Ellen Trayhurn

Management Consultant

  • Life Sciences
  • Project Management
  • Pharma

01 Apr, 2021

Life Sciences and Pharmaceuticals: A Project Manager's Perspective

Improving lives requires effective planning. The goal of any pharmaceutical company is to develop and launch quality products to improve lives. Throughout this journey, there are many obstacles faced by pharma companies as they attempt to compete and survive in an industry that is complex and rapidly changing. Skilled project managers can untangle and mitigate these challenges, successfully planning and delivering to demanding schedules so quality products are delivered at pace. They ensure business processes satisfy stringent regulatory requirements whilst being tailored to changing customer and stakeholder needs. To combat the increasing cost of drug development, project managers can ensure new strategies are implemented to cut internal costs. Through pro-actively managing global stakeholders, they can maximise engagement and collaboration across diverse teams.

This article captures the typical and emerging challenges faced by the life sciences and pharmaceutical industries and, through insights gained from our direct experience, illustrates how project managers can drive efficiency and rigour to pro-actively tackle them.

Plans are constantly changing.

Scientific research inherently involves a degree of uncertainty, which leads to constantly changing plans. Through all stages of the drug development process, from regulatory strategy to clinical studies and supply chain, unexpected events have the potential to significantly delay the time to market during drug development. For example, the outcome of clinical trials and data interpretation will dictate subsequent activities and timelines during the drug approval process. Project goals are always subject to change based on research progress, changes to company strategy, major organisational changes such as mergers and acquisitions and changes in leadership.

Our life sciences project managers have learnt that flexibility is key. It is futile to insist on rigid schedules due to the unpredictable nature of life sciences. As project managers, we must be prepared to adapt to these circumstances quickly and seamlessly, ensuring plans are updated accordingly and the organisation is supported in managing the change. We must strike a balance between adapting to changing requirements whilst keeping the project on track.

A stringent regulatory environment must be navigated.

In parallel to changing plans, regulatory, quality and safety requirements are constantly evolving and becoming even more stringent. Although a product may be effective as intended, failing to meet these requirements can result in regulatory inspection fines and possible exclusions or rejections. Meticulous planning is required to avoid deviations from strict safety plans causing serious delays and re-work.

Balancing the flexible approach required with operating in a highly regulated environment is a steep learning curve. In pharmaceuticals, all decisions must be based on quality data and data integrity is crucial. Therefore, as project managers we must adopt a unique approach combining agility with meticulous attention to detail.

Projects are of long duration and have complex dependencies.

Having worked across all leading pharma companies, our teams have witnessed the extended project lifecycle times in comparison to other industries, for example due to increasingly long lead times for obtaining authorisation for newly developed products. To compensate, pharma companies look for new strategies to accelerate drug development. Many products are therefore developed in parallel to maximise efficiency.

Further adding to the complexity, project plans in life sciences are usually inherently linked to other areas of the business. This presents a need for thorough planning and analysis of conflicting activities and interdependencies. Project managers play a key part by thoroughly capturing these interdependencies and devising solid risk mitigation and remediation plans.

Resource and stakeholder management are often challenging.

With an increased portfolio of products in development often coinciding with increasing pressure to cut costs, pharma companies explore alternative strategies such as the use of third-party contract research organisations to coordinate trials on their behalf. In addition, the pool of resources holding the niche technical expertise needed for these projects is slim, which can cause conflicting priorities that may impact project timelines. Resource constraints are a major concern and efficient resource management is crucial in the execution of drug development projects.

One further challenge is the high number of global stakeholders often involved. In a single project, a project manager may need to navigate the complex relationships and differing agendas between teams as well as external vendors. Managing these relationships and ensuring stakeholders are satisfied can be challenging; impactful and insightful communication is key. Utilising value adding techniques such as data reporting tools to visualise interactive project plans can promote open communication and ensure effective alignment of different stakeholders’ needs.

Projects must deliver products that outperform competition.

With fast paced competition closing in on pharma companies and the cost of drug development rising exponentially, efficiency in all business areas is paramount. Patent expiry and increased competition for generics put pressure on pharma companies to deliver affordable products at pace. They must adapt to increasingly sophisticated customers with continuously evolving product needs and technological demands. Pressure to deliver quality products on time and within budget to outperform competition presents an exceptional challenge. Comprehensive project management is fundamental if this challenge is to be overcome.

Strong project managers are the enablers of successful pharmaceutical project delivery. They are invaluable as pharma companies develop, test and bring to market new products. Many project management roles demand skilled staff with a winning suite of skills. No longer are excellent project management skills enough. Understanding of the environment, culture, dependencies and interplay is critical to ensure success. At Chaucer, a strong background in life sciences and capable project managers with the ability to switch seamlessly between the skillsets required enables us to successfully manage pharmaceutical projects from organisational transformations to new drug submissions.

Although the challenges faced in this industry are immense, our skilled project management workforce can surmount these obstacles and support pharma companies in their mission to improve lives through quality products.

To find out more about how Chaucer can help your organisation deliver successful life sciences projects please contact Ellen.Trayhurn@chaucer.com

Ellen Trayhurn

Management Consultant

“Innovative thinking drives business growth and transformation at pace.”

Ellen is an experienced Project Manager and Scrum Master. She manages complex projects in the Life Sciences sector and specialises in design thinking, innovation, data analysis and visualisation.

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