Art or Science?
How—And Even Does—the Pharmaceutical Industry Apply the Discipline of Project Management?
Is, and indeed can, the “D”iscipline of Project Management be fully applied—let alone recognized and utilized—in the field of Pharmaceutical development and marketing? I highlight the D of discipline to pose a bigger question. Is this discipline only, and always, the well-defined set of techniques and technical skills as specified in such approaches as PMBOK® or PRINCE, or is it really an application of thinking that relies more on behavioral “arts” and customization of management capabilities to meet specific business/environment needs? Indeed as far back as 1995 Fortune magazine claimed “Project Management is evolving from a specialty into the central task of middle management” (Fortune, July 1995). In fact American management guru Tom Peters believes “all white collar work today is project work” (Tom Peters, Fast Company, May 1999)—and therefore all white-collar managers are (by extrapolation) Project Managers!
Clarity around the scope and roles of formal Project Managers, with the “D”iscipline of Project Management (PM) as their business contribution, versus the “art” of delivering a successful project using a variety of project management skills, that all successful business managers use today, has been a frequent and often heated discussion throughout my industry sector; i.e., pharmaceuticals, as well as many others. Are influence and negotiation more, equally, or less critical capabilities than say the ability to analyze a timeline and crunch the critical path or calculate the earned value? “Project managers” in this industry range from schedulers, to clinical monitors, to autonomous team leaders. Companies vary from totally focused and structured around projects, to classic line department driven with part time “drafted” teams and project managers. Although changing, PM is more commonly viewed as a support function. The leaders of the teams and in fact the overall organizations in this industry, are generally highly educated and experienced in some other discipline; e.g., medical or marketing. They believe they have learnt all they need to know to effectively develop and deliver a new project, and therefore the value of a consistent PM process is not readily perceived—a fact underscored by the inability of the pharmaceutical project management group/discipline to “own” and evaluate objective metrics. Numerous efforts to measure or benchmark the value of PM in pharmaceuticals often end-up evaluating the effectiveness of the team structure or the drug development process as a whole (Case, 1998; Grindel, 1988; Foulkes, 1991; CMR, 1998; Kasher, 1998). However, this is clearly not limited to the pharmaceutical field, as recently as 1999, the DAU has signed a memorandum of understanding (MOU) with PMI to research and “demonstrate” the tangible value of Project and Program Management in the defense industry (PMI Today, 1999). Career progression, business contribution and the recognition of PM value, in a project-based but technical-led team organization proves a significant challenge not only for the individual, but also for any Project Management function and their leaders. What role are we really hiring for—scientist or PM? How standard should the skill set and application of templates be (project process execution vis project delivery)? Is previous “PM” training or experience in a different industry applicable? Would “professional” status aid in resolving this challenge?
So can PM metrics be generated or does it de facto become measuring the overall product development business in these days of ubiquitous projects?
We (Pfizer Pharmaceuticals PM) have been exploring and refining our own applications and understanding of traditional PM techniques for the last 5–10 years. During this time we have assessed and developed both our own capabilities and our organizations “readiness” for traditional PMBOK® type techniques with growing, but mixed, success. The ability to use earned value; the use of resource leveling; when, what and how to outsource; what type of contracting to use; scope and success definition, these are among the skills and techniques that we have assessed—and in some cases adopted, on our path to a more successful PM contribution and professional status. We have also looked into what are the inherent components and “arts” that make for a “successful” project—and project m an-ager—in both our company and others within our field.
Firstly it is helpful to understand our environment. Pharmaceutical projects are both highly regulated and high risk. The averages currently quoted for large pharmaceutical product development through approval to market are 10–12 years and approximately $500MM. Additionally, approximately only one in every 10,000 compounds screened gets approved (PhRMA, 1998). Lifecycle management while allowing > 100% growth post initial product launch can also lead to large-scale “follow-on” programs with multiple projects of varying scope and schedule definition. You can see, therefore, that projects and programs in our industry can range from one month efforts, costing six-figures; e.g., a simple clinical study, to 12–20 year, multimillion-dollar (with multibillion-dollar potential) joint alliance global development programs, requiring new manufacturing plants to be built, etc. Project management is applied—and often “owned” for each of these projects and subprojects via a variety of individuals with varying skill sets.
