2023 Veeva R&D and Quality Summit Opening Keynote Ft. Replimune and Gilead

This video provides an in-depth exploration of Veeva's vision, technological innovations, and product roadmap for its R&D and Quality Summit in 2023. Peter Gassner, Veeva CEO, sets the stage by outlining Veeva's commitment to building the "industry Cloud for Life Sciences," encompassing software, data, and services designed to enhance efficiency and effectiveness across the sector. He emphasizes Veeva's unique status as a Public Benefit Corporation (PBC), prioritizing the balanced interests of customers, employees, shareholders, and the industry over mere shareholder value, positioning Veeva as a durable, long-term partner.

A significant portion of the keynote addresses technology trends, particularly the rise of Artificial Intelligence (AI) and Large Language Models (LLMs). Gassner offers a pragmatic view, asserting that while AI applications will become powerful tools, they will not replace humans or create lasting competitive advantage on their own. Instead, Veeva's approach to AI is focused and practical, centered on two key areas: "application Bots" designed to automate repetitive, high-volume functions within specific applications (e.g., TMF bot for document classification, RIMbot) and a "Direct Data API." This groundbreaking API, developed over two years, promises to extract full and incremental data from Veeva Vault applications up to 100 times faster than existing methods, enabling customers and partners to more easily build their own AI applications requiring complete and current data views.

The presentation then delves into the Veeva Development Cloud, which serves as the technological foundation for drug development across clinical, regulatory, safety, and quality domains. Gassner highlights the comprehensive nature of Veeva's Clinical Platform, aiming to be the most complete and highest quality solution for patients, sites, and sponsors, with over 30 applications including seven new ones announced. Key innovations include SiteVault for site collaboration, Study Training, randomization and trial supply management (RTSM), e-PRO for patient-reported outcomes, and new industry data areas like SiteBase and Open Data Clinical. A major focus is on improving the site experience through free software like SiteVault, and the introduction of Veeva ID and Study Portal to simplify login and system access for clinical research coordinators who often manage dozens of different credentials. The Regulatory, Safety, and Quality platforms are also detailed, with emphasis on continuous improvement, increased automation, and the development of unified systems like the Quality Platform for manufacturing and R&D, including new applications such as e-forms and Batch Release.

The keynote concludes with insights into Vault Platform innovations, such as "action layouts" for streamlined user interfaces and a significant reduction in upgrade downtime (aiming for 10 minutes or less). Customer interviews with Replimune (an emerging biotech) and Gilead (an enterprise pharma) illustrate how companies are leveraging Veeva's platform approach to unify processes, reduce manual work, and drive efficiency, with Replimune citing a 30% reduction in site data entry burden and significant cost savings. Finally, Veeva introduces "Veeva Business Consulting," a new service offering deep industry expertise to help clients align software investments with strategic business objectives, focusing on process optimization, change management, and value realization.

Key Takeaways:

