Information Management in Pharmaceutical R&D
Strategic Management
Information is belatedly gaining recognition as a key business driver that must be managed as effectively and efficiently as possible. This publication reports on the extent to which pharmaceutical companies are using information systems in their R&D and regulatory departments to reduce research costs and R&D times.
Containing primary survey data, this report answers your key questions including:
Scrip's Information Management in Pharmaceutical R&D looks ahead to how ISs must develop to meet the significant challenges caused by the increase in time and costs in developing new drugs.
Published: March 2001
Pages: 117
Ref: BS1060E
Price: £495/$1,040/¥119,000
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CONTENTS
LIST OF TABLES
LIST OF FIGURES
FOREWORD
ABOUT THE AUTHORS
EXECUTIVE SUMMARY
ABBREVIATIONS
CHAPTER 1 INTRODUCTION
1.1 Early advances
1.1.1 Targeted research
1.1.2 Legislation
1.2 Pharmaceutical industry trends
1.2.1 The decline of NDAs and NCEs
1.2.1.1 The current situation
1.2.1.2 A summary of the costs involved
1.2.2 The time factor
1.2.3 Other issues
1.2.4 Recent pharmaceutical industry consolidation
1.3 The introduction of information technology and information systems
1.3.1 Computerised submissions
1.4 Pharmaceutical industry information systems issues and themes
1.4.1 Interoperability
1.4.2 Information architecture
1.4.3 The Internet
1.4.4 Organisational structure
1.4.5 The benefits of information systems
1.5 Scope and methodology
1.5.1 Scope and data gathering methods
1.5.2 Company profile
1.5.3 Personnel
1.5.4 Analysis
1.5.5 Research questions
CHAPTER 2 INFORMATION SYSTEMS THEMES
2.1 Information management
2.1.1 Information generated internally
2.1.1.1 The development of laboratory information management systems
2.1.2 Information generated from external sources
2.1.3 Information management strategy
2.1.3.1 Earl's Structure
2.1.3.2 Development of the information management plan
2.1.3.3 Information management fit with the organisation
2.1.3.4 Control of information management systems
2.1.4.5 Information management systems strategy
2.2 Intraorganisational change: effect on job roles and information systems implementation
2.2.1 Types of organisational change
2.2.1.1 Continuous incremental change
2.2.1.2 Socio-technical systems
2.2.1.3 Business process re-engineering
2.2.2 Social and human elements of information systems
2.2.2.1 Job security
2.2.2.2 Deskilling
2.2.2.3 Status
2.3 Interorganisational change: outsourcing
2.3.1 Outsourcing of clinical research
2.3.1.1 Collaboration and control
2.3.1.2 Remote data entry
2.3.2 Outsourcing information systems development
2.3.2.1 Management of outsourcing
2.3.3 The decision to outsource
2.4 Electronic submissions
2.4.1 Data format
2.4.2 Multiple filings
2.4.3 Global submissions
2.4.4 The advantage of size
2.5 Conclusions
CHAPTER 3 THE SITUATION IN THE MID NINETIES
3.1 Background to company information system structure
3.1.1 The responsibility of information departments
3.1.2 Deviations from the model
3.1.3 Globalisation
3.2 Information management
3.2.1 Information departments supporting R&D
3.2.1.1 Group roles
3.2.1.2 Supplying information
3.2.1.3 Information management and use
3.2.1.4 Transfer to internal databases
3.2.1.5 Current awareness bulletins
3.2.2 Research and development departments
3.2.2.1 Forming the strategic plan
3.2.2.2 The value of externally generated information
3.2.2.3 Information management and use
3.2.2.4 Data presentation
3.2.2.5 The regulatory environment
3.2.2.6 Standards
3.2.2.7 Communication with trial centres
3.2.2.8 Computer-based information systems
3.2.3 Regulatory departments
3.2.3.1 Information management and use
3.2.3.2 Archiving regulatory documents
3.2.3.3 The impact on the regulatory process
3.2.3.4 Regulatory creep
3.2.3.5 Managing interactions with regulatory agencies
3.3 Intraorganisational change
3.3.1 Information departments supporting R&D
3.3.2 Research and development departments
3.3.3 Regulatory departments
3.3.3.1 The issues
3.4 Interorganisational change
3.4.1 Information departments supporting R&D
3.4.2 Research and development departments
3.4.2.1 Phase III trials
3.4.2.2 Focus
3.4.2.3 Staff overheads
3.4.2.4 Transfer of data
3.4.2.5 Electronic transfer of data
3.4.3 Regulatory departments
3.5 Electronic submissions
3.5.1 Information departments supporting R&D
3.5.1.1 Direct links with the MCA
3.5.1.2 Data security
3.5.2 Research and development departments
3.5.3 Regulatory departments
