9:00 am-12:00 pm Pre-Conference Short Course*

Fit-for-Purpose Biomarker Assay Development and Validation

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 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

9:00 am-12:00 pm Pre-Conference Executive ThinkTank*

Partnering Strategies in Drug-Diagnostic Co-Development

A facilitated discussion with decision makers from pharma and diagnostic companies provides an opportunity to brainstorm actionable solutions, discuss implementation strategies and learn from a group of peers.

Discussion topics include:

• What factors influence the pharma's choice of diagnostic partner (including IP considerations, diagnostics platform requirements, commercialization capabilities, etc.)?
• What are the advantages for pharma to develop in-house diagnostics vs. partnering with Dx companies?
• How to navigate the regulatory landscape for Rx-Dx co-development? What strategies can expedite approval of Rx-Dx product? What additional regulatory guidance is needed?
• What are the strategies to develop biomarker clinical development programs that lead to companion diagnostics? How to get both partners involved at early stages of drug development?
• What make a diagnostics company an attractive partner for co-development partnership? What are the benefits of IVD manufacturing capabilities and CLIA laboratory infrastructure in potential Dx partners?
• What are the different collaboration models in Rx-Dx co-development and what are the strategies in negotiating a successful collaboration agreement?
• What are the risks and benefits to both partners in the Rx-Dx co-development partnership? What strategies can minimize the risk for the Rx-Dx product development?
• What are the requirements from the diagnostics partner in assay development and validation?
• What are the strategies to get buy-in from payers, physicians and patients?

*Separate Registration Required