The human side of automation: experience in clinical pharmacology.

Abstract

A vision of automation presented by the media is that robots are inherently smarter than humans. Robots whirl around efficiently doing a complex, tedious task. A single human monitors and programs many robots and markedly increases productivity and quality, while many previously employed, error-prone employees collect their unemployment benefit. My experience of automation from an industrial clinical pharmacology department is quite different fiom this. In an environment where workload and complexity increase progressively in the face of a fixed human and financial resource, seeking efficiency through automation has been synonymous with success, if not survival. In addition to using robots to automate physical processes, we automate intbrmation with computers and standardize repetitive, labour intensive tasks with more efficient processes. Direct by-products of the increased productivity through automation are enhanced creativity and job satisfaction. The irony to me is that automation is by its nature, very human. Betbre can describe automation in my environment I have to explain the nature of our work and the challenges We face. In our drug development environment, clinical pharma-cology is the customer of preclinical development in pharmacology, toxicology, drug metabolism and pharma-ceutics. We work with drug discovery and preclinical development to provide a clear phase I target for patient type, human dosage range estimate and route of administration. Clinical pharmacology customers are the phase II/III and IV therapeutic groups in gastrointestinal, cardio-vascular, infectious, central nervous systems, cancer, and respiratory diseases. We provide these groups an early estimate for drug safety, therapeutic activity, and dosage recommendations. International coordination is required between clinical pharmacology groups The overall complexity and required speed of our work is further challenged by the current re-engineering targets to increase productivity several tbld and decrease our development and FDA drug approval times. I hope this background picture demonstrates the acute need for efficiency in planning, research execution, decision making and flexibility to recycle our resource as needs change. Automation is not an interesting experiment it is central to our success! Glaxo has been a rapidly growing company for the past 15 years. The current clinical pharmacology department had its origins when a bioanalytical group was formed 10 years ago to service clinical studies. Seven years ago, pharmacokineticists were hired to service new formulations being developed for UK discovery drugs. Three years ago our mission expanded to bring new chemical entities into human phase I studies. The mission is now to advance or stop …