Speeding Time to Market With Better Pharmaceutical Project Management

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.

References 
1. ICH, ICH E6 R2, ich.org. 
2. Gartner, “Seven Best Practices of Highly Effective Project Management Groups,” gartner.com. 

-Philip Martin

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:

1. 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  

1. A high degree of regulation, and complex compliance processes 
2. Relative lack of understanding of the importance of project management, especially among senior executives 
3. Lack of sponsorship or visibility for project management from top decision makers 
4. Geographic dispersion of corporate research projects
5. Increased use of outsourcing, not only for IT and back office function, but for research and manufacturing
6. Diffuse management of resources
7. Lack of a single project management process framework
8. The difficulty of reporting progress or financial results to boards and investors 
9. 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. 

Effective pharmaceutical project 

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:  

1. Scope management of individual projects and overall programs
2. Project planning, execution, and monitoring
3. Implementing strategic plans 
4. Establishing measures of success for each project
5. Standardizing routine tasks, especially those that are centered around regulatory compliance issues
6. Managing budgets and timelines 
7. Managing change 
8. Managing the value chain management 
9. Incorporating best practices for quality (for product and process)
10. Optimizing availability and use of resources 
11. Managing stakeholder expectations and communication
12. Providing senior management insight into the progress of each project
13. Managing regulatory and compliance strategies
14. Ensuring environmental health and safety compliance
15. Managing risk.

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).

PMO as the single source of truth

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:  

1. Providing direction and oversight of project management policies, procedures, and templates
2. Sponsoring project tools for planning and controlling
3. Being held accountable for the creation of auditable and traceable documentation through research and development project phases
4. Co-ordinating project initiation, planning and closing phases of projects 
5. Owning the program roadmap 
6. Being held responsible for the alignment of projects against the strategic objectives 
7. Tracking portfolio and performance
8. Developing a centralized archive of lessons learned
9. Providing administration support, e.g., facilitating project web site, special meetings and war rooms,
10. Managing relationships with outside contract partners such as CROs and CDMOs (contract development and manufacturing organizations) 
11. Providing project management training, coaching, or mentoring. 

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

Alignment to strategic objectives

1. Process alignment, to determine how useful, consistent and comprehensive the company’s project management processes are across the entire enterprise
2. Program/project roadmap, in which project objectives and goals are presented alongside a timeline
3. 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
4. Organization architecture/modeling, or defining the organization’s roles and responsibilities 
5. 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
6. Information architecture that ensures ready access to project information.

Managing CRO and CDMO relationships

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: 

1. Easier and better decision making 
2. Minimized risk to individual projects, and lower negative business impact
3. More controlled and efficient resource management
4. Full transparency into all aspects of the projects
5. Better control over projects
6. Less uncertainty and associated risks
7. 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. 

All of these factors have made more companies aware that big budgets and complex projects depend on highly skilled project managers and proven practices to work, offering the collaboration, coordination, tools, process, negotiation, reporting and clear and consistent processes that pharma companies need to succeed. Every pharmaceutical project of any significance requires a spectrum of new project management skills. If you don’t have these skills in-house, then invest in them and support the establishment of an enterprise project management office at your organization. 

References

1. “Small Steps with Giant Impact in Pre-Clinical Research,” elsevier.com. 
2. B. Hirschler, New Drug Approvals Fall to Six-Year Low in 2016, Reuters.com, January 2017. 
3. “2016 FDA Drug Approval Trends,” ogilvychww.com. 
4. FDA, 2016 Annual Report, Office of Generic Drugs, fda.gov. 
5. “Assessment of Cost to Develop and Win Marketing Approval for a New Drug,” Tufts Center for the Study of Drug Development, March,2016.
6. State of the PMO 2014, pmsolutions.com. 
7. The Need for an Enterprise Project Management Office, projectsmart.uk.
8. ISPE, “Project Management in the Pharmaceutical Industry.” 

Article Details

Pharmaceutical Technology
Supplement: Outsourcing Resources
Vol. 41
August 2017
Pages: s46-s50

Citation

When referring to this article, please cite it as P. Martin, "Speeding Time to Market  With Better Pharmaceutical Project Management," Pharmaceutical Technology Outsourcing Resources Supplement (August 2017).