EXECUTIVE SUMMARY
- ➔ Within the pharmaceutical industry, project management provides necessary best practices, but different companies choose varied approaches.
- ➔ Wyeth employs a distributed project management system.
- ➔ With a matrixed structure, Sanofi Pasteur relies on centralized governance.
- ➔ TargeGen, a smaller company, recruits staff with project management experience to lead its efforts.
SIMPLY AVERAGE PHARMACEUTICAL COMPANIES may find the industry hazardous to their health, as project management is vital to a long corporate life. A fiercely competitive market forces ever-shorter product life cycles, making identification of promising compounds, research and drug development increasingly difficult. Only the strongest performers survive, and the trend toward industry consolidation continues.
Despite this fact, many pharmaceutical companies lack project management professionals. For example, clinical research organization Chiltern International reports that 15 out of the world's top 75 medicines were discovered and developed in the United Kingdom, more than any other country outside the United States. Yet, the U.K.'s biotech companies, which account for 43 percent of all biotechnology drugs in advanced clinical trials in Europe, are short on project managers, the firm reports. “There are around 4,500 clinical trial applications in the U.K. each year, but if we want to maintain this high level of research activity then the industry needs experienced staff,” says Linda Christmas, associate director of Chiltern Integrated Resourcing Solutions. “The presence of individuals who have a good blend of technical and communication skills are what makes the difference between project failure and project success.”
Companies spend billions on drug discovery and development, infrastructure and IT-related projects—as well as on skilled clinical, scientific, research and engineering professionals—yet they often don't pay the same attention to project execution.
As a consequence, many may find their projects failing or needlessly suffering because of a lack of necessary budget, schedule and scope controls. As important as project management is to pharmaceutical success, there is a distinction between formula and being formulaic. Three organizations provide good snapshots of project management best practices, from the project-driven culture at Wyeth to the matrix-style workplace of Sanofi Pasteur to the fledgling principles at TargeGen.
Wyeth: Many Working as One
Collegeville, Pa., USA-based Wyeth Pharmaceuticals has a long history of pioneering developments, with products in women's health care, neuroscience, musculoskeletal disorders, cardiovascular therapy, immunology and oncology. With so many types of compounds and conditions to address, the company needs—and utilizes—many project managers. But rather than centralize the project management functions through a single office, the company organizes project management staff from managers to support personnel along divisional lines.
“Within Wyeth, there are a lot of different project management groups across various functions of the company,” says Jann Nielsen, Ph.D., a Wyeth director of project management. “I am associated with overseeing drug development projects, and there are more than 85 people in our group, from administrators to technical support. But in addition to our group, there are also project management groups in the clinical area, chemical and pharmaceutical control, drug safety and other areas.”
PORTFOLIO MANAGEMENT AS
A DRIVER OF SHAREHOLDER VALUE
Dr. Nielsen, who has managed pharmaceutical projects for 13 years, says he has witnessed a marked evolution in project management as the Wyeth's portfolio has expanded. “There were already established project leaders here doing the good work of project management when I came on board, but in the time I've been here, I've seen that bolstered with alliance management and portfolio management,” he says. “Portfolio management has become increasingly important. We do it well, but that's because the people on our project teams know that they need to gather and communicate the information that senior management needs. Without being clear within our team about what information we need to gather and manage, and without communicating that to portfolio staff, it would be impossible to do proper portfolio management.”
Alliances between Wyeth and other companies have become more frequent over the past two years. With increased competition and limited resources, Dr. Nielsen doesn't think collaborations with other companies will decrease any time in the foreseeable future. However, while alliances are a boon to Wyeth, they can complicate the project management process. “Our project managers are also in charge of leading teams that are part of an alliance,” he says. “That's becoming more the standard.”
Working in-house, Dr. Nielsen notes, it is easier to collaborate with a project management group from another business area within Wyeth—because they share a similar philosophy and corporate experience—than with a team from an outside company, which could have an entirely different style and approach. “We think alliances will become more a part of our business, maybe even a core part of it, so we make quite a bit of an effort to make sure we have good alliance management,” he says. “And that is handled in a twofold way: not just through good project management, but also business development staff.”
THE PORTFOLIO MANAGEMENT PROCESS
Excellent communications skills factor heavily into the alliance issue but also are necessary for in-house work. “It is key that the people on the core team can communicate well among themselves and that each person be responsible for communicating through their specific line function so that communication occurs rapidly, accurately and efficiently,” Dr. Nielsen says.
Equally as important is the ability to identify issues—positive or negative—that can affect projects. All project management team members must understand the project and all the risks involved. “Ultimately, the appropriate governance body will make the final decision how to handle the particular problem or issue, but the project management person leads the team to help identify those issues and to find recommendations to offer and potential resolutions to consider,” Dr. Nielsen says.
Although the project management teams aren't centralized, there is a central repository of knowledge to help guide project teams and keep everyone on the same page, Dr. Nielsen says. “We maintain a database that project managers are responsible for—a unified database of key project information,” he says. “It's in there for the senior management and others to quickly find information on all the drug development projects. It's a homegrown product that people find very useful. It has improved our project management by making sure we meet stakeholder and customer needs throughout the company.”