• Veeva's foundational vision centers on building an "industry Cloud for Life Sciences" that integrates software, data, and services, aiming to be essential and appreciated by every company in the sector. Their Public Benefit Corporation (PBC) status underscores a commitment to balancing the interests of all stakeholders for long-term industry benefit.
• Veeva adopts a "focused and practical approach" to AI, viewing it as a powerful tool rather than a human replacement or a standalone competitive advantage. Their strategy involves embedding AI into specific applications to automate repetitive tasks.
• "Application Bots" are a core component of Veeva's AI strategy, designed to perform specific, high-volume functions within applications, such as the TMF bot for document classification and the new RIMbot, freeing human users for more complex work.
• The "Direct Data API" is a groundbreaking innovation, enabling extremely fast extraction of full and incremental data from Veeva Vault applications (up to 100 times faster). This is crucial for customers and partners to build their own AI applications and robust data pipelines that require complete and current data.
• Veeva's Clinical Platform is designed to be comprehensive and high-quality, serving the entire clinical ecosystem by being patient-centric, site-centric, and sponsor-centric. It includes a wide array of applications from eTMF and CTMS to RTSM, ePRO, and new industry data solutions.
• Improving the site experience is a key focus, with initiatives like free SiteVault software, Veeva ID (a single login for all Veeva systems across sponsors), and the Study Portal, which collectively aim to alleviate the burden of managing multiple logins and systems for clinical research sites.
• Veeva's Regulatory and Quality platforms are mature and continuously evolving, with features like collaborative authoring in Microsoft Word, continuous publishing, and unified quality systems across QA, QC, and training, demonstrating ongoing innovation even in established areas.
• The Safety and Quality areas are seeing significant investment, with new applications like Safety Workbench, Signal (for analytics), e-forms (to replace paper-based processes), and Batch Release (for faster product release decisions), all aimed at increasing automation, efficiency, and data-driven insights.
• Vault Platform innovations include "action layouts," which provide highly optimized, role-specific views to streamline user workflows and training, and a commitment to "10-minute upgrades" to minimize downtime and ensure world-class availability for critical operations.
• Customer case studies highlight the tangible benefits of Veeva's platform approach: Replimune, an emerging biotech, achieved a 30% reduction in site data entry burden and nearly $1 million in monitoring cost savings per trial by pooling vendor and EDC data in Vault CDB.
• Gilead, an enterprise pharma, demonstrated an evolutionary approach, leveraging Veeva QualityDocs and QMS to unify processes, reduce risk, improve visibility, and align business processes globally, emphasizing the value of coupling technology modernization with process improvements.
• Veeva Business Consulting is a new strategic service offering, providing deep industry expertise to help clients optimize business processes, navigate change journeys, and ensure value realization from their software investments, bridging the gap between technology and strategic objectives.
• Veeva positions itself as a conduit for industry collaboration, fostering a community where companies can share ideas and collectively drive positive change in life sciences through better ways of working.

Tools/Resources Mentioned:

• Veeva Vault (overall platform)
• Veeva Development Cloud (suite for R&D and Quality)
• Veeva Commercial Cloud (mentioned as a separate offering)
• Application Bots (TMF bot, RIMbot)
• Direct Data API
• Veeva Clinical Platform (eTMF, CTMS, SiteVault, Study Training, RTSM, ePRO, SiteBase, TrialBase, Open Data Clinical)
• Veeva ID
• Study Portal
• Veeva Regulatory Platform (publishing, archive viewer)
• Veeva Safety Platform (Safety, SafetyDocs, Safety Workbench, Signal)
• Veeva Quality Platform (QualityDocs, QMS, Training, Validation Management, LIMS, e-forms, Batch Release)
• Vault CDB (Clinical Data Management)
• Microsoft Word (for collaborative authoring)
• SAP (for integration with Batch Release)

Key Concepts:

• Industry Cloud for Life Sciences: Veeva's vision of providing comprehensive software, data, and services tailored specifically for the life sciences sector.
• Public Benefit Corporation (PBC): A legal status indicating a company's commitment to balancing stakeholder interests (customers, employees, shareholders, industry) beyond just maximizing shareholder value.
• Application Bots: AI-powered tools embedded within specific software applications to automate repetitive, high-volume tasks.
• Direct Data API: A high-speed, foundational API designed to extract complete and incremental data from Veeva Vault applications, enabling external AI development and data integration.
• Clinical Ecosystem: The interconnected network of patients, research sites, and sponsors involved in clinical trials, emphasizing the need for platforms that serve all three.
• Site-centricity: A focus on designing solutions that cater to the needs and challenges of clinical research sites, improving their experience and efficiency.
• Unified Quality System: An integrated approach to managing quality across quality assurance, quality control, and training within manufacturing and R&D.
• Action Layouts: Specialized, optimized user interface views within Veeva Vault applications, tailored to specific activities and user roles to streamline workflows.

Examples/Case Studies:

• Replimune: An emerging biotech that utilized Vault CDB to pool vendor and EDC data, resulting in a 30% reduction in site data entry burden and an estimated savings of almost $1 million per trial across three phase two oncology trials.
• Gilead: An enterprise pharmaceutical company that implemented Veeva QualityDocs and QMS in an evolutionary manner, starting with external partner collaboration and expanding to internal document management. They focused on aligning business processes globally, leveraging Veeva's industry best practices to achieve risk reduction and improved visibility.