Enhancing drug development planning through the use of facilitated planning
Martin D. Hynes III, Ph.D.,Thomas J. Konechnik, Sheryl L. Burris, Mary Chris Broughton,and Stephanie A. French, Pharmaceutical Projects Management, Eli Lilly and Company, Lilly Research Laboratories
The development of a new drug is a long, complex, and costly process. This is substantiated by the fact that studies of current industry performance show that on average it takes 14.7 years from synthesis of a new molecule to launch of a new product (DiMasi et al., 1996) at a cost between 300 to 608 million dollars (DiMasi et al., 1995; Lehman Brothers). Given these long time frames and high costs, pharmaceutical companies have been working to reduce both cycle times and costs while maintaining or enhancing quality. Lilly, as nearly all of its counterparts, has engaged in efforts to improve both cycle times and costs. A variety of approaches have been taken toward these ends. These approaches have included efforts to improve the competencies of our project managers (Hynes et al., 1999; Kerzner, 2000) and enhance the communication of team information to the global research organization (Hynes et al., 1999; 1998), to name a few. Additionally, we have been trying to strengthen our planning process with the goal of being able to achieve schedules and enhance our ability to plan and track actual costs. In order to accomplish this, a facilitated planning session has been developed and deployed. In fact, facilitated planning sessions have become the standard methodology utilized for planning new drug development projects.
The goal of these sessions, in addition to developing robust plans that would allow the achievement of cycle time and cost reduction goals, was to actually reduce the time it takes to plan a drug development project and increase the consistency of the plan. Past practice had been to plan the project in the first 100 days after the cross-functional project team had been established (Hynes, 1998). Frequently, teams would spend one or two hours per week to develop their project plan. This approach tended to be inefficient and lengthy as well as unique to the project manager leading the team. Thus, one of the additional goals of the facilitated planning session was to not only to reduce the time to plan, but also to bring a degree of standardization to the planning process. Part of the standardization effort included the move toward enhanced documentation of the plan through the use of standard templates. The move to this planning methodology also allowed for the fuller utilization of project management techniques, such as risk and cost management.
The objectives of these facilitated planning sessions, in addition to the development of a cross-functional drug development plan, were to ensure that the team had a common understanding of the goals or strategy of the project. In addition to building a detailed plan, the sessions were designed to develop a detailed schedule of milestones, mini-milestones, a critical path, and costs, both in dollars and full-time equivalents (FTEs). Another important goal was to take the functional employees assigned to the project and build them into a team while doing project-related work.
Facilitated planning sessions are conducted when a team is first formed with the goal of identifying a candidate molecule for clinical testing. A second planning session is conducted at the time the clinical candidate has been identified by the team. At this planning session, a high-level plan is developed through the end of Phase II efficacy trials. A more detailed plan is developed to include the work necessary to move the clinical candidate to and through Phase I. The team then has the option of having another facilitated planning session prior to the start of Phase II efficacy trials and at each significant milestone thereafter.
A typical facilitated planning session includes all of the members of the cross-functional core project team. In general, there are functional area representatives from discovery, biology, chemistry, legal, marketing, toxicology, metabolism, regulatory, medical, clinical pharmacology, and product and process development. The sessions are led by the project manager who has cross-functional responsibility for the project.
The project manager is supported by a staff of trained facilitators from our project office within the project management center of excellence. These facilitators assist the project manager in preparing the prework for the session as well as helping facilitate the planning session itself, thereby allowing the project manager to participate fully in the discussions at these sessions. These trained facilitators also play a key role in entering the plan in Microsoft® Project. The project office staff has, at times, been augmented or supported by external consultants. One of the primary drivers for using external consultants was to provide additional manpower for a large number of planning sessions. Additionally, it brought outside project management expertise and perspective to the session, thus allowing us to meet demand for the sessions while providing both novel perspectives as well as the ability to challenge established internal processes and beliefs. Identifying a vendor or vendors that can provide the needed capacity and expertise is critical to the success of the endeavor. Additionally, it is important to identify a vendor with whom you can establish a good working relationship. Additionally, the vendor needs to have the appropriate degree of customer focus and flexibility.
Prior to the start of the facilitated planning session, each team member is sent a team member guide. The guide includes the agenda for the planning session, roles and responsibilities for key team members, the scientific background of the project, the team’s scope, and task description worksheets. The team members are asked to study the materials in the guide prior to their participation in the planning session. Additionally, they are requested to complete the task description worksheets. These sheets specify what work a function needs to perform during the course of the project. These prework assignments have been found to dramatically improve the effectiveness of the session. It also helps keep session time to a bear minimum. Once all of the cross-functional team members have completed their pre-work assignments, the concentrated planning activities are ready to start.
