St Augustine, Florida, United States
As a highly accomplished Clinical Pharmacology Professional, I bring over 10 years of experience in healthcare, including over 7 years in drug development and 2.5 years in pharmacy practice. My background in NASA Human Research Program has provided me with unique exposure to spaceflight pharmacology. I excel in overseeing all stages of drug development as well as creating and executing clinical pharmacology strategies that improved success rates, accelerated regulatory submissions, and ensured optimal dosing across various therapeutic areas. My expertise includes model-informed drug development (MIDD), modeling and simulation (M&S), exposure-response analysis, dose optimization, and first-in-human dose selection. By applying analytical skills, scientific rigor, and collaborative approaches, I have succeeded in advancing clinical programs, enhancing regulatory outcomes, and promptly solving problems to deliver impactful results. Whether working on early- or late-stage clinical development, I integrate quantitative modeling strategies that accelerate drug development timelines and improve decision-making. In addition to my technical expertise, I am an articulate communicator and a natural leader, able to work effectively with diverse teams of professionals, researchers, and industry experts to address complex challenges. My commitment to collaboration and scientific excellence has been highlighted through my contributions to high-impact publications, including co-authoring a manuscript that was recognized as one of the top 10 most-cited papers in CPT: Pharmacometrics & Systems Pharmacology in 2023. Fluent in both English and German, I strive to foster global connections in the ever-evolving landscape of drug development.
➤ Cardiometabolic and Ophthalmic Diseases
➤ Led clinical pharmacology, modeling and simulation, and immunogenicity analyses and strategies for Tividenofusp alfa, a brain-penetrant enzyme replacement therapy for the rare pediatric disease Hunter Syndrome, including support for pivotal Phase 2/3 trial and BLA submission for accelerated approval. ➤ Author and reviewer of key BLA documents for Tividenofusp alfa, including the Summary of Clinical Pharmacology (2.7.2), Integrated Summary of Immunogenicity (ISI), pre-BLA briefing book, and clinical study reports (CSR); participated in regulatory interactions, including Type C meetings with the FDA, to support clinical pharmacology analysis for submission. ➤ Utilized MIDD approaches including population PK modeling, population PK/PD modeling, and exposure-response analyses to support accelerated approval submission. ➤ Member of cross-functional teams, including the filing team, to align with internal stakeholders on analyses and strategies to ensure regulatory success. ➤ Drafted and reviewed clinical study protocols, amendments and reports.
➤ Co-drafted the PK Written Summary (Section 2.6.4) and generated the first-in-human dose selection report for an investigational new drug (IND) application and successfully defended the clinical pharmacology strategy and addressed inquiries from regulatory agencies. ➤ Served as the Clinical Pharmacology Lead for nine early-stage clinical development programs targeting solid and liquid tumors, spanning across diverse therapeutic modalities including bispecific T-cell engagers, monoclonal antibodies, TCRTs, and small molecules. ➤ Applied M&S techniques including hands-on PK/PD, population PK, and exposure-response analysis to refine dosing regimens, inform first-in-human dose selection, predict human exposures and mitigate clinical risks. ➤ Communicated with a multidisciplinary team to shape clinical development strategies and support asset life cycle management. ➤ Contributed to the late and post-marketing stages of the program for IMLYGIC® and VECTIBIX® by providing valuable clinical pharmacology insights and expertise.
see above (Clinical Pharmacologist, Senior Scientist at Amgen)
➤ Conducted modeling and simulation of pharmacokinetic and pharmacodynamic responses to medications used during spaceflight using NONMEM and R.
➤Demonstrated that covariate effects assessed using aggregate patient data can introduce bias compared to covariate effects identified based on individual patient data in model-based meta-analysis (MBMA). ➤Carried out hands-on MBMA for DPP-4 inhibitors in Diabetes Mellitus using R, that resulted in earning recognition with the Presidential Trainee Award at the ASCPT 2016 Annual Meeting.