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The medical and regulatory writing landscape is being fundamentally redefined by AI, and the DIA Webinar 2025, titled "How Leading Global Pharma Embraces AI to Automate Regulatory and Medical Documents with Quality Control," provided a critical roadmap for navigating this change. Held online on November 12, 2025, the session offered a rare, high-value opportunity for the industry to hear directly from regulatory authorities, top global pharma leaders, and technology solution providers.

AlphaLife Sciences was proud to participate as the solution enabler, showcasing how our flagship AuroraPrime platform is tackling the complex, time-sensitive nature of regulatory documentation, which often creates a bottleneck in bringing therapies to patients. Our mission is focused on delivering AI-Driven Medical Writing Acceleration and AI-Powered Regulatory Document Automation to accelerate submissions, ensure compliance, and deliver measurable outcomes. The discussions confirmed that the future lies not just in faster writing, but in achieving true enterprise-grade quality control at scale.

Sharon Chen’s Vision: Agents That Understand Rules

AlphaLife Sciences Founder and CEO, Sharon Chen, presented the core philosophy and functionality of the AuroraPrime RMA platform, which is built on a strategy that places the user experience at the center. She highlighted the urgent need to reinvent manual processes in pharma, particularly given the enormous value unlocked by accelerating document authoring timelines.

Sharon showcased that the AuroraPrime solution works directly within the familiar Microsoft Word environment as an add-in, integrating seamlessly with RIM systems like Veeva for version management. It is built to scale across the full spectrum of required documents, including Protocols, CSRs, DSUR/PBRERs, and CTD Module 2.7.x.

A core message was that speed must be intrinsically linked to compliance. Sharon emphasized that every output generated by the AI agent is linked back to the source data, establishing a critical lineage for transparency and auditability. This approach is what allows organizations to confidently achieve measurable impact: clients are seeing a 30% to 50% cycle time reduction in CSR authoring, translating to potential revenue acceleration of $1.2 billion for a top ten blockbuster drug.

She demonstrated how the platform utilizes GenAI in three strategic ways: content reuse (leveraging structured logic from past documents), lean writing (extracting structure and writing logic), and complex referencing (for critical sections like statistical models). This ensures the content is not only generated quickly but is also grounded in validated, domain-specific knowledge.

The Panel Discussion: Trust, Transformation, and Quality

The subsequent panel discussion, moderated by Eunice Youhanna, Industry Advisor for Health & Life Sciences at Microsoft, offered perspectives from across the industry value chain. Ms. Youhanna set the stage by stressing that AI is emerging as the catalyst for higher revenue and faster business outcomes, noting that medical writing has consistently been the number one use case across pharma.

The Regulatory Imperative: Quality Over Speed

Providing the crucial regulatory perspective was John Jenkins, Former Director of the Office of New Drugs at the FDA. Dr. Jenkins acknowledged the exciting potential of AI in drug development, noting that the FDA is exploring its use internally. However, he emphasized that while the FDA does not directly regulate the internal medical writing process, its major interest remains maintaining and improving the quality and accuracy of regulatory submissions. Dr. Jenkins stressed that human oversight is critical; while AI can assist with initial drafts, summaries, and formatting, humans must remain directly involved to ensure consistency. He anticipates that the FDA’s feedback on AI use will initially occur at the individual reviewer level, focusing on quality problems and inconsistencies.

The Business Strategy: Augmentation, Not Automation

Darren Weston, Head of Integrated Data Analytics & Reporting at Johnson & Johnson, shared his organization’s motivation for exploring AI. He noted that the growing complexity and volume of regulatory documentation required a strategic approach to augment medical writing. Mr. Weston identified that successful AI adoption is fundamentally a people and process transformation. He emphasized that J&J started with high-volume, low-risk use cases, such as AI-assisted Clinical Study Reports, to build internal trust and validation. Crucially, he framed the AI strategy as augmentation, not automation, stressing that the goal is to free up expert time for higher-order strategic thinking, not to replace expert judgment.

Elevating the Writer’s Role

Neil Garrett, Head of Regulatory Medical Writing at Johnson & Johnson, elaborated on the impact of this shift, stating that success metrics must look beyond simple efficiency gains to measure the overall impact on R&D development. He observed that AI’s ability to handle highly curated, controlled data makes the medical writing use case unique and highly suitable for GenAI. Mr. Garrett confirmed that AI elevates the medical writer’s role, allowing them to focus on strategic input and interpretation, rather than repetitive, non-value-added tasks. He also shared that vendor selection required prioritizing close collaboration and flexibility, recognizing that a solution must be an evolution that adapts to a company's unique system architecture.

The Path Forward: Orchestration

Looking ahead, the panelists agreed that AI’s evolution will move from being a single point solution to becoming the "connective tissue" across the entire regulatory and clinical content ecosystem. Mr. Weston suggested the shift will be from automation to orchestration, where AI ensures content contracts, manages changes, and enables reuse across different submissions and geographies. Sharon Chen concurred, noting that the focus must move to building the relation topology of information across all related document types to ensure consistency and quality.

We extend our sincere gratitude to Dr. John Jenkins, Darren Weston, Neil Garrett, and Eunice Youhanna for sharing their insightful perspectives and candidly addressing the complexities of AI adoption in this highly regulated space.

Accelerate Your Journey with AuroraPrime

The DIA Webinar 2025 provided clear direction: compliant, scalable AI is here, and it is mandatory for competitive advantage. The future of regulatory writing is collaborative, traceable, and strategically driven by agentic AI that empowers human experts.

If you missed this powerful discussion on maximizing quality and efficiency in regulatory and medical authoring, the recording is now available.

Download the webinar recording and presentation slides here: https://connect.diaglobal.org/alphalife-sciences-webinar-registration?hs_preview=zpJjzaht-281558991048

To learn more about how AuroraPrime can accelerate your R&D pipeline and streamline your regulatory process, please explore our solutions.