My Advice: Overcoming the Challenges to Innovation in Regulated Industries

June 26, 2024

In the pharmaceutical industry, regulations can often hinder innovators from advancing great ideas. However, you can overcome these challenges.

Sara Kraft, Director of Transformation at AstraZeneca

While pharmaceutical companies regularly push scientific boundaries with new drug discoveries, they also must comply with regulatory requirements for routine processes. As innovators, the question arises: how can we improve these processes while adhering to regulatory standards?

Before diving in, it’s important to differentiate between two types of innovation: exploratory and exploitative. Exploratory innovation involves looking ahead to new technologies or working methods that could provide a competitive advantage. This is where most innovators focus their efforts. On the other hand, exploitative innovation involves evaluating current processes for operational efficiency and making changes to streamline work.

It is vital to maintain a balanced innovation portfolio that includes both exploratory and exploitative innovations. This ensures the ability to adapt the innovation portfolio from forward-thinking to cost-effective, depending on the business environment. Whether the aim is to explore new ideas or to optimize existing processes, the innovation team should have a well-defined methodology for processing innovations, ensuring a standardized approach across the entire team. One important framework for innovation teams is the 4P framework: People, Process, Platforms, and Partners.

Effecting change in a highly-regulated industry like pharmaceuticals requires the comprehensive integration of the 4P framework. Detailed standard operating procedures (SOPs) are typically in place to guide employees — people — in their tasks. Hence, understanding the current processes and having a detailed change management plan is crucial when introducing new ideas that alter established work methods. Collaborating with those responsible for drafting or modifying SOPs is vital for successfully navigating process change management and ensuring proper documentation. Additionally, platform teams can assist in aligning technology with SOPs, thus helping to maintain process compliance. Lastly, partners must be involved in any change, assuming that you work with outside vendor. For example, if you are licensing a technology from a partner, they could be a critical ally in delivering an innovative change.

At AstraZeneca, we identified a growing challenge: many of our routine operational procedures for ensuring compliance were being managed using Excel spreadsheets. This led to difficulties in effectively monitoring quality and compliance, as well as obtaining clean analytics to ensure smooth process operations. To address this issue, we established a partnership with Veeva Platforms to leverage their technology and transition from Excel spreadsheets to a relational database. This shift enabled us to enforce compliance, enhance quality oversight, and obtain essential analytics.

Upon deployment, the impact was immediate. We gained the ability to access data and metrics promptly, while the quality teams experienced a reduction in manual oversight work.

Under the Digital TMF Strategy, an exploitative strategy, we meticulously examined each Excel spreadsheet and orchestrated their migration to the Veeva platform. (A TMF is a trial master file, a set of documents that prove that the clinical trial has been run in adherence with regulatory requirements.) This process involved collaboration within the 4P framework, where we mapped out the current state process documents, conducted brainstorming sessions to improve the process, and worked on transitioning away from the spreadsheets with the help of Veeva.

Upon deployment, the impact was immediate. We gained the ability to access data and metrics promptly, while the quality teams experienced a reduction in manual oversight work. Additionally, we observed a decrease in quality events. In the pharmaceutical industry, this reduction is significant, as quality events often trigger a substantial amount of additional work in processing corrective and preventative actions (CAPA). Throughout the entire process, we fully engaged all 4Ps to ensure that we remained compliant through the entire change process.

Addressing the obstacles we encountered, we found it necessary to collaborate across functions and take on leadership roles despite lacking formal authority. When proposing ideas and implementation plans, obtaining the support of cross-functional leaders is crucial to ensure that each department has the necessary resources to drive the desired changes. If all functions are not in sync with the overarching strategy, progress may be hindered. In some cases, it is beneficial to have the process and platform teams working together to ensure alignment.

Additionally, it is important to prioritize these changes to prevent change fatigue within the organization. We staggered the launch of each migration to coincide with a release cycle, which occurred three times a year. Furthermore, we deliberately selected Excel templates from different areas of the business for each migration, allowing sufficient time for the changes to become fully integrated into the workflow before moving on to the next one.

In conclusion, driving innovation in pharmaceuticals — and other regulated industries — requires careful consideration of the 4Ps and their interaction, ensuring that changes are aligned across functions, compliant, and smoothly implemented.

Sara Kraft is currently a Director of Transformation at AstraZeneca, where she leads Global Commercial Oncology transformation initiatives. She is dedicated to bringing strategic innovations to life by employing a range of innovation and transformation methodologies. (Featured image by Roberto Sorin on Unsplash.)