Effective Project Management

Creating opportunities for lower costs and faster time-to-market

By Peter Soelkner

The squeeze is on. The cost of development, discovery and manufacturing of new drugs is continuously rising. Economic realities are forcing pharmaceutical and biotechnology companies to be on the lookout for an enduring solution to meet market challenges and control development and manufacturing costs.

Moreover, to control costs, streamline the development cycle and maximize their return on investment, many pharmaceutical companies are embracing collaboration with CMOs. While these productive partnerships offer significant value-added benefits, they also open a new set of challenges.

A drug’s time-to-market can take years, and there is no guarantee it will succeed, no matter how much research, effort and financial resources are ultimately invested in a product. In addition, pharmaceutical and biotech companies continue to face increasing market challenges, including stringent regulatory standards, strict quality control criteria and stronger global competition. These issues can make effective communication increasingly difficult between the stakeholders of the pharmaceutical company and their collaborative CMO. Can all of these challenges be addressed — and solved — to make contract manufacturing a worthwhile pursuit?

Through effective project management and industry experience, the answer is “yes.” Project management for drug development is a highly specialized and relatively new practice. But with the right project management process in place, companies can drastically reduce a product’s time-to-market, cut their costs and increase their RoI. First, however, they must select a CMO that can prove its project management prowess.

A Healthy Start

Regardless of the industry, project management typically addresses several universal steps: initiation, planning and coordination, controlling, and closing. In the pharmaceutical industry, these steps are increasingly more complicated, and the risks involved with drug research, discovery and development must be taken into account from the very beginning.

To ensure a successful partnership, pharmaceutical and biotechnology companies must engage a CMO that can fulfill their needs to provide a streamlined turn-key approach that reduces a drug’s time-to-market. Eager to win business in today’s competitive environment, some CMOs will submit unreasonably low project estimates. This practice often leads to the CMO cutting corners to control costs, putting the entire project at risk.

Mitigating these risks requires a thorough upfront analysis of the entire project. From formulation to packaging and more, specifications of each aspect of the project — as well as the product’s specific attributes — must be discussed. Therefore, it is very helpful to start a relationship with the CMO in the early development phase (preclinical / Phase I).

It’s also beneficial to consider a CMO that abides by the standards set forth by a valued industry resource, such as the International Project Management Association (IPMA), a non-profit organization that represents 45 national project management associations on the international level.

In addition to establishing testing processes that ensure project managers are prepared for the tasks that lie ahead, IPMA facilitates best practice models that are used in quality project management procedures. These include management processes, methods, techniques, tools and functions that help boost efficiency by keeping a project on schedule and within budget.

The Right Team

Once a CMO with the experience and capacity to successfully complete the project has been selected, the real work begins. To ensure an effectively managed project, a project manager must be designated by each partner organization. The project manager should:

• Demonstrate a background in natural sciences;
• Show professional experience working with and managing teams that include scientists and manufacturing specialists;
• Offer significant soft skills, such as leadership, negotiation skills and public speaking

Once project managers have been chosen, the selection of members for each organization’s project team is critical. The CMO must be prepared to address and solve all existing and potential issues throughout the entire development and production process. To ensure a streamlined process, the CMO’s team should include members with expertise in:

• Packaging
• Development
• Process development
• Qualification and validation
• Production
• Regulatory affairs
• Quality management
• Supply chain management

To maintain continuity and ensure effective communication, the pharmaceutical company’s project management team should mirror the CMO’s team. A steering committee, comprised of senior managers from both companies, should be developed to serve as an interface between the two companies, keep the teams abreast of the project’s progress and make critical decisions regarding investments, timelines and other key issues.

Creating the Plan

Investing resources in careful and detailed planning in the earliest phases of a project results in rapid project implementation and the ability to properly plan for potential issues throughout the initial product launch, if not throughout the entire lifecycle of the drug.

Proper planning includes providing each team member, from both the pharmaceutical company and the CMO, the opportunity to submit questions to the group based on each member’s own functional expertise. The use of a standardized questionnaire is an effective tool that can act as a guide throughout all project phases. Consider an example of a drug that is delivered via a pre-filled syringe. The questionnaire might ask:

• Is the active substance incompatible with any materials commonly used in packaging?
• How much silicon is required for the plunger to move smoothly?
• Is the substance sensitive to oxygen?

