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Interest in improved project management practices is growing in the fast-moving pharma industry.
On average, it takes at least 10 years for a new medicine to complete the journey from initial discovery to the marketplace, with clinical trials alone taking six to seven years on average. How do we, or should we increase scientific productivity? Pharma’s output level has remained more or less at a stable level for the past decade. And there is little reason to believe that this productivity will suddenly increase any time soon. Precision or personalized medicine, to get the right patient the right treatment at the right dose the first time, can potentially be addressed by technological advancements.
The harsh reality is that through increased consumer demand, shorter research and development lifecycles and a competitive environment, the pharmaceutical industry is moving faster than ever. Some would argue that pharmaceutical companies suffer from a legacy of “the old guard” style of management where the cultural environment can feel similar to public sector. Massive organizations need to change and change fast if they are to survive.
Large pharma companies are buying earnings through mergers and acquisitions, developing internal generic pipelines, looking at emerging global markets, collaborating with other large pharma companies, diversifying product or biosimilar categories and looking for new techniques to speed up the time to market. It’s becoming an ever more complex industry, which explains the overwhelming interest in better and faster project management practices.
Project management is a key solution
Project management for drug development is highly specialized and is still a relatively new practice. Taking on a role as project manager is no easy task; requiring skills and qualities around communication, decision-making, delegation and risk taking. You are expected to deal with the day-to-day challenges that arise from managing projects including the following:
Project management is the key practice in bringing all aspects of pharmaceutical projects together.1 Project managers are becoming an increasingly integral part of the entire process. The question of “what is pharmaceutical project management?” may appear to be a fairly rudimentary question, but it is an important one. The PMI defines a project as “a temporary endeavor undertaken to create a unique product, service, or result.” Projects are “temporary” and therefore distinct from operations, whose primary goal is sustaining the core business. Effective pharmaceutical project management organizes and manages resources in a way that achieves project completion within the defined scope, quality, time and budget.
In general, project managers need to have very strong people and analytical skills, negotiating skills, and the ability to resolve conflict and communicate progress effectively. These are skills that are not normally associated with scientists or academics alike. In order to overcome these skills shortages, there has been an observable increase in the number of management consultancy firms offering specialized pharmaceutical project management services. Contract development and manufacturing organization (CDMO) have become an important part of the success of the drug industry. The Pharma company must place their trust in a reliable CDMO. For their part, CDMOs can help build trust, and ensure on-time and on-budget delivery with effective communication facilitated through providing talented project managers.
In the pharma industry, with all the added uncertainties from the process of scientific research, project management encompasses the following activities:
Founding an EPMOPM Solutions have been carrying out PMO yearly surveys since 2000, providing insightful empirical data for 17 years. In 2014 they concentrated the survey on the foundation of PMOs with a massive 90% (up from 47% in 2000) of large companies having a PMO, and 30% of those without a PMO plan to implement one within the next year. Mid-size (88%) and large (90%) companies are far more likely to have a PMO than small companies (61%). The average PMO is four years old, with 47% of them five years old and older (up from 34% in 2012).2 In the United States, the PMO budget is 4.4% of the total average project budget. Most PMOs report to a VP or higher; 43% directly to the C-level. Undoubtedly strong executive management commitment and support is one of the key criteria for success.
The reality is that if a pharmaceutical company does not have Enterprise Project Management Office (EPMO)3 to govern the overall portfolio of related projects then they should. The aim to this approach is the central coordination of all aspects of the projects in an organization. It becomes the single point of success or failure and the single source of truth. The biggest challenges PMOs face are that they’re seen as overhead and their organizations continue to be resistant to change. The PMO covers the three areas critical to any pharmaceutical project’s success: scientific operations, client services and resource management.
What is a successful EPMO?
In this section we take a brief look at the functions, benefits and objectives of a successful PMO. Some of the key functions are as follows:
The following are a number of key objectives that a PMO should be responsible for:
The key benefits of establishing a centralized PMO include:
Further help with PM practices
ISPE, the International Society for Pharmaceutical Engineering, is a not-for-profit international society providing scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle for professionals involved in the engineering and manufacture of pharmaceuticals and related products. ISPE provides baseline guides to help interpret and implement difficult processes and for the design, construction and operation of pharmaceutical facilities. This could help pharmaceuticals that may have recently failed an FDA audit or non-approval of drug.
IPSE has an excellent guide entitled: Project Management for the Pharmaceutical Industry.4 It’s a good reference for any project manager and it describes the tools and techniques supporting pharmaceutical project delivery, the life cycles in a typical project and how to navigate complex compliance and regulatory projects.
A lot has changed to the pharmaceutical industry in the past 20 years, and yet in so many ways the fundamentals have stayed the same. A new drug cannot be released without going through strict regulatory processes. Generics are challenging the industry as a whole. Discovering new exciting compounds are rare. Pharmaceutical companies, like every other industry, is intensely competitive and under more scrutiny than ever before for better value. New emerging markets are being explored while scientific research has become more result oriented.
There is now growing awareness that these big budget, complex projects need highly skilled project managers and proven practices to make them work-collaboration, coordination, tools, process, negotiation, reporting and clear and consistent processes are what companies need to succeed. Every pharma project of any significance requires a spectrum of new project management skills. If you don’t have these skills in-house, then go and invest in them now. In this paper, the most important overall message is that pharmaceutical companies need to embrace the founding of an Enterprise Project Management Office.
Dr. Justin Kelleher, Consultant, Cora Systems