NEW YORK, March 30 Reportlinker.com announces that a new market research report is available in its catalogue:
Combination Drug/Diagnostic Products and Other Applications of Personalized Medicine-Strategic Issues Facing Companies in this Market
The focus of this report is on drug/diagnostic combinations -- drugs used to treat patients, and on diagnostic tests that can provide information about how a patient may respond to treatment with that drug.
Personalized medicine has emerged as an important field for companies in both the pharmaceutical and the diagnostic industries. While many drugs in development and on the market today still follow the traditional approach where drugs are developed to treat all patients with a certain disease or condition, the "one-size fits all" approach, it is now widely recognized that not all drugs work equally well in all patients. Also, some percentage of patients experience adverse reactions, sometimes severe, to drugs while other patients experience few or no side effects.
Many different factors can affect how a patient responds to a particular drug. These factors can include the genetic makeup of the patient, genetic changes that occur with diseases such as cancer, as well as diet, age, environmental factors. Considerable interest exists in the identification of methods to determine which patients will respond well to a particular therapy and which patients are likely not to benefit from therapy as well as which patients are likely to experience adverse side effects from the therapy. This interest is leading the advancement of personalized medicine.
The term "personalized medicine" is a broad term that is defined somewhat differently by different people. Chapter 2 discusses various definitions of "personalized medicine" as well as different definitions for terms such as pharmacogenomics, pharmacogenetics, and other terms used in personalized medicine. Chapter 2 also briefly discusses the wide range of disease applications in which personalized medicine can be used, and technologies used in personalized medicine tests.
Chapter 3 discusses many examples of drug/diagnostic combinations currently available today for use in personalized medicine. Some combinations (such as testing for HER2 over expression in breast cancer before treating the patient with Herceptin) have been available for a number of years and are now widely used. Other examples of available drug/diagnostic combinations discussed in Chapter 3 are available, but are not necessarily widely used at this time. The largest number of personalized medicine tests are available for oncology drugs, although personalized medicine is already being applied to many different disease indications. Extensive tables in Chapter 3 provide information on diagnostic companies that market personalized medicine in vitro diagnostic (IVD) tests and/or test services through their own CLIA laboratory.
Chapter 4 highlights some aspects of the development of diagnostic and therapeutic products that apply to the filed of personalized medicine, but not necessarily to all diagnostic tests and drugs in development. This includes identification of biomarkers and validation of personalized medicine tests. This validation includes analytical validation, clinical validation, and validation of clinical utility or benefit. In addition, development and regulatory issues facing both therapeutic and diagnostic companies are discussed. Finally, Chapter 4 concludes with a section that discusses certain specific personalized medicine tests and why they either are, or are not, widely used at this time.
As with all emerging and rapidly changing fields, companies participating in this field face a number of different strategic issues. This is especially true for personalized medicine, where companies from two different market segments (diagnostics and pharmaceuticals) are both participating and must interact with each other. Selected strategic issues discussed in Chapter 5 include the need for more research and knowledge, models and options for pharmaceutical companies developing the drugs in drug/diagnostic combinations, models and options for diagnostic companies developing the tests in drug/diagnostic combinations, options for diagnostic companies for delivery of these tests, a number of aspects of health economics and reimbursement, intellectual property issues, and certain critical issues facing companies as they try to penetrate the market with newly developed personalized medicine products. Company perspectives on this market are discussed in Chapter 6.
Today, personalized medicine is a rapidly growing field with many pharmaceutical and diagnostic companies actively participating. As with personalized medicine drug/diagnostic combinations available today, the greatest focus of activity is in the field of oncology. Many different products in development programs in oncology are discussed in Chapter 7. In addition, Chapter 7 discusses personalized medicine products in R&D directed to a wide range of other disease indications. These indications include autism, autoimmune disease, cardiovascular disease, CNS disorders, HIV infection, osteoarthritis, osteoporosis, pain, type-2 diabetes, and others.
A number of pharmaceutical companies are now interested in personalized medicine. Since many of these companies do not have internal diagnostic divisions (or internal capabilities to develop and market diagnostic tests), this has led to a number of agreements between pharmaceutical and diagnostic companies. These agreements are discussed in the final section of Chapter 7, and 34 agreements are listed in Table 7-3. Of these, 14 agreements were made or announced in 2009, and another 3 agreements have been announced to date in 2010. It is likely that even more pharmaceutical/diagnostic company agreements have occurred recently. This activity demonstrates that companion diagnostics is a topic of interest to at least some pharmaceutical and biopharmaceutical companies.
The final chapter of this report, Chapter 8, includes interviews with executives at both pharmaceutical and diagnostic companies that are actively participating in personalized medicine. These experts in personalized medicine discuss the activities of their companies, the overall field of personalized medicine, and many of the issues facing companies in this field.