3.5.3.1 Choice of format for electronic submissions
3.5.3.2 The formation of the EMEA
3.6 Future directions
3.6.1 Information departments supporting R&D
3.6.1.1 Issues
3.6.1.2 Future information needs
3.6.2 Research and development departments
3.6.2.1 Increased automation
3.6.2.2 Openness
3.6.2.3 Better use of information systems
3.6.2.4 Electronic data transfer
3.6.3 Regulatory departments
3.6.3.1 Global regulatory systems
CHAPTER 4 ANALYSIS
4.1 Introduction
4.1.1 Information gathering
4.1.2 The value of information
4.2 Information management
4.2.1 Information management strategies
4.2.1.1 Development of the information management plan: information and technology
4.2.1.2 Information management and business
4.2.1.3 Dislocation
4.2.1.4 High-throughput screening
4.2.1.5 Information management fit with the rest of the organisation
4.2.2 Structural changes
4.2.2.1 Decentralisation
4.2.2.2 Control
4.2.3 Information management systems technology
4.2.4 A review of Earl's Structure against IM strategies
4.3 The static environment
4.4 Intraorganisational change: effect on job roles and system implementation
4.4.1 Organisational effects of information systems
4.4.2 Fragmentation
4.4.3 Measuring benefits
4.4.4 Systems failure
4.4.5 Social effects of information systems
4.4.5.1 Deskilling
4.4.5.2 Status
4.4.5.3 'Knowledge is power'
4.5 Interorganisational change: outsourcing
4.5.1 Outsourcing of clinical trials
4.5.1.1 Selective outsourcing
4.5.1.2 Data formats
4.5.2 Outsourcing of information technology
4.5.2.1 Dependence on external suppliers
4.5.2.2 Hollowing out
4.5.3 Retaining control
4.6 Electronic submissions
4.6.1 Lack of standardisation
4.6.2 Dossier submission as a competitive lever
4.7 Summary
4.7.1 Old problems in new processes
4.7.2 Increases speed and volume
4.7.3 Transient competitive advantage
4.7.4 Sustainability
4.8 Conclusions
CHAPTER 5 MANAGING INFORMATION TODAY
5.1 Information management
5.1.1 Amounts of information
5.1.2 Data searches
5.1.2.1 Electronic journals
5.1.2.2 Sharing information
5.1.2.3 Paper
5.1.3 Speed
5.1.4 Information overload
5.1.5 Security
5.2 Intraorganisational change
5.2.1 Acquisitions and mergers
5.2.2 Globalisation
5.2.3 The effects of globalisation
5.2.4 Staff savings and skill sets
5.3 Interorganisational change
5.3.1 Clinical trials and data capture
5.4 Electronic submissions
5.4.1 Dossier submission
5.4.2 The EMEA
5.4.3 The Medicines Control Agency
5.4.4 Dossier preparation
5.4.5 The International Convention on Harmonisation
5.4.6 Common formats
5.4.7 Standard packages
5.4.8 Speed in the regulatory process
5.4.9 Regulatory creep
5.5 Future directions
5.5.1 The next 5 years
5.5.2 Publishing on the Internet
5.5.3 Orphan drugs
5.5.4 Electronic submissions
5.5.5 Challenges for the future
5.6 Conclusions
CHAPTER 6 THE IMPORTANCE OF KNOWLEDGE MANAGEMENT
6.1 The current trend
6.1.1 The drivers
6.1.2 Critical mass
6.2 Implementation
6.2.1 Lack of involvement
6.3 The regulatory issues
6.4 Research and development
6.4.1 Change in R&D
6.4.2 Blockbuster drugs
6.5 Culture
6.6 Disadvantages of M&A
6.7 Knowledge management
6.8 The strategy
6.8.1 The importance of knowledge management
6.9 Elements of the knowledge economy
6.10 Some of the key benefits of knowledge management
6.11 Specialist tools
6.12 Knowledge management by function
6.12.1 Partnerships
6.12.2 Mergers and acquisitions
6.12.3 Research and development
6.12.3.1 Integrated knowledge spaces
6.12.3.2 Decision-making
6.12.3.3 Discovery to development
6.12.3.4 Transfer of learning
6.12.4 Regulatory
6.13 IM as the enabler of knowledge management
6.14 Chapter conclusions
CHAPTER 7 CONCLUSIONS
7.1 Managing information loads
7.1.1 Modern information management
7.2 New ways of working
7.2.1 The Internet
7.2.2 Organisational change
7.2.3 Acquisitions and mergers
7.2.4 Streamlining processes
7.3 Globalisation
7.3.1 Networking � organisational change/networking
7.3.2 External links � globalisation
7.4 Specific solutions
7.5 Organisations of people
7.6 Process automation
7.6.1 Speed
7.7 Effect of the introduction of IS on individual's operations
7.7.1 Social systems
7.7.2 Sharing culture
7.7.3 Moving population
7.8 Perceptions of current impacts and future effects
7.8.1 Lack of return on investment
7.8.2 More technology to cure technology
7.8.3 De-coupling
7.8.4 Competitive advantage � technology vs business
7.9 The future role of IS
7.9.1 Customer focus
7.9.2 Openness
7.10 Conclusions
7.10.1 Some specific conclusions
7.10.2 General recommendations
