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Reportlinker Adds Personalized Medicine 2010: Assessing the Opportunities and Challenges in Commercializing Companion Diagnostics and Targeted Therapies
Date:6/29/2010

dose

Safety biomarkers

Preclinical safety biomarkers

Clinical safety biomarkers

Implementing a biomarker strategy

Development of biomarkers

Biomarkers as clinical end points

Validating biomarkers with regulators

Biomarker Programs Created by Pharma

Novartis

Personalized Medicine and the Optimization of R&D

Identify patients to give maximum efficacy (responders versus non-responders)

Predict Adverse Drug Reactions and Identify genotypes correlating to Adverse Drug Reactions

Develop targeted drugs for specific genetic disorders

Identify patients at different stages of a disease

Monitor clinical responders in novel and comparator drugs to allow potential strategic alliances

Identify patients with drug resistance

Alter clinical trial paradigms

Intro of Phase 0

End of Phase I and IIA

Adaptive Phase IIB and Phase III

Phase IV

Cheaper drug development

Chapter 6 Personalized Medicine Regulatory Issues

US Regulation

FDA Pharmacogenomic submissions

FDA Labeling and recommendations

FDA Voluntary Genomic Submissions Program

Critical Path by FDA


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