As your company eagerly awaits the results of its Phase 2 trials, all signs point to success. This milestone has the leadership team focused on the next big step: the successful design, launch, and execution of a Phase 3 trial. As the Quality leader, your role is critical, even if the clinical and supply chain teams are steering much of the process. The question in front of you now is how to best use the time available during the preparation and execution of your Phase 3 trial to prepare your company for a successful commercial launch. In this piece, we outline what to know when preparing for a GxP commercial launch.

Preparing for a GxP Commercial Launch 

The challenge lies in striking the right balance—establishing robust quality processes at the right time to enable sustained growth. Quality will play an ever-larger role at your company during this time. How do you use that influence to move forward strategically? Let’s break it down into three key areas: people, process, and technology. 

People 

Now is the time to focus on building your team. If you wait until new product submission, it will be a scramble for talent, and those team members will struggle with making a meaningful impact on building culture, processes, and compliance.  

So, what should you be looking for? First, consider your own areas of strengths and weaknesses. The goal for the fully formed team should be that it has expertise across all quality functions. If your experience is lighter in complaints, look for people with strength there. If you are strong on supplier quality management, then that is not a top priority experience for which to hire.  

On top of strong, complementary quality expertise, these first hires should have strong business acumen. They will need to position new ideas and processes as benefits for the company. This is the group that will be foundational to building a culture of quality and continuous improvement. They also need to be creaive thinkers. Your business partners will be looking to you for guidance on how to maintain and prepare for compliance as well as ensuring continued innovation.    

Looking across the organization now, many companies at this stage have a mix of employees with experience ranging from first company to a career at Big Pharma. The operations and clinical team has typically been with your company the longest – perhaps even from the beginning. This group will need some general education in Quality’s role and its positive impact in their business areas to an already lean group.  

The employees from Big Pharma will be very familiar with quality processes – in particular, well-established processes that are just part of doing “business as usual.” These team members will need to believe that your group is meant to be a business partner helping to prepare for and drive sustained success. The group that has done this before should have the best perspective on the kind of quality culture that you are trying to build. Seek their input on what worked and did not work at their previous company to better build process and culture. Nothing will help you gain others buy-in into what you are trying to do as seeking input from these team members early in your process design work. https://clarkstonconsulting.com/insights/change-management-stakeholder-inclusion/ 

Remember, it will be a journey to establish a quality mindset across the organization. Work done at this time is an important first step. Even if it only sinks in about where you need to start with compliance, that is a win and place that you can continue to build from. 

Process 

Next, make sure the leadership understands that just like every other business area, Quality will be evolving as your company continues to mature. While it’s not necessary to implement a full suite of GxP processes at this time, you should use this time to develop a roadmap for when and how these processes will be implemented over the next few years. For example, a recall process can wait until commercial operations are ready to begin; however, deviations and CAPAs should be established much earlier with document management and audits coming somewhere in between.  

Of course, the order in which you develop your processes should be aligned with your company’s specific growth strategy and to the regulatory/submission activities related to that strategy. Take the time to evaluate the quality operations required for regulatory inspections and commercial readiness, and map these requirements against what is already in place and what your expected business operations will demand. For instance, if your company relies on a limited number of CMOs and suppliers, supplier quality management may not be urgent, but risk management will be critical. Tailor your roadmap to these unique dynamics. 

Technology 

There have undoubtedly already been technology solution decisions made to reach the significant milestone of Phase 2 trial success. The combination of technology, spreadsheets, paper, and no small amount of determination has helped reach this point. This approach might suffice to begin Phase 3, but preparing for new product submissions and pre-approval inspections will require a more mature technology landscape.  

This is not the time to go purchase every best-in-class software. There are different tiers of software providers and features for good reasons, so don’t go at this alone. Take this time to partner with your IT group to begin selecting and right-sizing the technology that will facilitate your business process and quality operations. Partnering with IT leadership early will help build your influence in the organization and lead to better outcomes. 

Preparing for a Successful GxP Commercial Launch 

This is an exciting time at your company. Successfully completing Phase 2 trials and preparing for Phase 3 is a significant achievement. With line of sight to new product submission, excitement is high, and the time-consuming task of preparing for submission is years away. You should take advantage of this time to establish quality as an important business partner across the organization. Work hard on the job description for the team members you will be onboarding soon, and be very selective. While you are searching for your team, begin to draft your timelines for establishing robust quality process at your organization. Remember the goal is to facilitate innovation and help drive the business forward. 

Not sure how to navigate this or simply want to speak to people that have helped others be successful? Contact our team at Clarkston. We have helped quality leaders in this position successfully navigate the unique challenges companies at this stage encounter and prepare them for future success.  

Contributions from Josh Edwards