Project outline

People, Organization, Strategy and Technology in the pharmaceutical industry

Abstract

The PharmaPOST project is aiming at the investigation and critical analysis of change issues in the pharmaceutical industry. An initial case study during the period Janauary-May 1998 has been conducted at Astra Hässle within NUTEKs CorePoint investigation, and has documented initial findings and outlined a project plan for a longitudinal study. Initially, the implementation of technology for reducing clinical tests' cycle times through RDC (remote data capture) is investigated, together with its impact on organizational and human behaviour. The initial findings will be documented in a report/research paper.

Background

Within the pharmaceutical industry, there is an increasing pressure to shorten product development time. One crucial issue in this concern is the conduct of clinical tests and research, i.e. testing and documenting new drugs (CDs - candidate drugs) before submitting an application (NDA - new drug application) to the approving authorities (USA: FDA, Sweden: Läkemedelsverket). This process is both lengthy and costly. In addition, it is conducted within the patent protection period, i.e. a patent for a 20 year priod is granted for a new substance, and all subsequent research and tests are conducted within this period. Thus, every day that can be saved during this process lengthens the patent period during which the company can reap the benefits from the product without competition from producers of generic products. For a successful product, this can mean several billion kroner.

In order to improve its operations, a variety of projects has been conducted at Astra Hässle, including organizational restructuring, introduction of new information systems, and more recently a business process oriented project under the name of FASTRAC (Fastest And Smartest To Registration And Commercialization). The project aimed at a complete overhaul of operations within the clinical unit of the company, thus attempting to cut the average time for testing new products by half, from 8 to 4 years. The project outcome was documented and reported to the steering group and company management in 1996. The project report contained a set of 11 recommendation, ranging from technological issues over operating values to structural organizational changes.

In 1996, another major change effort was initiated on corporate level (Astra group). This project, termed CANDELA, is dedicated to investigate and analyze business processes on Astra group level and to propose new strategies, structures, processes and technology to be implemented in all Astra companies. The work conducted within this project and its outcome naturally affects Astra Hässle and its processes significantly, and the implementation of measures must be coordinated and aligned between the two projects.

PharmaPOST project outline

The PharmaPOST project, conducted by researchers from the Viktoria Institute in Göteborg, and supported by staff from Astra Hässle, is concerned with following the implementation of measures taken as a consequence of the FASTRAC and CANDELA project. The analysis of these measures and their implementation will identify factors being critical to the success of the conduct of these projects, and generalize the gained knowledge in order to make it accessible for other organizations.

Special attention will be paid to the following issues:

• Infrastructural aspects - which kind of organizational and information infrastructure is necessary and feasible? This part is conducted in cooperation with the trans-european project InfraGlobe (see below).
• IT-implementation - how can the use of information technology contribute to reduce time-to-market, and how well are the systems adopted by the organization, i.e. organizational fit.
• Organizational change - to which extent becomes organizational redesign necessary, how is it conducted and considered and received by individuals, and to what extent can it deliver increased value and actually contribute to cycle time reduction? In this concern it is relevant to point out, that the aim of neither of the projects conducted at Astra Hässle is aiming at organizational downsizing.
• Knowledge Management - which mechanisms are used for collecting and disseminating knowledge in complex organizations.

Contribution to MTO objectives

The MTO programme has been designed to address a variety of aspects that allow Swedish companies to sustain or improve their competetive position. In today's competitive environment, this objective is closely related to factors such as knowledge management, innovation and organizational renewal, and the company's ability to employ technology and organizational competencies.

Considering the main sectors of the MTO-programme, as being defined in the programme definition statement, they are primarily focusing on three areas, which are essential for competitiveness, namely

• new products and services,
• processes and organizational structures, and
• interorganizational cooperation/collaboration.

While we believe, that these areas can not be separated easily from each other and must be considered holistically, the PharmaPOST project should take its departure in the product and service innovation area. Therefore, the need for product development process innovation will be conceived as the initial driving force, while changes in processes, structures and collaborative patterns are sub-sequent results.

Documentation and dissemination of results

The project results will primarily be documented as research reports and articles to be published at scientific conferences. Further dissemination activities, in terms of conference participations and seminars, will take place. The members of the research team, as well as Astra Hässle staff are also prepared to participate in events arranged as part of the dissemination activitites within the MTO participant group.

Project people

• Antonio Cordella 
• Elof Dimenäs, Astra Hässle
• Mikael Palmblad, Astra Hässle
• Kai A. Simon

BSc/MSc-Thesis 

• David Shem-Tov, student in the Master of International Management Program at Göteborg Business School
  Knowledge diffusion mechanisms, information technology and communities of practice

Publications and other writings (in chronological order)

• Astra Hässle Core Point. (PDF, Swedish)
  Original case descriptio. , being the background of the research project. The paper provides a general overview of Astra Hässle and addresses briefly some aspects of change projects being conducted in the company. 
• Astra Hässle Core Point. (PDF, Swedish)
  Summary description of the Astra Hässle case, based on the initial case description by Kai A. Simon above. The full publication, containing all Core Point case studies, can be obtained from NUTEK:
  Karin Lundqvist et.al. (1997), "Företagsperspektivet", NUTEK-Verlag. 
• Pilot study report. (PDF, English)
  The pilot study report, authored by A. Cordella and K. Simon is published as a chapter in the InfraGlobe case study collection. It addresses the implementation of an IT-system for remote data collection and the organizational issues associated with it. Also, a theoretical approach to analyzing technological and organizational inscription in change initiatives is outlined. 
• Project outline for the full study. (PDF, English) 
• The Effect of IT on Coordination Cost. (PDF, English)
  A research paper, authored by A. Cordella and K. Simon, outlining the relation between investments in infrastructural technology and coordination cost in the organization.
• Forskningsperspektivet. (PDF, Swedish)
  A summary and outlook of the project, for a NUTEK-published book taking the researchers' perspective on their projects.

"In the pipeline"

• Article: Managerial issues in infrastructure design and implementation
  This article, authored by Kai Simon and Jan Ljungberg addresses the managerial agenda for infrastructural change.
  Abstract. In conjunction with large-scale change initiatives, many companies are investing heavily in infrastructure. Infrastructure technology for Enterprise Resource Planning (ERP) and enterprise-wide communication and knowledge management, such as SAP and Lotus Notes, are promoted as enablers for more efficient business operations and management. This paper is investigating the crucial aspect of leveraging organizational change with the implementation of infrastructure technology and outline the managerial agenda for infrastructure related change.
• Article: Knowledge diffusion in complex organizations
  This article, authored by Claudio Ciborra and Antonio Cordella outlines the mechanims being used for knowledge diffusion in organizations.
• Article: Clinical Operations On-Line - Using common information spaces for improving clinical studies
  A paper authored by Elof Dimenäs and Mikael Palmblad (both Astra Hässle), describing the impact of an on-line system for clinical studies on work organization and processes.

OH-slides (Acrobat PDF-formatted)

• OH-slides for a theory presentation of the project.
• Developing the clinical trial process in a rapidly changing environment. A presentation given by Elof Dimenäs (Astra Hässle) for the Clinical Information Association in Den Haag, March '99.

Other relevant information and WWW-resources

• Link to articles related to the pharmaceutical industry from TechWeb
• Related publications on Kai Simon's WWW-site
• NUTEK - Swedish National Board for Industrial and Technical Development

Links

Research area IT & Management Homepage

Viktoria Institute Homepage

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