Driving Forces for Global Technological and Process Change
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D ~ UInformation R J o u m ~ lVol. . 32, pp. 859-860. 1998 Printed in the USA. All rights reserved.
DRIVING FORCES FOR GLOBAL TECHNOLOGICAL AND PROCESS CHANGE RONALDD. FITZMARTIN, PHD, MBA Purdue Pharma L.P., Norwalk, Connecticut
“Doing it fast forces you to do it right the First time.” -John Young, CEO, Hewlett-Packard
SPEED HAS BEEN CONSIDERED one solution to the survival of corporations today. Getting to the market before the competition with high quality products will allow the firm to capture a larger market share. The faster a product application is submitted, reviewed, and approved by the regulatory authority the longer the patent exclusivity and the larger the market share. A delay in development of only one day could mean millions of dollars in lost revenue. The Pharmaceutical Research and Manufacturers Association (PhRMA) has estimated that over the course of 20 plus years the average time to develop a drug has increased over 30% from 11 years to over 15 years. As a result, the cost of development has increased by 500% from $54 million in 1976 to $360 million in 1990. In the United States, the mean number of Phase 1-111 clinical trials has doubled from 30 trials per New Drug Application (NDA) in the 1970s to 60 trials in the 1990s. Of course, as the number of trials increased over the years so did the number of patients in the clinical development program, a 2000 patient increase per NDA from the 1970s to the 1990s. Reprint address: Ronald D. Fitzrnartin. PhD. MBA, Purdue Pharma L.P., 100 Connecticut Avenue, Norwalk. CT 06850.
As regulatory requirements increased the number of trials, patients, and clinical procedures, the result has been a significant increase in the amount of data that requires corporate staff to electronically capture, review, analyze, interpret, and summarize in the form of regulatory study reports, product quality sections, and summaries. During the past 15 years, the number of trials in an NDA submission has increased by 10070,the number of patients in an average NDA has increased by, 126%, and due to the enormous data analysis and reporting effort the number of pages has increased by 138% to more than 9oooO pages. The implementation of technology has been the most compelling strategic tool utilized by companies to address the “need for speed” and mega-volumesof paper generated in preparation and support of regulatory product submissions worldwide. The biopharmaceutical industry has embraced and begun to exploit technology to enhance its competitive edge. On the whole, technology is available to all and can provide a level playing field, however, the key to success is how well and how fast a company applies the technology to the business need. The implementation of technology must be rapid and those companies which get caught up in “analysis paralysis” will lose. Technology is changing at such a super accelerated rate that it is becoming obsolete before companies have the opportunity or ability to implement it across the entire organization. Systems
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