Journey of an API: Pharmaceutical project management

When considering an API’s journey to market, the most technical and scientific stages tend to come to mind first: chemical process development, analytical method development, hazard evaluation and others. However, an additional, more nuanced aspect of the journey is equally important: project management. Project management is seldom referenced directly when talking about the molecule lifecycle, and its impacts are both comprehensive and significant—felt in every stage of the journey to market.

In this instalment of our Journey of an API blog series, we’ll explore project management’s role as a fundamental part of API development and manufacturing. Even with well-developed processes and thorough risk assessment, effective project management can make or break a programme. Successful project management hinges on the principles of flexibility, close collaboration and thorough planning. Let’s take a closer look at some of the key objectives and obstacles in the pharmaceutical project management function.

Breaking it down: Early involvement to set an API programme up for success

The primary goal of project management is to ensure a successful outcome in an API development programme or manufacturing campaign, whilst aligning with customer expectations and simultaneously maximising efficiency and effectiveness. Every project begins with a proposal outlining the customer’s specific objectives and scope of work. The project manager then serves as a liaison between the project team and the customer, coordinating all project activities, advocating the customer’s requirements to the internal team and keeping the customer up to date on project progress and any challenges that may arise.

The most effective project management approach is one that begins early and remains active throughout the entire development and manufacturing process. Engaging a dedicated project manager from the earliest stages facilitates a deep understanding of the project and its nuances, maximises engagement and transparency among key stakeholders, and upholds critical continuity as the project scales.

Measuring success: Key objectives for pharmaceutical project management

In project management, success is measured primarily against the project proposal, which clearly defines requirements and expectations. However, remaining within budget and project timelines is not the only measure of success for an API development and manufacturing programme. A successful engagement is one that meets the customers’ key objectives, with an emphasis on maintaining product quality, collaborating effectively, and successfully navigating technical challenges.

Let’s take a closer look at some key objectives as they apply to pharmaceutical projects, along with tangible ways scientists and project managers can measure their success. Note that these objectives are not exclusive to project management but represent goals for the programme as a whole, as the ultimate aim of project management is to successfully steward the project from start to finish.

Modern pharmaceutical and biotechnology organisations are not only concerned with adhering to project timelines but also with reaching clinical trials and, ultimately, the market as quickly and safely as possible. In 2023, there are more than 21,000 drugs in the global R&D pipeline, which is double 2013 numbers. This rise in competition has created an increased sense of urgency for organisations aiming to bring their project to clinical trials and, ultimately, to the market as quickly as possible. The project manager’s role is to ensure everything remains on track throughout development while keeping ahead of any challenges or changes to scope that could impact a customer’s speed to clinical trials or market.

How it’s measured: Project managers should actively manage cycle times at each critical stage, such as the timeframe for process development and analytical method development, time required to scale up in the plant, and more. By evaluating these actual timeframes against a proposed schedule, project managers can effectively manage timing while identifying possible bottlenecks that may have created delays. Then, the project manager can work with the team to understand these challenges while remaining vigilant for opportunities to expedite activities.

In any API development programme, product quality is a key measure of success. Is the product meeting its required specifications around stability and purity in the required yield? How can we mitigate risks that could impact quality as the product scales? Are we remaining compliant? The project manager must carefully consider each of these variables, work with the appropriate teams to ensure ongoing quality, and continually align with the customer to provide updates along the way.

How it’s measured: Product quality can be evaluated in several ways. From a purity perspective, techniques like high-performance liquid chromatography (HPLC) and gas chromatography (GC) are useful in characterising and quantifying impurities. Assays are used to evaluate potency and ensure the API is meeting specifications, and stability studies are used to assess the product’s stability over time and under certain conditions.

From a regulatory perspective, it is important to produce thorough documentation of production, testing and results. While regulatory requirements become more stringent as a project moves through the regulatory phases, maintaining updated documentation throughout the process makes it easier to monitor and track changes while ensuring that all the necessary data has been produced.

One of the most important measures of success from a project management perspective is whether a project successfully scales. From the earliest stages of a project, scalability is key, as chemistry that functions as planned at the lab scale may not always produce the same results at a much larger scale. The project manager should work with the project team to ensure that thorough testing has been done to assess scalability and work tirelessly with the engineering team to validate that proper controls and equipment configurations are in place prior to scale-up.

