By Peter Soelkner
Outsourcing of drug manufacturing can be highly effective — especially for parenterals, which are perhaps the most costly and complex drugs to produce. CMOs can apply their special expertise to support all phases of a drug’s development and commercial manufacture. But if a CMO does not harness project management processes, quality and efficiency can suffer. Project management is a powerful tool that enables contract manufacturers to perform multiple complex tasks simultaneously, in close collaboration with their biopharmaceutical partners. That, in turn, helps bring products to market quickly, maximizing return on investment.
FROM BEGINNING TO END
Although the pharmaceutical industry is challenged with unique complications and risks, effective project management in any industry is generally characterized by four phases:
Initiation: Define objectives, scope, and deliverables, and select the project team.
Planning and coordination: Create a plan that delineates who does what and when. Identify project risks, and develop contingencies to address them.
Controlling: During project execution, monitor for problems, and address them immediately.
Closing: At project’s end, document lessons learned.
Starting out right is critical. Ideally, the CMO should be engaged during early clinical development, to perform a start-to-finish analysis of a project’s needs, from drug formulation to packaging to commercial supply.
BUILDING A TEAM
To be effective, the CMO’s project team leader should possess a sciences or engineering background, excellent organizational ability, as well as finely honed interpersonal skills. The project team includes personnel with expertise across all stages of delivery-systems development and manufacturing, including process development, qualification and validation, and supply-chain management. Knowledge of regulatory requirements worldwide is another valuable competency, enabling sound decision making right from product inception. The biopharmaceutical partner should establish its own team of similar members. A steering committee of senior managers from each team then facilitates communication, providing everyone updates on project progress and enabling prompt decisions on critical issues like budgets or timelines.
Asking the right questions is the first step in creating an effective project plan. For example:
Is the active substance incompatible with any materials commonly used in packaging?
How much silicone is required for the plunger to move smoothly?
Is the substance sensitive to oxygen?
Experienced CMO staff know how to elicit potential problems before they can become realities and promote solid planning up front. During the project, enterprise resource planning (ERP) software enables project managers to track costs, forecast project resources, and provide regular status reports. Such methods help keep projects on track and prevent delays.
Traceable documentation and clear communication between both sides will not only keep all team members informed, but will help prevent misinformation, minimize risks, and foster productive team relationships. Regular conference calls or meetings among project managers — followed by reports to team members — can ensure transparency and flow of information. To facilitate decision making, a predetermined communications tree can be used to quickly assemble the appropriate people on the issue at hand.
PUTTING THE PLAN INTO ACTION
With a complete team and a project plan in place, the project can move forward, with project managers continuously tracking needs, resolving emerging issues, and enforcing timelines. Establishing specific milestones and decision points at critical junctures help to ensure that objectives, resources, costs, and deadlines remain in line with the plan.
Drug development is a high-risk endeavor. Partnering with a CMO that employs strong project management processes helps reduce risk and costs and promotes a faster pace to the marketplace.
Peter Soelkner is managing director of Vetter Pharma International GmbH, an independent international specialist in the production of aseptically prefilled syringe systems, cartridges, and vials.