“INFORMED CONSENT FORM ANALYSIS WITH GENERATIVE AI: ENHANCING EFFICIENCY IN DRUG DEVELOPMENT AND DATA RE-USE”
by Andrew Borgman, Associate Director, Decision & Quality Analytics at Biogen, Grand Rapids, MI

The pharmaceutical industry faces challenges in reusing samples, data, and images for secondary research. Complex guidelines governing data re-use are often buried in Informed Consent Forms (ICFs) that are manually reviewed by subject matter experts (SMEs) on a case-by-case basis. This process is time-consuming and hampers efficiency. We developed a novel Artificial Intelligence (AI)-driven workflow leveraging Large Language Models (LLMs) for computer-assisted analysis of ICFs. This cutting-edge method substantially simplifies our process by using generative AI to summarize and identify allowable data usage promptly and precisely. This adaptable framework is applicable to any company requiring comprehension and analysis of ICFs or data use agreements. Through a domain-specific validation framework, combining manual SME review and quantitative measurements, we achieved 96% accuracy in Biogen study ICFs tested to date. The paper delves into the current workflow design, associated cost estimation, a multi-layered strategy to address potential hallucinations in LLMs, considerations for safeguarding data privacy within a secure computing environment, the design and development of an interactive chatbot powered by LLMs, and other pertinent technical details. Our overarching goal is to enhance data reusability by improving the efficiency of ICF document analysis and expediting the dissemination of therapeutic insights to the patient community.
 
BIO: Andrew Borgman is a seasoned data scientist with a passion for developing innovative solutions and a knack for transforming complex datasets into actionable insights. He currently serves as Associate Director, Decision & Quality Analytics at Biogen, where he helps the organization make better decisions leveraging data and analytics.  Andrew's career has taken him from academia to industry, where he has consistently demonstrated his ability to bridge the gap between theoretical knowledge and practical application. His experience spans a wide range of industries, including healthcare, pharmaceuticals, and biotechnology. Prior to joining Biogen, Andrew held key roles at Bristol Myers Squibb, Corewell Health, and the Van Andel Research Institute, where he honed his skills in data visualization, machine learning, and software development. He has a proven track record of success in building and leading high-performing teams, developing and deploying enterprise-level software solutions, and driving innovation through data-driven decision making. Andrew's expertise extends beyond the technical realm. He is also an accomplished communicator and mentor, with a passion for sharing his knowledge and empowering others to reach their full potential.