Project Management in the Pharmaceutical Industry

A Statement of Issues and Observations

ROBERT STAPLES

Smith, Kline, and French Laboratories

PMI — 79 Session

This paper attempts to capture the sense of the discussion held during the ad hoc technical session of the 1979 seminar/symposium of Project Management Institute held in Atlanta, Georgia.

PMI-79 became the forum in which project management personnel in the pharmaceutical industry could develop statements of issues relevant to their industry. Most participants were from R&D and corporate staffs. There were others from outside our industry who came to find out just what we were interested in. One person from Mexico joined the twenty from the U.S. in what proved to be the most well-attended, interactive, pharmaceutically-oriented PMI session in recent years.

It was agreed that this would not be a time for “show and tell.” On the contrary, we sought to identify some issues that influence our project management profession or perspective. In the identification process, some in the group discovered that many issues that have long been begging solution were shared by many others in the group. Some people were reinforced; others reinfected. The topics that surfaced are listed below and some discussion is included where appropriate.

• If “standards” are “statements of professional intentions,” then could (or should) project management standards be formulated for

a) the pharmaceutical industry or

b) specific segments within our industry, such as research, development, marketing, regulatory affairs, manufacturing, engineering, etc.?

• How is the effectiveness of a project management professional or tool/technique demonstrated or measured? What should be the evaluative criteria?

• Where are prospective project managers or staff support people to be found?

• What factors should be considered in determining the size and placement of a project management group in the organization? If one centralized group is considered, to whom should it report? Or, should project management staff be decentralized or scattered throughout the company?

• What are the conflicts between responsibility and authority which project managers or staff must face? Could (or should) they ever be resolved? Can some problems be solved by constructing creative conflict?

• If allocating technical resources is a legitimate management concern, then how is it best accomplished and what role should a project management group play in the process? Who makes effective use of available automated resource allocation software?

• What role should a project management group play in communications between various components of our industry such as R&D, marketing, manufacturing/engineering, top executives, “bench-level” science, etc.?

• What image(s) do project management personnel convey?

• What, if any, is the relative importance of academic degree, project management training, job experience, technical competence, age, sex, or any other factor to project management success?

• Is there a correlation between successful project management and a successful project by whatever criteria of success used? How may a project be managed without “project management”?

• What are some pros and cons of particular organizational forms (i.e., functional, projectized, matrix, task force) for R&D or elsewhere? Are these general perceptions of R&D personnel correct and do they relate to the selection of a particular project management style or organizational form?

• Comparison of the perceptions of research versus development personnel to items of management concern:

Perception
Item Research People Development People
Definition of goals Prefer less statements Prefer well-defined statements
Relationships with others Usually more independent Usually more “team aware”
Reaction to orga-ni/ation structure Prefer less Work well in structured environment
Management orientation Usually less Usually more
Comfort with estimating timing Usually difficult Usually less difficult
Possessiveness Usually less willing to share with those outside specialty Usually less possessive than “R-type”
Work perspective Usually happy with “problem” orientation Probably prefer “product” orientation

• Should responsibility of the project manager or project director, if you prefer (i.e. “leadership”), change throughout project life history? If so, at what transition points? Who causes these changes? How are changes accomplished?

• What are some criteria for determining appropriate size of a project management (PM) staff group? Would ratios of number (or cost) of PM function and other measurable denominators be appropriate? Here are some expressions:

Abbott: PM represents less than 1 percent of R&D budget

Merck: PM staff is about 1 percent of total
number of R&D employees

SK&F: PM staff is about 0.5-1.0 percent of R&D employees

Warner Lambert/Park Davis: 2 PM staff handle 30 projects

• Does good project management save a company money? Some engineering companies estimate that saving to be 5 percent of project costs. Do you agree?

How could we prove it?

Conclusion

Participants in this ad hoc session who sought specific answers to specific questions were probably disappointed. Those who sought confirmation that project management philosophy and tools may be used effectively in the pharmaceutical industry were encouraged. Most pleased with the meeting were those who came to meet face-to-face with other professionals with whom dialogue would provide mutual benefits. To the extent that this seminar/symposium provided the forum for this dialogue to take place, that PMI objective was fulfilled. The ad hoc group discussed the possibility of expanding this forum to encompass a one- to two- day workshop in which participants might explore suggested resolutions to the issues raised.

I believe firmly that pharmaceutical project management is alive and improving and that no doubt health care is ultimately improved because project management professionals bring together the forces of good science, good medicine, and good judgment.

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