The following is a brief outline of the daily agendas for the facilitated planning session. The first day of the planning session starts with introduction of the team members and an overview of the ground rules. The discovery scientist then provides the team with a brief overview of the scientific background underpinning the project. Once the team has been grounded in the scientific aspects of the project, the team attempts to start with the end in mind by developing a draft package insert that describes the key product indications and features. Once these indications have been agreed upon, then the clinical plan can be developed to establish/obtain their indications. The program team strategy can then be solidified and a cross-functional work plan crafted. The goal for the end of the first day of the facilitated planning session is to have a completed work breakdown structure.
The agenda for the second day includes the development of a network chart, the establishment of team operating agreements, and a review of any project-related issues. Day two of the planning session begins with the development of the network chart that depicts the dependencies among functional area tasks. Then the individuals on the team work on how they plan to operate as a team, dealing with such topics as how they will communicate with one another. Additionally, they will deal with topics like change control and document management on their team. The day ends with a discussion of any issues that are relevant to the development of the molecule.
Day three of a typical session includes a review of the critical path, a check of the program strategy, a review of the work assignments to pull the planning document together, and lastly an action plan. A review of the critical path to the next major milestone occurs in the morning of the third day. After the review of the critical path, the team revisits its strategy, thus allowing the team the opportunity to make any changes to the strategy or the plan prior to its finalization. Once the strategy has been finalized, the team then works through the tasks that need to be accomplished to pull the planning document together. A standard template for the documentation of the plan is utilized by all teams. In addition to the cross-functional sections, it has sections that need to be completed by the functions. The team agrees on who will complete each of the sections and by when they will be finished. Following these agreements, the team then develops an action plan to obtain approval for their plan. The approval process, in general, requires the agreement of functional area management as well as review and approval by cross-functional management committees.
During the course of these facilitated planning sessions, a number of tools are utilized in an effort to build a more robust plan. These include standard project management tools such as Microsoft® Project, WBS Chart™, and Pert Chart Expert™. The objective of utilizing these tools is to help the team visualize the plan as well as look for opportunities to shorten drug development timelines. The facilitators can utilize the output from these tools to help the team focus on task durations and dependencies. Therefore, the team has a much better understanding of key project timing assumptions as a result of utilizing these project management tools.
Several nonstandard project management tools have also been utilized in the planning session with good success. Most notable are Post-it® notes, Post-it® notes printer applications, and a large-scale Hewlett-Packard® plotter.
Project tasks have been captured on Post-it® notes so team members can arrange them on large wall-mounted sheets of flipchart paper. The team can then reorder tasks to ensure that they are appropriately sequenced. Once the team has agreed on the appropriate order of tasks, interdependencies can be understood and they can be captured in the teams’ plans. The plan can then be entered into Microsoft® Project; the graphics for Microsoft® Project can then be sent to the large-scale plotter. The plotter will print out Gantt charts and critical paths on 3' by 15' size paper. These plots can then be posted on the wall to display the plan to the team.
A team assessment is conducted prior to the start of the planning session and again at the end of the third day. The instrument assesses mission and goals, clarifying roles, leadership, efficiency and productivity, creativity, cooperation, communications, conflict resolution, and team rewards. Team participants are asked to rate the team on these parameters on a four-stage rating scale or system. Stage 1 is questioning; Stage 2 is challenging; Stage 3 is understanding; and Stage 4 is achieving. Detailed descriptions for each dimension by stage are provided to the team members to aid in the assessment process.
The participants are asked to provide feedback on the planning session itself. A nine-item survey is utilized. Each participant is asked to rate the session on a scale from 1 to 4 for each of the nine dimensions. The items rated include the meeting of objectives, quality expectations, constructive dialogue, understanding of team strategy, clarification of roles, encouraging others to attend these sessions, getting work accomplished, usefulness of the session deliverables, and the value of the sessions.
Exhibit 1. Summary of Participant Feedback From Facilitated Planning Sessions for Teams Earlier in the Process
These intense three-day sessions have allowed us to significantly reduce the time it takes to develop a plan. In the past, teams met for numerous hours over the first 100 days of their existence to develop a plan whereas with this process the plan is complete within two to three days with 16-24 hours of total time invested. While decreasing the cycle time for planning, we have been able to increase the quality of the plans. In our experience to date, teams that utilize the facilitated planning sessions to build their project plans have a much higher likelihood of achieving their milestones than teams that do not. The data should be treated as preliminary as we need to allow sufficient time to gather data on conformance to plan given the industries long cycle times.
To date, 16 early-phase teams have been through the facilitated planning process. The feedback from the participants is shown in Exhibit 1. As can be seen from the exhibit, the average for all teams on all dimensions was a 3.37, which falls between agreeing and strongly agreeing. The overall average for teams ranged from a low of 3.06 for Team B to a high of 3.66 for Team G. The lowest rating for any dimension for all teams was for clarification of roles and responsibilities within the team which averaged 3.20, while participants felt the strongest about the sessions allowing the team members time to engage in constructive dialogue, as evidenced by the rating of 3.69.
