The Project Manager in Pharmaceutical R&D
Simon B. Dowden
What's wrong with this scenario? The scene is a large research and development complex of a major research-based pharmaceutical company. The facilities are well established, but an addition is being built to improve the capability of the R&D organization; a new chemistry pilot plant is being built at a cost of $15 million. The construction is being run out of a series of mobile offices put in place by the contractor responsible for the job.
The construction is the responsibility of a project manager and the project team. The project manager and the engineers use sophisticated project management techniques to control and monitor the project. The system is used to level resources (manpower and materials) over the work schedule, to provide detailed Gantt charts to foremen for scheduling work, to tell the project manager and team when deliveries of building materials are required, and to monitor the costs (materials and labor) on adaily basis. The project logic network contains thousands of activities constructed from detailed work breakdown structures, and with resources assigned to most activities. The system is used to report back in detail the progress, costs, and exact status of the construction project to both the contractor's home base and the buyer.
Author's Note: The opinions expressed in this article are purely those of the author.
The scene shifts to a different part of the site, to the project management department of the R&D organization. Here, we find a project manager who is responsible for one or more of the new drug development projects being brought forward by the organization. The project, if it goes all the way to market, may cost the company as much as $250 million. The project is in clinical development, just entering efficacy trials. A close look at the project manager's tools for managing the project reveals yellow stickys, plenty of project notes, scientific data summaries, meeting minutes, thick typed project plans with study outlines, a stack of presentation materials on all aspects of the project. Oh, and sitting in the corner an unopened box of project management software.
|In the past, resistance to project management in pharmaceutical R&D may have been based on the perception that it could interfere with good science, and that the development process would be reduced to ticking off boxes.|
All right, I've exaggerated; some project managers in pharmaceutical research and development have opened their boxes of software, and a few of them even use them. But the reality is that the application of sophisticated quantitative project management techniques to pharmaceutical research and development is rare and does not occur on the scale of that found in the engineering and aerospace industries on projects of equivalent (or even substantially less) value. The purpose of this article is to briefly review the reasons for this and to provide an overview of the contrasting roles of project managers in the different industries.
The Pharmaceutical Research and Development Process
How is the development of a new drug different from R&D projects in other industries?
The relative lack of sophistication of formal project management in pharmaceutical research and development begs the question of why these well-developed techniques have not been embraced with the same enthusiasm as in other fields. Is management behind the times in pharmaceutical R&D? One of the standard texts on project management, Harold Kerzner's Project Management, a work of over 1000 pages, devotes only 15 pages to project management in research and development. Let's take some time to compare the objectives of development programs in the pharmaceutical and engineering arenas. The purpose of the development program as it relates to a new drug is different from that of engineering, aerospace or software development in several major respects. The object of the exercise in drug development is to generate a body of scientific information about a new molecule that will persuade the regulatory agency to approve it as a new therapy, and moreover to convince physicians to prescribe it. The molecule itself does not change—it is the same at the end as it was at the beginning of the process. In other words, the drug development process does not “make anything.” In this respect the pharmaceutical research and development project is unique compared even to projects in other R&D fields.
Another difference is that the number of new drug development projects that are initiated greatly exceeds the number successfully completed. Few new drug candidates entering the development process result in successful marketing applications, whereas most large engineering development projects have a technically successful conclusion (even if they come in over budget, late, or make no money in the long run). Projects in the engineering field are not initiated unless there is general agreement that the technology is sufficiently well developed to result in the successful application of that technology—such as the construction of a new structure or machine. Furthermore, resources can be applied as required to solve technical difficulties in engineering projects with some confidence of a positive result. Rather than a question of technical success, the concern is usually how much extra cost is incurred or time is lost in fixing the problem.
In contrast, a new drug development project may be initiated and taken into the clinic on the basis of an untested hypothesis about a receptor antagonist or enzyme inhibitor being useful in treating a particular disease. In other words, before “proof of concept” has been demonstrated for the biological rationale. These are extremely speculative ventures, but they may yield real therapeutic advances if the concept is proved correct. Unlike a machine, if a new candidate drug exhibits some aspect of its profile that is unacceptable for its chosen indication, very little can be done to rectify the situation no matter how much money is spent. You have to go back into discovery and change the molecule or discard the hypothesis. The pharmaceutical research and development process is not like a series of construction and prototype testing activities, but is a series of studies defined to ask specific questions about the molecule's behavior in various biological systems. This means that the process is very dynamic from an informational point of view. Every study conducted is built upon the data from those preceding it, often from those immediately preceding it. This is a very fluid environment, requiring much flexibility in the approach to project management.
