Integrating project management with knowledge management to improve the speed and quality of drug discovery
This paper illustrates how web-enabled Information and Knowledge Management (IKM) systems can support and enhance research-driven Project Management (rPM) and project outcomes in Drug Discovery. Although the origins of IKM derive largely from Document Management (DM), it is now primarily about e- (web-enabled) collaboration, and the connecting of many types and levels of “Knowledge Communities” and “Communities of Practice” that populate an organization. “Web-enablement” provides the “connectivity” between these communities and the open and meaningful sharing of the many categories of information and knowledge that exist within an organization. With PM software becoming increasingly web-enabled, it is timely to focus on the value that can be gained through integrating e-IKM with rPM in the Pharmaceutical Drug Discovery setting, i.e., from Target Generation through clinical Proof of Principle (cPOP). To do this, we must first clarify and understand the needs, context and organizational settings both for drug discovery projects and for e-IKM.
Exhibit 1. The Drug Discovery Operational Matrix
The Organizational Matrix
The organizational structure of a company can have substantial impact on the effectiveness of operations and how the projects within them are managed. The PMBOK® Guide (2000) considers several examples with extremes represented by (a) a purely “functional” organization and (b) a dominantly “project” organization. In some companies organized around business units, there may be a high-level functional structure, coupled with a project orientation within some or all business units. The levels of hierarchy vary substantially but larger R&D companies typically adopt a matrix of functions and projects. The “Strong Matrix” reflects the inclusion of a Project/Program Management Office (function), from which are drawn professional project managers and leaders, as well as other types of support. The same is true of the research-based Pharmaceutical and Biotechnology industries. Smaller niche research companies or service providers are often totally project-oriented across a narrow range of disciplines, dependent on marketing their intellectual capital, property—and knowledge—at the appropriate phase of R&D, and/or forging strategic alliances with larger corporations. The strong matrix is commonly employed in large Pharmaceutical companies (“big pharma”) to manage clinical development programs but is uncommon in the drug discovery phases of R&D. For a variety of reasons, classical PM, per the strong matrix, has generally not been adopted in the research environment and most (by no means all) discovery groups are organized into projects within a weak matrix, i.e., no formal Project Office or PM group.
Exhibit 2. The Knowledge Pyramid
The Operational Matrix
An “Operational Matrix” describes the business processes of a company and the interfaces between them. The PMBOK® Guide provides important definitions to distinguish “Process” from “Project” but does not examine details of an Operational Matrix and the many important implications it may have for PM.
The complexities are often overlooked insofar as each operational element reflects varying degrees of individual and group specialization, skills, know-how and activities that typically roll up to the strategic direction of the company or group. Each strategic and operational element is an important communications interface and informational environment for a project. For example, such strategic direction in drug discovery may consist of a commitment to one or more broad Therapeutic Areas of interest (e.g., cardiovascular, oncology), embracing multiple disease indications, supported on a foundation of Core Research (or technical) Competencies in one or more fields of research. Each of these might contribute to multiple therapeutic areas and disease indications. Numerous specific Projects, which collectively constitute the Project Portfolio, will reflect these strategic elements and be positioned along a Discovery Process. Projects aligned with one therapeutic area or, in some cases, a field of research, constitute a Program of related projects. “Big Pharma” and fully integrated companies often adopt many of these principles. Smaller companies are likely to be more flexible yet focused on a single core competency, therapeutic area or indication. Often, the competency per se is a central part of the broader discovery process, e.g., genomics and target identification, high throughput screening and lead generation.
The Drug Discovery Process and Research-Driven Project Management.
A typical drug discovery process (see Exhibit 1) epitomized as Target Generation, Lead Generation, and Lead Optimization, etc. is constructed along high-level “stage gate” and milestone principles with decision points and generic transition criteria at each process step. Every project is unique with its own specific sets of objectives and target criteria (deliverable specifications) that it should attain or exceed before proceeding to the next phase. The implementation of an effective research-driven PM system allows teams to focus on this uniqueness.
