Project Management for the Pharmaceutical Industry

Laura Brown, Tony Grundy

• Publisher: Routledge
• Year: 2016
• Print ISBN:
  9781409418948
• eBook ISBN:
  9781317075127
• Topic: Business
• Subtopic: Business General
• Index: Business

The pharmaceutical industry has encountered major shifts in recent years, both within the industry, and in its external environment. The cost of healthcare rising due to an ageing population, the intensification of regulatory requirements and mergers within the industry have led to an increased need for restructuring, cost reduction and culture change projects. Project management is the key to addressing these needs, and also to effective drug development. Given the costs of development and the critical issue of 'time to market', project management techniques - appropriately used - are a key factor in bringing a drug to market. In this book, Laura Brown and Tony Grundy's pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects. The text has been revised for this edition and now includes some additional material on risk management.

1
Managing Pharmaceutical Projects Strategically

Introduction

In this chapter we first take a further look at the deficiencies of conventional project management in relation to the pharma industry. Then we explore the need for strategic thinking in managing projects. We illustrate this with a case study drawn from one of the author’s experiences of project managing pharma projects at a biosciences division of ICI (now AstraZeneca). Finally, we introduce the five key steps of the pharma project management process:

• defining the project;

• creating the project strategy;

• detailed project planning;

• implementation and control;and

• review and learning.

Throughout the book you will be invited to invest some time in working through exercises on your own projects so that you can extract maximum learning. Whilst some readers may be tempted to skim these they really will enhance your retention and incorporation of the tools and techniques by the order of at least 100 per cent. Please do not be tempted just to browse the book.

Deficiencies in Conventional Project Management

Conventional project management is very much the offspring of Taylorian Scientific Management. Although the idea that management is a science, and should be managed as such, is no longer much in vogue, the rationalist assumptions embedded in project management carry on.

Not that there is anything in principle wrong with the idea that business projects can and should be managed on a rational basis. Indeed this book very much springs from that premise, however much modified its approach – to deal with the messier aspects of projects. Nevertheless, we believe it is important to avoid the naivety of assuming that rational analysis is the prime mover in project management. Chapter 7, in particular, highlights the role of people and behaviour in the project management process. This is especially relevant in any R&D context – as managers are likely to be emotionally and politically attached to certain technical approaches to project implementation. Rather than being a little extra, an add-on to the more rational techniques of project management, the softer, behaviour-related aspects are fundamental in this industry.

Whilst many generic books on project management contain something on the behavioural side, one’s impression is that this is very much about ‘by the way, whilst you are at it, remember that people need to be managed alongside the projects’. For the very heart of conventional project management texts centres, invariably, on activity management – the targeting, scheduling, measuring and controlling of tangible activities through time.

The real issue is not just about the management of project detail. It is also about making sure that managers do not lose sight of the really big picture. ‘Why are managers even doing this project and not another one?’ is often a very real question to ask, even if this seems unthinkable at times in the pharma industry, and even if the project is a given, we have found in the pharma context there are still – invariably – many different ways of implementing them.

Also, where pharma projects are inherently uncertain, the relatively precise definition of activity durations can become almost an academic irrelevancy. Further, as pharma projects are particularly vulnerable to knock-on effects, the most important critical success factor seems to be to identify how these projects can be made more resilient generally rather than worrying about whether a particular activity might overrun by 10 per cent or so.

Now please try the following exercise which is designed to tease out the importance of a pharma project’s strategic context:

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EXERCISE – REVIEWING THE PROJECT’S OBJECTIVES

For one pharma project which you have undertaken in the past:

• Why did you embark on this project?

• If you cannot easily say why, what should have been your objectives (looking back)?

• Where the project ran into difficulties, to what extent were these due to:

– traditional deficiencies in project management (for example, estimating the time, resource management and monitoring);

– less tangible deficiencies (for example, politics, stakeholder agendas, ownership of goals, interdependencies, uncertainties, and so on)?

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The above exercise is likely to have shown that you may not have had sufficient process in your project. But you can have too much process, rather than too little.

Project management ought not to imply a burdensome bureaucracy. Indeed, in today’s pharma industry the organisational imperatives can kill organisational speed by placing extensive form-filling demands on you for all projects.

Further, the advent of personal computers may not necessarily have helped either. Whilst fulfilling a useful role in helping project managers capture key data for projects, there may be a tendency to collect information so that it can just go on the computer. (In fact we have heard a number of project management practitioners say that the last thing one should do is to put project details onto project management software. In their view it is essential to make sure that a company has got used to project management routines first.)

So looking back at your exercise (above) were not the most difficult issues of your project of a less tangible nature?

We are not, of course, suggesting for a moment that one should not perform activity analyses, and in considerable detail. We are merely highlighting that it is essential to keep a very strong sense of proportion when doing so, and especially to avoid making it look more complicated than it is. If one does overcomplicate things, then one will surely miss the other and frequently more crucial issues which surround why we are doing the pharma project, what value do we hope to get out of it, and how can we avoid the greatest sources of difficulty.

So let us now begin to draw the contrast between the traditional and a more contemporary form of project management, which we advocate, and which is more relevant to the diversity and complexity of projects found in the pharma industry.

Table 1.1 Traditional versus contemporary project management

You are now invited to reflect on the critical success factors of a post-pharma project.

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EXERCISE – REFLECTING ON A PAST PHARMA PROJECT

Thinking back to a project in which you
have been involved in the past, to what extent should its critical success factors be addressed by:

• Traditional project management approaches?

• More contemporary project management approaches?

and to what extent were these addressed for this project?