Eleven late-phase teams have been through the facilitated planning sessions. The feedback from the participants in these sessions is summarized in Exhibit 2. As can be seen from this exhibit, participants agree that these sessions added value as evidenced by an overall rating from all teams on all dimensions of 3.40. The overall rating for each team ranged from a low score of 2.87 for Team J to a high score of 3.71 for Team E. A review of the data for each one of the nine dimensions assessed shows the lowest rating was for the outcomes from the session meeting the team members’ expectations with a score of 3.19, while the highest score observed was 3.60 for allowing team members to engage in a constructive dialogue.
In addition to the feedback from the team members who participated, data have been gathered on team effectiveness. These team self-ratings were made at the start of these sessions and again at the conclusion of the sessions. The data for the team effectiveness self-ratings are shown in Exhibit 3 for early-phase planning sessions. As can be seen from the data that are summarized in this exhibit, effectiveness improved from the first to the last day on all of the team characteristics. The data for later-phase teams are depicted in Exhibit 4. On all team characteristics, effectiveness improved from day one to day three.
Exhibit 2. Summary of Participant Feedback From Facilitated Planning Sessions for Teams Later in the Process
The feedback from both types of sessions demonstrated that the participants believe that these planning sessions are valuable. The data are supported by our belief that people vote with their feet; that is, they would stop coming to these sessions if they were not seen as worthwhile and that has not happened.
It is interesting to note that the overall scores for both types of teams were very similar. The data were a bit surprising, as we had expected lower scores for those teams operating in the earlier phase of development. Our rationale was that the members on these teams are more focused on basic research where there is a greater degree of skepticism about the value of planning given the high attrition rate for this phase of development.
The fact that both types of teams reported the greatest value in allowing team members to engage in constructive dialogue indicates that these sessions have been designed to provide appropriate interaction among team members.
The fact that the team self-effectiveness ratings all increased from the start to the end of the session is consistent with the assessments of participant’s feedback showing that these sessions are valuable in building both a plan as well as a team.
Despite our positive experience with this approach to project planning, there have been a number of issues that we have had to work through. First and foremost, there has been some resistance to this methodology on the part of some team members and their functional management. This has stemmed from the perception that we are spending more time planning than doing, which is aided and abetted by a general negative attitude to planning in a research environment. With time, positive results, and experience from these planning sessions, these attitudes and perceptions have changed significantly. However, that is not to say that these perceptions have totally disappeared.
Based upon our positive experiences to date, this approach may prove viable for other research-based organizations. If you are considering this approach for planning within your organization, you should be prepared for some organizational resistance to change. Additionally, you should be prepared for some early failures; it is important to keep in mind that this is an iterative process and you will improve dramatically with time. Do not underestimate either the resources or the time commitment it will take to get these sessions up and running. We believe that the efforts invested in establishing this type of planning session will be well worth it.
Exhibit 3. Average of Team Effectiveness Before and After the Early Phase of Facilitated Planning Sessions
Exhibit 4. Average of Team Effectiveness Before and After the Later Phase of Facilitated Planning Sessions
Hynes III, Martin D., & Konechnik, Thomas J. (1999). The development of a core competency model for pharmaceutical projects managers. Proceedings of the 30th Annual Project Management Institute 1999 Seminars & Symposium. Newtown Square, PA: Project Management Institute.
Kerzner, Harold. (2000). Applied project management. John Wiley & Sons, Inc.
DiMasi, Joseph A., Hanson R.W., Grabowski H.G., & Lasagna L. (1995). Research and development costs for new drugs by therapeutic category: A study of the U.S. pharmaceutical industry. PharmacoEconomics 7, 152-169.
McElwain, Karen J., Swiontek, Ann M., Hynes III, & Martin D. (2000, June 11-15). The use of a facilitated planning methodology to develop a clinical functional plan. Poster presentation for the DIA annual meeting.
Hynes III, Martin D., Getzin, Scott A., McQuaid, Loretta, Seward, Cathleen M., Miller, Nicholas L., & Field-Perez, Rebecca R. (1999). Creation of a knowledge-based system to accelerate drug development. Drug Information Journal, 33 (2), 641-648.
Hynes III, Martin D., Schrock, Brian P., Miller, Nicholas L., & Perez, Rebecca R. (1998, Oct. 9-13). The use of the communication fundamental to facilitate the drug development process. Proceedings of the 29th Annual Project Management Institute’s 1998 Seminars & Symposium. Newtown Square, PA: Project Management Institute..
Hynes III, Martin D. (1999). Developing a strategic approach to preparing for a successful pre-NDA approval inspection. Preparing for FDA Pre-Approval Inspections. Ed. Martin D. Hynes III. Marcel Dekker, Inc.: 11-29.
DiMasi, Joseph A., Brown J.S., & Lasagna L. (1996). An analysis of regulatory review times of supplemental indications for already-approved drugs: 1989-1994. Drug Information Journal, 30, 315-337.
Proceedings of the Project Management Institute Annual Seminars & Symposium
September 7–16, 2000 • Houston,Texas,USA