Kay Larholt, ScD
Director of Integrated Knowledge Solutions
As Director of Integrated Knowledge Solutions, Dr Larholt is responsible for the development of programs that fulfill the mission and vision of NEWDIGS in the area of Knowledge Generation and Use 2.0, including the Data Project, Efficacy-to-Effectiveness Strategies and Study Designs, and the emerging PIPELINES project. She designs and implements the Adaptive Biomedical Innovation (ABI) Scenario Design Labs (SDL); drives the vision and strategic direction of the Knowledge Management Repository Team to achieve maximum impact; and runs the Data Project.
Dr. Larholt is a seasoned statistical professional with over 25 years of experience in the Pharmaceutical, Biotechnology, and Medical Device industry. She has global experience with all phases of clinical trials and regulatory submissions. An experienced statistical collaborator providing strategic input to clinical program design and analysis, she has supervised large groups of statisticians, statistical programmers, data managers and medical writers.
In addition to her experience with the approval process for therapeutics and devices, Dr. Larholt has applied her expertise to the post-approval setting, in particular studying the effectiveness of products and their value to patients and medical providers in the real world.
Dr. Larholt has extensive experience in the design, implementation and analysis of prospective observational studies and Pragmatic Clinical Trials including integrating administrative claims data with clinical data to answer real-world research questions.
Dr. Larholt was the key presenter in a recent webinar for ISPOR entitled, “How to be Pragmatic about Pragmatic Trials: Trends, Trials and Timely Tips”.