Management Method Boosts Drug-Development Timelines	January 2009

By Colette Pilkus

As many R&D organizations struggle to meet deadlines and launch products, Procter & Gamble Pharmaceuticals has found a way to revitalize its clinical trials process – Critical Chain Process Management, or CCPM. Company executives claim that this management method has revved up drug-development timelines, helping the company to increase the number of projects completed per quarter – from three to 14 – and pushed date compliance from 55% to more than 90%.

Traditional project management methods, although effective in many industries, are not always optimal in drug-development circles, where uncertainty and constantly evolving variables are the norm. First introduced in 1997, CCPM is based on methods and algorithms derived from the Theory of Constraints, which applies scientific principles and logic reasoning to guide organizations to achieve their goals. CCPM puts more importance on the resources required to execute project tasks with flexibility, compared with traditional methods of Critical Path Method, or CPM and Program Evaluation and Review Technique or PERT, which emphasize task order and rigid scheduling. CCPM also emphasizes problem solving on an ongoing basis.

Using CCPM has clear advantages, according to Michelle Smith, project management and planning for Procter & Gamble Pharmaceuticals Inc. (pgpharma.com). She says enrolling patients for studies is a highly variable process that often takes much longer than estimated. CCPM allows for such unpredictability by putting buffers into project cycle times.

“Rather than estimating 12 months for enrollment and watching that slowly become 18 months, CCPM would use an aggressive duration of eight months, and four months would be added to the project buffer,” Ms. Smith says. “Through the ongoing buffer management process, the team has an early warning of issues and can proactively manage them rather than fight fires after it’s too late. CCPM requires a complete, logic-driven, resource-loaded, and networked schedule.”

CCPM prioritizes work at the project/portfolio level as well as at the task level, which is a valuable tool for multiple projects. In addition, CCPM prioritizes the portfolio or pipeline in connection with buffers so that tasks at risk of not meeting deadlines are made the highest priority. With this aspect, CCPM has ensured that Procter & Gamble’s entire pipeline is adequately staffed and that early phase projects receive the same attention as late stage projects.

Ms. Smith says that this strategy is in contrast to the approaches of CPM and PERT, where “whoever screams the loudest” gets the resources.

Procter & Gamble uses a software platform called Concerto to implement CCPM for its projects. Concerto was created by Realization Technologies (realization.com), a project execution management company that provides software as well as management services.
According to Ms. Smith, Procter & Gamble values the Web-enabled enterprise aspect of Concerto, which means no additional software is needed for each user’s computer and all project plans are in one place and can be seen individually or as a portfolio. The software also identifies opportunities for improvement that will affect the overall performance of a project.

Concerto – with the buffer management feature – was the first enterprise project management software to enter the field as well as being the first Web-based project management system, according to Sanjeev Gupta, CEO, Realization Technologies (realization.com).

“This software lets the organization proactively stamp out problems that could become major fires,” Mr. Gupta says. “Concerto enables and enforces execution management rules: pipelining of projects so that resources are not spread thin, ensuring that planning estimates do not become execution commitments, and providing execution priorities and early warning signals.”