CAMBRIDGE, MASSACHUSETTS—The MIT New Drug Development Paradigms Initiative (NEWDIGS) announced today the hire of Dr. Kay M. Larholt as their Director of Integrated Knowledge Solutions. Dr. Larholt will lead a portfolio of activities focused on “Knowledge Generation and Use 2.0,” a critical component of Adaptive Biomedical Innovation.
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.
“We’re thrilled to welcome Dr. Larholt to the team,” said Dr Gigi Hirsch, Executive Director of NEWDIGS and the MIT Center for Biomedical Innovation. “She has an unusually wide scope of expertise that makes her particularly well-qualified for the role.”
Dr. Larholt has experience with the approval process for therapeutics and devices, and 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. In addition, she 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.
As Director of Integrated Knowledge Solutions at MIT NEWDIGS, Dr. Larholt will expand the use of growing health-related data pools and analytic methods, improving decision-making to accelerate safe delivery of new treatments to the patients who need them.
“I’m delighted to bring my experience and ideas to MIT NEWDIGS,” said Dr. Larholt. “The time has come for bold new thinking about how therapeutics are developed, studied, and delivered to patients, in a way that integrates efficacy and effectiveness while ensuring safety. I look forward to helping NEWDIGS advance this cause.”
The hire comes as NEWDIGS expands its capabilities for better decision making through improved knowledge management and analysis. Dr. Hirsch remarked, “Dr. Larholt’s expertise and talents will help our member community develop powerful new practices and tools for strategic decision making.”
About MIT NEWDIGS
MIT NEW Drug Development ParadIGmS (NEWDIGS) is an international “think and do tank” dedicated to helping biomedical innovation benefit all healthcare stakeholders faster and reliably. NEWDIGS designs, evaluates, and initiates advancements that are too complex and cross-cutting to be addressed by a single organization or market sector. Its members include global leaders in research, development, insurance, regulation, and patient advocacy. For more information, visit http://newdigs.mit.edu.