The Role of Simulation in The Management of Research: What Can The Pharmaceutical Industry Learn from The Aerospace Indu

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0092-8615/98 Copyright 0 1998 Drug Information Arrociation Inc.

1998

Printed in the USA. All rights reserved.

THE ROLE OF SIMULATION IN THE MANAGEMENT OF RESEARCH: WHAT CAN THE PHARMACEUTICAL INDUSTRY LEARN FROM THE AEROSPACE INDUSTRY? SHAWNC.D.JOHNSON, MS, MBA MGA Software, Concord, Massachusetts

This paper provides an overview of simulation technology and how it is used within research and development. A history of computer simulation is provided. Similarities between the aerospace and pharmaceutical industries are presented, followed by a discussion of the management of simulation technology within an organization. The current drug development process and where simulation technology fits within this process are presented. Barriers 10 the adoption of simulation technology in the pharmaceutical industry are covered. Key Words: Computer simulation; Pharmaceutical industry; Aerospace industry

INTRODUCTION

THE ROLE OF SIMULATION in management of research, regardless of the industry in which simulation technology is applied, is really to improve the process and efficiency of research and development (R&D). Simulation technology is used to understand complex systems and products prior to these ideas being prototyped, scaled up, and put into full production. The important management questions regarding the use of simulation technology are: How valuable is this? Where does it tit? Who owns it? and

Presented at the DIA Workshop “Improving Clinical Trials: Contemporary Design Solutions,” October 2728. 1997, Philadelphia, Pennsylvania. Reprint address: Dan Cui. MGA Software, 200 Baker Ave.. Concord, MA 01742.

How is it implemented within an organization? These questions are relevant to managers in all industries that employ simulation technology. Many of the pharmaceutical industry conferences over the past few years discussed issues in R&D management that could just as easily have been given at management conferences hosted by the American Institute of Aeronautics and Astronautics. The speakers would simply have to take the word “pharmaceutical” and replace it with “aerospace,” and they have exactly the same problems. This paper provides an overview of simulation technology and how it is used within R&D. Specifically, a history of computer simulation technology is provided to ensure that everyone is working with the same definition. Similarities between the aerospace and pharmaceutical industries are presented, followed by a discussion of the management

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Shawn C. D.Johnson

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of simulation technology within an organization. A brief description of how the drug development process works today and where simulation technology fits within this process is also presented. Finally, some closing thoughts on existing barriers to pharmaceutical industry adoption of simulation technology and some personal observations are also presented.

HISTORY OF COMPUTER SIMULATION Based on the author’s experience to date in the pharmaceuti