Approaches for Successful Project Management Highlighted at Interphex

April 24, 2007
Patricia Van Arnum
Pharmaceutical Technology

Interphex2007, New York, NY (Apr. 24)-Effective project management is critical for successful outsourcing between a pharmaceutical company or sponsor and a contract manufacturing organization (CMO), and the strategies for such success was highlighted at the Interphex2007 Conference and Exhibition.

Interphex2007, New York, NY (Apr. 24)-Effective project management is critical for successful outsourcing between a pharmaceutical company or sponsor and a contract manufacturing organization (CMO), and the strategies for such success was highlighted at the Interphex2007 Conference and Exhibition.

Beginning the project
“Project management begins prior to outsourcing,” advised David Flowers, senior manager, business development with HollisterStier (Spokane WA, www.fill.hollisterstier.com), who presented at the “Project Management at Your CMO: The Good, The Bad, and the Ugly” conference session. The sponsor company needs to know what services it requires, how those processes fit at the CMO, and the timing of the projects. “Each party needs to know its risk tolerance,” said Flowers, “and understand how the risk for the CMO and sponsor differ.”

The view of success of the project will differ between CMO and sponsor. “You need to define success,” said Flowers. For a CMO, success may mean that the project came on time, on budget, and produced positive cash flow. For a sponsor, success may be defined as receiving product on time and in specification to proceed with clinical trials.

With those fundamentals in place, the next step for the sponsor is to conduct a technical evaluation of the CMO, which includes securing a confidentially disclosure agreement, and perform data acquisition and evaluation in order to assess the CMO’s capability in taking on the project. If it is agreed that the project should move forward, the CMO and sponsor must decide the vehicle for agreeing to do business. These vehicles may include a letter of intent, a development agreement, a signed quotation or a supply agreement. Once this step is completed, a formal agreement may be signed between the sponsor and CMO. “The key here is to take your time and allow sufficient time for all the necessary document approvals,” said Flowers, such as how to deal with cancellation of the project or failed batches.

Project management: A technical perspective
Peggy Flowers, senior manager business development at HollisterStier, provided a technical operations perspective on project management. She emphasized the importance of establishing a project leader and team at both the sponsor and CMO and to assign specific roles and responsibilities of the team in line with the project’s goal and agreement.

“It is then important to schedule a project kick-off meeting,” said Flowers. “A face-to-face meeting is preferred, but teleconferences may also be used,” she said, emphasizing the need to schedule at least one full day or more for this meeting.

Once the project is launched, routine meetings between the project teams of the CMO and sponsor should be scheduled with agendas set in advance. The minutes of those meetings should be communicated not only to team members, but other interested parties such as corporate management and facilities management. “Also, it is important to include in the project’s discussion corporate terminology,” she said, so all terms and wording used in the project is mutually understood.

Quality and regulatory management
Sandra Lueken, senior manager quality control at HollisterStier, discussed the roles of the CMO and sponsor in meeting regulatory and quality requirements. She emphasized the need for the sponsor to understand the CMO’s quality systems, establish expectations for quality, learn of the CMO’s documentation and corrective and preventive actions (CAPA) systems, provide the CMO with a product development report, and conduct a quality audit. In turn, she stressed that the CMO must ensure the robustness of their quality systems, understand the sponsor’s expectations, educate the sponsor on its CAPA systems, allow for product evaluation, and provide meaningful audit support. These expectations and processes need to be carried out for a successful project, which would also include successful methods transfer.