DIA Annual Meeting 2025

Session Chair: Steve Sibley​

Panelists: Natalie Tolli (Abbvie), Namandje Bumpus (former FDA), TBD (EMA)​

The ICH improved global drug development, but rising country-specific   regulations increase complexity and costs for multinational submissions. This session explores key harmonization challenges, regulatory trends, and strategies to navigate diverse requirements for successful drug approvals. Effective communication between sponsors and regulatory agencies is critical for the successful development and approval of new medicines. This forum will explore the similarities and differences in how major global regulators—such as the U.S. Food and Drug Administration (FDA), China’s National Medical Products Administration (NMPA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and the European Medicines Agency (EMA)—engage with sponsors throughout the drug development lifecycle. We will delve into the formal channels and informal practices each regulatory body uses to guide sponsors, address compliance issues, and expedite approvals. Key similarities, such as scientific advice meetings, regulatory guidance documents, and the use of conditional approval pathways, will be examined. At the same time, critical differences, including cultural approaches to engagement, the role of pre-submission meetings, and divergent regulatory timelines, will be highlighted. Through a comparative lens, this forum will also address how recent trends, such as digital transformation, the COVID-19 pandemic, and emerging policies on patient-centric drug development are shaping interactions with regulators worldwide. The session will provide attendees with practical insights into navigating global regulatory landscapes, fostering better communication with agencies, and optimizing regulatory strategies for successful drug approvals across diverse markets.

Presenters: Nick Brown and David Meats​

Generative AI adoption within the regulatory writing field has made tremendous progress over the last year. However, to maximize ROI, teams need to identify ways to expand automation beyond traditional benchmarks and clinical study report (CSR) applications. In this session Certara will share practical approaches for leveraging generative AI across the submission dossier from pre-clinical module 3 documents to PK study reports to PBRERs and more.

Location: Innovation Theater #2 – PM Break​

Session Chair: David Meats​

Speakers: Louise Lind Skov, PhD, Eishita Agarwal, MSc

Artificial Intelligence (AI) and Structured Content Authoring (SCA) tools are here. The challenge of seamlessly integrating these technologies into compliant and efficient workflows is reshaping the regulatory document development process. This session will delve into the balance and interdependence of four pillars (technology, process, people, and organization) to drive the business value of these tools. The interplay of these elements stokes an environment of thriving innovation, leading to enhanced efficiency, quality, and value proposition for the underlying business. AI/SCA have been thoroughly discussed in the regulatory writing process. Now there is focus on evolving technologies, the challenge lies in integrating these advancements into our workflows and processes, or implementing change management processes to allow for their use. Utilizing these tools coupled with organizational and process driven acceleration levers will condense the time to document approval and decrease the number of resources need to produce these documents. Moreover, the concerted and collaborative efforts across various functions, ranging from clinical sciences to biostatistics programming to review and approval pathways, ensures a thorough and compliant documentation process. It is time to focus and clearly define, emphasize, and promote the importance of the human element in the utilization of these tools, the people and the processes, at the heart of transformative authoring. Attendees will gain insights into the strategic integration of the four pillars in medical writing, drawing real-world use cases of these technologies in industry. These strategies, while transformative, do not necessitate a radical shift when applied independently. Instead, their true power lies in their harmonious application, which collectively refines traditional authoring paradigms.