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Assessing the Opportunities and Challenges in Commercializing Companion Diagnostics and Targeted Therapies
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.
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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
Genomics
Introduction to genomics
Mechanisms of gene modification, regulation and expression
Methylated Gene (meDNA) Patterns
RNA
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
Proteomics
Introduction to proteomics
Proteins
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
Tarceva
Xeloda
MabThera/Rituxan
Avastin
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
J&J
Novartis
Pfizer
Roche
GSK
Merck
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
Medicare
Medicaid
NICE
Chapter 9 Personalized Medicine Therapeutic Applications
Drug Metabolism: The Cytochrome System
CYP2D6
CYP2D6 polymorphic variations
Ultra rapid metabolizers
CYP2C19
CYP3A
CYP2C9
Oncology
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
Taxanes/anthracyclines
Biologicals
Herceptin
Triple Negative breast cancer
Colorectal cancer
Introduction to Colorectal cancer
Epidemiology of Colorectal cancer
Colorectal Cancer Biomarkers
Prognostic tests
Predictive tests
Erbitux
Panitumumab
Lung cancer
Introduction to Lung Cancer
Epidemiology of Lung cancer
Lung Cancer Biomarkers
EGFR
Avastin
Tarceva
Iressa
Erbitux
CVS
CVD
Asthma
COPD
Indoctoral P2 Norvartis
Beta adrenergic receptor
RAS polymorphisms
Pgp
Thiazides
825T allele
Statins
CNS
Improved diagnosis and follow up tools
Alzheimer’s disease
Introduction to Alzheimer's disease
Epidemiology of Alzheimer’s
Alzheimer’s Biomarkers
APOE4
Parkinson’s disease
Intro to Parkinson’s disease
Epidemiology of Parkinson’s disease
Parkinson’s Biomarkers
Depression
Introduction to Depression
Epidemiology of Depression
Pristiq Wyeth
Schizophrenia
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
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