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The Relevance of Strategic Thinking to Pharmaceutical Project Management

Strategic thinking is an essential part of managing projects in the pharma industry. First of all, business projects do often materialise as a result of formal strategy development. For instance, in the ICI Biosciences case study described later in this chapter, the ambitious growth plans ICI (now AstraZeneca) had for a biotech division involved a number of acquisitions, which were projects, and these led to an even greater number of integration projects. In addition to projects which are external-facing, there are frequently internal projects which are aimed at achieving major organisational change, for example, SmithKline Beecham’s (now GSK) ‘Simply-Better-Way’ project, for change within the organisation.

Secondly, strategy comes in at the level of the individual pharma project which has materialised in relative isolated basis. Each project of that kind then needs to be linked back up to the business strategy of the pharma company. This should be accomplished by teasing out the strategic objectives of each and every major pharma project.

A third level for strategy input is within the pharma project itself, for each and every project has both an internal environment and, hopefully, also some strategy for achieving its own, inherent advantage.

Strategic thinking is often associated with ‘very big picture’ thinking. But, in reality, there is just the same need for more localised strategic thinking for specific pharma projects as there is at that much higher level. Also, as we have already mentioned, the more narrow, operational focus of projects does tend to lead people to ask the question, ‘Why do I need a strategy for that pharma project?’

So what does ‘strategic thinking’ mean more generally? It can be defined as:

The creative and relentless pursuit of options for action which leverage resources, and produce shareholder value more easily and in less time.

Strategic thinking thus contains a number of key elements:

• Creative: strategic thinking requires thinking outside the box.

• Relentless: it is not something just purely intuitive, but typically requires analysis techniques.

• Options: invariably there are many options, not merely for what you could do, but also for how you might do it.

• Action: strategic thinking does mean thinking in concrete terms of the actions that will be needed – by whom and by when.

• Leverage: strategic thinking is continually focused on getting a lot out of the minimum.

• Shareholder value: the generation of cash flows which profile over time is more than enough to cover the cost of capital.

Strategic thinking is often depicted as ‘helicopter thinking’. This is now embedded in the strategic thinking guides of diverse pharma companies (see Figure 1.1) including Amgen, Amersham plc, Tripos Receptor Research, and others.

Figure 1.1 depicts a helicopter flying over rough, hostile terrain. The alternative to the helicopter (walking) only obscures vision – notice how the competitor with the bow and arrow is concealed from vision – and the project’s customer, whether external or internal. Also, there is every tendency (if walking) to go down the rabbit holes – which are inordinately interesting.

Figure 1.1 Helicopter vision

Having made extensive use of this picture over the past eight years we coined the phrase ‘rabbit-hole management’ to capture the fact that going down the rabbit holes can become too much of a habit (this is especially relevant for pharma projects which often involve a lot of complex, technical detail). Figure 1.1 should be used during each and every major project management meeting in order to avoid too much preoccupation with the wrong level of detail. It is particularly useful for helping managers to avoid getting entangled in petty or narrow, personal agendas.

In summary, strategic (or ‘helicopter’) thinking is useful for:

• checking whether a particular pharma project is the appropriate vehicle for the strategy in any event;

• generating other options for implementing the pharma project;

• understanding key opportunities and threats that the project faces in its environment and its internal strengths and weaknesses;

• interrelating the project with others in order to understand its total rationale, and its value.

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CASE EXAMPLE – MANAGING PROJECTS STRATEGICALLY: ICI BIOSCIENCES

We now examine a live illustration of project management in action as told by one of the authors. This case study highlights:

• the importance of prioritisation in pharma project management;

• the need to manage uncertainty, ambiguity and interdependencies;

• the importance of thorough diagnosis;

• the significance of the ‘softer’ factors, including stakeholder management.

Although the events of this story occurred some years ago, the experiences are as vivid as if they had happened yesterday. So let us time-travel back to when one of the authors was seconded from a large consulting group to become Head of Finance, Planning and Acquisitions for a division of ICI (now AstraZeneca). This business no longer operates in the same or even similar form to the way it did then. We will call the division ‘ICI Biosciences’. This case study illustrates a range of projects which posed major management difficulties.

ICI Biosciences was a (then) £100 million turnover mini-group of companies with operations in three countries:

• UK: a major research centre; also some minor manufacturing activities.

• US: a significant biosciences business with manufacturing facilities.

• Continental Europe: a very recently acquired business in continental Europe which was a major and successful manufacturing operation. (By ‘recently’ I mean one week before I arrived on the scene.)

ICI Biosciences’ headquarters was located in a beautiful rural setting, in woodland. It shared a common site with a large part of the company which we will call ICI Global Technology. I was to have a joint reporting relationship to the European General Manager (who in turn reported to the Managing Director of the International Biosciences Division) and also to the Divisional Financial Controller, ICI Global Technology.

Following ICI’s recent acquisition of its European manufactu...

Table of contents

• Cover Page
• Title Page
• Copyright Page
• Contents
• List of Figures
• List of Tables
• Preface
• 1 Managing Pharmaceutical Projects Strategically
• 2 Linking Pharmaceutical Projects with Business Strategy
• 3 Defining Pharmaceutical Projects
• 4 Developing Pharmaceutical Project Strategy and Plans
• 5 Evaluating Pharmaceutical Projects
• 6 Pharmaceutical Project Mobilisation, Control and Learning
• 7 Influencing People and Behaviour
• 8 Project Management Checklists and Cost-management Project Case Study
• 9 Conclusion
• Glossary of Key Project Management Definitions
• Bibliography
• Index