Overview of Personalized Medicine
2.1 What is Personalized Medicine? What are Drug/Diagnostic Combinations? Drug/Diagnostic Combinations
2.2 Selected Terms Used in Personalized Medicine
Other Terms Used in Personalized Medicine
2.3 Disease Applications in Personalized Medicine
2.4 Diagnostic Technologies Used in Personalized Medicine
SELECTED EXAMPLES OF PERSONALIZED MEDICINE AVAILABLE TODAY
3.1 Cytochrome P450
CYP2D6 Phenotype and Response to Tamoxifen
Cytochrome P450 Enzymes and Other Drugs
3.2 Estrogen Receptor and Progesterone Receptor Status and Hormone Therapy for Breast Cancer
3.3 HER2 Overexpression and both Herceptin and Tykerb - Tests for HER2 Overexpression Alone and in Combination with Other Biomarkers
3.4 Multi-Gene/Biomarker Tests for Determining Breast Cancer Prognosis and Treatment
Applied Genomics' MammoStrat
bioTheranostics' Theros Breast Cancer Index
Genomic Health's Oncotype DX
Ipsogen's MapQuant Dx Genomic Grade
3.5 Multi-Gene/Biomarker Tests for Determining Diagnosis, Prognosis and
Treatment of Other Cancers
Applied Genomics' PulmoType
Aureon Laboratories' Prostate Px
bioTheranostics' Theros CancerTYPE ID
Pathwork Diagnostics' Pathwork Tissue of Origin Test
3.6 Epidermal Growth Factor Receptor (EGFR)
Currently Available Therapies That Target EGFR
Testing for Expression of EGFR
Testing for EGFR Mutations
3.7 KRAS Mutations and Anti-EGFR Therapy for Colorectal Cancer
3.8 BRAF Mutations and Anti-EGFR Therapy for Colorectal Cancer
3.9 UGT1A1 Genetic Variants and Treatment with Camptosar (irinotecan)
3.10 DPYD and TYMS Variants and 5-Flurouracil Therapy
3.11 Biomarkers in Leukemia and Lymphoma
Gleevec and Other Tyrosine Kinase Inhibitors for Treatment of
Philadelphia Chromosome Positive CML
Philadelphia Chromosome and Busulfan
PML/RARalpha and Vesanoid (tretinoin)
Rituxan and Other Antibodies That Target CD20 Antigen for
Treatment of Lymphoma or Leukemia
Many Additional Biomarkers for Leukemia and Lymphoma
3.12 Personalized Medicine and HIV Therapy - Moving Beyond HIV Viral Load and Drug Resistance Testing
HLA-B*5701 Testing and Hypersensitivity to Abacavir
CCR5-Tropic HIV and Selzentry (maraviroc)
3.13 CYP2C9 and VKORC1 Variants and Warfarin Dosing
3.14 Thiopurine Methyltransferase and Metabolism of Thiopurine Drugs
3.15 Selected CNS Applications of Personalized Medicine
HLA-B*1502 and Carbamazepine
3.16 Selected Other Personalized Medicine Tests
DEVELOPMENT OF DRUG/DIAGNOSTIC COMBINATIONS/PERSONALIZED MEDICINE PRODUCTS
4.1 Identification of Personalized Medicine Biomarkers
4.2 Validation of Diagnostic Tests for Personalized Medicine
4.3 Development and Regulatory Issues Facing Diagnostic Companies in Personalized Medicine
4.4 Development and Regulatory Issues Facing Therapeutic Companies in Personalized Medicine
4.5 Selected Personalized Medicine Examples - What Tests are Used by Physicians?
Why Isn't Warfarin Sensitivity Testing Performed Routinely Now?
Screening for HLA-B*5701 Hypersensitivity to Abacavir
Genomic Health and Validation of OncoType DX
Agendia and Validation of MammaPrint
STRATEGIC ISSUES FACING PHARMACEUTICAL AND DIAGNOSTIC COMPANIES DEVELOPING PERSONALIZED MEDICINE PRODUCTS
5.1 Need for More Research and Knowledge
Biomarkers and Other Factors Influencing Response to Therapy
Validation Studies and Outcome Studies
Other Research and Information Needs
5.2 Models/Options for Pharmaceutical Companies Developing Drug/Diagnostic Combinations
5.3 Models/Options for Diagnostic Companies Developing
Personalized Medicine Tests - Test Development
5.4 Delivery of New Diagnostic Tests - IVD versus CLIA Laboratory
5.5 Health Economics, Reimbursement, and the Payers' Perspective
Health Economic Studies for Personalized Medicine Tests
Perspectives Expressed in Expert Interviews
Payer Perspectives and Policies
Medco Health Solutions
5.6 Intellectual Property Issues
5.7 Penetrating the Market
Does the Test Affect Physicians' Decisions?
Acceptance by Experts; Incorporation into Guidelines
COMPANY PERSPECTIVES ON PERSONALIZED MEDICINE
6.1 Potential Benefits, Risks, and Challenges for Biopharmaceutical and Pharmaceutical Companies
6.2 Potential Benefits, Risks, and Challenges for Diagnostic Companies
POTENTIAL OPPORTUNITIES FOR THE FUTURE
7.1 Tests in Development for Prediction of Breast Cancer Prognosis and Determining Treatment
Applied Genomics (Subsidiary of Clarient)
Prediction Sciences and Clarient
Additional Tests in Development for Prediction of Breast Cancer
Prognosis and Determining Treatment
7.2 Tests in Development for Determining Prognosis and Treatment of Other Cancers
Applied Genomics (Subsidiary of Clarient)
Additional Tests in Development for Prediction of Prognosis and Determining Treatment for Other (Non-Breast) Cancers
7.3 Other (Non-Cancer) Personalized Medicine Tests in Development and/or Used in Pharmaceutical Research
7.4 Pharmaceutical/Diagnostic Company Agreements
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Drug and Medication Industry: Combination Drug/Diagnostic Products and Other Applications of Personalized Medicine-Strategic Issues Facing Companies in this Market
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