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Cell and Gene Therapy Test Environment Management 

Project management in the cell and gene therapy industry requires thoughtful execution. Commercializing a product, opening a new facility, or starting a new business unit often means implementing multiple new systems at one time.  The complexity is always immense, the timelines are always tight, and the requirements are a moving target – businesses often use the phrase “building a plane while it’s flying” to describe this process. There are a few common frustrations in these large programs that drive up cost, and throughout this Program Management Series, we’ll explore how to get after these frustrations and turn problems into advantages.

Learn More About Our Cell and Gene Therapy Consulting Team

For our first topic of the series, we are diving into IT test environment management. Systems testing is complex and needs to be well coordinated, especially when multiple systems are working together through interfaces or integrations. Managing enhancement testing over many releases can be a nightmare and a huge drain on resources. However, we want to share our insights on test environment management and how setting up a process can quickly save time and money.

Setting the Stage for Cell and Gene Therapy

One Clarkston client has been working on a cell and gene therapy project that requires high levels of coordination for testing in your technology landscape. With the importance of data integrity in the highly regulated pharmaceutical industry, testing systems across multiple applications is extremely key, especially due to the complexity and scale of data integrations. The need to create a simple and seamless patient experience with systems is also imperative as a core goal for these companies.

Understanding the Problem

After system enhancements are made, it is important to perform testing, but this can become a complex issue. Discussions about what exactly should be tested rarely happens early enough in the process, leading to a lack of transparency. So why isn’t testing one of the first priorities discussed and clarified? There are three key reasons for a lack of transparency that cause the overall issue.

  1. Lack of Testing Policy and Strategy by the Company
    Currently, a clearly established testing policy or strategy defining what needs to be tested after initial validation either rarely exists or is not matured in companies. The testing policy and strategy should define specifics about how for certain enhancement scenarios, certain tests need to be conducted. Failing to have a developed strategy can create confusion. In our client example, the organization was thoroughly trained with a testing curriculum, but over a year of enhancements, there was still no clear direction for testing. They questioned whether all changes over the last year should be tested, or whether tests should just be run as applicable to the risks that new enhancements bring. Additionally, there was no true, defined testing strategy for the specific cell and gene therapy program.
  2. No Ownership or Accountability
    Often, it is unclear who is actually responsible for testing. Who owns the test policy and strategy, and who owns the execution? Businesses may question where roles and responsibilities lie for IT testers, as compared to business process owners.
  3. Lack of a Coordinated, Streamlined Approach
    There can also be confusion about who should be overseeing systems testing. Not knowing who to rely on for coordination can fragment processes, meaning that nothing about testing can be streamlined through a governance body. This can be especially detrimental when testing across platforms, as is the case for our client.

Resolving the Issue

To resolve a lack of policy and strategy, a lack of ownership and accountability, and a lack of a coordinated approach, transparency and setting standards can help.

First, set a testing policy and strategy upfront with criteria, clearly defining effort requirements and total time estimated. Step back to look at the strategy in the scope of the project to understand what resources will be needed. Since organizations are inherently inefficient and simple things can get lost very quickly, defining strategies upfront can help teams understand if they have enough resources for the lift required, and how testing could impact a project timeline.

Another method to help resolve the issues with accountability and transparency is to develop a standard RACI, a Six Sigma tool that can help allocate responsibilities to everyone. By spending an appropriate amount of time developing roles and emphasizing the Responsibility, Accountability, Contributing, and Informed methodology, teams will better understand who needs to do what, and when. Additionally, it can be helpful to have some type of central governance body such as a PMO to manage testing efforts across applications and systems. This can further help manage testing and ensure that processes are moving along properly.

Lastly, preparing a value stream map can help make it clear to everyone how processes start, progress, and end. Even in testing, it is important to illustrate or draw out the value stream map, because while processes may appear to be simple, a multitude of actions often need to happen to get from A to B. Providing set standards and actions to promote transparency and define roles and responsibilities can help alleviate the pain of testing across platforms, adding value and reducing complexity across systems.

A Case for Success in Cell and Gene Therapy

Though putting these processes into place to improve testing seems like it would take a long time to reach adoption, this does not have to be the case. Considering our tips for successfully resolving the issue, our client was able to adopt changes almost immediately, creating great dividends for the business. Since August of 2020, approximately 60% of major case problems have been resolved through prioritization and execution on helpful solutions. In this client’s cell and gene therapy business, testing happens frequently, but to complete integration testing, a high level of coordination is necessary. The major solution implemented was fairly simple – quickly developing an intake process, which was stood up by the PMO within two weeks. The key was using multiple channels and forums to spread the word that the intake process had been developed and was running, then working on adjusting to recommendations and continuing to iterate moving forward. The major takeaway is that after identifying a problem gap, getting a tangible process stood up as soon as possible can help increase adoption, providing opportunities to perfect through iteration for as long as timelines allow. It is also highly important to note that testing policies and strategy were developed in parallel to this process to bring forward additional resources for support.

Overall, it is important for teams hoping to develop successful test environment management strategies to consider what can get done quickly with a large impact and start there, while keeping the momentum on building out the balance of the government model in parallel. Clarkston has been managing platform level programs since our founding. Our meaningful program management processes will mitigate program complexities, standardize processes, and efficiently execute multiple operations that deliver a robust and resilient organizational model that can scale with a client’s needs.

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Contributions by Courtney Loughran

Tags: Project & Program Management
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