Project & Program Management in the Biopharma Industry, Particularly in Advanced Therapies

In today's ultra-fast-moving and highly regulated landscape, the biopharmaceutical industry is grappling with mounting challenges in delivering breakthrough therapies, especially as biologics, gene therapies, and other advanced treatments evolve at an unprecedented pace. The development of these therapies typically spans 7 to 12 years before they make it to market. This lengthy process is continually disrupted by emerging technologies, shifting regulations, geopolitical factors, and evolving market needs. Research indicates that between 90% and 95% of products fail during early-stage and preclinical development, with these failures often taking 2 to 5 years to unfold, resulting in substantial time and financial losses. As such, effective project and program management are crucial to navigating these challenges and ensuring the successful development and commercialization of these promising therapies.

In 2024, the global biologics market was valued at approximately USD 369.39 billion. This market encompasses a wide range of products, including monoclonal antibodies, vaccines, and gene therapies, which have become integral to modern medicine. Looking ahead, the market is projected to reach USD 732.4 billion by 2030, reflecting a compound annual growth rate (CAGR) of 8.2% from 2023 to 2030. This is a clear indication of the benefit that would come from a careful selection of biopharmaceutical projects that are commercialized.

Furthermore, advanced therapies, including gene therapy, cell therapy, and tissue engineering, present additional challenges to project managers. These therapies often involve cutting-edge science and technology, clinical trials, and regulatory frameworks that are less well-established compared to traditional pharmaceutical development. Therefore, managing these types of projects requires specialized expertise, careful coordination, and a deep understanding of the unique risks involved.

Given this context, let's delve into how the principles outlined in the Project Management Body of Knowledge (PMBOK) by the Project Management Institute (PMI) influence the biologics industry. When I studied Project Management using the PMBOK, I realized that it provides a comprehensive framework that covers essential areas such as scope, time, cost, resources, risk, quality and stakeholder management. In the biologics industry, where projects are highly complex, heavily regulated, and often span several years, the application of these principles is critical. By aligning project management practices with the PMBOK, organizations can enhance their ability to navigate challenges, manage risks effectively, ensure regulatory compliance, and ultimately drive the successful development of biologic therapies.

1. Scope Definition: The complexity of biopharmaceutical and advanced therapy projects requires that the scope be clearly defined early to ensure alignment with scientific, regulatory, and commercial goals. Understanding the regulatory landscape for both advanced therapies and biosimilars is critical in this process. Comparability studies, manufacturing challenges, and approval pathways play a key role in shaping the project scope. Furthermore, clinical considerations such as defining success endpoints and long-term safety monitoring, especially for cell and gene therapies must also be carefully defined within the scope.

This brings me to an important point about the preparation of project charters. Many biopharmaceutical companies do not establish project charters with a clearly defined scope, key success indicators, and deliverables before the project even begins in the R&D phase.

This lack of clarity can lead to misalignment and inefficiencies as the project progresses.

What can be the best practices for defining scope early on:

We are all familiar with the concept of SMART goals (specific, measurable, achievable, relevant, and time-bound). In the context of biologics, this could involve assessing the regulatory landscape early, benchmarking safety and efficacy in clinical trials, and allowing flexibility to incorporate emerging data as it becomes available. Essentially, it means ensuring the scope can be adjusted to integrate new findings from other clinical studies and market analysis. Additionally, engaging all key stakeholders is crucial when preparing a project charter.

2. Risk Management: Biopharmaceutical projects, particularly those involving advanced therapies, carry inherent risks, such as technological failure, clinical trial challenges, and regulatory hurdles. A comprehensive risk management plan is essential. This is one area of project management where early engagement with regulatory bodies can help shape the project scope to align with regulatory expectations, minimizing the risk of significant revisions later in development.

Another important aspect of risk management is understanding that early-stage trials in biosimilar and gene therapies are particularly sensitive, with unique challenges such as immunogenicity and long-term safety issues. Recruiting and retaining patients for clinical trials can be difficult, especially in rare diseases or niche therapeutic areas. The risk of insufficient enrolment can delay trial timelines and increase costs. Furthermore, patient compliance during trials is crucial for collecting accurate data, and loss to follow-up can skew results.

Companies dealing with advanced therapies especially need to anticipate potential disruptions, such as clinical trial failures, regulatory rejections, or manufacturing issues, and prepare contingency plans that outline alternate strategies. In my experience, ambiguity in regulatory tracks to advance therapies is one of the key risks that might change the trajectory of a project.

It is, therefore, crucial to evolve from anticipating risks and working around them to identifying risks early on, maintaining risk registers and risk response plans for comprehensive risk management.

3. Timeline Management: Advanced therapies often require long and rigorous testing phases, including preclinical studies, clinical trials, and regulatory submissions. Effective timeline management ensures that milestones are met, and resources are appropriately allocated. Most companies actively monitor project timelines, but missing components such as rigorous risk management planning, unclear scope result in highly improper timelines.

