Stacey Tannenbaum, PhD, FISoP is a scientist and leader in Model Informed Drug Development, serving as a consultant to the MIDD community to help individuals, teams, and organizations become even more impactful through the development of communication and professional skills. She is a sought after public speaker, with 80+ conference presentations, training lectures, webinars, and podcasts. She has demonstrated expertise in coaching and training on impactful scientific presentation development and execution. She has also supported scientists in attainment of critical strengths such as negotiation, conflict resolution, change management, process improvement, and relationship building.
Stacey has worked at Metrum Research Group as VP of Scientific Engagement, following 20 years of Pharmacometrics experience in industry from Novartis and Astellas, where she led the US Pharmacometrics group. Stacey earned a BSE in Biomedical Engineering (Duke University), a PhD in Pharmaceutical Sciences and Applied Mathematics (University of Arizona), and a post-doctoral fellowship at the Center for Drug Development Science (Georgetown University). During her 25+ years as a PKPD scientist in Pharma and consulting, she contributed to multiple drug development programs and successful submissions, optimizing dosing for future trials and labels, predicting efficacy and safety with confidence, designing smarter studies and identification of key covariates, and bridging across populations (animals to humans, healthy subjects to patients, adults to children). At Novartis, Stacey supported the successful registration and approval of canakinumab (Ilaris) for CAPS, the extension of omalizumab (Xolair) for IgE-mediated allergic asthma to pediatric patients and the expansion of the dosing table to patients with higher body weights and IgE levels to satisfy an unmet medical need, and the optimization of dosing of daptomycin (Cubicin) in patients with Staphylococcus aureus bacteraemia and severe renal impairment. At Astellas, she contributed to the successful extension of both solifenacin (Vesicare) and mirabegron (Myrbetric) to pediatric patients with neurogenic detrusor overactivity, and to the approval of the combination of these compounds in adult patients with overactive bladder. She also supported the registration of roxadustat for anemia in patients with chronic kidney disease, which has been approved by the EMA, and the development of an approved MIDD-based extrapolation approach for pediatric CKD.
Stacey has had significant impact on the global Pharmacometrics community. She co-founded the International Society of Pharmacometrics (ISoP), serving as its first President and is an ISoP Fellow, and co-founded the American Conference on Pharmacometrics (ACoP). Stacey was conference chair for the first three events and remains an active volunteer in both ISoP and ACoP. She is the Executive Committee chair for the World Conference on Pharmacometrics (WCoP), and the chair of the Quantitative Pharmacology Network at the American Society of Clinical Pharmacology and Therapeutics (ASCPT). She served as a board member of the American Association of Pharmaceutical Scientists (AAPS), chaired the AAPS M&S Focus Group, and was the co-chair for the AAPS Forum for Connecting Predictive Modelers. Stacey also co-founded the networking group Modeling and Simulation Applications in Clinical Pharmacotherapy (MoSAiC), now ISoP NJ/NY/PA.