26 July 2008 Imaging and Cardiology Jonathan Goldman ... - ICON plc

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Pg 08may vary greatly, from spectrophotometry (cardiac) to multiplexedELISA assays (renal) or genomic signatures (liver). But based onthe rapid growth of our knowledge in genomics, transcriptomics,proteomics, and metabolomics and the ensuing growth in thediscovery and development of novel biomarkers, it should beanticipated that the clinical laboratory will assume an even greaterrole in the provision of safety testing in the future.Resources1Handler S, Altman R, Perera S, et al. A systematic review of theperformance characteristics of clinical event monitor signals used to detectadverse drug events in the hospital setting. J Am Med Inform Assoc2007;14:451-458.2Challenge and Opportunity on the Critical Path to New Medical Products.http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html. Accessed 17Aug 2008.3Fung M, Thornton A, Mybeck K, et al. Evaluation of the characteristics ofsafety withdrawal of prescription drugs from worldwide pharmaceuticalmarkets: 1960 to 1999. Drug Info J 2001;35:293-317.4Olson H, Betton G, Robinson D, et al. Concordance of the toxicity ofpharmaceuticals in humans and in animals. Regul Toxicol Pharmacol2000;32:56-67.5O’Brien P. Cardiac Troponin is the most effective translational safetybiomarker for myocardial injury in cardiotoxicity. Tocicology 2008;245:206-2186Metzger J, Westfall M. Covalent and noncovalent modification of thinfilament action. The essential role of troponins in cardiac muscle regulation.Circ Res 2004; 94:146-158.7Waxman D, Hecht S, Schappert J, Husk G. A model for troponin I as aquantitative predictor of in-house mortality. JACC 2006;48:1755-17628Suter T, Meier B. Detection of anthracycline-induced cardiotoxicity; is therelight at the end of the tunnel (Editorial). Ann Oncology 2002;13:647-649.9Devarajan P, Williams L. Proteomics for biomarker discovery in acutekidney injury. Semin Nephrol 2007;27:637-651.10Schmidt-Ott K, Mori K, Li J, et al. Dual action of neutrophil gelatinaseassociatedlipocalin. J Am Soc Nephrol 2007;18:407-413.11Ichimura T, Asseldonk J, Humphreys B, et al. Kidney injury molecule-1 isa phosphtidylserine receptor that confers phagocytic phenotype onepithelial cells. J Clin Invest 2008;118:1657-1668.12Parikh C, Devarajan P. New biomarkers of acute kidney injury. Crit CareMed 2008;36:S159-S165.13Bagshaw S, Langenberg C, Haase M, Wun L, May C, Bellomo R.Urinary biomarkers in septic acute kidney injury. Intensive Care Med 2007;33:1285-1296.14Navarro V, Senior J. Drug-Related Hepatotoxicity. NEJM 2006; 354:731-9.15Guidance for Industry: Drug Induced Liver Injury: Premarketing ClinicalEvaluation. http://www.fda.gov/cder/guidance/index.htm. Accessed 17Aug 2007ICON Acquires Prevalere Life Sciences Inc.ICON has expanded its bioanalytical and immunoassay servicesinto the United States through the acquisition of Prevalere LifeSciences Inc., a wholly owned subsidiary of ORS Labs Inc.Prevalere is one of the leading providers of bioanalytical andimmunoassay laboratory services to the biotechnology andpharmaceutical industries and operates from a 49,000 square footfacility in Whitesboro, New York. Prevalere will complement ICON’sexisting European-based bioanalytical lab capabilities, where ICONDevelopment Solutions recently moved to a new, purpose-builtbioanalytical and immunoassay laboratory in Manchester, England.Commenting on the acquisition, Peter Gray, CEO, ICON plc, said,“The acquisition of Prevalere gives ICON much greater scale in therapidly growing market for bioanalytical and immunoassaylaboratory services and adds value to our service offering in earlyphase clinical development. Prevalere brings to ICON a highlyexperienced team, an excellent lab facility in the United States anda strong market reputation amongst top-tier pharmaceutical andbiotechnology companies.”More information about Prevalere can be foundat www.prevalere.com.44021 US.indd 10 12/1/08 10:19:59 AM
Pg 09Technological advances in clinical trial managementKris Gustafson l Sr. Vice President & Global Head, Interactive Technologies and Lifecycle Sciences GroupICON Clinical ResearchTwenty years ago, pharmaceutical researchers looked forward tothe day when advances in technology would reduce or eveneliminate the truckload of paperwork required for a typical NDAsubmission. Many in the industry visualized an all-electronicclinical trial, and sophisticated software that could track patients,analyze data, resolve queries, prepare reports, create models,send alerts and even project outcomes, based on biochemicaland genetic data.That day is here. Today, every clinical trial in the world relies onelectronic tools for data management and communications.Researchers use an array of tools that didn’t even exist 20 yearsago. From laptops and Blackberries, from electronic CRFs to IVRphone systems, the clinical trial of 2008 is critically dependent onthe silicon chip. And as studies become larger, more globalized,and more logistically complex, technology will play an evenbigger role.A profound shiftIn 2004, an article in Applied Clinical Trials noted that:“The use of paper in offices, from the printing of emails and Webpages, is growing at 6-8% per year, with the average employeeprinting 33 Internet pages per day. Paper usage doubled from1981 (the introduction of the PC) to 1995. We still print out ourdocuments to read and review, keep paper to-do lists, and getour industry news in printed magazines.” 1It is an indication of how fast things change today that thesewords, written just four years ago, already feel out-of-date. Forone thing, an increasing number of people – including clinicalresearch and pharmaceutical professionals – are more comfortablethan ever communicating, learning and archiving informationin an online-only environment.Trend analysts and learning experts agree that the shift to avirtually paper-free world is gaining speed. As this happens, it isprofoundly changing the way human beings process information.Even highly educated people today have noticed a difference inthe way they read and absorb information. Many are finding itharder to focus on information presented in long-format text,preferring spreadsheets, graphics and short paragraphs –formats that are ideally suited for the electronic environment.As technology grows more powerful and pervasive,we will see significant changes in the way clinical trialinformation is gathered, organized and presented.Technology trends in clinical trialsOver the last decade, pharmaceutical, biotech companies andCROs have been implementing an increasing array of technologicalresources. Over this period we have watched as cutting-edgetrends have become established industry practices. Here are themost popular clinical trials technologies – and a few trends towatch.EDC (Electronic Data Capture)After an uncertain start in the 1990s, electronic data capture ishere to stay. Many of the initial drawbacks (including high softwarelicensing fees) have been addressed successfully, and there is anincreasing comfort level among sponsors and sites.There are many advantages to EDC beyond the reduction ofpaperwork. Real-time data checking can reduce queries andprevent costly errors from compounding. Regulatory submissionsare simplified. But perhaps even more significantly in today’s costandsafety-conscious environment, EDC can be used to conductprospective clinical trials on experimental compounds. The datafrom these prospective trials can help identify “winners” and“losers” before millions of dollars in research and developmentcosts are invested.IVRS (Interactive Voice Response Systems)Interactive Voice Response Systems are used extensively today astools for clinical trial management. These systems use telephonesto collect study data. While not as leading-edge as other technologies,IVRS has been successful precisely because it employs atechnology that is familiar everywhere. It has become particularlyuseful in emerging nations, where land-based telephone systemsmay be lacking and where cell phones are used by the majority ofthe population.44021 US.indd 11 12/1/08 10:20:02 AM
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