Applied Clinical Trials: Consider an Enterprise Wide Project Management Office

Applied Clinical Trials: Consider an Enterprise Wide Project Management Office

This paper was written by Justin Kelleher, PMO Consultant at Cora Systems and was published on Applied Clinical Trials.

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:

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.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:

Scope management of individual projects and overall programs
Project planning, execution, and monitoring
Putting strategic plans into practice
Establishing measures of success of each project
Standardizing routine tasks especially around regulatory or compliance
Budget and timeline management
Change management
Value chain management
Incorporating quality best practices
Optimization of resources
Stakeholder management
Providing senior management insight into project progress
Management of regulatory and compliance strategies
Environmental safety
Risk management
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:

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
Ownership of the program roadmap
Responsibility for the alignment of projects against the strategic objectives
Tracking portfolio and performance
Centralized archive of lessons learned
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
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
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

References
A program consists of a series of related and possibly interdependent projects that meet an overarching objective.
State of the PMO 2014. Publisher: PM Solutions (2014)
Readers of this paper should note that the author uses the term Project Management Office but could have also used Program Management Office. A program is simply a logical grouping of projects.
Publisher: IPSE URL: http://www.ispe.org/publications-guidance-documents/project-management-pharmaceutical-industry.

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