2016 ISoP Leadership Award Winner
Dr. Sandra (Sandy) Allerheiligen’s career has spanned more than two decades helping develop new medications and the field of Pharmacometrics. Through her tenure at the University of Texas, Lilly, and Merck, Dr. Allerheiligen’ s research has focused on population pharmacokinetic/ pharmacodynamic (PK/PD) modeling and trial simulation and their application to nonclinical and clinical drug development. More recently, her work expanded to establishing quantitative and systems pharmacology (QSP). Her research has centered on leveraging quantitative tools to inform critical internal and regulatory decisions. She has further expanded her efforts to integrate pharmacometric and economic models to answer questions for payers and health authorities. Over the last several years, Dr. Allerheiligen has helped extended model qualification, visualization tools, with a dream that the models are ultimately available at the patient bedside. She has been a significant contributor to more than 20 INDs, many development programs, as well as the dozens of global submissions for new drugs.
Sandy has served as an advisor on population PK/PD techniques for scientists in both academia and industry. In order to further collaboration between scientists, she co-founded two associations: the AAPS Focus Group on Population Pharmacokinetic/ Pharmacodynamic Modeling, and the Midwest User's Forum for Population Approaches in Data Analyses Pharmacokinetics/ Pharmacodynamic Methodologies. She has helped organize numerous symposia and FDA and NIH Workshops. She co-led the NIH workshop on Quantitative and Systems Pharmacology White Paper which enabled the expansion of the field of Pharmacometrics and QSP departments in industry and academia.
Dr. Allerheiligen is a frequent speaker on QSP at US and international meetings and with global regulatory workshops. She has been a member of the editorial advisory boards for The AAPS Journal, Journal of Pharmaceutical Sciences, and Pharmaceutical Research and participates in a number of University Scientific Advisory Boards and is active member of the Burroughs’s Welcome Institute of Regulatory Sciences Board.
By integrating quantitative approaches, Dr. Allerheiligen was influential in leading strategic change in Lilly’s approach to quantitative pharmacology in nonclinical and clinical drug development. At Lilly, she established an internationally known PK/PD group leveraging pharmacometric approaches to drive model informed drug discovery and development (MIDD). She taught internal and external courses and provided extensive mentoring for many scientists inside and outside the company. Over the last six years, she developed a new department, Modeling and Simulation at Merck and her new team fully established MIDD. The team impacted numerous decisions and in her publications has shown the value of these important approaches. More recently, she accepted a new role as Vice President of Data Sciences (real-world data) and Predictive and Economic modeling at Merck. She has been challenged to build a new department that leverages pharmacometric and economic modeling techniques to enable right drug for the right patient. Throughout her career, Sandy has been passionate about developing the science of model informed drug discovery and development to provide new medicines to patients and mentoring scientists inside and outside the company.