The cost of developing imaging agents for routine clinical use

Investigative Radiology

Volumn 41, Issue 3, 2006, Pages 206-212

  Nunn, Adrian D ^a  

^a Bracco Research USA   (United States)

Author keywords

Biomarker; Costs; Development; Imaging agent

Indexed keywords

DIAGNOSTIC AGENT; FLUORODEOXYGLUCOSE; GADODIAMIDE; GADOLINIUM PENTETATE; IODIXANOL; IOHEXOL; IOPAMIDOL; IOPROMIDE; METHOXY ISOBUTYL ISONITRILE TECHNETIUM TC 99M; TETROFOSMIN TC 99M; CONTRAST MEDIUM;

ARTICLE; CLINICAL ASSESSMENT TOOL; COST CONTROL; COST UTILITY ANALYSIS; DIAGNOSTIC IMAGING; DRUG COST; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MARKETING; ECHOGRAPHY; FINANCIAL MANAGEMENT; GOVERNMENT REGULATION; NUCLEAR MAGNETIC RESONANCE IMAGING; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; RADIODIAGNOSIS; X RAY; COST; ECONOMICS; HUMAN; PHARMACEUTICS; RESEARCH; REVIEW;

CONTRAST MEDIA; COSTS AND COST ANALYSIS; DIAGNOSTIC IMAGING; DRUG COSTS; DRUG INDUSTRY; HUMANS; RESEARCH; TECHNOLOGY, PHARMACEUTICAL;

EID: 33745918013     PISSN: 00209996     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.rli.0000191370.52737.75     Document Type: Article

References (37)

1. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ. 2003;22:151-185.
2. IMS World Review 2004. Available at: http://www.ims-global.com/insight/ news_story/0403/news_story_040316.htm Accessed July 1, 2005.
3. GSK. Annual Report 2004:61.
4. Stewart JJ, Allison PN, Johnson RS. Putting a price on biotechnology. Nature Biotech. 2001;19:5-9.
5. Tufts Drug Study Sample Is Skewed: True Figure of R&D Costs Likely Is 75 Percent Lower. December 4, 2001. Available at: http://www.citizen.org/ pressroom/release.cfm?ID=954 Accessed July 1, 2005.
6. Mullin R. Drug development costs about $1.7 billion. Chem Eng News. 2003;81:8.
7. Abbott Annual Report 2004:33, 46, 57.
8. GSK Annual Report 2004:10, 60.
9. Genentech Annual Report 2004:12.
10. BMS Annual Report 2004:35, 36.
11. Schering AG Annual Report 2004:3, 4.
12. BIO-TECH Report #200, The Market for PET Radiopharmaceuticals & PET Imaging, Available at: http://biotechsystems.com/reports/200/default.asp Accessed July 6, 2005.
13. ad BIO-TECH Report #190, The US Market for Medical Imaging Contrast Media. Available at: http://biotechsystems.com/reports/190/default.asp Accessed July 6, 2005. BioTech Systems, Inc; Las Vegas, NV.
14. RC-211 Contrast Agents for Medical Imaging. Business Communications Company Inc. Available at: http://www.bccresearch.com/editors/RC-211.html. Accessed July 6, 2005.
15. Amersham Annual Report 2004:4.
16. Schering Annual Report 2004:31.
17. BMS Annual Report 2004:40.
18. Epix Pharmaceuticals Inc. SEC 10k filing, March 2004:27.
19. Epix Pharmaceuticals Press Release, December 2003. Available at: http://investor.epixpharma.com/phoenix.zhtml?c=91717&p=irol- newsArticle& ID=478126&highlight= Accessed July 7, 2005.
20. Available at: http://www.manufacturing.net/article/NEa1219003.5hc.html? ticker=EPIX.
21. Impact Report 2000; December 2. Tufts Center for the Study of Drug Development. Available at: http://csdd.tufts.edu/InfoServices/Impact.ReportPDFs/ impactReportDecember2000.pdf. Accessed July 7, 2005.
22. 2005 APC Chart - Nuclear Medicine Procedures, Radiopharmaceuticals and Drugs. Society of Nuclear Medicine. Available at: http://interactive.snm.org/ index.cfm?PageID=1981&RPID=43 Accessed July 21, 2005.
23. 21 CFR 316.21(b) and 21 CFR 316.21(c).
24. NIH Response to the Conference Report Request for a Plan to Ensure Taxpayers' Interests Are Protected. July 2001. Available at: http://www.nih.gov/news/070101wyden.htm. Accessed July 7, 2005.
25. Price JC, Klunk WE, Lopresti BJ, et al. Kinetic modeling of amyloid binding in humans using PET imaging and Pittsburgh Compound-B. J Cereb Blood Flow Metab. Advance online publication June 8, 2005. doi: 10.1038/sj.jcbfm. 9600146.
26. Press release. Roche and GE Healthcare to explore personalised medicine in patients with Alzheimer's disease, July 11, 2005. General Electric and Eli Lilly announce research collaboration to combat Alzheimer's disease. April 19, 2005 Available at: http://www.ge.com/en/company/news/archiveExpand.htm. Accessed July 12, 2005.
27. Accelerating Clinical Trials: Budgets, Patient Recruitment & Productivity (PH60), May 2004. Available at: http://www. acceleratedclinicaltrials.com/metrics.htm#body Accessed July 12, 2005.
28. US Food and Drug Administration. Challenge and opportunity on the critical path to new medical products. 2004; March, p11, 24 Available at: http://www.fda.gov/oc/initiatives/criticalpath/. Accessed July 11, 2005.
29. US Food and Drug Administration. Draft Guidance for Industry, Investigators, and Reviewers. Exploratory IND Studies. April 2005. Available at: http://www.fda.gov/cder/guidance/6384dft.htm. Accessed July 11, 2005.
30. EMEA. Position paper on non-clinical safety studies to support clinical trials with a single microdose. June 2004. Available at: www.emea.eu.int/pdfs/ human/swp/259902en.pdf. Accessed July 11, 2005.
31. Kelloff GJ, Hoffman JM, Johnson B, et al. Progress and promise of FDG-PET imaging for cancer patient management and oncologic drug development. Clin Cancer Res. 2005;11:2785-2808.
32. US Food and Drug Administration Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications. June 2004:14. Available at: www.fda.gov/cder/guidance/5742prt2.pdf. Accessed July 11, 2000.
33. Press release. North American Scientific Announces Cessation of Theseus Operations on September 15. August 30, 2004. Available at: http://www.nomos.com/ page?id=1410&key=1938. Accessed July 11, 2005.
34. Mandry D, Pedersen M, Odille F, et al. Renal functional contrast-enhanced magnetic resonance imaging: evaluation of a new rapid-clearance blood pool agent (P792) in Sprague-Dawley rats. Invest Radiol. 2005;40:295-305.
35. Tsuda N, Tsuji T, Kato N. Interstitial magnetic resonance lymphography using gadolinium-ethoxybenzyl-diethylenetriamine pentaacetic acid in rabbits with lymph node metastasis. Invest Radiol. 2005;40:306-312.
36. Simon GH, Yanjun F, Berejnoi K, et al. Initial computed tomography imaging experience using a new macromolecular iodinated contrast medium in experimental breast cancer. Invest Radiol. 2005;40:614-620.
37. Bremer C, Ntziachristos V, Weitkamp B, et al. Optical imaging of spontaneous breast tumours using protease sensing 'smart' optical probes. Invest Radiol. 2005;40:321-327.