You may have the next blockbuster molecule in your pipeline. However, if you fail to manage its reliable production in sufficient quantities for clinical trials and commercial supply, the success of the entire project is at risk. In other words, incredible ideas, if not well-executed, go nowhere. Great firms execute, and great entrepreneurs know how to get stuff done.
As Tom Mochal noted, "The right mix of planning, monitoring, and controlling can make the difference in completing a project on time, on budget, and with high-quality results." This leaves us with a critical question: How can we achieve this in the inherently uncertain world of bioprocess development and scale-up?
This concept is discussed in greater detail in an episode of the Smart Biotech Scientist Podcast, hosted by David Brühlmann, founder of Brühlmann Consulting.
The Cautionary Tale of the Failed Car Launch
Consider the cautionary example of the Ford Edsel in the 1950s. Ford had a seemingly great car idea, investing ten years and $250 million in research and planning. They were so confident in its success that the new car was named after Henry Ford's son, and an entire company division was devoted to its creation.
Extensive market research was conducted to ensure the car had the right 'personality' to attract the ideal customer. However, the project failed miserably, becoming one of the most spectacular examples of project failure in automotive history. When the car was finally unveiled in 1957, Ford had missed its chance; the market had already shifted to compact cars, a category the Edsel did not fit.
The Ford Edsel serves as a perfect illustration of the critical importance of speed to market and how even a major brand and product can falter if a project loses velocity. Poor communication and inaccurate deadlines can slow a project to the point where it becomes irrelevant or unvaluable, let alone unsuccessful. Bad planning can indeed leave project leaders with a sour aftertaste, thinking, "I could have organized the project better!"
Just like general project management, bioprocess development and scale-up demand meticulous planning, precise resource allocation, and effective communication. While dealing with complex biological systems, processes, and various stakeholders, the unwavering focus remains on achieving the end goal efficiently and on time. In today's intensely competitive market, where many companies are pursuing similar targets, getting groundbreaking therapies into clinics quickly has become more crucial than ever.
The Pillars of Project Success in Bioprocessing
Achieving project success in bioprocessing hinges on several key areas.
- First, it requires good upfront planning to lay a robust foundation.
- Second, securing resources from the beginning is non-negotiable for smooth execution.
- Third, a thorough evaluation of scalability potential is crucial, as this dictates long-term viability.
- Finally, paying close attention to areas like resource availability and utilization—ensuring project workers are operating at capacity and performing to the best of their ability—creates more accurate project timeline estimations and prevents projects from dragging on.
At its core, these efforts coalesce into the need for a solid, comprehensive project plan.
Once a project charter has been successfully written and key stakeholders identified, the next step is to develop a comprehensive project management plan.
The project charter provides the high-level vision, but the project management plan delves deep into the 'ins, outs, overs, and unders' of the project. It breaks down the vision into the actual day-to-day execution, covering everything necessary to achieve project goals. A detailed project plan will outline everything from timelines to budgets, resources, and deliverables, serving as a blueprint to guide and assess the project's progress.
Effective planning should encompass the following essential elements:
- Why: The big picture, defining the purpose and overarching goals.
- What: The specific deliverables (scope) and associated expenses (cost).
- When: The start date, end date, and overall timeline.
- Who: Identification of the individuals or teams responsible for the work (people).
- How: The detailed process and methodology to achieve the objectives.
The work invested upfront in creating a thorough project plan yields significant returns throughout the project's lifecycle. It eliminates guesswork, clearly indicating where focus, resources, and attention should be directed at each step. This proactive approach ensures that efforts are 100% focused on delivering results, rather than scrambling to determine the next course of action or prevent issues from becoming overdue or over budget.
The Five Benefits of Great Planning
Excellent planning offers distinct advantages that contribute significantly to project success:
- It provides your project with a baseline to work from: a clear starting point for tracking progress and performance.
- It creates project alignment (and removes confusion): Ensures everyone is on the same page regarding goals and methods.
- It fully outlines the scope of the project: Provides clarity on what is included and, importantly, what is not.
- It allows for better-resourced project management: Facilitates optimal allocation and utilization of personnel and materials.
- It builds confidence in your project: A well-thought-out plan instills trust among stakeholders and team members.
Five Essential Steps Before Detailed Planning
Before diving into the intricate details of planning, five fundamental aspects must be addressed:
- Identify the baselines for your project: Begin by establishing the baselines for the project's scope, schedule, and cost. These will serve as crucial constraints for the remainder of the planning process. While a rough outline may exist in the project charter, this stage requires mapping them out and creating accurate estimates. The more detailed these baselines are, the better they will serve as comparison points to measure project performance. This is also where the scalability potential becomes critical, requiring a big-picture understanding of the project's future.
- Identify your project dependencies: Ask, "What needs to happen before this other thing can happen?" Identifying dependencies at the outset enables more efficient timeline planning, helps identify potential blockers upfront, and prevents unnecessary delays.
- Identify project stakeholders: Many projects fail because leaders neglect the interests and requirements of their stakeholders. Effective stakeholder management is instrumental in facilitating clear communication, aligning expectations, and fostering positive relationships, ultimately leading to enhanced project outcomes, timely delivery, and increased satisfaction. The influence of key stakeholders cannot be underestimated; their decisions can make or break a project. Therefore, a well-structured plan to identify their needs and engage with them effectively must be a pivotal part of the overall project planning strategy.
