Considerations for a business model for the effective integration of novel biomarkers into drug development

Personalized Medicine

Volumn 5, Issue 6, 2008, Pages 641-649

  Frueh, Felix W ^a  

^a NONE   (United States)

Author keywords

Biomarkers; Business model; Collaboration; Consortia; Critical path; Drug development; Drug safety; Drug test co development; Efficacy; Open source

Indexed keywords

BIOLOGICAL MARKER; NEW DRUG;

ARTICLE; BIOINFORMATICS; BIOMEDICAL TECHNOLOGY ASSESSMENT; CLINICAL PRACTICE; CLINICAL TRIAL; CORRELATION ANALYSIS; DECISION MAKING; DOSE RESPONSE; DRUG DETERMINATION; DRUG EFFICACY; DRUG LABELING; DRUG SAFETY; DRUG SCREENING; DRUG SPECIFICITY; GENETIC VARIABILITY; GENOTYPE; HUMAN; MATHEMATICAL MODEL; MOLECULAR DYNAMICS; PATIENT CARE; PRIORITY JOURNAL; PROCESS DEVELOPMENT; RECEIVER OPERATING CHARACTERISTIC; RISK ASSESSMENT; TREATMENT RESPONSE;

EID: 57749196362     PISSN: 17410541     EISSN: 1744828X     Source Type: Journal    
DOI: 10.2217/17410541.5.6.641     Document Type: Article

References (8)

1. DiMasi JA, Hansen RW, Grabowski HG: The price of innovation: new estimates of drug development costs. J. Health Econ. 22, 151-185 (2003).
2. Wood AJ: A proposal for radical changes in the drug-approval process. N. Engl. J. Med. 355(6), 618-623 (2006).
3. Kapp AV, Jeffrey SS, Langerod A et al.: Discovery and validation of breast cancer subtypes. BMC Genom. 11(7), 231 (2006).
4. Maher PD, Haffner M: Orphan drug designation and pharmacogenomics: options and opportunities. BioDrugs 20 (2), 71-79 (2006).
5. Lasko TA, Bhagwat JG, Zou KH, Obno-Machado L: The use of receiver operating characteristic curves in biomedical informatics. J. Biomed. Inform. 38(5), 404-415 (2005).
6. Lesko LJ: Paving the critical path: how can clinical pharmacology help achieve the vision? Clin. Pharmacol. Ther. 81, 170-177 (2007).
7. Munos B: Can open-source R&D reinvigorate drug research? Nat. Rev. Drug Discov. 5(9), 723-729 (2006).
8. Taylor WC, LaBarre PG: Mavericks at Work: Why the Most Original Minds in Business Win. Harper Collins Publishers, NY, USA (2006).