The Management of Pharmaceutical "Discovery" Projects
This is a report of a data collecting effort at PMI'88 in San Francisco in conjunction with the meetings of the Pharmaceutical Special Interest Group. It provides an excellent view into the way project management is actually applied in this early phase of drug development. For more on the unique problems and practices of this industry, the Showcase Project for August will focus on the development of a new drug and the September PMJ will focus on the Pharmaceutical industry. Bob Staples is the Editor for the Showcase Project and the Special Topics issue of the PMJ.
For those not initiated in this field, IND stands for Investigational New Drug Application and GLP is the abbreviation for Good Laboratory Practices.
By: Robert G. Staples
Since it's origin about two decades ago, Project Management Institute has had a significant membership segment from the pharmaceutical industry. Most of these people have had a direct relationship to or responsibility for R&D project management. Most attention over this period has been devoted to principles and practices related to the drug development process. The management of pharmaceutical research projects has received much less attention by contributors to PMI literature. This might be due, in part at least, to concern for corporate security. It also might have something to do with a basic industrial “discomfort” with results (or lack of them) associated with current management of research projects and somewhat iconoclastic research scientists.
The survey reported herein focuses on that early part of R&D where projects are directed toward discoveries with profitable new product development potential. Some companies identify that “genesis” timeframe as the Discovery period.
The pharmaceutical industry is research-intensive and dependent upon the discovery or invention of new chemical entities or therapeutic approaches for the treatment or prevention of disease. Success in this venture means not only the expansion of human knowledge, it is crucial to the economic future of individual companies. But, modern research is expensive and the potential rewards are often distant, difficult to quantify and relatively unpredictable. Certainly, the research operation is a candidate for creative management as well as for creative science.
Can “Discovery” be managed?
If “discovery” is defined as that instant when an inquisitive mind begins to unravel mysteries of life's processes, relationships, ingredients or products then the answer to the title question is probably “no”. Phenomenal acts are rarely, if ever, “managed”. In fact, some researchers argue that “management” (often project management) actually reduces the probability of discovery thus defined. They suggest that there is empirical evidence to support the notion that management-required “paperwork” takes time away from research activity, hence slowing their rate of discovery.
In contrast, if “discovery” is defined as that somewhat protracted period of time more commonly known as “research’, then the answer is emphatically “yes”. Obviously, this period and the projects spawned by discoveries needs to be critically managed, remembering that discoveries come from the best minds, not the best management.
THE SURVEY ISSUE DEFINED
How are established project management principles and practices currently being applied in the Discovery continuum in contemporary pharmaceutical companies?
The topic has broad interest but is probably most relevant for companies which 1) support research to discover new molecules or chemical entities which might ultimately lead to new ethical drug products, and 2) have established a project management philosophy and support system (or group) chartered to provide project management services.
This report presents the results of a cursory survey of attendees of the PMI ‘88 Pharmaceutical Track, September, 1988.
Poster Data Board
A large board was designed in the form of a matrix in which the “X” axis portrayed an arbitrarily-defined “Discovery Period Continuum” ranging from “Program Established” through “IND Prepared/Submitted”. This time span was divided into 10 segments, each segment representing ten percent of the elapsed time. (No attempt was made to define the absolute duration of the Discovery Period in years, months, etc).
The “Y” axis listed eight commonly-described project management milestones. Space was provided for respondents to add others, if they felt the list to be incomplete.
Respondents were instructed to place a sticker on the Discovery Period time line in the segment which most closely located the milestone in their company. [Space was provided for extended comment at the discretion of the respondent.]
The board was mounted outside the entrance to the pharmaceutical track meeting room throughout the two and a half day duration of the proceedings.
A photograph of the board is shown in Figure 1.
QUESTIONNAIRE: DISCOVERY PROJECTS: WHY, WHEN, AND HOW PROJECT MANAGEMENT?
This instrument was composed of several sections to elicit responses about:
- Characterization of the respondent and the respondent's employer. The respondent was given the option of responding anonymously.
- Policies and Procedures
- Project Management Practices
- When to get Project Management Practices
- Benefits vs Risks of Project Management
Specific contents of each section are described in the Results portion of this paper.
Track participants were invited to complete the questionnaire prior to a session devoted to discussion of the topic. They were also encouraged to invite colleagues at their company to respond by mail to this investigator prior to November 30th.
