Pre-Conference Events

MONDAY, SEPTEMBER 13

10:00-11:00 am Registration for Pre-Conference Events

11:00 am - 2:00 pm Pre-Conference Short Course*

Fit-for-Purpose Biomarker
Assay Development and Validation

Course Instructors:

John L. Allinson, FIBMS, Vice President, Biomarker Laboratory Services, ICON Development Solutions

Viswanath Devanarayan, Ph.D., Director, Exploratory Statistics, Abbott Laboratories

This tutorial will provide recommendations on the “fit-for-purpose” best practices in the development and validation of biomarker assays for the intended exploratory or advanced biomarker applications. Strategies for different applications at various phases of biomarker development will be described. Key elements in the method development and validation will be illustrated with examples, including reference standard material, sample stability and collection integrity, validation and QC samples, validity of reference standards, calibration curve fitting methods, method optimization and method feasibility studies. The 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.

Outline:

• Introduction - Nomenclature, types of biomarker methods/assays, biomarker method development & validation road map, fundamental validity, similarity and differences from PK assays & diagnostic application
• Pre-analytical and bioanalytical elements: Target range, standards, validation & 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

*Separate Registration Required

11:00 am - 2:00 pm Executive Think Tank*

Strategies for Drug-Diagnostic
Co-Development

The Executive ThinkTank roundtable provides a facilitated discussion on key issues in co-development of drugs and diagnostics, allowing decision makers to share experience and brainstorm actionable solutions.

Discussion Facilitator:
Ruth E. March, Ph.D., Personalized Healthcare Leader, AstraZeneca

Discussion Topics Include:

• What regulatory guidance is needed for co-development of drugs and companion diagnostics?
• How to choose the right partner in the drug-diagnostic co-development program and manage the relationship?
• What is the best time line for development of a companion diagnostic?
• What is the ROI on personalized medicine programs?
• What are the incentives for collaboration for the pharmaceutical and diagnostics industries? How is each industry impacted by personalized medicine?
• What kind of clinical validation is required for targeted therapy programs?

*Separate Registration Required