A well-versed CMO will have the knowledge and experience to ask more detailed questions to uncover pitfalls early on in the process. By thoroughly investigating each and every question, serious delays and problems can be avoided in the later stages of the project. Potential changes should also be taken into account in case the process itself creates new and unforeseen situations.

Following review of the questionnaire, the CMO should outline the plan step-by-step to:

• Clearly define project goals
• Create well-defined workpackages and responsibilities
• Identify critical activities and milestones
• Design and analyze production processes and procedures and develop a complete risk analysis
• Share all data and project information with members of both teams
• Remain flexible and willing to adjust the process if the situation warrants

Partnering with an experienced CMO that understands where potential problems lie will expedite the planning process and reduce the drug’s overall time-to-market.

Embracing ERP

Successful project management includes the utilization of effective technology systems. In most cases, Enterprise Re-source Planning (ERP) software offers solutions to:

• Collate information from existing catalogues
• Calculate and describe resources critical to the project
• Track costs
• Divide the project into individual phases for easy tracking (project gates)

To maintain time and budget goals, the CMO’s project manager should review ERP reports monthly at a minimum. In addition to staying on course, this will allow the project to be adjusted to current situations if needed.

Opening the Channels of Communication

Effective communication and sharing of information is a key element and should flow freely between all stakeholders throughout every phase of the project. Such dialogue prevents failures due to misunderstandings, lack of information, erroneous interpretation and overlooked risks, and creates a positive project relationship between the two partners and all team members.

To ensure each party is fully aware of a project’s progress and informed of any potential roadblocks, the project managers from both organizations should schedule and facilitate weekly conference calls and/or project management meetings to track accomplishments and missteps, as well as to determine any required solutions. This will ensure the project is being handled properly and communication channels are open.

The project managers should also document and distribute regularly scheduled reports on centralized platforms, such as Internet share points, to ensure all teams are abreast of the latest project information. Internal and external access, combined with conclusive and traceable documentation through the process development and implementation phases, are essential for maintaining a seamless communication flow.

In addition to open communication channels, each project requires a well-thought-out communication tree. What if a decision needs to be made urgently, yet is beyond the project manager’s scope? The entire steering committee should be assembled to address the issue. If a resolution is needed even faster, each organization’s regular hierarchy must be approached.

From Planning to Realization

Once the playbook has been written and the experts have molded into a strong project team, work can begin. During the development and validation phases, work packages outlined in the plan are transformed into a tangible product. The project manager continues to play a critical role in this phase, closely monitoring project needs and overall costs to avoid delays, manage crises and ensure the project remains on track based on tactics developed during the planning phase.

To avoid unnecessary delays or expenses, the project management team must carefully plan and constantly track the project’s progress. Knowledge transfer and open communication are crucial during this particular phase in the process. To assure this, well-defined milestones and project gates at the end of critical or important project phases have to be established to control and review the project progress against the plan for:

• Quality of achieved objectives / work packages
• Needed resources / cost
• Time to market

Crisis management is especially important during this final phase as a crisis can have serious impact on an organization’s reputation and can drastically affect customer confidence. Pharmaceu-tical companies are already faced with increasing production costs, intensifying global competition and growing regulatory stringency. Each project will have its own issues and challenges. Establishing a strong crisis management plan allows the project manager to control many situations and minimize or even avoid possible negative impact that results from unfavorable situations.

At the end of a project the team will conduct a thorough project review and develop lessons learned that may help improve future projects.

A Successful Conclusion

Pharmaceutical project management is a complex issue, but successful outcomes are consistently possible with the right elements in place. Key components include:

• A strong management commitment from the very beginning;
• An understanding of product-specific needs, process know-how and proven project management skills;
• A well-structured approach in all project phases;
• Project tools for Planning and Controlling;
• Conclusive and traceable documentation through process development and implementation;
• Identification and quick follow-up on critical project tasks

A careful and detailed approach can make a significant difference in the outcome of a drug’s success by saving time and money while improving results. Each project must be managed within its own set of circumstances. And a CMO that understands its uniqueness can make all the difference in the world.

Peter Soelkner is managing director of Vetter Pharma International GmbH.