Core Project Teams
In the pharmaceutical industry the formal use of core project teams to accelerate drug development began in the early 1980s. Rather than review the attributes and value of the team concept here, the reader is referred to an excellent text on the subject by Katzenbach and Smith (15). The current standard for biopharmaceutical project team structure is the matrix team, which is made up of core team members from relevant functional organizations that are needed for the development of a new drug (i.e., toxicology, discovery, analytical, formulations, clinical, and regulatory), a project team leader, and a project manager. It is the project manager's role to ensure that current project information has been incorporated into the various project planning and management tools that the organization is using. Using project management tools, the project manager develops various project scenarios for use at project decision-making meetings. Each core team member represents the combined functions of his or her department and is supported by his or her own set of team members back in that department. Each core team member is also the team leader of his or her respective functions for the project, which maybe called subteams (e.g., clinical subteam, regulatory subteam).
The term matrix refers to the fact that project team members have a dual reporting relationship and therefore are known as multiply supervised employees (MSEs). The traditional matrix team concept has performed adequately. But, as initially conceived, the performance evaluation of team members was conducted only by their departmental management, so that the focus of team members was usually centered on their functional department. However, this evaluation structure was modified in the early 1990s by having each team member's performance evaluated, at least in part, by his or her project team leader. This change has greatly increased the effectiveness of the matrix team approach.
In the mid-1980s, Abbott Pharmaceuticals introduced the concept of the "project venture team" in which those who worked on a particular project reported to a project department head. In the mid-1990s, Lilly introduced the concept of "heavyweight teams." Heavyweight teams are formed at the end of Phase II and members of these teams devote their entire time to the advancement of a single project to NDA submission, approval, and launch. Most recently, both matrix and heavyweight teams are adopting the concept of colocation or a project "village." Although the core team team members are formally part of a functional department, their "project offices" are all within a few feet of each other. This project village concept has been particularly successful because it fosters rapid and frequent communication among the core team members. Several large biopharmaceutical companies are now building new facilities just to create space for the "villages" for the colocation of project teams.
Project Team Leadership and Project Support
Project teams can be led and supported in a number of different ways, as identified in Table 27.11.
With the advent of the Prescription Drug User Fee Act (PDUFA), which legislated new timelines for NDA reviews, the FDA introduced the project team concept for both IND and NDA reviews. For INDs, an FDA project team is established upon IND submission. When an NDA is received, an important responsibility of the NDA review team is to determine whether the submission is adequate for review by the FDA. Within 45 days of the NDA submission, the NDA review team will either accept the NDA for review or return the submission to the sponsor along with the reasons why it was not acceptable for review (Refuse to File). The role of project manager has been created in both CDER and CBER. An FDA medical officer generally leads the technical review and a project manager, sometimes called a regulatory manager, oversees the process.
TABLE 27.11 Team Leadership and Project Support Alternatives
Dual Leadership Technical Process Technical (usually clinical)
Full-time team leader
Dedicated project manager
Provides both strong technical and process Two bosses, mixed signals leadership
Strong technical leadership Team leader is dedicated to project
Provides both strong process and project planning and management support
Limited management of process; usually a part-time role in a full-time job
Might not have strong technical knowledge of the project; might be leading multiple projects
Places excess burden on the project team leader to both lead and provide process and project planning and management support
The ability to manage a meeting effectively is a skill that is most highly regarded in all types of organizations. Effective meetings rarely occur without good preparation and effective meeting management. A well-developed agenda is the most effective tool for holding a successful meeting. Indeed, in some organizations the mantra is becoming "no agenda, no attenda." Having the right people attend the meeting is as important as having an effective agenda. This means that the team leader, the project manager, and all of the team members have a special responsibility to ensure that those who are needed at the meeting do indeed attend. With modern-day video capabilities and conference calling, many meetings can be very effective and productive even when not all the participants can be at the same physical site. It is important for one person to be responsible for ensuring that all of the remote-site participants receive meeting materials in advance of the meeting, either electronically or by fax or mail. It is not acceptable to delay a meeting for 15 to 30 minutes while everyone is waiting for a fax to be sent to participants at a remote site. Most organizations have multimedia tools in their libraries to help their staff develop effective meeting management skills.
Resource allocation has become more important with the advent of prioritized portfolios. Once a portfolio is prioritized by the PMT, and the core project team has been informed of their project's priority, the core project team will allocate the available resources for their project in a manner that will provide for the most progress to be made over a given budget period, usually 12 months. For those who manage a department, resource allocation takes on an added dimension, for although a department head may have adequate resources for all of the approved projects, the need for the resources might not be evenly spaced over the next 12 months. For example, the portfolio of projects might need 75% of the department's annual resources in the first 6 months and the remaining 25% in the second 6 months. Ideally, project team leaders, project managers, and department staff will help to resolve this mismatch by meeting and developing several alternative scenarios for senior management review and approval. For the decisions to be soundly based, management will ask each team to identify the impact of each alternative scenario on the project objectives and milestones.
Effective Project Decision-Making
An excellent example of a decision trees is shown in Figure 27.8. This example outlines the IND regulatory review and approval process. Similar decision trees are developed by project teams within the biopharma-ceutical industry. Project teams are now being asked not only to construct decision trees, but to develop contingency plans based on "what-if" scenarios far in advance of the next decision points. The goal is to ensure that the project will not lose forward motion in the event of a "no" decision that requires rework or another loop through the project cycle, or a decision by the PMT that resources for a particular project are more urgently needed for another project.
To facilitate the decision-making process, project teams should develop prespecified criteria for each decision point or contingency. These criteria provide the critical targets for the project and speed up the decision-making process. An example of clinical go/no-go decision criteria for a potential antihyper-tensive drug might be "lowers diastolic blood pressure by at least 10 mmHg for at least 6 months in at least 80% of the subjects treated with the middle of three doses, with a side-effect profile no worse than that observed for the active control." One can only imagine the debate that will occur if the blood pressure lowering observed at 6 months is 8 mmHg. Finally, effective decision-making must include an assessment of resource allocation because, as previously emphasized, decision-making is in reality the allocation of resources.
It is appropriate to conclude this chapter with some comments about process leadership and benchmarking. The ability to understand how all the complex pieces of drug development come together can only be learned through hands-on experience as a team leader or project manager. Corporate management in the biopharmaceutical industry is now counting on individuals with this experience to identify ways in which the drug development process can be shortened even further than we have seen in the recent past.
Benchmarking has become an important tool that is being used to identify ways in which an organization can quantify, and then exceed, industry standards for the time, cost, and quality of the R&D activities that are needed to discover and bring a new drug to market. Benchmarks can be as broad as "How long should it take from the FIH trial to NDA submission?" to "How long should it take to design an approvable clinical protocol and case report form for a one-site clinical study?" The Centre for Medicines Research (CMR) has been formally conducting benchmarking studies for the industry and additional information can be found on their web site (16).
The emphasis on both process leadership and benchmarking in the project planing and management domain of biopharmaceutical R&D truly illustrates the level of maturity and sophistication that the discipline of PPM has achieved.
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What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.