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

Jun 29, 2010, 07:29 ET from Reportlinker

NEW YORK, June 29 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

Personalized Medicine 2010: Assessing the Opportunities and Challenges in Commercializing Companion Diagnostics and Targeted Therapies

Report Description

The era of Personalized Medicine is set to revolutionize the healthcare industry. As our knowledge of genetics and molecular biology rapidly expands, a personalized approach to medical care is becoming increasingly important. Not only does this paradigm promise to improve an individual's treatment outcome and reduce healthcare expenditure, personalized medicine is set to transform the pharmaceutical/biotechnology and companion diagnostic markets. Arrowhead's Personalized Medicine 2010 report provides an in-depth assessment of this burgeoning market, and examines the major challenges that need to be overcome to maximize success.

Key features of Arrowhead's Personalized Medicine 2010 include:

* Case studies of leading pharmacogenomic products

* Analysis of the personalized medicine market, including seven major market sales forecasts to 2016

* Regulatory and legal issues surrounding personalized medicine

* Payer reimbursement challenges

* Marketing strategies to capitalize profits

* Survey results from key opinion leaders across the life sciences industry

Key questions answered by Arrowhead's Personalized Medicine 2010 include:

* What are the major challenges in this market and how can these be overcome?

* How will pharmacogenomics transform clinical trials?

* What are the leading pharmacogenomic products on the market?

* Who are the key players involved in the market and what strategies are they using to enhance product performance?

* What pharmaceutical/biotechnology and diagnostic companies are seeking alliances in 2010?

* How can company alliances maximize commercial success?

Table of Contents

Chapter 1 Executive Summary

Scope of Personalized Medicine: Market Trends and R&D Insights

Methodology of Personalized Medicine: Market Trends and R&D Insights

Key challenges in the commercialization of personalized Medicine

Overview of current therapeutic applications of personalized Medicine

Market Potential of personalized Medicine

Strategic Implications of personalized Medicine

Chapter 2 Introduction to Personalized Medicine

How bio-molecular advances have influenced changes in the healthcare industry

What is personalized medicine?

What are pharmacogenomics and pharmacogenetics?

The history of personalized Medicine…the story so far

Timeline of Personalized Medicine

Why are personalized Medicine important?

Population and disease-based bio-banks

Increasing healthcare costs

The aging population

Rising R&D expenditure

Long development time

High risk venture for drug development companies

Personalized approach versus current treatment strategy…a patient case study

Increased efficacy

Reduced toxicity

Reduced hospitalization

Putting Personalized Medicine into Practice …a case study of CYP2D6

Chapter 3 Overview of Genomics and Proteomics


Introduction to genomics

Mechanisms of gene modification, regulation and expression

Methylated Gene (meDNA) Patterns


Transcription Factors

Circulating Cell-free nucleic acids

Identification of the human genome

The Human Genome Project

The International HapMap Consortium

CDC and the development of the Centers for Genomics and Public Health

Genomic Research into Genetic Polymorphisms

Single Nucleotide Polymorphisms (SNPs)

The SNP Consortium

Companies and academic centers involved in the SNP Consortium


Introduction to proteomics


From genes to proteins

The human genome versus the proteome

The relationship between the proteome and the genome

Widespread genotyping and the creation of a genetic database

The pharmacogenetics knowledge base (PharmaGKB)

Chapter 4 Overview of Pharmacodiagnostics (IVDs)

Predictive diagnostics

Roche AmpiChip P450 Test

Prognostic diagnostics

Pharmacogenetic testing





The Importance of Tissue banking…focus in oncology

Regulators response to emerging diagnostics

Chapter 5 Personalized Medicine R&D Optimization

Overview of standard clinical trials

Biomarkers for Personalized Medicine clinical trials

What are biomarkers?

Biomarkers of response

Biomarkers of Efficacy and 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







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

NIH Research Tools Policy

NIDDK model

FDA Pharmacogenetic approval for marketed drugs

EU Regulation

EMEA Pharmacogenomic submissions

EMEA Labeling and recommendations

EMEA Pharmacogenetic approval for marketed drugs

Japan Regulation

Global Personalized Medicine Harmonization: ICH

The Interdisciplinary Pharmacogenomic Review Group (IPRC)

Chapter 7 Personalized Medicine Ethical Issues

Informed consent

Electronic medical record standards

Adoption of electronic health records and healthcare IT (HIT)

Protection of medical records and privacy

Nuffield Council on Bioethics

Equitable distribution of benefits

Prevention of discrimination

Administration of personalized Medicine

Limited to wealthy individuals/markets

Race issues BiDiL

Lack of Asian and African Research

Cost of genotyping

Guidelines for genetic screening

National Society of Genetic Counselors Guidelines for genetic testing

NSGC Recommendations for protocols relating to predisposition genetic testing

Chapter 8 Personalized Medicine Legal and Reimbursement Issues

Intellectual Property Issues

US Patent and Trade Office (USPTO)

SNP Consortium

Payer reimbursement




Chapter 9 Personalized Medicine Therapeutic Applications

Drug Metabolism: The Cytochrome System


CYP2D6 polymorphic variations

Ultra rapid metabolizers





9.2.1 Breast cancer

Introduction to breast cancer

Epidemiology of breast cancer

Breast cancer Biomarkers

Prognostic tests

MammaPrint 42

Oncotype DX

Predictive Tests

Hormonal therapies




Triple Negative breast cancer

Colorectal cancer

Introduction to Colorectal cancer

Epidemiology of Colorectal cancer

Colorectal Cancer Biomarkers

Prognostic tests

Predictive tests



Lung cancer

Introduction to Lung Cancer

Epidemiology of Lung cancer

Lung Cancer Biomarkers










Indoctoral P2 Norvartis

Beta adrenergic receptor

RAS polymorphisms



825T allele



Improved diagnosis and follow up tools

Alzheimer's disease

Introduction to Alzheimer's disease

Epidemiology of Alzheimer's

Alzheimer's Biomarkers


Parkinson's disease

Intro to Parkinson's disease

Epidemiology of Parkinson's disease

Parkinson's Biomarkers


Introduction to Depression

Epidemiology of Depression

Pristiq Wyeth


Intro to Schizophrenia

Epidemiology of Schizophrenia

Schizophrenia Biomarkers

DAAO D-amino acid oxidase

Atomoxetine Strattera Eli Lilly ADHD

Chapter 10 Market Potential of Personalized Medicine

The end of the blockbuster? …Niche/ Orphan drug status markets and its benefits

Minimize failures of late-stage candidates

Cheaper drug development

Reviving Failed Drug Candidates

Expanding Indications for Launched Drugs

Arrowhead's Personalized Drug Revenue Forecast 2004-2019

Chapter 11 Personalized Medicine Strategic Implications

An Interdisciplinary challenge...The Personalized Medicine Coalition Recommendations

Pharma Strategies

Biotech Strategies

Pharmacodiagnostic strategies

Company Alliances are fundamental

Independent biotech companies are driving the personalized medicine revolution

Successful Alliances

To order this report:

Diagnostics Industry: Personalized Medicine 2010: Assessing the Opportunities and Challenges in Commercializing Companion Diagnostics and Targeted Therapies

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Nicolas Bombourg



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