How it’s measured: Scale-up success can be measured by comparing the results achieved in the lab to those achieved at the plant scale. Has yield met the target or increased? Is the product meeting quality specifications? Factors like cost and efficiency are also key measures of success as a project scales.

In addition to these tangible measures of success, there are several key indicators that are more challenging to quantify, particularly when working with customers. Namely, customer satisfaction and partnership are vital to the success of an API development and manufacturing programme. As a result, maintaining full transparency with the customer at each stage and working in true partnership are critical, and the project manager is responsible for fostering and maintaining this collaborative relationship.

Overcoming obstacles: Navigating pharmaceutical project management challenges

As API development and manufacturing projects evolve, challenges can arise. The following are some of the most common challenges that pharmaceutical project managers face, along with effective ways to address them.

Scope changes are among the most significant challenges that can arise in pharmaceutical project management. Customer priorities may shift, or challenges related to raw material suppliers, equipment, resource utilisation and more can arise at a moment’s notice. For example, when an analytical method that has been used in the early development of a process reaches validation and is found to have an issue with selectivity or robustness, this will drive re-development of the method. This change to the scope of the project will necessarily change analytical timelines, and it is the job of the project manager to manage its impact on other linked activities, such as manufacturing. Consistent communication, both with the customer and among internal teams, is critical for the project manager, particularly amid any unforeseen challenges or evolving priorities. This ensures that partnership and customer satisfaction, both critical indicators of success, are upheld.

Risk can arise in various forms during development and scale-up, not only in the form of safety risk but also in the form of impurities, low yield, inconsistent results, and other challenges that prevent the product from meeting specifications. Through conducting early phase risk assessments, scientists can proactively understand parameters that might impact quality or safety and then take measures to control them before the project scales. Then, the project manager and development team can continually evaluate metrics against these benchmarks to ensure continued quality. For example, if early-phase analytical studies indicate potential impurities, changes to reaction temperature or time may aid in mitigating these impurities. The project manager should work with the chemistry team to determine if and how these adjustments may impact project timelines through additional lab work, then ensure the product remains within specification after implementing these changes.

Scaling a project from the lab to plant comes with a number of important considerations and potential challenges, and the project manager must help to ensure that the transition is as seamless as possible. Some components related to scaling up represent a necessary trade-off. For example, if a customer wants to start manufacturing earlier, this may be possible, but the risk profile increases as a consequence. The project manager must clearly express these potential risks and trade-offs and work with the customer to align on the most feasible approach that does not compromise quality or safety. In addition, by creating a well-rounded, multidisciplinary team that has visibility into the project from its onset, the project manager can help to ensure continuity and avoid potential knowledge gaps that can impede successful scale-up.

Back to the big picture: Balancing timelines, costs and quality with effective project management

In API development and manufacturing, the project manager is tasked with balancing numerous variables to help define the most efficient and effective path to scale up and beyond. By becoming involved in the project from its onset, forming a well-rounded team, and consistently communicating with the customer and internal teams, the project manager can more effectively monitor project progress, ensure everything remains on track, and maximise customer success.

Another key element of project management is adapting to the customer’s way of working. While some customers prefer to define their own processes and procedures, others desire more guidance and closer collaboration. An adept project manager takes the customer’s priorities and requirements into close consideration and tailors their approach accordingly.

Project management at Sterling

When it comes to effective pharmaceutical project management, the right partner makes all the difference. At Sterling, a dedicated project manager works on each customer project from the very start, providing guidance and collaboration every step of the way. We maintain consistent communication with our customers to align on project requirements, discuss challenges together, adapt as the programme progresses, and ensure each project remains on track. Our flexible approach to project management allows us to support a wide range of project requirements while mitigating knowledge gaps and enabling our customers to count on the support of a dedicated, multidisciplinary team over the course of their projects.

As we work as an extension of our customers’ teams, effective project management comes as second nature. We treat our customers’ projects as if they are our own and work in true partnership to ensure their project goes as smoothly as possible. If you’d like to hear more about how our collaborative project management approach can set your programme up for success, speak to an expert. Visit our Knowledge Hub to explore more useful resources.