Industry experts from Veeva Systems have outlined key predictions for the life sciences sector in 2023, highlighting how integrated data strategies will reshape drug development and regulatory processes.
Data Integration to Drive European Market Success
The European pharmaceutical landscape faces increasing complexity due to regulatory and cost pressures. Chris Moore, president of Veeva Europe, emphasizes that successful companies will need to revolutionize their data management approach for product launches. "In 2023, successful companies will be more deliberate in how they access, manage, and learn from data ahead of a product launch," Moore states.
Companies are expected to maintain internal control of data management while outsourcing trials, enabling better tracking and utilization of trial execution data. This strategy will facilitate earlier collaboration between clinical, commercial, and market access teams, accelerating product launches across European markets.
Streamlined Drug Development Through Technology
Jim Reilly, vice president of development cloud strategy, predicts a significant transformation in drug development efficiency. The convergence of operational simplification and technological advancement will create a more streamlined development process, characterized by lean execution and higher-quality data.
"Connected data across the development lifecycle will enable different functions to coordinate decisions, and a common technology framework will eliminate duplicate data capture and inefficient processes," Reilly explains. This integration is expected to significantly reduce time-to-market while maintaining product quality.
Evolution of Patient-Centric Clinical Trials
The clinical trial landscape is becoming increasingly sophisticated, with umbrella, adaptive, and platform trials becoming standard approaches. Richard Young, vice president of strategy at Vault CDMS, predicts an increase in patient data collection, particularly in oncology and diabetes trials, where real-life movement data will become crucial for demonstrating quality of life outcomes.
"We're entering a new era of patient choice," Young notes, emphasizing that participants will have greater flexibility in choosing between in-person and digital participation methods based on their daily health status and personal preferences.
Enhanced Safety and Quality Management
Kelly Traverso, vice president of Vault Safety Strategy, forecasts a broader focus on safety-related content management. Organizations will implement more rigorous controls over document development, review, and approval processes, creating a single source of truth for safety-related information.
In the quality domain, Ashley Wentworth, senior director of Vault Quality Strategy, predicts increased collaboration between biopharmas and CDMOs through enhanced technical innovations that enable secure information sharing while maintaining strict access controls.
Regulatory Innovation and Data-Based Submissions
The regulatory landscape is poised for significant change, according to Marc Gabriel, vice president of Vault RIM. The industry will witness a transition from document-based to data-based regulatory submissions, beginning with FDA initiatives focused on manufacturing CMC submissions.
"In 2023, more companies will focus on developing the systems, infrastructure, and skill sets required to work with data-based submissions," Gabriel states, highlighting that this transformation will require substantial organizational changes and new operating models.
