8:30-12:00 Pre-Conference Short Course*

(*Separate Registration Required)

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, Global 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 method development and validation will be illustrated with examples, including references to 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

9:00-12:00 Executive ThinkTank*

(*Separate Registration Required. Access is limited to delegates who are Management-level at pharmaceutical, diagnostic or biotechnology companies.)

Overcoming Challenges in Biomarker Implementation

Discussion Facilitator:
Geert J.C.M. Kolvenbag, M.D., Ph.D., Global Product Vice President, Oncology, AstraZeneca Pharmaceuticals, Inc.

The Executive ThinkTank roundtable provides a facilitated discussion on key issues in biomarker implementation, allowing senior managers to share experience and brainstorm actionable solutions.

Discussion Topics Include:

• Which types of biomarkers should be developed at various stages in the drug pipeline?
• What strategies help translate biomarkers from preclinical to clinical development?
• What are the current obstacles in clinical implementation of biomarkers?
• How should pharma address drug-diagnostic co-development?
• What type of biomarker data should lead to terminating a target or a compound? What type of data should lead to increased investment in a compound?
• How should biomarker data be weighed against “traditional” safety and efficacy data? Can “general” toxicity biomarkers be re-used across programs?
• What level of validation is required for which types of decisions?
• What are the current biomarker “best practices” in place at big pharma?
• How to estimate and measure ROI on biomarkers?
• Which biomarkers should big pharma develop independently and which can be co-developed in a cost-sharing model as pre-competitive information?