The Project Management Process in Pharmaceutical R&D
So how are projects managed in this environment? In fact, is project management an essential function in pharmaceutical research and development?
Senior managers in pharmaceutical research and development have usually been selected and promoted on the basis of their expertise in a scientific or clinical discipline. They rarely, if ever, have been exposed to formal project management training or techniques (unlike their engineering colleagues), nor has the project management function historically been regarded as essential in pharmaceutical R&D. Many successful drugs were developed by companies long before the introduction of formal project management functions in pharmaceutical research. In the past, resistance to project management in pharmaceutical research and development may have been based on the perception that it could interfere with good science, and a related fear that the development process would be reduced by a project management approach to ticking off boxes.
Senior management needs pharmaceutical R&D project objectives to be met on time and within budget if possible. They are only interested in project management as a separate entity if this arrangement increases their ability to meet these commitments. In such an environment it has been very much up to individuals in these organizations to champion the role and value of project management as a separate function. The character and success of the project management function in pharmaceutical R&D organizations have often therefore been functions of the individuals who have set the system up, as well as the management environment that nurtures them. Only positive contributions over a period of time have established the project management function in the eyes of many organizations.
Most pharmaceutical R&D organizations now possess a discrete project management function, but it was not always so, and many individuals struggled during the late seventies and eighties to establish the credibility of project management as a distinct discipline in pharmaceutical research and development. Although not regarded as essential, project management as a function is generally regarded as desirable by pharmaceutical R&D senior managers. This is simply because, if an organization is going to spend tens to hundreds of millions of dollars on a project, it is a good idea to have at least one or two people devoted to thinking about that project management full time and in a disciplined and analytical way. The discipline of project management is, after all, a body of knowledge and techniques devoted to the analysis and application of logic to projects.
The Plan: How Much Detail is Right? One challenge for any product development organization is to come to terms with itself on the level of detail it wants to see in its project plans. This very much affects the project manager's working environment. Due to the constantly changing project environment of a new drug candidate, there is a level of effort in the planning process that, when exceeded, consumes more resources than is liberated by the end result. The job of the project manager and team is to articulate the project plan at an appropriate level of detail that the organization needs and wants. At the very least, every major, discrete, study thought to be needed for registration should be captured in the project manager's project database. Departments may also keep their own detailed plans.
Table 1. Management Points of Difference in Pharmaceutical R&D Projects
- The project goal is to build a body of evidence to support a clinical claim for the agent; this is inherently different from building a new structure, machine, or software program.
- Resources may be difficult to quantify in a way that can be tracked and monitored in a project management software network, because the resources that matter are often skill sets residing in many different individuals.
- The elements that make up a project workplan change constantly in detail, even though the overall project strategy may remain the same.
- It may be difficult, if not impossible, to assign formal logic between activities in a meaningful and rigorous manner.
- The great majority of projects in the pre-Phase II (efficacy) stage will fail. High risk is inherent in pharmaceutical R&D projects.
- Projects are made up of elements, some of which can and some of which cannot be managed in a quantitative formalized fashion.
Beyond capturing individual studies and activities in the project management database, the project manager must reflect on how much lower levels of detail are useful to track, or are practical to track. A sad but familiar figure in some pharmaceutical R&D organizations is the project manager who spends time and effort constructing and maintaining complex logic networks and schedules that no one needs or uses. For projects in continual flux, articulating greatly detailed, operational-level, long-range plans that change on a regular basis is extremely labor-intensive for both the project manager and those responsible for management and planning in the line. Many experienced project managers, instead, plan in detail only to the next milestone, which may be scientific (such as demonstration of efficacy) or operational (such as filing an IND (Investigational New Drug Application). This practice is in sharp contrast to the development planning of a new experimental machine or device whose construction, assembly, and testing must be planned in great detail before any work starts if the enterprise is to be successful.
In fact, many pharmaceutical research and development activities and studies are difficult to link up in a justifiable logic network, not because they are not needed in the development process, but because their discrete relationship to other studies or milestones is rather woolly at best. An example would be pharmacology or drug metabolism studies, many of which are “nice to know” and give everyone a confidant feeling about the long-term viability of the project, but which are not essential from a regulatory or clinical point of view. Another factor affecting the ability to come up with a “definitive” plan or logic network is that of risk. It may not be prudent to conduct a “fastest possible” development plan (for instance, by carrying out as many studies in parallel as possible) if it is felt that the project has a substantial chance of failure. With such candidates, development speed is not the only consideration. So the formally defined “network logic” of nearly all new drug candidate development projects is to an extent defined by a subjective assessment of risk on the part of the project team and management.
