The Landscape of Companion Diagnostics: Challenges, Opportunities, and Future Trends
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| Introduction: Diagnostics can be used to identify subgroups of patients who may or may not benefit from a companion drug, who may have adverse reactions to that drug, or who may require different doses of that drug because of their particular metabolic activity. The concept of companion diagnostics as an integral component of personalized medicine--RxDx--is an emerging and critical paradigm for drug development and use. What is driving that paradigm. Get the Answers You Need to Shape Your Strategy: More than a dozen companion diagnostic tests are approved for use in the United States and guide the prescription of products in oncology, cardiovascular disease, and infectious diseases. What are the most successful RxDx products, and will their success encourage further development? Why are companies reluctant to abandon the blockbuster model in favor of personalized medicine? Personalized medicine continues to be heavily debated within the industry, and future growth depends on more attention from all stakeholders. What is each stakeholder’s role in RxDx collaborations, and how can these collaborations drive development? What does each player have to offer the others to encourage development and reconcile debate? Why are parallel development programs critical? Reimbursement issues are an important factor that will determine whether the pharmaceutical industry is willing to invest in RxDx, but current reimbursement policies can be discouraging. What evidence must companies provide to third-party payers to demonstrate value and ensure reimbursement? What are the policies and issues surrounding reimbursement? With few RxDx products on the market and even fewer reimbursed, how can R&D costs ever be recovered? Scope: Key players: Abbott Diagnostics, Clinical Data, Dako, Genzyme Genetics. Challenges in RxDx development: technological challenges, regulation, drug labeling, reimbursement. Emerging companion diagnostics by therapeutic area: oncology, infectious diseases, cardiology, central nervous system (CNS) indications, diabetes, respiratory therapeutics; profiles of select companies working in RxDx. Outlook: future of companion diagnostics development, company buy-in, the affect of personalized medicine on prescription sales, the role of regulatory agencies. |
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By Cheryl Barton, Ph.D. / Publication Date: 1st June 2008
Contents:
Executive Summary5
Strategic Considerations 5
Stakeholder Implications 5
Why Companion Diagnostics? 6
RxDx Market Status.8
Companion Diagnostic Tests on the Market 8
Key Current Players in Companion Diagnostics 10
Abbott Diagnostics 11
Clinical Data 11
Dako 11
Genzyme Genetic11
Determinants of Codeveloping Companion Diagnostics 12
Why Should Companies Codevelop Targeted Therapies and Companion Diagnostics? 12
Why Do Pharmaceutical Companies Need to Establish Parallel Programs? 14
Economics of Producing Companion Diagnostics 17
Challenges in Developing Companion Diagnostics 17
Technological Challenges17
Regulation of Diagnostic Tests 18
United States.18
Europe. 20
Drug Labeling 20
Reimbursement Issues and Challenges20
Personalized Medicines 20
Payers 20
Reimbursement Policies 21
Coding Issues22
Determining Prospects and Potential for Reimbursement 22
Emerging Companion Diagnostics by Therapeutic Area 22
Oncology 22
Biodesix23
bioMérieux23
Celera 23
GE Healthcare23
Monogram Biosciences 23
Roche 23
Source MDx .25
Infectious Diseases 25
Abbott25
Monogram Biosciences 25
Roche 25
Visible Genetics 25
Cardiology 25
PGxHealth 26
LabCorp 26
Nanosphere 26
Central Nervous System Indications 26
Adlyfe 26
Curidium 26
Clinical Data 27
ExonHit Therapeutics 27
Vanda Pharmaceuticals 27
Diabetes 27
Perlegen 27
Tethys Bioscience 27
Respiratory Therapeutics 27
Market Opportunities for Companion Diagnostics .28
Getting the “Buy-In” from Companies.28
Expanding Therapeutic Area Coverage 29
Outlook 30
Will We See More Companion Diagnostics on the Market? 30
Will RxDx Negatively Affect Rx Sales? 31
Will More Companies Join the Personalized Medicine Bandwagon? 31
Will There Be More Codevelopment of Therapeutics and Diagnostics? 32
Sidebars
Common Defi nitions of Terms Associated with Companion Diagnostics .6
Regulation of Diagnostic Tests in the United States 19
Third-Party Payers Infl uencing Reimbursement for Diagnostic Tests 21
Case Study: An RxDx Partnership Informing HIV Treatment 24
List of Tables:
Tables
1. Select FDA-Approved Companion Diagnostic Tests and Associated Therapeutics 9
2. Collaborations of Leading Companion Diagnostics Developers, 2007-2008 10
3. Select Companion Diagnostic Tests for Warfarin Dosing 13
4. Recent Key Collaborations for Companion Diagnostic Development 14
5. Advantages and Disadvantages of Establishing a Drug and Diagnostic Codevelopment
Program 16
6. Comparison of the Pharma and Diagnostics Industries Business Models 29
Figures
1. RxDx Codevelopment Process 15
2. Potential Biomarkers to Guide Treatment with AstraZeneca’s Iressa (Gefi tinib) 16
3. Impact of Biomarkers on Therapeutic Development and Prescription 30
4. Benefi t of Companion Diagnostics in the Characterization and Validation of Targeted Therapeutics 32