Figure 1. Participant Response Board
SUMMARY OF RESPONSES FROM 21 QUESTIONNAIRES RECEIVED
[Note: Percentage is based upon the total number of responses to the inquiry. That total may be more or less than 21, since some questions permitted multiple responses by an individual]
Pharmaceutical industry experience
Project management experience in pharmaceutical industry
Experience just prior to current project management position
|Student||R&DLabs||R&D non Lab|
Other experience mentioned:
Hospital/Health care, Government/Regulatory, Engineering, and Psychology,
Highest degree obtained
ABOUT RESPONDENTS' EMPLOYER
Scope of Business Activity
|U.S.-based multinational||13 (65%)|
|Non U.S.-based multinatl||6 (30%)|
|Business in U.S. only||1 (5%)|
Relative Scope of Discovery Organization
|No Discovery organization||1 (5%)|
|Discovery group 50 or less||1 (5%)|
|Discovery group over 50||18(90%)|
Scope of Formal PM Activity
|No formal PM group in R&D||3(14%)|
|R&D PM supported by non-R&D PM group||1 (5%)|
|Well-experienced R&D PM||11 (52%)|
|PM group new to company||6 (29%)|
In the following sections the question is stated and the responses tabulated and/or summarized
ABOUT POLICIES AND PROCEDURES
1. Define “Discovery Project”. Differentiate between a “Discovery Project” and a “Development Project”, as you use the terms.
|Discovery project……||pharmacological profiling being done with medicinal chemistry; non-GLP toxicity screens.|
|Development project..||following decision to proceed to subacute toxicity, metabolism, preformulation; has a defined regulatory objective|
Discovery projects are therapeutically-centered; development projects are product-directed.
2. Does your company have a formal, written procedure for the establishment of projects originating from…
- in-house “Development”...............................62%
- in-house “Discovery” (Research)..................67%
- other in-house groups (c.f., marketing)........24%
- in-licensed from outside source....................48%
- I am not aware of such procedures...............33%
3. Do you think such procedures are (or could be) useful for projects arising from Discovery organizations?
|Yes - 100%||No - 0%|
- Should be “guidelines” (checklist?) rather than rigid rules.
- Rapid growth has depersonalized
- Needed to improve “buy-in” from business side.
- Serves as “strainer” to make sure “champion” doesn't overstate (oversell).
- Clarifies relationships between domestic and foreign branches.
- Useful to establish decision criteria, team selection, milestones, marketing connections, etc.
4. What role should a project management group play in the formulation of policy/procedure for initiation of “Discovery projects?
- A leading role..............................................14%
- Participate, but not lead...............................71%
- Not participate..............................................15%
- PMG should provide guidance and perspective, but not lead.
- Discovery projects must be initiated by researcher (i.e., stakeholders).
- PMG should observe only.
- Must have PMG to assure smooth technology transfer.
- If PMG were a “task force” participant, then could possibly “lead” subsequent project.
ABOUT PROJECT MANAGEMENT PRACTICES
1. Who authorizes Discovery projects and approves plans…
- Highest level of corporate management.... 14%
- Highest level of R&D management............57%
- Highest level of “Discovery” management. 29%
- Formal presentations from R&D Discovery Team coordinated by PMG to obtain go-ahead.
2. Are your company's Discovery projects planned …
- By “Discovery” people only......................62%
- With involvement of a PM group.............24%
- With aid of network diagrams of flowcharts..................................................5%
- By an interdisciplinary team....................33%
- Plans based on product “champion”.
- PM group integrates tracking.
- Sometimes a PM is member of a task force.
- Teams include marketing for broad direction, but Discovery does the specifics.
3. Once planned, do you produce “schedules” for project participants (i.e., target start/finish dates, etc.)?
|Yes - 50%||No - 50%|
- Via project coordinators
- Two formal reviews per year; many informal meetings.
- Milestones only.
- Not connected to any logic diagram.
- A “pre-development” plan.
4. Do you monitor status of Discovery projects relative to their baseline plans, i.e., assess progress toward some goal?
|Yes - 47%||No - 53%|
- Very informally!
- Yes, but not in project management group
5. If you “track” or monitor in some way, how often do you update Discovery projects …
- Every 4-6 weeks.........................................38%
- Only when asked by management...........16%
6. Do you do any sort of analysis of resource demand/availability created by a Discovery project?
|Yes - 32%||No - 68%|
- PM group is responsible for this.
- Done “seat of the pants” by preclinical directors only.
- Prioritization vs existing projects (low projects are doomed).
- Historically, we've found no need.
- Functional groups do this.
7. If you analyze resources, do you permit schedule alterations on the basis of potential resource conflicts?
|Yes - 86%||No - 14%|
- Don't analyze!
- Schedules occasionally change when priorities adjusted.
- Done verbally - no software or formal system.
8. In summary, briefly compare/contrast your company's practice of project management for Development projects with that practices for Discovery projects. Comments:
- Many Discovery projects are done as “bootlegged” activity.
