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