- Identify project milestones: These are the key markers of a project's progress. Whether a concrete deliverable or the end of a phase in a stage-gate process, breaking the project into manageable chunks with defined goals keeps the team motivated, allows for celebrating achievements, and signposts overall progress.
- Identify roles and responsibilities: Once the overall work and available resources are understood, assign clear ownership to each task. This eliminates ambiguity ("Oh, was I supposed to do that?") and ensures accountability and transparency within the team.
Beyond the Technical: Leadership, Communication, and Scalability
While the technical aspects of project management are crucial, project success fundamentally relies on people. Communication, leadership, and problem-solving skills play a vital role. It is about the project leader's capability to build and lead a winning team, communicate effectively, and possess sufficient technical knowledge to make informed decisions.
Assuring long-term success, especially in technology or product development, necessitates a keen understanding of scalability potential. This should be a reflex for every process development manager. When developing a manufacturing process, it's crucial to consider that production will likely need to scale up at some point.
For instance, a brilliant idea to cool a chromatography step to increase yield might work in R&D by simply placing a column in a fridge. However, scaling this to a 120 cm stainless steel column would require cooling the entire system or performing the step in a cold room, leading to wasted energy and non-ideal working conditions for personnel. Such developments, though seemingly "silly," are not uncommon. Scalability is at the core of transforming great ideas into innovation success stories.
The principle of scalability also extends to product development. For tech companies to succeed or even survive, they need a large user base of returning customers. This makes it vital to (1) consider whether an idea has the potential to scale and (2) start building the product and operations with scaling in mind.
Not all ideas are equally scalable. Software-centric innovations have a significant scale advantage because the marginal cost of copying software is zero; Microsoft can easily sell another Excel license, scaling with minimal additional cost. Conversely, ideas requiring material, energy, and labor to produce each unit of innovation have a lower scale advantage.
To effectively evaluate scalability potential, two things should be assessed:
- Identify your target market: Clearly define your end-users.
- Develop your growth hypotheses: Formulate assumptions about how your idea or process will evolve and develop over time.
The benefits of innovation are often amplified by economies of scale. To fully leverage an idea, focus on developing intellectual assets that can be traded at zero marginal cost to a growing number of customers. In process development and scale-up, scalability is an integral part of the process.
A process might work well on a small scale but fail when attempts are made to scale it up. After all, what is the point of developing a drug that cannot be manufactured? Therefore, considering scalability from the very start of the project is vital to ensure long-term success.
Building a High-Performing Team: Three Bonus Tips
At the core of any project's success are the people. Their creativity, dedication, and hard work drive progress and outcomes. Fostering a supportive, encouraging, and collaborative environment where everyone feels valued and heard is key to a successful project.
How is this achieved?
- Build a "High-Performing You." Outstanding leadership begins with self-leadership. Leaders cannot give what they do not possess. This means cultivating stamina, modeling the correct behavior, and exuding confidence and positive energy. People seek leaders they can trust and rely on.
- Get the right people. Focus on character, competence, chemistry, and culture. This does not necessarily mean hiring only the most experienced individuals, but instead seeking a balance between skills and positive energy. Cultivate a warm, open, collaborative culture where people are comfortable taking risks and even failing. By tapping into the potential of others, results can skyrocket. A decisive shift in mindset involves moving from asking, "How am I going to achieve x, y, z?" to the more effective question: "Who can help me do that?" While high achievers often focus on the 'how' to control outcomes, learning that others are perfectly capable of handling many of the 'hows' allows leaders to focus on their strengths.
- Empower your team. A high-performing team is empowered to make decisions on behalf of the leader. As Maxwell suggests, a leader's mindset should be about connecting, not correcting. Leaders of the future connect today: they are trustworthy, talkative, listen, ask questions, and provide answers. Becoming a connector means believing in team members' ability to make the right decisions that serve the project's goal.
Final Remarks
Effective project management in bioprocess development and scale-up is critical for bringing groundbreaking therapies to market. It necessitates meticulous upfront planning, strategic resource allocation, and a relentless focus on scalability.
The Ford Edsel's failure serves as a stark reminder of the perils of neglecting market timing and thorough preparation. Beyond the technical blueprint, success is profoundly intertwined with leadership, effective communication, and the ability to cultivate a high-performing and empowered team.
By embracing comprehensive planning, prioritizing scalability, and investing in human capital, bioprocess projects can overcome complexity and achieve long-term success.
What are your insights on these project management principles in bioprocessing? Feel free to share your experiences.
David Brühlmann is a strategic advisor who helps C-level biotech leaders reduce development and manufacturing costs to make life-saving therapies accessible to more patients worldwide.
He is also a biotech technology innovation coach, technology transfer leader, and host of the Smart Biotech Scientist podcast—the go-to podcast for biotech scientists who want to master biopharma CMC development and biomanufacturing.
Hear It From The Horse’s Mouth
Want to listen to the full interview? Go to Smart Biotech Scientist Podcast.
Want to hear more? Do visit the podcast page and check out other episodes.
Do you wish to simplify your biologics drug development project? Contact Us