Edition 1 / March 2020
Interim Head of Development, Manufacturing & Project Management,
Drug development is an inherently complex endeavor, involving numerous scientific disciplines and a high degree of scientific uncertainty – will the compound perform as anticipated or even survive during clinical trials?
Chemistry Manufacturing and Control (CMC) is a critical element of the drug development process, involving the manufacture of bulk Drug Substance (DS) and its final Drug Product (DP) for use in the clinic, along with a myriad of supporting activities. CMC management is a demanding and complex undertaking, which is frequently underestimated. It requires a high level of scientific & technical expertise, a full understanding of the relationships and interdependencies between synthesis, formulation & quality control, coupled with a high level of interpersonal skills to facilitate close coordination of the diverse range of activities required to deliver a successful project.
Project management of CMC activities is even further complicated by the surge in numbers of accelerated approvals, and by ever-reducing development timelines driven by a need to take advantage of patent exclusivity. CMC team and project management are therefore under significant pressure to deliver within the parameters of these demanding schedules. This factor, aligned with the increasingly complex nature of DS syntheses and DP formulation technologies, as well as an ever-changing regulatory landscape, places a huge onus on effective project management to enable effective & efficient delivery on CMC projects.
According to the Project Management Institute (PMI), organizations that undervalue project management report an average 40-50% more of their projects failing outright, a statistic that would be clearly unsustainable for CordenPharma, an organization which prides itself on being an industry-leading CDMO. As your full-service partner, CordenPharma has long recognized the criticality of a strong Global Project Management Team (GPMT) to oversee and coordinate smooth execution of large multi-site projects.
A Project Manager is not simply present to track deadlines and budgets, but rather take full control of a project throughout its lifespan in order to gain true stakeholder support, get the entire team on the same page, and ultimately ensure delivery against project goals. In other words, an effective Project Manager is the focal point that tightly controls and coordinates various project activities, driving towards strong project execution.
CordenPharma’s Global Project Management Team also recognizes that while every project is unique, and no two customers alike, there are several fundamental activities that apply to all projects. To that end, we have developed a series of core documents & procedures that form the backbone to every project undertaken within our organization, regardless of complexity. This framework ensures a consistent, structured approach to projects, while providing full transparency to clients from setting the overall project plan, scope definition, assignment of appropriate resources, project kick off, budget tracking and all subsequent tasks, right through to project completion. It also lays out expectations on project communication, reporting and procedures to efficiently deal with any unexpected deviations that might arise.
In addition, our GPMT, relying on their in-depth CMC experience & project management expertise, conducts a thorough risk assessment for each project aimed at identifying potential problems before they arise, and highlighting any major gaps that might exist. This analysis then enables the development of a comprehensive and viable risk mitigation strategy, designed to minimize avoidable surprises and their associated delays to project timelines.
Our Project Managers also possess the experience & knowledge, coupled with access to significant expertise within our integrated network, to deal with any unexpected setbacks that will inevitably arise as part of any CMC project. This is critically important because the inherently uncertain nature of drug development will inevitably necessitate periodic changes or modifications to project plans in response to such issues as they arise.
If the risks associated with these uncertainties are not managed in a timely and effective manner, the complexity of the situation could increase dramatically – leading to timeline & cost blowouts. The CordenPharma Global Project Management Team is acutely aware of the importance of this aspect of project management, and proactively seeks to mitigate risk & exposure as a project evolves, thereby minimizing negative impact on your projects.
Operating in a world where every day lost or gained can equate to a significant financial impact – not to mention its effect on a project’s survival and the patients it serves – our GPMT understands the criticality of their role as your primary contact & advocate. They are the link between various activities, teams and sites potentially involved, and as such rely heavily on a tried & trusted roadmap of experience & expertise to guide your projects, each with its own unique requirements, complexities & challenges, through to successful project conclusion.
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