- In Discovery projects project management is done in individual Discovery departments, there is no central project management group involvement. In Development projects a team is established and a preliminary plan is constructed just after the start of subacute toxicity. At this time cost/resource estimates are done.
- Slippage is tolerated more in Discovery.
- In Discovery, status is for “information only”, not decision-making.
- Discovery has a “university atmosphere”
- Basically, we have no project management for discovery.
- Development is management-directed, controlled. Discovery is scientist-directed and relatively uncontrolled.
About When to Get Project Management Groups Involved
1. Is your project management group involved in the process of identifying lead compounds (i.e., those showing promise in target indication(s) in animal or in-vitro models)?
|Yes - 20%||No - 80%|
|Should it be?|
|Yes - 41%||No 59%|
- Project management groups usually do not have the needed scientific expertise.
- Project management could provide input regarding direction from marketing.
- Project management should become involved later, as sections “draw closer”.
2. Do you think that project management techniques might be applied usefully to the early stages of Discovery?
|Yes - 60%||No - 40%|
- Yes, but only at interdepartmental connections.
- Maybe these stages are not controllable.
- Formal updating/scheduling etc. can demotivate and corrupt an open atmosphere.
- Project management must first be demonstrated efficacious in Development.
- Use for tracking and resource allocation.
- In Discovery, limit to reviews of objectives/status/plans one to two times per year.
3. Are there particular stages or aspects of Discovery in which project management techniques should be consciously avoided?
|Yes - 61%||No - 39%|
- Techniques aren't dangerous … people are!
- During creative, basic science aspects.
- During lead compound identification.
4. It has been noted that many of our industry's discoveries have resulted from “bootlegged” research … that is, from studies not formally sanctioned or funded from a particular project or account. What should a project manager do when confronted by such “bootleg” research?
- Point it out to management..............................10%
- Do nothing and keep silent.............................10%
- Express quiet encouragement to researchers.. 23%
- Attempt to have it recognized/authorized.......37%
- Offer other kinds of support............................17%
- Inform Accounting that codes are being mis-applied........................................................0%
About Benefits vs Risks of Project Management
1. List the benefits (to self, to company, to therapeutics, etc.) of involving formal project management at the earliest possible moment in the drug discovery process.
- More realistic resource allocation, resource and cost estimation.
- Improved “timeframing” and forecasting for downstream alerts.
- Better inter- and intra-disciplinary coordination.
- Shortens time to decision stages or to market.
- Provides clear organizational framework.
- Provides better goal definition; maintains focus on milestones.
- Improves communication, commitment, and information management.
- Contributes perspective against which to kill a project ... something scientists seldom recommend
- Increases recognition.
- Increases likelihood of commitment of funds.
- Increases accountability … measurement of progress vs investment.
2. List the risks of involving formal project management at the earliest possible moment in the drug discovery process.
- The supportive role of project management people for later development activities would be compromised.
- Could apply unwanted pressure to “discoverers”.
- Stifles creativity.
- The uncertainty of work makes estimation difficult ... so much so that it might not be worth the effort.
- It creates the perception that schedule is more important than the quality of science.
- Overmanagement is a form of castration.
- Discovery is “high risk” and project management may “take the heat” for a high failure rate.
- More information increases the chance of novel research “leaking” to competitors.
For Pharmaceutical Project Management Practitioners
Pharmaceutical discovery projects, like development projects, are managed according to the “style” and techniques developed within their specific R&D and corporate cultures. What works well for one company need not necessarily “fit” the competitor. The specific degree of “hands-on” involvement by established project management groups may vary from one company to the other; and the specific location of traditional milestones in the continuum may likewise vary. Indeed, this survey may have shown that some of that variance may be less than expected. One conclusion which may be drawn from this survey of a small, but relevant group is that project management principles and practices are applied very early in the R&D continuum, most often initiated formally with the involvement of a “project management group” during the time in which lead compounds are being characterized as clinical candidates. This conclusion is not the least unexpected.
The results presented on the preceding pages speak for themselves. Reader insight into the collective views expressed in this study could be useful to reinforce established ideas or practices or to support needed changes in project management philisophy and practice in a particular company.
For Readers from other Industries
For those outside the pharmaceutical industry or who are not close to an R&D-intensive business, an amplification of some basics might be useful to identify why there continues to be so much interest in and sensitivity to the management of Discovery projects and people.
Scope of Pharmaceutical R&D Projects
Classic definitions of the term “project” in the pharmaceutical industry usually include the following ideas:
- Applies to a new, perhaps unfamiliar, often complex long-term effort to accomplish unique objective(s), and has specific beginning and ending points.
- Work is performed according to a logical order, each task dependent upon some preceding task(s).
- Much of the work breakdown structure is “conditional”, that is, conducted as a “study” which could result in the redefinition of the logic of the project plan.
