Philip Martin is CEO of Cora Systems. He has almost30 years of experience in the enterprise portfolio,program and project management (EPPM) industry in lifesciences, healthcare, engineering and other industries,as well as the public sector.

Philip Martin

Over the past 20 years, the pharmaceutical industry has experienced significant change. Some fundamentals may have stayed the same, e,g., stringent regulatory processes, the rise of generics, and the difficulty of discovering new, commercializeable drugs. However, the understanding of diseases at the molecular level is improving rapidly, creating scientific, technical and regulatory challenges that make drug development more difficult and risky than ever. Today, any new drug entering clinical testing is only 12% likely to be approved (1).

	Recent drug approval rates tell the story. In 2016, FDA approved only 22 medicines, 50% fewer than it had the year before (2). Similarly, the number of new drugs approved by the European Medicines Agency (EMA) was down significantly from 2014, the agency’s record year for drug approvals (3). 

	Failures in the manufacturing supply chain played a major role in the drop in new drug approvals, according to FDA’s annual report for the Office of New Drugs (4), attesting to the increased regulatory scrutiny of drug development. 

	Drug development: Not for the faint of heart

	In 2014, the Tufts Center for the Study of Drug Development examined 10 pharmaceutical companies and 106 randomly selected drugs that were first tested in human clinical trials. Experts at the center concluded that the true cost of bringing a new drug to market was $2.56 billion (in 2013 dollars) (5). 

					Best Regulatory Practices for Managing Projects with Contract Partners

					With the onset of new regulatory guidelines by the International Council on Harmonization (ICH), ICH E6 R2 (1) in mid-June of 2017, clinical trial sponsors and contract research organizations (CROs ) are gearing up and tightening the framework for launching new risk-based management approaches to onsite monitoring activities. The new addendum represents the largest revision to ICH guidelines in 20 years, and places all responsibility of conformance on the clinical trial sponsor. These guidelines also impact a pharmaceutical company’s enterprise project management office (PMO), requiring that they establish firm, but flexible best practices to ensure the reliability of clinical trial outcomes.  

					In a 2016 report issued by Gartner (2), the following best practices were cited for PMOs managing projects with both external and internal teams: 

					All of these best practices require agility and flexibility, and will result in successful outcomes. Given the cost of drug development, it has become critical for pharmaceutical companies to shore up operational procedures. Project management can help, not only to ensure that appropriate risk management policies are in place, but that drug development meets all regulatory guidelines so that time to market can be minimized.

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					2. Gartner, “Seven Best Practices of Highly Effective Project Management Groups,” 

	On average, they noted, 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. This begs the question: How do we, or should we, increase scientific productivity? 

	Pharma’s output level has remained relatively steady for the past decade. There is little reason to believe that this productivity will suddenly increase any time soon. 

	Considering that the 20-year patent exclusivity period commences once the clinical trials have been approved, investors have relatively little time to get a return on their investment, which explains the ever-escalating prices for pharmaceuticals and medical devices. Couple these challenges with resistance from insurers and payers and pharma faces a tough business. So far, pharmaceutical companies are responding by buying earnings through mergers and acquisitions, developing internal generic pipelines, looking at emerging global markets, collaborating, diversifying product or biosimilar categories, and exploring new ways to speed time to market.
	In R&D, the area of precision or personalized medicine, which aims to get the right treatment to the right patient at the right dose, first time, offers the industry a business solution that can be addressed by technological advancements. In 2016, in the United States, the 21st Century Cures Act authorized $6.3 billion in funding to help speed up the drug and medical device approval process, especially for diseases with unmet medical needs. Could this signal increased government support for industry research in the future? 

	Perhaps, but what is clear is that complexity is increasing at all points along the pharmaceutical value chain. Pharmaceutical manufacturers are in urgent need of better project management practices that will improve agility.

	Project management for drug development is a highly specialized, and still a relatively new, role in pharma. It demands skills and qualities around communication, decision-making, delegation, and risk taking, as well as the ability to deal with day-to-day challenges based on the following:

		The need for intense coordination between functions that haven’t historically worked together, such as R&D, regulatory, legal, finance, supply chain, sales, and marketing  	

		A high degree of regulation, and complex compliance processes 	

		Relative lack of understanding of the importance of project management, especially among senior executives 	

		Lack of sponsorship or visibility for project management from top decision makers 	

		Geographic dispersion of corporate research projects	

		Increased use of outsourcing, not only for IT and back office function, but for research and manufacturing	

		Lack of a single project management process framework	

		The difficulty of reporting progress or financial results to boards and investors 	

		Lack of training in the types of project management skills uniquely needed by pharma companies.

	Project management brings all aspects of any pharmaceutical project together. Given the term’s relatively new status in pharma, a clear definition is in order. The Project Management Institute (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, but successful projects lead to successful operations. 

	A program consists of a series of related and possibly interdependent projects that meet an overarching objective. It organizes and manages resources in a way that achieves project completion within the defined scope, quality, time, and budget. 

	In general, project managers should 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. In order to overcome these skills shortages, an increased number of management consultancy firms have started offering specialized pharmaceutical project management services.