The application of an increasingly defined discovery process creates a clear opportunity for more effective project management in research. For example, a 3rd or 4th level process breakdown structure (PBS) is a powerful tool and template for developing a project Work Breakdown Structure (WBS) and project plan that recognizes the specific scientific needs of that project. A project can be initiated at any stage of the process, provided that entry criteria are fulfilled. However, its management implications increase with each subsequent process step because few disciplines are directly involved at early stages (e.g., target generation), but further along the chain, e.g., lead optimization, a project explodes across many disciplines. Project scope and complexity increase, the volume of data and information generated and used increases, the level of risk may (paradoxically) increase, and the project value increases. Thus there is a progressively increasing need for effective rPM along the drug discovery value chain. Regrettably, many opportunities for valuable medicines languish or are lost, not through poor science but inadequate project management. While it may be highly desirable to appoint an originating scientist to a project leadership or management position (potentially mission-critical), we repeatedly fail by not providing the training, support, tools, and techniques essential for the job. Above all what characterizes drug discovery projects are:
Exhibit 3. View from the Cockpit
- High levels of uncertainty and risk
- Intellectually challenging and technically complex activities
- Driven by creativity and the need for innovation and novelty
- Renewed & intense competition
- Prolonged yet urgent time scales (still, despite process!)
- Historically independent isolationist cultures
- Relatively few regulatory requirements (cf. clinical development).
Project Management in drug discovery must therefore be both sensitive to the needs of research and fully utilize the operational dimensions discussed earlier. Professional, entrepreneurial rPM that continuously evolves throughout the discovery process and on through clinical development is key. The model of rPM adopted must be carefully considered and the rPM cloth cut to fit the need, focusing on the features that will generate the most benefit to drug discovery. Foremost amongst these are communication and collaborative skills, project planning and risk management.
In any case, it is critical to fully appreciate that the ONLY project deliverables from research are data, information and knowledge. Everything else is but a means to the development of information on which to base decisions and its broader intellectual capital. How well we manage this information becomes, therefore, a critical success factor, easing the challenges of managing scientifically complex projects
Some Essentials of e-Information and Knowledge Management
Definitions and Concepts
Let's get back to basics. Sumner-Smith (2001) reviews the current state of IKM in Pharmaceutical R&D. Surprisingly, for such an information and knowledge-intensive industry, IKM, for most companies, is only now emerging. For present purposes IKM should be considered as an e- collaboration and business integration tool with the particular purpose of enabling efficiency and success through more effective project cycle management and portfolio management. It operates by “making available what is known by individuals … to everyone who may need to know it, reducing redundancy and facilitating better decision-making at any level and process step” (Sumner-Smith 2001).
Knowledge is built on the foundations of accumulated information distilled from data (e.g. experimental data) to levels that allow its interpretation, conclusions to be drawn and decisions to be made. It is the individual and/or group intellectual awareness and know-how developed from assimilation and critical evaluation of information and the events and decisions resulting from it. To be knowledgeable is to be well informed.
Data (‘raw data” or other, e.g., protein sequences, gene coordinates, biological observations) typically reside at the functional level and are rarely the currency of cross-functional projects. It is the information distilled from and that interprets data, usually as a report, which is normally shared between functions and project teams in order for an informed decision to be made and next actions to be agreed. “A study is not complete until reported.” [There are many other sources of information such as reports of discussions, news, agenda and minutes from project meetings, email memos, publications, etc.] In the event that clear-cut criteria are either not established or are not met by the study/activity outcomes, the combined wisdom of project team and function may be applied to the knowledge gained and provide the judgment for a decision, recommendation, or the referral of impeding issues to management.
Table 1. Key Features of e-IKM Systems
|Information Context||Information Content|
|Document Management||Rapid Access & Retrieval|
|Mirrors the Organization||Supports Operational Matrix|
|Application-Independent||Internal & External Reach|
|Structured & Unstructured||Secure|
|Information||Full Search & Visualization|
|Intuitive Navigation||Robust & Easily Managed|
|Alerts! & Change Notification||WorkFlow & PM compatible|
|Project & Portfolio Tracking||Literature, Patents & Database Access|
Divergent and Convergent Communication
Information sharing can be very inefficient, even with email, attachments, and distribution lists, etc., itself a huge advance on previous systems. Consider a report being distributed by a Project Leader to his or her team. Commonly this will be attached to an email, carry a cover note, and be sent to a predetermined distribution list (the project team). Each, in turn, will download the report, file it in their own system, and may forward the report to others for interest or need, who in turn repeat the process! This typifies divergent communication and information distribution.
A web-enabled IKM system obviates the need for divergent communication of this sort. Instead, both originators and receivers of information access a common repository. In the above example, the project leader would simply file the report in the appropriate Project folder, an automated alert and/or URL link would be issued to all with access to the folder (q.v.) and information receivers/users would access the report directly, at their convenience, with no need to ever download or file separately. All previous and related materials will be in the same repository and immediately accessible or, alternatively, accessed via full text search capability. The inherent timesavings that accrue from this feature alone are very significant.
