About Exelixis
Exelixis, a leader in biopharmaceutical innovation, is dedicated to developing therapies that meet critical medical needs. However, as DSCSA requirements and regulations continued to evolve, Exelixis encountered obstacles in maintaining a compliance framework that could keep pace with its rapid growth. Delea Magana, Executive Director, Global Logistics, Distribution, & Inventory Management at Exelixis, explains,
“We take regulations very seriously and want to make sure that, right out of the gate, we’re compliant.”
This commitment to regulatory excellence drove Exelixis to seek a partner that could enhance its compliance infrastructure, and after extensive consideration, Exelixis trusted Two Labs for the task.
Challenges and Initial Gaps
Before engaging with Two Labs, Exelixis identified several gaps in its Standard Operating Procedures (SOPs) related to serialization and compliance:
- Limited Documentation: Exelixis’s SOPs initially focused narrowly on technical processes like managing system access and moving serialization data. However, broader regulatory details—such as those required for Product Identifier Verifications, Suspect Drug Investigations, and comprehensive DSCSA Policy documents—were either incomplete or absent. This lack of robust documentation exposed the company to compliance risks, particularly in areas requiring clear process-level guidance for regulatory adherence.
- Resource Constraints: Exelixis did not have a dedicated DSCSA team, so compliance responsibilities were split among team members whose main duties lay elsewhere. This added strain to staff, created knowledge gaps, and limited the team’s ability to fully address DSCSA requirements as part of their daily operations.
- Increasing Regulatory Complexity: Through industry events and internal reviews, Exelixis saw the rising need for well-documented processes. As DSCSA regulations evolved, Exelixis recognized that more than its limited SOPs would be needed for future requirements and risked inconsistently addressing critical areas like verification timelines and response procedures.
Recognizing these challenges, Exelixis sought a partner with deep industry expertise. After exploring options, Exelixis engaged Two Labs, trusting its reputation and commitment to quality in pharmaceutical compliance.
“Any question that we had, Two Labs was able to come in and provide a response, walking us through it… even if they weren’t certain about something, they would get us a response right away.”
Key Improvements and Impact
The collaboration between Exelixis and Two Labs led to substantial improvements in Exelixis’ compliance structure, enhancing both documentation and operational consistency. Through the engagement, Exelixis’ SOPs evolved from system-focused documents into comprehensive, process-level guidelines, significantly reducing compliance risks. Key activities, such as product returns and complaint handling, were thoroughly documented to establish a solid compliance foundation. These refined SOPs and structured workflows also streamlined Exelixis’ internal processes, leading to smoother daily operations and minimizing non-compliance risks. With reliable, accessible documentation, team members could quickly resolve compliance-related inquiries, reducing time spent on internal approvals. The partnership also addressed inconsistencies within Exelixis’ verification timelines, standardizing responses across SOPs to ensure regulatory adherence and uniformity throughout all compliance-related documentation.
Results and Tangible Benefits
The tangible benefits of the partnership included:
- Time Savings and Reduced Workload: With Two Labs handling the majority of SOP revisions, Exelixis could allocate its resources to other priorities without compromising compliance. Project timelines were met consistently, reducing internal workload and creating a smooth, uninterrupted workflow.
- Enhanced Compliance and Risk Mitigation: The updated SOPs established a robust compliance framework that addressed documentation gaps and high-risk areas, aligning Exelixis with DSCSA requirements and reducing regulatory risks.
Cost-Effective Compliance Support: Two Labs’ efficient, structured approach enabled Exelixis to manage compliance more economically, meeting both immediate and future regulatory needs without overextending resources.
“Without Two Labs, we’d still be working through [the SOPs] and not getting them completed. They provided the guidance and resources we needed to document everything properly… it just didn’t feel like an overwhelming task that we couldn’t get done.”
Long-Term Benefits and Future Planning
With a newly structured SOP framework, Exelixis is now better positioned to handle ongoing and future DSCSA requirements. The SOP improvements provide a stable foundation for future compliance needs and give Exelixis confidence in its regulatory standing. Exelixis also anticipates that this collaborative experience will enhance its approach to future SOP updates, applying Two Labs’ methodologies for sustained compliance success.
Two Labs has been a pivotal partner in Exelixis’ compliance journey, transforming a previously fragmented SOP framework into a robust compliance program that meets current DSCSA requirements and prepares the company for future regulatory needs. The collaboration exemplifies how Two Labs’ industry expertise and responsive support help biopharmaceutical companies like Exelixis enhance compliance processes and streamline operations effectively.