The Special Interest Advisory Committee (SIAC) for PM of the Drug Information Association (DIA) and the Pharmaceutical Special Interest Group (SIG) of the Project Management Institution (PMI) have been meeting to assess the best approach to advance the “professionalism and discipline” within the pharmaceutical industry. A number of concrete steps have been taken to outline an approach for joint advancement between the SIAC and the SIG including signing an MOU, developing agreed standards and the possibility of Certification and/or a Certificate of Added Qualification (CAQ). However, before we formally initiated a certification/CAQ or standards project it was critical to ensure that we clarified what the market might be and even what the baseline of understanding was. We sought “sponsor” scope clarity. The SIG chair distributed a questionnaire to his constituents that has been published separately, where he ascertained that 60 of the SIGs’ 800 members were formally qualified via PMP (McDonough, 1999). As, presumably, this group of pharmaceutical project managers is some of the most attuned to the theory and “D”iscipline of PM, this was a surprisingly low number with formal qualifications. As chair of the DIA SIAC I used a similar approach but broader survey. I wanted to assess both the current practice and understanding of the >5,000 DIA “PM members” regarding this discipline, as well as their appetite to advance their professionalism in project management. The interim results of that survey are discussed below (the survey will be closed post writing of this paper but final results will be discussed at the June meeting and published in the Journal of the DIA). As highlighted above, one of our main challenges has been to clarify the scope and terminology/use of PM that we are referring to in this field. Although some of the experience I present will be personally based from a large pharmaceutical firm background, the DIA constituents represent a far broader environment including biotechnology firms, smaller manufacturers, providers of outsourced resources (e.g., contract research organizations—CROs or consultants), etc. The survey results presented within this paper are representative of that broader field and those perceptions and applications of PM throughout the full landscape of the “drug industry.”
The DIA is the largest not for profit drug development educational organization with over 23,000 members worldwide and ~5,000 “registered” as affiliated or actively interested in the Project Management field. Indeed the PM track is one of the largest and fastest growing areas of the DIA meetings. PM has been applied and developed for ~20 years in the drug industry—and educational and professional networks such as the PMI SIG or the PhRMA PM subsection (latter disbanded approximately seven years ago) have had plenty of energy and debate around professionalism. It has however, only been in very recent years that there has been some real progress to consistent application and standard terminology and development. The DIA's SIAC for PM was formed about six years ago (initially mainly from the members of the disbanded PhRMA group) and sponsors a series of educational and networking initiatives to advance the knowledge and professionalism of Project Managers throughout the “drug” industry. One of these was the need for standards—and possibly certification—a joint effort with the PMI SIG. A survey was developed by the SIAC, based on both the key PMBOK® categories and joint SIAC/SIG conversations. The SIAC survey was posted on the DIA's web page and completed by individuals who are either members of DIA's PM contact list (the ~3,700 PM members who accept e-mail distribution) or by those who “surfed” their way to this area and felt interested/compelled to answer. The answers and findings therefore are very open to interpretation and cannot be validated. The consistency in understanding of terminology or accuracy of the respondents’ answers cannot be fully ascertained within this effort and therefore must be discussed (as designed) as informative, not definitive. However, simple the approach, we were wanting to look for trends and differences within our broad industry base and therefore built in some internal consistency checks and ways of stratifying the answers. The interim results are discussed below.
A response rate of approximately 12% (444 of the 3,700 e-mail registered PM “members”) was the basis of this presentation of the results—a final set will be submitted to the DIA journal. Of these respondents, a third (34%) felt their role was “purely” project management and while 62% had had training only 15% claimed “formal” qualifications. Of the respondents to this DIA survey 19% were also members of PMI. The respondents were asked to state the nature of their firm, i.e., did they work in a large or small pharmaceutical manufacturer, a biotechnology firm, a CRO or consultant/other. The rate of responses were distributed as follows: 35% large pharmaceutical; 14% small pharmaceutical; 14% biotechnology; 18% CRO; 19% consultant/other. The level of role clarity and “ownership” around pure project management did not vary widely across the different segments—with a slight decrease in focus within the CRO and consultant arenas.
To assess the alignment to PMBOK® or see whether there were components of it that were less relevant to this industry's project management community, the respondents were asked to classify whether the key areas were theirs—“my responsibility,” a “shared responsibility” or they “didn't know/NA.” The results of the “key area of responsibility” are presented by type of firm in Exhibit 1. While obviously this terminology and breadth of interpretation of key areas is very open, the results didn't vary widely across types of firms, or between those who felt that project management was their main role and those who were more flexible in their ownership/application of the discipline. There was one exception to this. Of interest—the one area that appeared to have greater ownership—or at least alignment with PMBOK®—was Risk, in those respondents who felt that their role was “purely” project management. While not overwhelming, this subset of respondents recorded a 37% “my responsibility” compared to 15% of the interested in PM but not “purely my role” (p0.001) and the 22% overall finding. In an industry highly attuned to risk, this is not a surprise. “Risk Management's one of the key responsibilities of the PMs leading the (drug) development projects” (Lewis, 1998).
In addition to what respondents were currently doing, we were also interested in understanding their appetite for additional training and potentially even certification. Eighty four percent of the respondents felt that industry specific standards would be useful, however, only 10% felt that this step alone (without testing) would provide enough benefit. Sixty seven percent of the respondents were interested in additional qualifications (slightly higher in large pharma. and CRO sectors). Of that subset a full 80% claimed that they would be willing to study for a PMP® qualification. Seventy five percent of those interested in further qualification would be interested in an additional pharmaceutical based certification (e.g., CAQ) with the PMP® as a prerequisite. However, given alternatives, and when asked to think of the industry as a whole, respondents interested in further qualification felt that a new integrated pharmaceutical certification, i.e., an alternate to the PMP® in project management, would provide the most benefit. The preferences are shown in Exhibit 2 again by type of firm. Of interest 60% of the overall respondents felt that their organization would recognize or reward their additional professionalism, i.e., there were respondents willing to pursue additional qualification without organizational support.
