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The EMWA Virtual Conference 2025, celebrating its special 60th gathering from November 14th to 29th, delivered two weeks of expert-led discussion focused on the critical challenges and innovative solutions shaping medical writing today. AlphaLife Sciences was proud to contribute to this essential conversation, showcasing how our AI-powered regulatory and medical authoring platform, AuroraPrime RMA, is accelerating document cycles and enhancing efficiency across the life sciences industry.

Our participation was centered on the need for AI solutions that not only increase speed but also maintain the non-negotiable standards of regulatory integrity and compliance. As Eric Henze, Senior Health Industry Digital Strategist at Microsoft, noted during the session, getting a blockbuster drug to market just one month faster can result in over $400 million in revenue impact—underscoring the competitive advantage gained by inserting AI efficiencies across the entire drug concept-to-market lifecycle.

The Fireside Chat: AI, Authority, and the Human Editor

The presentation, "How Leading Global Pharma Embraces AI to Automate Regulatory and Medical Documents with Quality Control," featured a dynamic fireside chat hosted by Eric Henze, kicking off the session with the landscape of generative AI and its impact on medical writing.

Ellis F. Unger, MD, Principal Drug Regulatory Expert at Hyman, Phelps & McNamara, P.C., and former director of several FDA offices, provided a vital real-world perspective on AI adoption. Dr. Unger stated that the ceiling is the limit for AI, expressing excitement about its potential. He emphasized the critical role of documentation quality, observing that regulatory authorities often judge a company by the quality of its documents, and poor documents can create a negative opinion of the company.

Dr. Unger saw AI’s greatest strength in handling the "grunt work"—specifically, summarizing information and reporting facts—making it perfect for generating documents like clinical study reports. However, he stressed that the AI must be supervised by a human. He advised that a thoughtful human must interact with and edit the document, ensuring that the review goes beyond simple grammar to check for sophisticated errors, such as tables using too many significant figures relative to the precision.

The consensus was clear: AI should not handle interpretation. Dr. Unger argued that complex intellectual activities, such as interpreting data for safety documents or writing thoughtful summaries of important risks for the DSUR, require human judgment, thought, and integration. While AI is excellent for the first draft, he suggested that the ideal workflow involves AI generating the first draft, a thoughtful human working on it, and then the document returning to the AI solely to polish the language and formatting without changing the meaning.

Mr. Henze reinforced this perspective, noting that AI is not a magic bullet but rather a tool that allows content writers to work at the top of their license, focusing on stretch goals like interpretation and narrative development, rather than repetitive work.

Sharon Chen: Showcasing Enterprise-Ready Automation

Following the fireside chat, AlphaLife Sciences Founder and CEO, Sharon Chen, presented a demo of AuroraPrime RMA, our generative AI product suite. Sharon noted that many solutions have been well-adopted by pharmaceutical companies, but emphasized that the journey is just starting.

The demo focused on providing domain-specific content authoring and quality control (QC) tools that integrate seamlessly with existing industry ecosystems, specifically the Microsoft Office environment (through a Word add-in) and RIM systems like Veeva, for document version management and review.

Measurable Value and Key Use Cases

Sharon highlighted that AuroraPrime is designed to automate complex, high-value regulatory documents, including Clinical Study Reports (CSRs), Protocols, CTD Clinical Summaries (2.7.x), and safety reports (DSUR/PBRERs).

Tangible Results: Early client rollouts confirmed that AuroraPrime delivers real-world value, translating to significant timeline cuts. Sharon reported client confirmation of a 30% to 50% reduction in the life cycle cut of CSR writing. This efficiency gain allows medical writers to be freed up from repetitive groundwork and focus their expertise on strategic thinking, decision-making, and final review.

End-to-End Automation Capabilities Showcased:

• CSRs: The platform generates an initial draft using an AI-instructed template, automatically retrieving TFLs (tables, figures, listings) from source data, and intelligently generating corresponding in-text summaries. The solution supports continuous iteration and includes built-in automated QC checking using customized verification rules.

• Protocols and Amendments: The system supports smart ideation, compliant drafting, and accelerated approvals for amendments. The platform automates the creation of key sections by referring to centralized reference pools and auto-generating detailed content, ensuring that all references are automatically cited and highlighted, with full traceability back to the original source.

• Clinical Summaries (2.7.x): For these complex documents that aggregate data across multiple pivotal studies, AuroraPrime extracts information across multiple sources, recommending table alignment, and allowing users to consolidate data from different studies into a single, organized view while preserving data consistency.

• Safety Documents (DSUR/PBRERs): The solution addresses the challenge of periodical updates and dynamic cross-referencing between the two documents. AuroraPrime supports dual-track updates, automatically detecting amendments within a specific time range and highlighting changes for review, ensuring both reports remain aligned and synchronized.

Partnering for the Future of Medical Writing

The session concluded by reinforcing AlphaLife Sciences’ position as a production-ready solution provider. Our dedication to traceability and compliance means that content generated by AuroraPrime is traceable back to the data sources for regulators and auditors. By providing this AI-Driven Medical Writing Acceleration and AI-Powered Regulatory Document Automation, AlphaLife Sciences empowers organizations to confidently accelerate their R&D pipelines.

We extend our sincere thanks to Eric Henze for hosting and to Dr. Ellis F. Unger for sharing his provocative and insightful real-world perspectives on AI in the regulatory domain.

We invite you to explore how AuroraPrime is setting new benchmarks in efficiency, compliance, and innovation.

To learn more about AuroraPrime’s leading solutions or schedule a personalized consultation with our team, please visit our event page: https://alphalifesci.com/events/emwa-virtual-conference-2025.