- Projects are multidisciplinary and are undertaken within the confines of a matrix organization in which many non-project tasks compete for resources.
Characteristics of the Discovery Environment
Project management's best contributions are most noticed in Discovery organizations characterized as follows:
- Feasible investigative areas have been identified according to corporate strategic objectives.
- A research environment has been established to facilitate the latest in technology and allow for serendipity. Policies and procedures are in place to support this environment.
- Appropriate resources (people and equipment, etc.) are on-board or available.
- Research plans or criteria are clear or approaching clarity.
- Scientific and economic evaluation criteria are in place.
- Investment parameters (Time, money, and other resources) are defined or “bracketed”.
- Test methods are developed and exploration is encouraged.
- Study plans and “milestones” are defined and updated routinely.
- Management processes are defined, skills are high, and there is commitment from “top to bottom”.
- Morale is high; trust is firm: “power brokers” and “stakeholders” are known and appreciated.
- Internal and external communications channels are open.
Project Management and the Discovery Environment
The practice of project management during the Discovery period may be “formal” or “informal”. “Formal” project management implies the involvement in some way of a group within the parent organization which is chartered with the responsibility of providing project management services. The existence of such a group implies that more than one project requires services and that some of these projects may, indeed, be in Discovery stages. Classic characteristics of the Discovery environment usually include:
- Shared resources
- Multiple interfaces, internal and external
- High stakes
- Structured accountability
- Periodic publication, including some “standard” reports.
- Occasional “simulations” to support the decision process
“Formal” project management, therefore, most often serves the needs of those responsible for multi-project management.
In contrast, “informal” project management may be practiced by individuals, with project scope limited to the interests of a particular investigator or department. Project management techniques and tools may be applied by each individual to the degree which best supports that person's productivity. These include team building, particularly within a single investigative or functional area, and a variety of automated management systems, including network-based project management software. This kind of project management is often practiced when interdependencies are limited and publication/reporting formats and frequencies are relatively unstructured.
Systematic Project Managementln Discovery
One of the real issues addressed in this survey is, “To what degree should project management be formalized in Discovery organizations?” Effective project management affords enhanced planning and control but over-control may impede the discovery event. What benefits may be expected, then, from systematic “formal” project management in Discovery? Two come to mind:
- Visualization of Discovery planning - the creation of “art” in the form of networks (either arrow or precedence) or flowcharts may provide the mechanism to view an abstract idea or process objectively without being critical of people.
- Simplification of communication with non-Discovery interfaces, including:
- Other scientific groups
- Non-scientific groups (marketing, operations, some corporate management, etc.)
Some of the “formal project management systems” which might be incorporated in Discovery, therefore, include:
- Administrative - minutes, notices, archives, summaries, publications and a host of other “information about the project” examples.
- Logic-based Predictive - goal-setting, baseline establishing, or other “best-guess oriented” examples; usually network-based.
- Short-term Tracking
- Resource Planning
The survey indicated that, indeed, these “systems” have a place in the “formal project management systems” in which many of the respondents practice their art and science daily.
This study has demonstrated that people-oriented project management practiced according to mandates established within a unique corporate or R&D culture, involving the sensitive application of contemporary systems and tools, is being applied successfully to pharmaceutical projects in relatively early stages of the Discovery period. Usually the scope of these projects is limited to the study of entities identified for future clinical investigation. In some companies, however, project planning techniques are being applied even earlier to the process of identification/selection of clinical candidates.
Classic concerns about the relationship of “science/research” and “management” and the use of systems or “tools” as clubs over the head of “science” are still with us, and evidence suggests that such concerns will continue as long as creative people work in the discovery-dependent pharmaceutical industry.
Robert G. Staples is a project management consultant and educator with particular interest in project planning and management information systems applications for pharmaceutical research, development, and related projects. Mr. Staples retired from Smith Kline and French Laboratories in 1986, following a 24-year career in R&D beginning as a pharmacologist and later sewing in various project management roles. He was a “charter member” of one of the first R&D project management groups in the industry in 1967, eventually having responsibility for R&D Management Systems and Services, and was involved in the implementation of a worldwide R&D project management system.
Mr. Staples has been a member of PMI since 1969. He was elected a Fellow of the Institute in 1986 and has served PMI as Director, (Secretary; Vice President), Project Manager, and Nominations Chairman. He was the originator and first editor of Project Management Quarterly, the predecessor of the PMJ and PM NETwork.
Prior to entering the pharmaceutical industry, Mr. Staples taught science and mathematics in New Jersey secondary schools. He is a graduate of Rutgers University and holds a Masters Degree from Syracuse University.
February 1989 pm network