7.10.3 Specific recommendations for individual departments
7.10.3.1 Information departments
7.10.3.2 R&D departments
7.10.3.3 Regulatory departments
REFERENCES
Executive Summary
The introduction and development of new information systems such as global databases and the increase in the amount of information pharmaceutical companies need to manage, have necessitated new work practices and a re-evaluation of the traditional business model.
Their introduction also emphasises the need for comprehensive information management (IM) and information systems management policies, without which information may not be generated, may be lost, duplicated, or not used, because people do not know it exists, or cannot find it.
Investigations have been carried out into the effects of information systems in many industries, but relatively little has been done to assess the impact on the pharmaceutical industry. This report examines the impact information systems have had on the UK pharmaceutical industry, and attempts to answer the following questions:
A representative sample of UK pharmaceutical companies was interviewed, covering major therapeutic areas, and including a broad range of large and small proprietary and generic companies.
As a result of visiting these companies and analysing the feedback in relation to the information systems literature, the main recommendations for the future development of IM and information systems are:
Chapter 1 starts with a description of early advances in the industry, and the increasing move towards targeted research. It also analyses the current decline of new drug applications and new chemical entities and possible causes. It provides a summary of the scope and methodology used to prepare the report, outlining the themes of:
Chapter 2 examines the four themes in greater detail. It also introduces Earl's Structure: an information systems structure developed by Michael Earl, and against which the performance of pharmaceutical companies was assessed. Apart from technology, this chapter focuses on change processes such as continuous incremental change, socio-technical systems, and business process re-engineering; and their effect upon the organisation.
Chapter 3 presents the results from the original research. It is clear from the uncertainty expressed in many areas, that the industry as a whole was unclear as to the role of and place for systems. They had not been recognised as an integral part of the business strategy. Because of that, they were implemented to automate specific processes; and were not integrated into the whole. This led to fragmentation and uncertainty as to approach.
Chapter 4 analyses the findings, and some of the issues facing the industry. These include the role of the individual; the change process and how it is implemented; the decision to outsource; the globalisation of systems; and the organisational fit. It is clear that while there was some awareness of IM as a business driver, there was little recognition of the quantum changes the organisation would have to make to optimise its use.
Chapter 5 discusses the industry today, and the changes that have taken place. In particular the Internet has affected business processes and the organisational structure. The talk today is of globalisation and merger and acquisition (M&A). However, the larger an organisation gets, the larger any cracks at the micro level will appear. Just as organisations consist of individuals, so systems and networks consist of integrated substructures.
Chapter 6 discusses two themes in particular: M&A activity; and knowledge management. The rise of huge corporates is driven by market factors, but there are many risks; and many issues to overcome to ensure successful integration. And given the size of today's super companies; the application of knowledge management strategies and tools is indispensable. Industry, however, has been slow to recognise the fact; and perhaps unwilling to implement yet another change process.
Chapter 7 concludes with some specific recommendations; and some new factors to consider in today's market. One of these is the concept of collaborative working rather than the traditional hierarchical structure. It summarises some of the aspects of modern IM, including the increasing need for customer focus, new ways of working, and the need to value the individual. Individual expertise and knowledge is one of the pharmaceutical industry's key competitive advantages.
© PJB Publications Ltd. 2001
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