|The drug development process is a chimera of segments, some of which are rigidly organized and very amenable to quantitative project management techniques, and some of which are an ever-changing melange of scientific issues and studies that are not. The trick is to know when to apply project management and when not to.|
Quantitative Methods. Despite these caveats, some aspects of the drug development process are highly regimented and are just as amenable to quantitative project management techniques as their counterparts in other fields. In general, as a project moves through the development process and clinical trials are initiated and expanded, the nature of the line function activities becomes highly regulated. Once efficacy has been demonstrated (post Phase II) projects become less prone to unexpected changes in direction. After this stage they become larger, more complex, but also more stable from a project management perspective and thus more amenable to formal project management techniques. For example, the conduct of a large clinical trial program by the Clinical Research Department, although very complex, is highly regimented in terms of process, data management, and standard operating procedures (partly because of the need to adhere to Good Clinical Practice guidelines and regulatory obligations). As such, the clinical trial process is very amenable to sophisticated project management planning and tracking systems, and even quantitative methods for assigning resources such as investigator grants and clinical research associate monitoring time can be, and are, used.
Clinical project management software is used routinely by pharmaceutical research and development companies to both monitor and control the progress of the clinical trial. There is an abundance of software available specifically designed for various aspects of the clinical research process. The status of the site monitoring visits, case report form retrievals, patient enrollment projections, and so on, can all be captured and planned electronically. Although these functions are usually run and coordinated by personnel within the clinical organization itself, they are directly comparable to quantitative project management functions in other organizations such as engineering, with the possible reservation that they are not all logic-driven. Other disciplines that organize and contribute large bodies of information to the NDA (New Drug Application) submission use similarly complex project management techniques; Regulatory Affairs departments, whose activities can rival those of a medium-size publishing house during the runup to an NDA, also routinely use what can be classed as project management techniques.
So the drug development process is a chimera of segments, some of which are rigidly organized and very amenable to quantitative project management techniques, and some of which are an ever-changing melange of scientific issues and studies that are not. The real trick is to know when to apply project management techniques and when not to.
Bad Science vs. Bad Management. To what extent can the project management function in pharmaceutical research and development accept responsibility for the quality of the development program? Is this responsibility purely a line issue? How can management distinguish between poor science and poor project management? This is not as easy a distinction as it may seem. Very serious delays can result when either a pivotal preclinical or clinical study design was misconceived, the need for a particular study was missed completely, or the study was well done but the interpretation was colored to an excessive degree by wishful thinking on the part of the organization. Examples might be the failure to conduct a survival study in support of a particular indication, even though historical precedent made the need for such a study very high. Literally years of delay are the result of conducting inappropriately designed studies that are then found lacking by regulatory agencies. It often seems that delays due to inefficient execution of a sound development program (good science, bad project management) are much less severe than good execution of an unsound development program (bad science, good project management).
Assigning blame for projects that fall behind but where no single factor can be blamed is surprisingly difficult. Senior management understands and accepts reasonable delays due to scientific or technical problems that arise. However, consistent insidious delays due to no apparent cause are the bane of the matrix system and can be difficult to eliminate. They are usually due to small delays in frequently iterative activities where there are many repetitive handoffs between departments. Individuals and departments involved may only be responsible for delays of a few days and do not see this as a major crime; but when these occur in repetitive functions, substantial delays can and do build up. The only way to prevent this is very close monitoring of the handoffs between departments by the project manager and team representatives.
How Project Management Recognizes Projects That are On-Track, Off-Track, No-Track. How do pharmaceutical research and development organizations, then, distinguish between bad science and bad project management? A successful submission is way too late in the process (by several years) to be a useful yardstick. Many organizations use target labeling and/or some well-articulated framework of scientific goals to provide a common vision for both the project team and departments. These approaches are very useful, and continual comparisons of the plans and data generated to date with the intended clinical indication, for instance as stated in the draft product labeling, can provide an ongoing reality check for both teams and management. These documents provide the strategic vision for the project.
Another quite different tool for the project manager is the operating plan for the project. This is a comprehensive list of all the studies and activities anticipated to be required to result in a successful registration package. This may be captured in a formal project management software system with real logic linking the activities and studies, or it may simply be an exhaustive list of studies with start and finish dates.
These two types of roadmap are very different in purpose, and both are required for a project to progress on track and in the right direction. Without a strategic vision for the projects, as articulated in target labeling, it is very difficult to measure the quality or relevance of the work being done. Without a detailed operating plan of studies and schedules, it is very difficult to measure progress towards agreed submission target dates. It is part of project management's job to continually assess both the quality and the rate of progress using both these tools.