	Outsourcing demands better project management

	The move to outsourcing has intensified the need for project management. Contract development and manufacturing organizations (CDMOs) have taken on some of the project management burden for pharma, and are becoming a strategic part of any drug company’s projects and operations.

	However, working with CDMOs and other outsourcing partners makes project management more important, both within the sponsor company and within the CDMO, in order to build trust, and ensure on-time and on-budget delivery. Effective communication can be facilitated by talented project managers, who must address the following:  

		Scope management of individual projects and overall programs	

		Project planning, execution, and monitoring	

		Establishing measures of success for each project	

		Standardizing routine tasks, especially those that are centered around regulatory compliance issues	

		Incorporating best practices for quality (for product and process)	

		Optimizing availability and use of resources 	

		Managing stakeholder expectations and communication	

		Providing senior management insight into the progress of each project	

		Managing regulatory and compliance strategies	

		Ensuring environmental health and safety compliance

	Over the past 17 years, according to Project Management Solutions (6), the title and function of the project management office (PMO) have become more important, and more visible, at more companies. In 2000, the survey found, only 47% of companies surveyed had a dedicated enterprise PMO, where, in 2014, 90% did. Of those who did not, 30% of those without a PMO planned to implement one within the next year. In 2014, medium and large companies were more likely to have a PMO than small companies. That year, 88%-90% of respondents from mid and large companies reported having a dedicated office, compared to 61% for small companies. 

	At that point, the average PMO was 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 an executive at the vice-president level or higher; 43% directly to the C-level. Undoubtedly, strong executive management commitment and support are equired for success.

	If a pharmaceutical company does not have an enterprise-wide PMO to govern the overall portfolio of related projects then it may be losing an opportunity to improve collaboration and communication. The aim of this approach is to coordinate all aspects of projects in an organization (7).

	Thus, for project management, the PMO becomes the single point of success or failure, and the single source of truth. However, PMOs face a number of challenges, the biggest ones being the fact that they’re often seen as overhead and the fact that organizations continue to resist change. The PMO covers three areas critical to any pharmaceutical project’s success: scientific operations, client services and resource management.

	An enterprise PMO handles a number of functions that include the following:  	

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

		Sponsoring project tools for planning and controlling	

		Being held accountable for the creation of auditable and traceable documentation through research and development project phases	

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

		Being held responsible for the alignment of projects against the strategic objectives 	

		Developing a centralized archive of lessons learned	

		Providing administration support, e.g., facilitating project web site, special meetings and war rooms,	

		Managing relationships with outside contract partners such as CROs and CDMOs (contract development and manufacturing organizations) 	

		Providing project management training, coaching, or mentoring. 

	
	Key objectives that a PMO should be responsible for include the following: 

		Process alignment, to determine how useful, consistent and comprehensive the company’s project management processes are across the entire enterprise	

		Program/project roadmap, in which project objectives and goals are presented alongside a timeline	

		Performance management, to determine how well the projects add value to the overall organization and how well teams and individuals are rewarded for contribution to successful projects	

		Organization architecture/modeling, or defining the organization’s roles and responsibilities 	

		Staff culture, i.e., how well understood the role of the PMO is, and how the organization encourages, recognizes and develops the behaviors needed for success	

		Information architecture that ensures ready access to project information.

	With the continuing trend toward outsourcing all, or parts of clinical trial projects, it’s incumbent on the PMO to -ensure, first and foremost, a high level of communications among all involved--internally and externally. The objective is to reach what might be called a single version of the truth, making sure that knowledge transfer and pipeline goals are abundantly clear and that there are specified milestones to be met by all constituents involved in the clinical trial. 

	Four major elements are key, including early involvement of all end users with tutorials on how knowledge and tools will be used and how applicability and impact will be measured.  A common process should be employed to identify and prioritize critical knowledge areas and key people and positions. 

	Making sure that knowledge capture and transfer initiatives are linked to succession planning, hiring, onboarding, and training and development throughout the entire process is critical as CROs/CDMOs may be brought into the trial process at different stages. And finally, by training personnel and providing support systems, a process for harvesting and packaging knowledge is essential.

	CROs/CDMOs are focused on delivering sustained quality for their sponsors.  Helping to achieve that objective can be pivotal for the PMO, which has much the same focus.  With teams working globally, there’s an added complexity for the PMO in making sure that all in sync with strategy, process, technology, and knowledge transfer.   

	There are a number of key benefits from establishing a centralized PMO, including: 

		Minimized risk to individual projects, and lower negative business impact	

		More controlled and efficient resource management	

		Full transparency into all aspects of the projects	

		Increased support and buy-in from stakeholders.

	Project management support and resources

	The International Society for Pharmaceutical Engineering (ISPE) offers “Project Management for the Pharmaceutical Industry (8),” which describes the tools and techniques that support pharmaceutical project delivery, life cycles in a typical project, and how to navigate complex compliance and regulatory projects.

	As they grapple with change, pharmaceutical companies, like their counterparts in every other industry, are intensely competitive and scrutinizing operations more closely than ever before to find better value. New emerging markets are being explored while scientific research has become more result-oriented. 

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Elevating the project management function can improve transparency and enable companies to react faster to internal and external change.