Dr Justin Kelleher

	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 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:

		Projects require massive coordination between R&D, regulatory, legal, finance, supply chain, sales, and marketing

		Projects are highly regulated with complex compliance processes

		Organizations lack an appreciation of the importance of project management especially the executive board

		Projects lack sponsorship or visibility from top decision makers,

		Research projects are often geographically distributed and disconnected

		IT and back-office functions including large CRO projects are often outsourced

		Resource pools are often distributed, with poor overarching resource management function

		Lack of a single project management process framework

		Reporting progress and financial burn down to boards and investors is very difficult

		Lack of specialized pharmaceutical project management skills

	Project management is the key practice in bringing all aspects of pharmaceutical projects together.

 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:

		Scope management of individual projects and overall programs

		Project planning, execution, and monitoring

		Establishing measures of success of each project

		Standardizing routine tasks especially around regulatory or compliance

		Providing senior management insight into project progress

		Management of regulatory and compliance strategies

 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).

 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)

 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.
	
	


	
	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:

		Provide direction and oversight of project management policies, procedures and templates

		Sponsor the project tools for planning and controlling

		Accountability for the creation of auditable and traceable documentation through research and development project phases

		Co-ordination of project initiation, planning and closing phases of projects

		Responsibility for the alignment of projects against the strategic objectives

		Project administration support including the facilitation of project web site, special meetings and war rooms

		Managing the CDMO (Contract development and manufacturing organization) relationship

		Providing of PM training, coaching or mentoring programs

	The following are a number of key objectives that a PMO should be responsible for:

		Alignment to Strategic Objectives: How aligned are projects and the portfolio to a firm’s strategic objectives?

		Process Alignment: How useful, consistent and comprehensive are the company’s project management processes across the entire enterprise?

		Program/Project Roadmap: A Project or Program Roadmap is a simple presentation of the project objectives and project goals alongside a timeline.

		Performance Management: How well do the projects add value to the overall organization and how well does it reward teams and individuals for contribution to successful projects.

		Organization architecture/modeling: Defining the organizations roles and responsibilities and agreeing an unambiguous organization chart.  

		Staff Culture: How well understood is the objectives and role of the PMO and how does the organization encourage, recognize and develop good behaviors.

		Information architecture: Ensuring that the organization have ready access to and make good use of project information for their decision-making.

	The key benefits of establishing a centralized PMO include:

		It fosters an environment where collaborative decision making is easier

		It minimizes the risks to individual projects in terms of business impact

		Controlled and efficient resource management

Articles

Interest in improved project management practices is growing in the fast-moving pharma industry.

Dr Justin Kelleher

Articles

Consider an Enterprise Wide Project Management Office