It is this aspect of pharmaceutical research and development project management that is so different from other fields. In a sense, the development program for a new drug is like that of building a case for the defense in a legal action: the process is one of continually amassing evidence to support your thesis that the drug is fit for its chosen purpose.
Project Management and Project Budgets. One of the attractions for senior management about a well-established project management function is the ability to generate and track project budgets and clearly relate them to the project work being performed. Yearly discussions on the total research and development budget are made easier if plans with well-defined activities are available to the line departments to allow them to better estimate what resources they will need to allocate to achieve project goals.
Senior research and development managers are occasionally haunted by the fear that what their people say they are working on is not, in fact, what they are working on (or at least the level of effort is misrepresented). Conceptually, a project budget controlled by the project managers and team could ensure that project milestones are met by ensuring that the allocated funds are indeed being spent on the project to which they are allocated, or, if a particular department is under-performing, to contract out the particular study or work being performed. This happens in project management in the engineering and aerospace fields where much work is done by outside contractors who are continually evaluated for performance.
In practice, few project managers in pharmaceutical research and development have direct control over the actual resources within the line functions. It is one thing to assist the budget process by furnishing detailed plans, it is quite another for the project manager to be in control of that budget.
A major reason for this is that the scientific expertise of the organization resides within the line management departments; the scientific discipline is responsible for generating the plan of studies required within that discipline to support the development project. Therefore, while the broad outline of studies needed to support a development plan are known well in advance (e.g., a one-year toxicology study), the details (dose, schedule, feeding regimen, special aspects) are not. The detailed design of these studies is not usually articulated until the study protocol is drafted (shortly before the study may actually start) and is based upon the most up-to-date data from a number of disciplines. The expertise to define these studies resides in the line departments, specifically where a number of subspecialties contribute to the overall design. Therefore it is impossible for the team and project manager to dictate the details of individual studies without the active cooperation and input of the scientific line departments.
In this situation it is difficult to visualize a way for the project manager and team to make use of budgetary authority to make alternative arrangements— one cannot approach a contract house and instruct them to perform a study without telling them exactly what it is. In order for a project manager and team to behave with confidence as an independent unit with full budgetary authority for the project, they would have to encompass a scientific skill set rivaling that of the entire pharmaceutical research and development organization of which they are but a small part.
Role of the Project Manager in Pharmaceutical R&D
How are project managers’ skills in pharmaceutical research and development different from the skills of their engineering cousins?
Engineering: Project managers in engineering must be capable of coping with projects that range in duration from months to years with corresponding degrees of size and complexity. They have a blueprint of the project (contract, design, specifications) and then are expected to manage the engineering, procurement, and construction aspects of the project as well as issues relating to finance; schedule; cost engineering; environmental agencies and regulations; inflation; public, client and contractor relations; labor relations; and seasonal considerations. They may well have direct control of budget, negotiate with external contractors for competitive bids, and monitor performance using quantitative project management techniques.Project managers in engineering development will usually be around to see the completion of the project.
Table 2. Project Management in Pharmaceutical R&D Compared to Other R&D Areas
|Pharmaceutical R&D||Engineering/Defense R&D|
|Project Manager||Project Manager|
| || |
Figure 1. Traditional PMBOK vs. Pharmaceutical R&D Skill Set Distribution
Pharmaceuticals: Project managers in pharmaceutical research and development must also be able to cope with projects that range in duration from six months (line extensions) to ten years or more. They must be able to manage and understand the interdisciplinary scientific issues arising around the disciplines of pharmacology, chemistry, toxicology, metabolism, pharmacokinetics, pharmacy, clinical research, and statistics. They must construct, maintain, and push forward a project plan of ever-changing complexity to attain subtly altering project goals over the life of the project, They rarely use quantitative project management techniques, and their formal management skills may be considerably more rudimentary than those of their engineering colleagues. They must continually reassess the project in the light of emerging scientific data, both internal and external. They will usually not see the successful completion of the project due either to project termination on scientific or commercial grounds, or simply because they have moved on.
Different Types of Project Manager in Pharmaceutical R&D. If you talk to project managers from different pharmaceutical research and development organizations about the work they do, you find that there is a broad spectrum of functions called project management. Titles can also be confusing; in some organizations the term project manager is synonymous with project leader. Other titles such as project administrator, development planner, project director also exist. Different types of individuals with different skills exist in the project management function, but in terms of scientific background and training, this experience can define the type of project management that the individual does. A relatively senior scientist who has joined from a senior laboratory post can be expected to run the project as a scientific leader, with emphasis on interdisciplinary scientific issues. A project manager who has joined with a lower level of scientific ability or training often develops more administrative skills, with emphasis on detailed plans and activities. He or she often will share the project leadership role with a senior scientist or clinician who provides the scientific leadership and who retains his or her scientific line responsibilities. These arrangements are two types commonly found in the industry, but really there is no typical background or training for a project manager in pharmaceutical research and development.
