Season 3 Episode 2: Special Episode: Boehringer Ingelheim’s One Medicine Platform

This video provides an in-depth exploration of Boehringer Ingelheim's "One Medicine Platform" project, a transformative initiative aimed at reimagining drug development through advanced data utilization and a connected technology ecosystem. Hosted by Nicole Raleigh, the discussion features Andrea Kloeble and Daniel Schwenk, Product Owners in Clinical Data Engineering at Boehringer Ingelheim, alongside Richard Young, Veeva's VP of Clinical Data Strategy. The conversation takes place on-site at Boehringer Ingelheim's Human Pharmacology Center in Biberach, Germany, highlighting the real-world context of Phase I clinical trials.

The central theme revolves around Boehringer Ingelheim's "Medicine Excellence initiative," which seeks to unify development processes and data within a centralized platform to address unmet medical needs and accelerate the innovation of new medicines. The speakers emphasize the exponential growth in study data volumes and sources, necessitating a robust and integrated technology landscape. This transformation focuses on reducing complexity, fostering an innovative digital culture, and moving away from the historical reliance on paper-based data capture towards fully digital and integrated solutions, including the consideration of direct integration of electronic health record (EHR) data into clinical trials.

A significant milestone discussed is the go-live of the Veeva Vault Clinical Data Management Suite (CDMS) at Boehringer Ingelheim, marking a pivotal step in their digital journey. This implementation is part of a broader, holistic ecosystem that includes Veeva Clinical for operations, Veeva Quality, and Veeva RIM (Regulatory Information Management), ensuring data is automatically available across different vaults for various functions like patient recruitment, data visualization, and dashboards. The collaboration with Veeva is highlighted as a true partnership, with a shared commitment to leveraging technology to free up scientists for core research and accelerate the delivery of breakthrough therapies, particularly in challenging areas like personalized medicine, cell and gene therapy, and rare diseases, while maintaining regulatory compliance.

Key Takeaways:

• Holistic Digital Transformation in Pharma: Boehringer Ingelheim's "One Medicine Platform" is a comprehensive initiative to unify development processes and data across a connected technology ecosystem, moving beyond incremental changes to achieve full digital transformation in drug development.
• Connected Technology Ecosystem: The project leverages the Veeva Development Cloud, integrating Veeva Vault CDMS, Clinical, Quality, and RIM to create a seamless flow of data and processes, reducing redundancies and handovers.
• Data-Driven Decision Making: The core objective is to accelerate access to data for faster, more informed decisions, ultimately bringing new medications to patients more quickly, especially for diseases with unmet needs.
• Transition from Paper to Integrated Digital Data: The industry has moved from 90% paper-based data capture to less than 10%, with a strong push towards integrating diverse data sources, including electronic health records (EHRs) directly into clinical trials.
• Multi-Dimensional Clinical Trials: Modern trials are no longer "one-dimensional" (does it hurt, does it work) but involve multiple questions and data points, including real-world data from wearables and everyday actions, creating pressure for more complex data management.
• Addressing Data Complexity and Risk: The influx of more data creates potential for "noise" and greater risk, necessitating robust systems to pull data into an intelligible format for good decision-making.
• FAIR Data Principles: The future of clinical data management will increasingly focus on making data Findable, Accessible, Interoperable, and Reusable (FAIR) to maximize its value and support advanced analytics.
• Strategic Partnership for Innovation: The collaboration between Boehringer Ingelheim and Veeva exemplifies a strong partnership where technology providers deliver tools that enable pharmaceutical companies to focus on scientific innovation and accelerate their drug pipeline.
• Focus on Patient, Site, and Sponsor Experience: The initiative prioritizes improving the experience for patients (faster access to medication), sites (easier processes for investigators), and sponsors (efficient data access for confident decisions).
• Regulator Engagement: Regulatory bodies play a crucial role, and the complexity of varying country-specific regulations adds another layer to data management challenges, requiring flexible and compliant solutions.
• Beyond Traditional EDC: While Electronic Data Capture (EDC) systems are fundamental, the future involves integrating data from a rapidly increasing variety of sources and data types, such as biomarkers, and utilizing cutting-edge tools for analysis.
• Role of Data Curators: With the growing volume and variety of data, there will be an increasing need for "data curators" to extract maximum value and ensure data quality and usability.
• Future Expansion with CTMS: The next major step for Boehringer Ingelheim is the release of Veeva CTMS (Clinical Trial Management System) for clinical operations, which will further expand the ecosystem to manage protocol deviations, payments, and other operational aspects.

Tools/Resources Mentioned:

• Veeva Development Cloud: A comprehensive suite of cloud software for the life sciences industry.
• Veeva Vault Clinical Data Management Suite (CDMS): A specific component for managing clinical trial data.
• Veeva Vault Clinical: For clinical operations.
• Veeva Vault Quality: For quality management.
• Veeva Vault RIM (Regulatory Information Management): For managing regulatory submissions and information.
• Veeva Vault CTMS (Clinical Trial Management System): For managing clinical trial operations.
• EDC Systems (Electronic Data Capture): General term for systems used to collect clinical trial data.
• Electronic Healthcare Records (EHRs): Digital versions of patients' paper charts.
• Fitbits/Wearables: Mentioned as sources of real-world data.

Key Concepts:

• One Medicine Platform: Boehringer Ingelheim's initiative to create a unified digital platform for drug development, integrating processes and data.
• Medicine Excellence Initiative: Boehringer Ingelheim's internal drive to optimize and innovate its medical development processes.
• Remote Data Capture: The process of collecting clinical trial data electronically from sites.
• Data-Enabled Clinical Trials: Trials that leverage digital data collection, integration, and analysis to improve efficiency and outcomes.
• Rubik's Cube Analogy: Used to describe the multi-faceted challenge of clinical trial optimization, considering patients, sites, data managers, clinical teams, and regulators as different sides of a complex problem that requires constant movement and perspective shifts to solve.
• Single-Use Data: The outdated concept of data being collected for one specific purpose and not being easily reusable or interoperable, which the industry is moving away from.
• FAIR Data (Findable, Accessible, Interoperable, Reusable): A set of guiding principles to enhance the reusability of scientific data.

Examples/Case Studies:

• Boehringer Ingelheim's Digital Transformation: The entire discussion serves as a case study of a major biopharmaceutical company undertaking a significant digital transformation, moving from paper to remote data capture, and now implementing a holistic Veeva ecosystem.
• Go-live of Veeva Vault CDMS: The specific example of Boehringer Ingelheim releasing its first clinical study to production using Veeva Vault CDMS highlights a concrete milestone in their platform journey.
• COVID-19 Pandemic Impact: The pandemic is cited as a catalyst that brought clinical trials into public gaze, demonstrating the industry's ability to accelerate trials (8-10 years to 8-10 months) and the importance of common goals and patient volunteering.