The most significant impact of improper schedule management is on cost and confidence. Development of advanced therapies is expensive, delay in any phase can increase additional

expenses significantly; including but not limited to clinical study, employee expenses, raw material, manufacturing and extending contract.

The second most important and often undermined impact is on the investors’ confidence in the fruition of the project. This could lead in the reduction of funding, termination of partnerships and loss of competitive advantage. Properly managing schedules and timelines in large, predictive-modelled biologics projects is critical to avoiding these cascading effects.

Effective timelines can be created by incorporating comprehensive planning, robust risk management, and proactive stakeholder communication at each stage of the biologics development process. Effective, realistic timelines are a direct outcome of clear scope definition and elaborate risk management.

4. Stakeholder Engagement: Successful program management in biopharmaceuticals requires close collaboration among scientists, regulatory bodies, clinical teams, and commercial stakeholders. Communication is key to managing expectations and aligning objectives.

Therapies, particularly cell & gene therapies, can have long development timelines and high costs, so aligning the expectations of all stakeholders, including patients, who may be participating in trials, is vital.

It may be underestimated, but the early identification of stakeholders, defining their roles and engagement levels in a documented register is of great importance. Over the long period of development of biologics, several stakeholders participate in different phases of development. It is important to establish their engagement level at each phase and define communication channels based on their engagement levels in the project. Communication also needs to evolve with emerging technology, the availability of new data, changes in leadership and the ethos of the organization.

Stakeholder registers are also useful in managing conflicts and ensuring alignment among various parties. When stakeholders’ concerns and feedback are tracked, program managers can more easily spot areas of disagreement or tension, such as differing priorities between regulatory bodies and investors, or concerns from clinical trial participants about treatment safety.

5. Quality: Quality in biopharma is a critical element that ensures the safety, efficacy, and compliance of therapies throughout the development and manufacturing process. In this industry, especially with advanced therapies like gene therapies, cell therapies, and biologics, quality management systems are meticulously designed to meet stringent regulatory requirements such as Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).

I also want to bring attention to another crucial aspect of quality that extends beyond drug quality: the quality of systems and frameworks within the organization itself. This involves fostering a culture where openness and adaptability are prioritized; creating an environment where employees are encouraged to embrace new advancements, evolving work styles, and flexible mindsets. Such an ethos is key to cultivating a culture that can seamlessly adopt stronger and more effective program management practices. Essential to this shift is the commitment to continuous training and development, ensuring that the workforce is equipped with the skills needed to navigate changes and drive improvement across the organization. Acceptance is key. We are required to let go of the mindset that ‘these

methodologies and practices cannot be used in our industry’.

6. Resource Allocation: Given the financial and human resource-intensive nature of biopharmaceutical development, ensuring the proper allocation of resources is crucial to project success.

As we talk about resources in biopharmaceuticals, it is important to talk about the role of CROs and testing labs. As stakeholders and contract partners, CROs provide scalable solutions, allowing biopharma companies to adjust resource usage depending on the needs of the project. They can quickly ramp up operations for clinical trials or other activities without the overhead of maintaining in-house resources.

By leveraging the expertise and infrastructure of CROs and testing labs, biopharma companies can expedite drug / therapy development. CROs also help manage time-sensitive activities such as patient recruitment, regulatory submissions, and trial management.

Here, we also highlight the importance of procurement management and contracts. CROs and testing labs are an indispensable part of drug development. Early identification and evaluation of these partners, along with including them in the stakeholder register, can significantly streamline the onboarding process and accelerate study execution. This approach ties back to clearly defining the project scope; understanding what tasks will be handled internally and what will be outsourced.

As we speak about the key principles of project management in biopharmaceuticals there is a particular methodology that is fairly well-established and adopted by most biopharma companies: the Stage-Gate process which has long been an established program management practice. This method breaks the program into distinct phases (e.g., research, preclinical development, clinical trials, regulatory submission, and commercialization), with defined "gates" that serve as decision points where stakeholders evaluate the success and risks of the program before proceeding. It is within these phases that project management frameworks need to further be strengthened.

In subsequent editions, we will delve deeper into the application of agile methodologies in early stage development and clinical studies, the use of software and AI for enhancing program management and a very critical topic: knowledge management in the field of advanced therapies.



As a program manager with limited experience in the biosimilars and advanced therapies sector, I’ve had the opportunity to contribute to only a few of projects in this field. While my experience may be limited, I’m confident that experts and seniors would agree that the program management frameworks in advanced therapies still lack the maturity seen in other industries. Given the complexity of our projects, the path forward isn’t always linear. However, through incremental progress, the industry is steadily building stronger frameworks and practices in project and program management.