For biopharma companies looking to ensure proper lifecycle management for their therapeutic, it is critical to design an adept regulatory strategy as early as possible. Depending on a company’s budget, internal capabilities, and regulatory experience, they may opt to develop their regulatory strategy in-house or collaborate closely with a regulatory service provider to identify where they can implement technology like artificial intelligence (AI), machine learning (ML), natural language processing (NLP), and language learning models (LLMs) to improve accuracy, efficiency, and regulatory compliance across their processes. If your team is considering how best to tailor your regulatory strategy, consider the emerging trends and best practices across the industry that may help guide your approach.

Why Is It Critical to Set Regulatory Strategy Early?

Developing a regulatory approach as early as possible can help your team adapt and respond to challenges more efficiently. Consider the following benefits:

• identify potential issues as soon as possible, reducing the risk of delays and setbacks during an asset’s lifecycle;
• optimize your assets for success by considering how to embed manufacturing, supply chain management, and pharmacovigilance into your regulatory strategy from the start; and
• streamline your pathway to approval and influence post-approval regulatory compliance.

What Are Some of the Emerging Lifecycle Management Trends?

The pathway to enhancing reliability and efficiency requires embracing technology and process improvement. For lifecycle management activities, which involve multiple regulatory submissions, different product types, and various countries, it is critical to ensure that standardized processes and up-to-date regulatory intelligence are used. To stay ahead of the curve for your lifecycle management goals, explore the trends emerging across the biopharmaceutical industry:

• flexible partnerships with service providers that allow drug developers to choose the arrangement that best suits their regulatory lifecycle needs, with optionality around pricing, oversight, accountability, governance, and geographic and organizational alignment;
• AI and ML technology implementation to monitor compliance and regulatory requirements in real time, alerting regulatory professionals to issues and providing strategic recommendations;
• predictive analytics that identify data patterns to help regulatory professionals make informed decisions and data visualization tools that present complex data in understandable formats; and
• a continually evolving regulatory landscape to which developers and providers must adapt.

Where Can I Learn More?

In a recent panel discussion on lifecycle management and regulatory strategy, IQVIA Leaders, Marcela Miño, Senior Director and Global Head of Lifecycle Management; Rama Mohan Rao Chikkam, Senior Director of Global Regulatory Operations and APAC RA; Keith McDonald, Head of Drug Development Strategy; and David Cameron, Senior Director and Global Group Head, Novel Trial Design Solutions, discussed emerging trends in lifecycle management, labeling, and publishing, and how drug developers are adapting their regulatory strategies to accommodate them. To learn more, download the full white paper, The Future of Regulatory Operations.