The DIA's SIAC—and other networking and educational groups—have been debating the level, best organizational approach and indeed required skills for project managers in the drug industry for many years. Both our group and the PMI's Pharmaceutical SIG are committed to improving the professionalism of PM within our industry sector. To do that it is important both to know where you are (baseline), but also where you are going (vision or end point) on this journey toward professional status.
The results presented above provide some insight into this topic and certainly raise more opportunities for research and study as well as help direct the SIAC (and hopefully SIG) efforts going forward. It has been felt during the discussions that I have been part of, and had the opportunity to read or observe, that the drug industry (I use that term to mean the broadest range of firms) is possibly only in its early exploration of applying and benefiting from this discipline. At first glance one could interpret the lack of consistent alignment and ownership of the classic areas of PM (using PMBOK® as a reference) reported above, to support this perception or feeling—that the drug industry is in kindergarten while construction and IT industries for example, are the university professors! However, on researching the literature further and opening my ears to the broader debate it is clear that most industries are still exploring, learning and even defining what this discipline is. “PM is an elusive discipline” (P. Morris IEE Review, 1999). If we delve a little deeper into this and explore some of these key areas, questions arise about the collection of these capabilities into a discipline applied by a set of individuals, versus a virtual model where the key “PM” disciplines/roles are distributed throughout an organization or team. Procurement is for example recognized across a broad range of industries as absolutely a responsibility of any project manager—100% alignment (P. Morris Project, 1999). In the results we collected from the drug industry only 18% felt this to be the project manager's responsibility—a far broader group (60%) held this to be a shared responsibility. This report is consistent across all sectors of our respondents with a slight (not significant) increased ownership from consultants who presumably have had to handle contracts routinely. Webster's defines discipline as “training to act in accordance with rules” (Webster Dictionary), and therefore understanding and agreement of the rules (standards) has to be an integral part of achieving the discipline. Many people recognize that different industries concentrate on different parts of the BOK, engineering and construction have a far more sophisticated range of practices around contract management for example, than IS procurement (Cooke-Davis, 1999). Of those respondents within our group who claimed their role was purely PM, only 12% felt procurement was their responsibility and not a shared one. Twenty percent of our respondents were unsure how procurement was handled or possibly not even comfortable with the terminology. This may well be a reflection of the use of separate procurement groups or functions in many firms, as well as a widely held belief in our industry (personal observation) that financial matters (broadly) are not what project management is about in the drug industry. While my group, Pfizer Pharmaceuticals, supports project budget management and understands procurement, we also have separate procurement functions and so our PMs are only peripherally involved.
Resource management and earned value—two other trademark tools—are also sparsely used throughout the drug industry. While my group in Pfizer Pharmaceuticals has developed tools and approaches to handle resource (dollars and headcount) forecasting for our project teams, these are used at a strategic directional level, not for real detailed project management resource success. We have assessed the use of earned value for our teams and currently believe that we neither collect project performance data at a level consistent with this approach—nor that the assessment would significantly benefit the overall performance of the projects—our ROI on effort was not sufficient (certainly in a time frame acceptable to management). Some of this is to be expected as pharmaceutical margins are not those of the construction industry (for example) and therefore the attention to and detailed project resource assessment is not as key a business driver as it is in that arena—and again from personal discussion and observation this is consistent across the industry. However it is not universal and there are sectors of the drug industry really starting to apply these techniques in a more robust way and exploring realigning their business into a truly project friendly organization (e.g., collecting project level resources for both direct and indirect costs), and as the industry goes through increasing market pressures this may become a critical success factor that is given attention.
There are numerous articles looking at various maturity models across industry sectors—some, where there seems strong alignment (Ibbs, 2000), and some, where there is more variation (P. Morris Project, 1999). Of interest—few assume that the pharmaceutical industry is worth (to date) including in these cross industry assessments. If one agrees that different industries and sectors concentrate and utilize different parts of the BOK discipline, then it is not surprising that the pharmaceutical industry is still debating how to apply project management. While not as rigorous or robust as the above works the results presented here—both in the appetite for qualifications—and the level of response (12% reply on an un-enforced survey), suggests there is real substrate and promise in this sector.
Open discussion about the relevance of these issues to other industries and groups of Project Managers will hopefully be deliberated and debated at the conference.
Acknowledgement and thanks to members of the DIA PM SIAC, and PMI SIG for directions; A. Allen, (Pfizer Inc.) Jack Mardekian (Pfizer Inc.), and A. Olivier (DIA) for technical support, and Gerardine Cox for enthusiasm and administrative support.
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Proceedings of PMI Research Conference 2000
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