References
- Lesko LJ , ZinehI. DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA. Pharmacogenomics11 , 507–512 (2010).
- Davies EC , GreenCF, TaylorS, WilliamsonPR, MottramDR, PirmohamedM. Adverse drug reactions in hospital in-patients: a prospective analysis of 3695 patient-episodes. PLoS ONE4 , e4439 (2009).
- Wilke RA , LinDW, RodenDM et al. Identifying genetic risk factors for serious adverse drug reactions: current progress and challenges. Nat. Rev. Drug Discov. 6 , 904–916 (2007).
- Spear BB , Heath-ChiozziM, HuffJ. Clinical application of pharamacogenetics. Trends Mol. Med.7 , 201–204 (2001).
- Kaplan RS , PorterME. How to solve the cost crisis in health care. Harv. Bus. Rev.89 , 46–52, 54, 56–61 passim (2011).
- Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin. Pharmacol. Ther.69 , 89–95 (2001).
- Desai M , StockbridgeN, TempleR. Blood pressure as an example of a biomarker that functions as a surrogate. AAPS J.8 , e146–e152 (2006).
- Psaty BM , LumleyT. Surrogate end points and FDA approval: a tale of 2 lipid-altering drugs. JAMA299 , 1474–1476 (2008).
- Baker SG , KramerBS. A perfect correlate does not a surrogate make. BMC Med. Res. Methodol.3 , 16 (2003).
- Wagner JA , WilliamsSA, WebsterCJ. Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs. Clin. Pharmacol. Ther.81 , 104–107 (2007).
- Hampel H , FrankR, BroichK et al. Biomarkers for Alzheimer‘s disease: academic, industry and regulatory perspectives. Nat. Rev. Drug Discov. 9 , 560–574 (2010).
- Goodsaid F , FruehF. Biomarker qualification pilot process at the US Food and Drug Administration. AAPS J.9 , e105–e108 (2007).
- Goodsaid FM , FruehFW, MattesW. Strategic paths for biomarker qualification. Toxicology245 , 219–223 (2008).
- Altar CA , AmakyeD, BounosD et al. A prototypical process for creating evidentiary standards for biomarkers and diagnostics. Clin. Pharmacol. Ther. 83 , 368–371 (2008).
- Dieterle F , SistareF, GoodsaidF et al. Renal biomarker qualification submission: a dialog between the FDA–EMEA and predictive safety testing consortium. Nat. Biotechnol. 28 , 455–462 (2010).
- Warnock DG , PeckCC. A roadmap for biomarker qualification. Nat. Biotechnol.28 , 444–445 (2010).
- Stephan C , BangmaC, VignatiG et al. 20–25% lower concentrations of total and free prostate-specific antigen (PSA) after calibration of PSA assays to the WHO reference materials – analysis of 1098 patients in four centers. Int. J. Biol. Mark. 24 , 65–69 (2009).
- Fillée C , TombalB, PhilippeM. Prostate cancer screening: clinical impact of WHO calibration of Beckman Coulter Access prostate-specific antigen assays. Clin. Chem. Lab. Med.48 , 285–288 (2010).
- Bellon E , LigtenbergMJ, TeiparS et al. External quality assessment for KRAS testing is needed: setup of a European program and report of the first joined regional quality assessment rounds. Oncologist 16 , 467–478 (2011).
- Poste G . Bring on the biomarkers. Nature469 , 156–157 (2011).
- Pirmohamed M . Acceptance of biomarker-based tests for application in clinical practice: criteria and obstacles. Clin. Pharmacol. Ther.88 , 862–866 (2010).
- Felker GM , HasselbladV, HernandezAF, O‘ConnorCM. Biomarker-guided therapy in chronic heart failure: a meta-analysis of randomized controlled trials. Am. Heart J.158 , 422–430 (2009).
- Impact report: personalized medicine is playing a growing role in development pipelines. TUFTS Center for Drug Development12(6) , 1–4 (2010).
- DiMasi JA , GrabowskiHG. The cost of biopharmaceutical R&D: is biotech different? Managerial Decision Econ.28 , 469–479 (2007).
- Kaitin KI . Deconstructing the drug development process: the new face of innovation. Clin. Pharmacol. Ther.87 , 356–361 (2010).
- DiMasi JA , FeldmanL, SecklerA, WilsonA. Trends in risk associated with new drug development: success rates for investigational drugs. Clin. Pharmacol. Ther.87 , 272–277 (2010).
- Grabowski H , VernonJ, DiMasiJA. Returns on research and development for 1990s new drug introductions. Pharmacoeconomics20(Suppl. 3) , 11–29 (2002).
Websites
- President‘s Council of Advisors on Science and Technology. Priorities for personalized medicine. www.whitehouse.gov/files/documents/ostp/PCAST/pcast_report_v2.pdf (Accessed 9August2012)
- US FDA. Draft guidance for industry and Food and Drug Administration staff. In vitro companion diagnostic devices draft guidance. www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM262327.pdf (Accessed 9August2012)
- US FDA. Guidance for industry. Qualification process for drug development tools draft guidance. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/UCM230597.pdf (Accessed 9August2012)
- EMA. Qualification of novel methodologies for drug development: guidance to applicants. www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004201.pdf (Accessed 9August2012)
- US FDA. Preliminary concept paper. Drug-diagnostic codevelopment concept paper (April 2005). www.fda.gov/downloads/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/UCM116689.pdf (Accessed 9August2012)
- EMA. Reflection paper on codevelopment of pharmacogenomic biomarkers and assays in the context of drug development. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/07/WC500094445.pdf (Accessed 9August2012)