The Bio-Pharmaceutical Industry: Analysis of the Evolving Impact of e-Enabled Technologies
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The Bio-Pharmaceutical Industry: Analysis of the Evolving Impact of e-Enabled Technologies
ogy adoption or under-
Otis E. Rounds MD, MBA San Pablo. California
Key Words Cycle time reduction: Drug development; e-enabled technologies: Clinical research process; e-technology adoption '
Correspondence Address Otis E. Rounds, MD, MBA, 2023 Vale Road, Suite 211, Sari pablo, 94806 @-mail: [email protected]).
OVERVIEW OF INDUSTRY ISSUES It is predicted that significant consolidation will continue to underpin future business development and growth by major pharmaceutical industry players. The projected major drivers of this consolidation process will be increasing research and development costs, sluggish sales, and decreasing product life cycles (1). Optimization of shareholder value will remain the key business imperative as consolidation continues to evolve within the industry. Drug development costs correlate with cycle time. Thus, cycle time reduction positively impacts on profitability. The four components of drug development cycle time are discovery, clinical trials completion, manufacturing, and marketing. Cycle times have been significantly reduced for three of these components. New chemical entity (NCE) discovery has seen a 100-fold increase in the number of new compounds isolated through combinatorial chemical techniques and throughput screening. Industry forecasts project that optimizing identification of NCE targets that will result in marketable products will require integration of e-enabled technologies. Drug development
costs have risen from about $54 million per year to more than $800 million per year over the last 30 years. Yet, a new drug is only projected to generate sales of approximately $180 million per year. As discovery cycle time has been decreasing, so have the cycle times manufacturing through just-in-time production processes and marketing through automation. Only the clinical research process lags behind in reducing cycle times. The Electronic Data Management Forum asserts that e-enabled clinical trials can decrease drug development times and costs by 30% to 50%. The Electronic Data Management Forum gives an example of how e-technology adoption can reduce costs through a cost comparison of patient queries conducted by Bayer (2). Bayer demonstrated that by using automation rather than paper, the average number of queries in a clinical study was reduced from eight to eight-tenths queries per patient. At a cost of $80 per query for 500 patients this resulted in a reduction in cost from $320,000to $32,000. Bayer also found that the time to obtain a clean database from the last patient visit decreased from 16 to 5 weeks. Jeffery Green cited data from the multicenter
Information Journal, VOI. 39, pp. 321 -333,2005 0092-8615/2005 Printed in the USA.All rights reserved. CopyrightQ 2005 Drug Information Association. Inc.
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COMMENTARY
European study published by Banik et al. in 1998 which demonstrated that
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