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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 9 Track 3: Taking Advantage of Generative AI to Optimize Regulatory & Medical Writing – Uses, Benefits and Risk Management

Session Chair(s)

Kristen  Sauter, MBA

Kristen Sauter, MBA

Senior Director, Head, Global RIM, Analytics & Digital Innovation

Takeda Pharmaceuticals, United States

With the advent of ChatGPT and other large language model (LLM) solutions, regulatory, medical writing and other R&D organizations have been exploring how LLMs can be used to save time and resources, improve speed to market, and enhance regulatory compliance. In this session, we will share the work that sponsors and other companies are doing to take advantage of LLM technology, the approaches they are taking, and where they are having successes or dealing with challenges. We will discuss the kinds of regulatory problems or use cases that these solutions can potentially solve as well as inherent functionality gaps and risks to avoid when using LLM tools. For example, LLMs can have challenges providing references for summary text and can even “make up” information to fill a gap (aka, hallucination). Given the popularity of LLMs and widespread adoption by the public, we will also talk about how to govern the use of such technologies, especially to support regulated business processes. Lastly, we will address how LLMs change our ways of working, the potential new roles these automations will introduce, and skill sets we may need to add to our Regulatory teams. This session includes case studies, experiments and information gathered from sponsor firms, the DIA RIM Intelligent Automation Team, consultancies and software vendors.

Speakers share what they are doing with generative AI to enable efficiencies across regulatory and medical writing, approaches for managing the risk of such tools and governing their application, and how LLMs change how we work.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Provide an overview of Generative AI
  • Identify how sponsor companies are exploring the use of Generative AI in Regulatory and Medical Writing and how that may change ways of working
  • Discuss approaches for governing Generative AI technologies and managing risks and limitations


Cary  Smithson, MBA

Taking Advantage of Generative AI

Cary Smithson, MBA

Leapahead Solutions, Inc., United States

Managing Partner

Bikalpa Bikash Neupane, PhD


Bikalpa Bikash Neupane, PhD

Takeda, United States

Head of AI and NLP

Ari  Caroline, MA, MBA

Can we Teach Language Models to Learn Facts?

Ari Caroline, MA, MBA

Weave, United States

CEO and Co-Founder

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