applications. Asuragen has pioneered the development of robust molecular methods for the characterization of microRNAs in clinical samples. Our results indicate that microRNAs can not only facilitate biomarker discovery in clinical specimens, but in due course, enable the development of better therapeutic strategies and diagnostic tools for cancer management.

2:00-2:30 Discovery of miRNA Cancer Biomarkers 
Søren Møller, Ph.D., Chief Scientific Officer, Vice President, R&D, Exiqon A/S
Abnormal expression of microRNAs (miRNAs) in cancer implies that these small ~22-nucleotide molecules play a role in oncogenesis. Therefore, miRNAs may constitute a novel class of biomarkers with diagnostic and prognostic potential. To identify new miRNAs biomarkers for breast cancer, we studied miRNA expression in breast cancer and normal adjacent tissue using a novel microarray platform based on locked nucleic acid (LNA). 

2:30-3:00 miRNAs: Cancer Biomarkers and Functional Regulators of Cancer Development 
Irena Ivanovska, Ph.D., Senior Research Biologist, Rosetta Inpharmatics, A wholly owned subsidiary of Merck & Co., Inc.
microRNAs (miRNAs) are small non-coding RNAs that regulate gene expression and function in tissue specification, cellular differentiation, and development of cancer. miRNAs may serve as biomarkers for disease prognosis or drug response, particularly due to their stability and abundance in clinical samples. Elucidation of the specific roles of miRNAs in tumor development will require a better understanding of their targets, a non-trivial task at present. We used microarray profiling and functional screening to identify targets and biological processes triggered by transfection of miRNAs into human cells. We demonstrate that several miRNAs coordinately regulate targets that act in concert to control cell cycle progression.

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