Continuous Process Improvement: The Secret to Navigating Early-Phase Drug Development 

Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, continuous process improvement enables both individuals and organizations to identify and overcome common points of failure. 

To be clear, continuous process improvement is not the same as finding the right method to address a singular challenge. Instead, it is an approach to solving problems and innovating sustainably. “Continuous” is the operative word. Once one problem is settled, continuous process improvement is the mechanism by which the next (and usually more complex) problems can also be solved. 

That’s what makes it so fascinating and so impactful. It’s not just a euphemism for increasing efficiency, saving money, and reducing headcount. It represents the next evolution of innovation. 

All best-in-class innovators have a process to create a space for innovation. While no part of the drug development cycle is easy, the most difficult challenges are often found right at the beginning. Therefore, deploying a robust continuous improvement methodology is especially beneficial in the earliest phases of drug development. It can help ensure the delivery of high-quality, reliable, timely bioanalytical and clinical data to make informed decisions about either moving on to the next drug development milestone or pivoting to another strategy. 

Build a culture of process improvement

As a research and development (R&D) scientist, I used to wholeheartedly believe the familiar adage, “Drug development takes the time it takes.” I was incredibly proud of my role in advancing ground-breaking pharmaceutical science, and I didn’t think that innovation could be “standardized.” Consequently, I didn’t believe it could be improved.

Then, I went through the eye-opening and humbling experience of objectively mapping the drug development process. Asking, “What is really unique?” revealed that a majority of the process is the same, regardless of the compound being studied or the methodology being used. 

Various compounds and methods have unique features, of course. However, as it turns out, somewhere around 80%-90% of the development process translates from one compound to another compound, one method to another method. That means there are many opportunities to leverage continuous improvement methodologies if the organizational culture is supportive. 

As mentioned, drug developers may be skeptical about continuous improvement initiatives. So, the first step toward success involves creating a bi-directional continuous improvement culture from the:

• Top-down. Leadership must commit to communicating why change is necessary and desirable, as well as to deploying the tools and education to support a culture of continuous improvement. 
• Bottom-up. Most improvement efforts fail because sustainability is not baked in through tools and teamwork. The real magic happens at the team level; it’s grassroots efforts that truly foster sustainability. 

Make no mistake: Building a culture of best-in-class continuous improvement takes the right mindset, discipline, and methodology. It’s hard work — a fact proven by poor results historically. Organizations must be ready to change. 

However, with a compelling reason for change, standard tools can help analyze data and a disciplined mindset can help ensure relentless adherence to the process. With these elements in place, teams become engaged, and continuous improvement is perceived as a way to create more headspace for innovators to innovate. 

Deploy strategies that support process improvement

Best-in-class innovators have a structure whereby teams and individuals feel empowered to say, “I have an idea…” After all, it’s the people who work in an area who best understand the problems they face. So, to develop a culture and a structure that encourages continuous improvement in the bioanalytics lab and other early-phase settings, leaders should:

• Meet teams where they are. Leaders tend to be visionary, but too often, they forget to explain their vision in ways that resonate with their teams. Meeting people wherever they are is a fundamental best practice that is especially impactful for organizations that start low on the continuous improvement maturity scale. 

• Be relentlessly curious. Visit the bioanalytics lab. Ask questions. Dig deep into the process layers to understand the “why.” If something is done to meet standard operating procedure (SOP), ask why. Is there a good reason for it, or does it merely reflect longstanding habits? Ask people, “If you could solve or create anything, what would you do?” It’s amazing what you learn just by being genuinely curious. 

• Communicate continually. The most successful initiatives have a compelling reason for change that is well-communicated across the organization. Success requires explaining the benefits of a continuous improvement culture and how it will make people’s professional lives easier. 

• Start small. Make your first continuous improvement projects small but meaningful. They should be “proof of concept,” enabling quick wins and early success. In a scientific environment where teams are used to developing new things one experiment at a time, the key is to open the door and create a space for engagement. Invite those who have achieved wins or experienced failures to share what they’ve learned with other team members. Organizations can generate a “virtuous cycle” by creating a space for innovators to talk about their innovations and learnings with other innovators. 

• Make everything visible. No matter what you’re trying to improve—professionally or personally — it’s reasonable to expect a 10%-15% improvement just by making it visible. Teams can’t fix what they can’t see. So, use visual management boards and other tools to make both successes and hardships evident to the team. Even for failures, transparency is paramount because it sparks open, organization-wide performance discussions. Engaged teams want to see how their work feeds into organizational decisions, goals, etc. 

• Document meticulously. It’s essential to catalog wins, losses, and their reasons. Ask questions and apply the Pareto principle to determine potential solutions and best practices. 

• Build sustainability. Most improvement initiatives fail because processes are dictated and implemented without the tools and education to continually evaluate, challenge assumptions, ask questions, listen, and remain curious. Success requires cataloging issues, trending them, identifying corrective action, and taking that action…continuously. Finally, it requires extrapolating and applying whatever has been learned to other processes that might benefit.

Focus on process, achieve better outcomes

Nobody goes to work hoping to be frustrated by ineffective endeavors and subpar results. I’ve never yet encountered a drug development organization that doesn’t want to be successful. However, many fail to recognize that outcomes are very much a consequence of process. 

Those organizations that invest in continuous improvement processes empower their people to contribute to problem-solving and innovation. Indeed, one of the best indicators that a continuous improvement initiative is maturing is when leaders no longer have to communicate wins to the team because team members are organically sharing their wins and learnings with leadership and each other. By giving people the tools and methods to continually offer their ideas for improvement, drug development organizations are better equipped to achieve the short- and long-term outcomes they desire.

Photo: metamorworks, Getty Images

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