EXTEDO eCTDmanager Customer Interview: Glenn Robertson, Puma Biotechnology

This video features Glenn Robertson, Head of Regulatory Operations at Puma Biotechnology, discussing his company's positive experience with EXTEDO's eCTDmanager software. Puma Biotechnology, a pharmaceutical company focused on developing a breast cancer drug, faced the critical challenge of simultaneously preparing and submitting both New Drug Application (NDA) and Marketing Authorization Application (MAA) dossiers. Robertson details how eCTDmanager provided an effective solution, enabling his team to develop both complex applications concurrently within the tool, which significantly enhanced efficiency and reduced the time required for these essential regulatory submissions.

Robertson highlights the invaluable "open sequences" or "parallel sequences" feature of the software. This functionality allowed his team to work on multiple submission sequences simultaneously without interrupting progress on larger, ongoing submissions. This capability meant they could efficiently manage smaller, incremental submissions while keeping the primary NDA/MAA dossiers open, thereby streamlining their workflow and preventing bottlenecks. The adoption of eCTDmanager also facilitated a strategic shift for Puma Biotechnology, allowing them to transition from outsourcing their regulatory submission activities to managing them entirely in-house, which provided greater control and operational efficiency.

The interview underscores the tangible return on investment achieved through the software, primarily measured in substantial time savings. Robertson specifically mentions a reduction in the initial application preparation time from an estimated eight weeks down to just three weeks. Furthermore, smaller, routine submissions that previously took a full day could now be completed in a matter of hours. These efficiency gains were crucial for accelerating market access for their cancer drug. Robertson also emphasizes the critical role of the partnership with EXTEDO, noting their willingness to provide on-site support during crucial submission periods, which ensured prompt resolution of any technical issues and directly contributed to Puma Biotechnology's overall success in their regulatory endeavors.

Key Takeaways:

• Streamlined Parallel Regulatory Submissions: Puma Biotechnology successfully managed the simultaneous preparation of complex NDA and MAA applications using eCTDmanager, demonstrating the software's capability to handle concurrent, high-stakes regulatory dossiers efficiently for global market entry.
• Significant Time and Cost Savings: The implementation of eCTDmanager led to a dramatic reduction in submission timelines, cutting initial application preparation from eight weeks to three weeks and smaller submissions from a full day to mere hours, directly impacting operational costs and time-to-market.
• Optimized Workflow with Parallel Sequencing: The "open sequences" feature was instrumental, allowing the regulatory team to work on multiple submission sequences concurrently. This capability enabled the efficient management of smaller, urgent submissions without disrupting progress on larger, ongoing dossiers, thereby preventing delays and improving overall productivity.
• Transition to In-house Regulatory Operations: The software empowered Puma Biotechnology to bring its regulatory submission processes in-house, moving away from outsourcing. This strategic shift offers greater control over critical data, fosters internal expertise, and can lead to long-term cost efficiencies.
• Tangible ROI Measured in Time: The primary metric for return on investment identified was significant time savings in regulatory processes. This highlights that for pharmaceutical companies, accelerating submission and approval cycles directly translates to business value, impacting revenue generation and patient access.
• Critical Role of Vendor Partnership and Support: The success was partly attributed to a close partnership with EXTEDO, including on-site support during critical submission phases. This emphasizes the importance of responsive and dedicated vendor assistance for complex, high-stakes regulatory activities.
• Accelerating Oncology Drug Development: The context of developing a breast cancer drug underscores the urgency and high stakes involved. Efficient regulatory processes are not just about compliance but also about expediting the availability of life-saving therapies to patients.
• Regulatory Compliance as a Strategic Imperative: The video reinforces that managing complex regulatory applications like NDA and MAA is a core strategic function that requires specialized tools and expertise, directly influencing a pharmaceutical company's ability to commercialize its products.
• Impact on Commercialization Timelines: While not explicitly detailed, the efficiency gains in regulatory submissions directly contribute to faster market approval and launch timelines, which are critical factors for a pharmaceutical company's commercial success and revenue generation.

Tools/Resources Mentioned:

• EXTEDO eCTDmanager: A specialized software solution designed for the creation, management, and submission of Electronic Common Technical Documents (eCTD) to regulatory authorities worldwide.

Key Concepts:

• NDA (New Drug Application): A comprehensive application submitted to the U.S. Food and Drug Administration (FDA) seeking approval to market a new pharmaceutical drug in the United States.
• MAA (Marketing Authorization Application): A similar comprehensive application submitted to the European Medicines Agency (EMA) or national regulatory bodies in Europe to gain approval for marketing a new drug within the European Union/EEA.
• eCTD (Electronic Common Technical Document): An internationally agreed-upon format for organizing and submitting regulatory applications electronically, ensuring a standardized structure for drug dossiers across various global regulatory agencies.
• Open Sequences / Parallel Sequences: A feature within eCTD management software that allows users to simultaneously work on and manage multiple distinct submission sequences. This enables efficient handling of both large, ongoing applications and smaller, concurrent updates or new submissions without data loss or workflow interruption.

Examples/Case Studies:

• Puma Biotechnology's Dual Submission Challenge: The central case study involves Puma Biotechnology's successful simultaneous preparation and submission of NDA and MAA for their breast cancer drug, demonstrating the practical application and benefits of eCTDmanager in a high-pressure regulatory environment.
• Quantifiable Time Savings: Specific examples of efficiency gains include the reduction of initial application preparation from an estimated eight weeks to three weeks, and the completion of smaller, routine submissions in hours instead of a full day.