Sanofi Pasteur: Enter the Matrix
In contrast, Paris, France-based Sanofi-Aventis angles for a more centralized project management office (PMO) approach for industrial operations. Admittedly, it hasn't reached this goal on a corporate level, but one of its divisions, Sanofi Pasteur Canada, a vaccine-focused arm of the company, does have a PMO for industrial operations and likely will serve as a model for similar implementation at other manufacturing sites.
May Lee, PMP, director of the industrial operations PMO at Sanofi Pasteur Canada, created the office three years ago. All projects must start with her, but there actually are a limited number of true project managers in the company. Instead, as a matrix-style organization, people are assembled into teams for specific projects. The PMO provides regular training to teach staff the project management basics. It oversees projects to make sure they stick to good project management principles. However, most team members are drawn from the company's general pool of professionals.
“I see a lot of improvement now that we have a centralized project management function,” Ms. Lee says. “Each little area of the company had its own project personnel and personality. They would have their own rules, and often the people in charge of a project team would get sidetracked by their other work in the company or would leave and no one else knew what was going on with the project. You'd have chaos. Projects would open but go nowhere and never close, wasting resources. Sometimes, you wouldn't even be able to figure out when a project opened or closed. A lot of projects would be delayed and waste valuable resources.”
Shortly after the PMO was established and people were given a standard template for project portfolio standards and expectations, projects began to close with on-time and on-budget performance improving by at least 50 percent. “It's critical from a management perspective to have a fixed set of principles and procedures so that the company always knows what resources are being consumed and by what,” Ms. Lee says. “With a centralized office, we can help project leaders—who are mostly scientists—do a better job of managing projects. We give them very clearly defines roles and responsibilities. From the central office, we can share the workload with them and handle issues that need a true project manager, just like we let them handle the jobs of, for example, developing a new vaccine.”
The PMO gives team members and leaders the process—essentially a set of standard operating procedures—and provides them with templates as needed. Ms. Lee says that, by and large, people in the company have taken to the new project management approach. However, her office has had to educate people about the importance of project management principles. “You need to build a project management culture in the organization first,” she says. “If you don't have that infrastructure in place, it won't work.”
CRITICAL CONCERNS
Without formal project management:
- Pharmaceutical projects may not be not assessed or estimated correctly. Requests for projects are dealt with as they come in, a rough estimate is provided to the client and a manager is assigned—without much thought about what is needed to get the job done.
- Companies are stifled with too much administration and do not spend quality time determining exactly what is needed prior to a project start.
- Project managers do not understand how to deal with contractual documentation. This predisposes the project to problems even before it begins. As a result, the release of a new drug into the market could be delayed and possibly cost a company millions of dollars.
Source: RCG Information Technology white paper, “Project-Centric Culture Simplifies Management of Pharmaceutical Projects,” 2002.
The educational process is ongoing, she says. This effort does not just include orienting people who are new to the company or adding to the knowledge of existing employees, but also just getting people to accept their roles. “In a matrix organization, you have to clearly define roles for projects; those are based on the skills people bring to the team,” Ms. Lee says. “On a team, the leader might be manager-level, and his or her director may simply be a team member. Even though that director may be the person's boss day-to-day, there must be a realization that in terms of the project and project team, that manager is the boss instead.”
Once the roles are in place, it's largely a matter of hammering home that planning, organization and execution lead to project success. “I'm a pushy person by nature,” Ms. Lee says. “In project management, you must be a bit pushy or nothing will get done.”
TargeGen: Setting the Stage
Based in San Diego, Calif., USA, TargeGen Inc. likes the idea of structure and wants to work toward a project management culture. While the company isn't large enough to warrant establishing a formal group, it does incorporate the essential tools, such as staff who have employed project management best practices within a drug discovery or development environment.
“In other companies I've worked at, I've used some elements of project management, such as pushing the idea of timelines and decision trees, so that you know from the start what you intend to accomplish, how you plan to get there and whether you're still on track and on schedule,” says Jennifer Grodberg, Ph.D., TargeGen's associate director for regulatory affairs and drug development. “That's one of the reasons TargeGen brought me on board, because of my [project management] experience.”
Dr. Grodberg says that planning ahead is critical, particularly for smaller companies like TargeGen. In part, it's because small companies often position themselves as being very flexible in making quick decisions and adjusting to changes. Without having some sense of project management principles, at least in having clearly defined criteria for go or no-go decisions, it is difficult to walk that talk.
“Also, because we're under greater financial constraints, we have to think very carefully about the kind of decisions we make, because we don't necessarily have the luxury of benefiting from lessons learned,” Dr. Grodberg says. “We don't have time to waste on a project and say, ‘Well, at least it was a learning experience.’ You need to have project management tools and skills so that you can make a general map and know where you are and when to call it quits. Big companies have the luxury of being able to more often say, ‘Let's give this project a little more time.’ Small companies, like TargeGen, cannot afford that, literally or figuratively.” PM