What Is the Future Role of Predictive Safety Biomarkers in Drug Development?

Abstract

Introduction

Predictive safety biomarkers are categorized by their target action - predicting drug toxicity, selecting patients for treatment, or predicting treatment effi cacy. Increasingly, diagnostics developers and pharmaceutical companies are collaborating on biomarker identifi cation and validation. The role of predictive safety biomarkers in the drug development paradigm is essential in today' s cautious and budget-sensitive environment because pharmacogenomic biomarkers are paramount to informing decisions of patient eligibility for drug treatment, potential toxicities, and drug dosages.

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• Many, but not all, available biomarker-based tests that predict safety have been approved by the FDA. Do physicians use non-FDA-approved tests? What challenges do the marketers of approved diagnostic tests still face?
• Approximately 50% of NMEs are estimated to have a biomarker element also in development. What does this mean for biomarkers that inform decisions regarding patient eligibility for drug treatment, potential toxicities, and drug dosages?
• Demonstrating the clinical utility of predictive safety biomarkers could be advantageous. How does clinical utility evidence infl uence reimbursement for a biomarker-based test?
• Monitoring mutations in the KRAS gene - a key predictive safety biomarker - determines response to certain therapies for select cancers. What is the future impact of this safety biomarker and other key markers on drugs and diagnostics in development market?

Scope

• Predictive biomarkers and diagnostic tests: drug development process, key reimbursement issues, and marketability.
• Case study on the utility of predictive safety biomarkers in the postmarketing setting: warfarin metabolism testing environment, lessons learned, and future impact.
• Codevelopment strategies to explore: drug-diagnostic codevelopment in HIV and oncology.
• Current applications: CLIA-laboratories and select companies in the fi eld, using predictive safety biomarkers to select patients for non-small-cell lung cancer and colorectal cancer therapies.
• Future role of predictive biomarkers: impact of KRAS gene, use of FDA guidance, and generating interest and support through consortia.

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Companies and Organizations

• Affymetrix
• Amgen
• AstraZeneca
• AutoGenomics
• Bristol-Myers Squibb
• Cepheid
• Chugai
• Clarient Diagnostic Services
• Clinical Data
• Dako
• Dana Farber Cancer Institute
• Defi niens
• Delphic Diagnostics
• DxS Diagnostics Innovations
• Genelex
• Genentech
• Genomic Health
• Genzyme Genetics
• GlaxoSmithKline
• ImClone
• Innate Pharma
• Kimball Genetics
• Luminex Molecular Diagnostics (formerly Tm Biosciences)
• Merck KGaA
• Moffi tt Cancer Center
• Monogram Biosciences
• Nanosphere
• NeoGenomics
• Novartis
• Oasis Diagnostics
• OSI
• Osmetech Molecular Diagnostics
• Paragon Dx
• Pfi zer
• Prediction Sciences
• Response Genetics
• Rules-Based Medicine
• Third Wave Technologies
• Verigene
• ViennaLab Diagnostics