Similarly, project managers in the engineering fields may have a wide variety of backgrounds (usually engineering-based), but, given a good grounding in one of the relevant fundamental disciplines, personal qualities rather than specific training denote long-term success.
Project Management, Not Project Managers. It is not necessary to have the job title of Project Manager to be one. Nevertheless, if a complex interdisciplinary scientific development project is to succeed, someone must act the role of project manager. The heads of small, one-product biotechnology companies often perform the project management function. It is probably not even true to say that a large, complex drug development project requires a project manager if that is the only project on the slate. In such a case, the head of research and development is effectively the project manager, and the heads of departments are the team members. In fact, where the project management function resides in an individual who also carries line management responsibility for the scientific departments, there is complete accountability. The sheer number and complexity of projects within the average pharmaceutical research and development organization usually precludes this arrangement.
Formal Training in Project Management Techniques. To what extent should project managers in pharmaceutical R&D be formally trained in project management techniques such as critical path analysis? Is it necessary, given the “fuzzy” logic of many activities in projects? Some would argue that a wide experience of the scientific disciplines involved is more important, and this may well be true.
However, even though most organizations do not use formal project management techniques to any large extent, such a choice should not have been made out of ignorance. There really is no excuse for a professional project manager working in the pharmaceutical R&D environment not to have attended one of the many courses on formal project management techniques and relevant software applications. There are courses run regularly that teach the application of project management techniques to the pharmaceutical industry (including research and development), and it is possible to obtain professional certification in project management. Although they sometimes present an idealized picture of their application to the development process, they do provide an encouraging vision of a formal project management ideal to which many practicing managers aspire.
What Personal and Professional Qualities Result in a Good Project Manager? In terms of interpersonal and organizational skills, the qualities that make a good project manager in pharmaceutical research and development are probably similar to those that make a good project manager in other fields.
Here is my own personal list; it's short but not too different from others:
- Infinite flexibility and good interpersonal skills
- Genuine interest in all aspects of drug development (not just the glamorous disciplines)
- Self-starter—particularly for beginners; people will not come to you and ask to be “project managed”
- A thick skin—if you don't have one, you will soon develop one
- Ability to live with constant change and a sometimes fairly ill-defined role
- A good all-around scientific education founded on one of the biological or chemical sciences
- Several years experience in one of the core development disciplines.
The Future of the Project Manager in Pharmaceutical R&D
So what does the future hold for this group? Will they evolve into someone more like their distant cousin, the engineering project manager? I doubt it, unless the nature of pharmaceutical research and development changes substantially in the future (which seems unlikely). I am aware of several serious attempts to apply quantitative project management to pharmaceutical R&D that have failed, although efforts continue, and failure in the past does not preclude success in the future. The project manager is a creature of his or her environment, and future changes in the research and development environment will be reflected in the role and day-to-day work of the project manager. Certain changes that are currently shaking the industry, especially in the United States, might be expected to affect the sort of work the project manager does. Control of costs is becoming paramount, and many project management systems are designed with close cost control in mind.
One emerging trend is that of contracting-out greater proportions of the development work, while retaining a core of expertise in the parent pharmaceutical R&D organization. This is in line with the need to reduce the numbers of permanent headcount across the board in the industry. This tendency towards the “virtual reality” pharmaceutical research and development organization may drive a move towards more formal project control methods; after all, it was partly the need to control multiple contractors in the defense industries that gave birth to formal project management in the first place. As some pharmaceutical R&D organizations shrink towards becoming small groups of experts (rather than large laboratory-based facilities) who can use contract research organizations for almost any aspect of the drug development process, it may be that more rigor will be applied to the practice of project management in pharmaceutical research and development along the lines of that found in other high-technology-based industries engaged in research and development. ■
Broshky, E. 1991. A Race to the Finish in the Development Game. Pharmaceutical Executive (May).
Hamner, C.E. 1990. Drug Development (2nd Ed.). CRC Press.
Kerzner, H. 1989. Project Management (3rd Ed.). New York: Van Nostrand Reinhold.
Murphy, P. 1989. Pharmaceutical Project Management – Is It Different? Project Management Journal, vol. XX, no. 3 (Sept), p. 35–38.
Simon B. Dowden is a project manager for Sanofi Research (formerly Sterling Research). He formerly worked with the Biotechnology and Development Planning Departments of Glaxo Research.
PM Network • May 1995