Personal and Community Workspaces
The above example of convergence is key to some of the core concepts, use and internal application of IKM. Central to this is to ensure that information is accessible to staff in the right context and of the right content to meet their needs, and that the people and groups that form an organization are fully connected. Multiple workspaces that reflect all levels and groups of an organization— the Knowledge Communities and Communities of Practice, within the organizational and operational matrices, are linked through a common server that manages all the information and controlling systems. It may consist of an isolated network or a network within a company “Intranet” with seamless access to other sites on the intranet, or external to it.
All participants will have a private personal workspace (a “launch pad” or “cockpit”) from which immediate access can be made to all other (group) workspaces to which one belongs or has access. Equally, one may directly access particular objects or sources within the system. This access would extend also to websites (e.g., company/project/function) if so chosen. Exhibit 3 (View from the Cockpit) depicts a metaphorical view from the cockpit and the multiple groups and sources of information, derived from the matrices discussed formerly.
Document Management, Repositories, Search, and Retrieval
HTML is the common format of the web, and thus e- IKM is largely application independent. Every file or object within the system has its own unique URL address. Original files can be deposited in the original software application, accessed for viewing in HTML format (online conversion), or retrieved for revision (or personal filing) in the original application. Document management features then enable version control and document tracking, etc. Levels of access and use of workspaces or the contained materials can be controlled by the assigning of privileges to participants. Full-text or keyword search capabilities can be applied to the whole system or to any chosen level within it (site, folder, file, etc.) including scientific publications posted at sites throughout the organization. Table 1 summarizes some of the more important features of e-IKM.
Project Interfaces, Communications and Knowledge Communities
Clearly, the project setting in drug discovery is truly multidimensional, not the flat two-dimensional matrix in which it is so often described. Far from being a problem however, this offers a great opportunity to leverage the power of the broader dimensions and to be more effective. The combined organizational and operational matrices can be visualized and represented along and between 3-dimensional axes and the intervening space occupied by the array of information generated and used by scientific staff, project team members, management (see exhibit 3). Some of the communication and informational interfaces important to a project can be identified by taking a viewpoint from the origin of the “graph” into the world surrounded by function (line), process (operations) and project-portfolio space. These coordinates define the critical links between strategy, science, process, projects and day-to-day activities. For project leaders and team members it is frequently useful to step back and view the working environment in this way. Some typical interfaces are listed in Table 2.
From the project perspective it is particularly important to forge strong informational and collaborative links between your project, its team members and all functions contributing to the project. From the function perspective and the individual within it, it is critical to have immediate and dynamic access to all the projects that the function and individual serves, and to be able to move seamlessly to specific databases that are the realm of that function. It is equally important to ensure total clarity of project information of the appropriate level and content for management use. This should all develop to the level of automatic daily working practice.
When applied in a basic, routine manner, IKM will
- Create a transparent operational matrix and information fluidity throughout the organization
- Enable fully coherent integration within and across projects, process and portfolio
- Provide a dynamic information repository with immediate access and retrieval, document management and full system, full text search and display capabilities
- Become a core working practice.
As the communication, collaboration and coordination skills of rPM link tightly to the context, content, and community connectivity of IKM individual and team awareness, knowledge, commitment and productivity will soar. If—WHEN—you decide to incorporate IKM and rPM as a working practice, identify with your team the three to four most important features that will enable you to better manage your project and that will help your project team members to do a better job. Institute these first before moving to higher levels of sophistication. Work together to build the knowledge plan and methods for your team and ensure that one team member, in addition to yourself and on a rotating basis, has responsibility for managing the project workspace (Project Knowledge Manager?). The upfront effort will be rapidly and richly rewarded.
Table 2. Project Communications and Information Interfaces
|Project||Project Team||Core Team Exteded Team Individual members|
|Project||Functions/Groups||Group Leaders Key players|
|Project||Management||Local Corporate & other|
|Project||Other Projects||Within Program Other programs|
|Project||Therapeutic areas||Immediate Others|
|Project||Collaborators||CROs., academia Industry, internal & External|
Project Management Institute. 2000. A Guide to the Project Management Body of Knowledge (PMBOK® Guide, 2000 Edition). Newtown Square, PA: Project Management Institute.
Sumner-Smith, Martin. 2001. Beginning to Manage Drug Discovery and Development Knowledge. Current Opinion in Drug Discovery & Development. 4, 3.
Further reading: The Knowledge Advantage. 1999. Ed. Ruggles, R. & Holtshouse, D. Capstone US.
Contact: [email protected]
Proceedings of the Project Management Institute Annual Seminars & Symposium
November 1–10, 2001 • Nashville, Tenn., USA