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 bio-similar 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:Founding an EPMO
PM 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:
- 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
- Full transparency into all aspects of the projects
- Better control over projects
- Being better equipped to make the optimal decisions related to projects
- Minimizing uncertainty and associated risks
- Increasing support and buy in from all stakeholders