| HOME >> BIOLOGY >> TECHNOLOGY |
INTRODUCTION
ROLE OF THE FOOD AND DRUG ADMINISTRATION
TABLE 7 FDA GUIDELINES FOR BIOMARKER APPLICATIONS
EUROPEAN MEDICINES AGENCY
REGULATORY IMPACT ON DRUG SAFETY
INTELLECTUAL PROPERTY AND COMPETITIVE POSITIONING
APPROVED PATENT ANALYSIS
TABLE 8 ANNUAL PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS IN U.S., EUROPE, JAPAN, THROUGH 2010
COMPETITIVE LANDSCAPE
LATE STAGE CLINICAL TRIALS: COMPETITIVE POSITIONING
TABLE 9 CURRENT GLOBAL MARKET FOR TOTAL CLINICAL STAGE BIOMARKERS BY SERVICES AND PRODUCTS, THROUGH 2010 ($ MILLIONS)
TABLE 10 SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY
TABLE 11 REPRESENTATIVE LIST OF APPROVED BIOMARKER PATENTS IN U.S., EUROPE, JAPAN
ETHICAL CONSIDERATIONS
SUMMARY
Respect for Persons
Beneficence
Justice
BIOMARKER APPLICATIONS OF ETHICAL CONSIDERATIONS
Race and Genotype
Negligence
Informed Consent
Privacy
Market Segmentation
Professional, Media, and Opinion Leader Edification
REGULATORY IMPLICATIONS
CHAPTER FIVE: APPLICATION BY THERAPY AREA
TABLE 12 GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS BY THERAPEUTIC AREA, THROUGH 2010 ($ MILLIONS)
ONCOLOGY
TABLE 13 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: ONCOLOGY
COLORECTAL CANCER
CETUXIMAB
PANITUMUMAB
ELESCLOMOL
HERCEPTIN
OTHER PREDICTIVE TESTS
TABLE 14 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: ONCOLOGY
BREAST CANCER
MAMMAPRINT
TABLE 15 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: BREAST CANCER
ONCOTYPE DX
TEST ADOPTION
OTHER PROGNOSTIC TESTS
PREDICTIVE TESTS
HORMONAL THERAPIES
TAXANES/ANTHRACYCLINES
BIOLOGICALS
TRIPLE NEGATIVE BREAST CANCER
OTHER NOVEL BIOMARKERS
LUNG CANCER
'/>"/>
| SOURCE MDX Copyright©2010 PR Newswire. All rights reserved |