The following is an excerpt from a white paper published by DIA
A McKinsey Report suggests that Generative AI could unlock potential value of about 2.6 percent to 4.5 percent of annual revenues ($60 billion to $110 billion) annually on the pharmaceutical and medical product industry.
Large Language Models (LLMs) are the foundation behind Generative AI and have become the topic of the year in 2023. With the increasing popularity of ChatGPT and the explosive use of Generative AI, we set out to explore the use of LLMs for some regulatory use cases within healthcare and life sciences.
In this article, we look into the application of LLM to gather regulatory intelligence information from global regulations issued by multiple health authorities.
Regulatory strategists within regulatory affairs and submission managers with Regulatory Operations are always interested in keeping abreast of regulatory guidelines and changes that happen across the world in order to prepare for regulatory and submission strategies. These professionals look up health authority websites or scan publications or look into subscriptions such as Cortellis. Significant time and effort are spent in scanning these sources and summarizing regulatory guidelines, changes, etc., to define regulatory pathways and strategies and prepare submissions in compliance with health authority regulations. The intent of our initiative was to look into potential improvements in productivity around the search and retrieval of regulatory guidelines in order to speed up the filing and submission processes.
Quest for Answers
Following are some examples of the type of information these professionals are typically looking for:
- “What is the FDA’s position on AI in drug manufacturing?”
- “What are the requirements for registering a new drug application in Singapore?”
- “List FDA’s criteria for clinical trial protocol design to encourage diversity in clinical trials.”
- “Create a detailed checklist for licensing healthcare facilities in Bahrain.”
- “What are the new drug application requirements for a biologic in China?”
As part of our efforts to evaluate the application of LLM to regulatory use cases, we decided to apply LLMs to the extraction of regulatory intelligence either as summaries or Q&A responses from regulatory guidelines and other sources through a ChatGPT-like interface.
