Session Description
Description: Alzheimer's disease (AD), a progressive neurodegenerative disease leading to dementia, imposes a substantial burden on patients, caregivers, and the healthcare system. Among the major diseases, AD is also one of the least well understood. Due in part to the long pre-symptomatic phase of the disease, the causal relationships between key pathological features (amyloid plaques, tau tangles, inflammation, and neurodegeneration) are poorly understood, as is the relationship of these features with cognitive and functional decline. As a result, the history of AD research is littered with failed development programs. With the emergence of novel biomarkers (plasma, CSF, brain imaging PET markers) and associated models, clinical trials were able to better target efficacious doses, leading to the approval of anti-amyloid monoclonals that have demonstrated slowing of disease progression. Diverse pharmacometrics approaches (pharmacologic, empiric and mechanistic disease models) were critical to address Right Dose, Right Patient, Right Study, Right Time, Right Approach questions. In the future, emerging data will provide deeper insight into disease processes and their impact on cognition, leading to even more efficacious treatments.
The role of pharmacometrics in the fight against AD is a compelling example of "Past as Prologue, Bridges to New Horizons". In this session, we introduce the historic role of pharmacometrics in designing and interpreting the clinical trials leading to the recent approvals. We show how pharmacometrics is well positioned to leverage the emerging data to enhance our understanding of the disease state and help optimize therapeutic strategies with the goal of eliminating AD.
Conference Date
November 10-13, 2024
Conference Location
Phoenix, Arizona, USA
DOI
10.70534/PTDQ3311
Julie Stone, PhD
Scientific Assoc. VP
Merck & Co., Inc.
Julie A. Stone, Ph.D., is a Scientific Associate Vice President in Quantitative Pharmacology and Pharmacometrics at Merck & Co., Inc. Julie joined Merck in 1995 following graduate studies in biomedical engineering at the University of Pennsylvania and postdoctoral research in pharmacokinetic modeling at Hoffmann-La Roche. At Merck, she has provided pharmacology and pharmacometrics support for a variety of programs, including 13 approved drugs. As a senior scientist on the research ladder, she divides time between individual scientific contributions in areas including Alzheimers Disease, osteoporosis, and antivirals with setting and overseeing wider scientific strategy of quantitative pharmacology and pharmacometrics application in drug development. In this role, she works to bring the power that the sophisticated quantitative tools of modeling offer together with effective, impact focused communication to enable better informed decisions and regulatory interactions.
Youfang Cao, PhD
Director of Pharmacometrics
Eisai, Inc
Dr. Youfang Cao is a Director of Pharmacometrics in Translational Sciences of Eisai US. Within this capacity, he leverages his expertise in Quantitative Systems Pharmacology (QSP) modeling, Pharmacokinetics/Pharmacodynamics (PK/PD), and Artificial Intelligence/Machine Learning (AI/ML) to contrite to end-to-end drug development processes. He leads and delivers innovative and robust solutions for clinical trial design, dose selection, and regulatory submissions. With over a decade of experience, Dr. Cao has specialized in developing and utilizing mechanistic models to drive drug discovery and development across both early and late stages, spanning diverse therapeutic areas such as neurology, infectious diseases, and oncology.
Prior to his tenure at Eisai US, which commenced in 2022, Dr. Cao was employed at Merck Sharp & Dohme (MSD), where he led the overarching QSP initiatives supporting the infectious disease portfolio, including the development of drugs for COVID-19 and HIV. He also led the AI/ML strategy supporting Quantitative Pharmacology and Pharmacometrics. Preceding his role at MSD, Dr. Cao served as a Postdoctoral Researcher at Los Alamos National Laboratory (LANL) and a Research Assistant Professor at the University of Illinois at Chicago (UIC).
Dr. Cao has an interdisciplinary academic training with Bachelor of Science in Mathematics and PhD in Biomedical Engineering with a focus on computational and mathematical modeling of complex biological and pathophysiological systems. He extensive experience in Model-Informed Drug Development (MIDD) is exemplified through over 50 co-authored research publications in peer-reviewed journals. Dr. Cao has been invited to give oral presentations in multiple academic and industry conferences.
Brian Willis, PhD
Head of Pharmacometrics
Biogen
Brian A. Willis, PhD, is Head of Pharmacometics at Biogen. He graduated from the University of Minnesota College of Pharmacy in 2007, with a PhD in Pharmaceutics. He joined Eli Lilly and Company in the same year as part of the Global PK/PD department. At Lilly, Dr. Willis focused on Lilly's neuroscience portfolio, working in alcohol use disorder and Parkinson's disease, but his major therapeutic area was Alzheimer's disease. He was appointed head of the Pharmacometrics group in 2018, and led the QSP group starting in 2020. He joined Eisai as Head of Pharmacometrics for the Neurology Business Group in 2022, leading modeling and simulation efforts for LEQEMBI. He started at Biogen in August, 2024.
Ivelina Gueorguieva, PhD
Sr Director, Global PK/PD and Pharmacometrics
Eli Lilly and Company
Iva Gueorguieva is a Senior Director and Team Leader in Global PK/PD and Pharmacometrics at Eli Lilly and Co. She completed her PhD, followed by a 3 year post-doctoral fellowship at University of Manchester, UK. Iva then joined Eli Lilly and is an experienced R&D leader with track record for people and project leadership.
Iva leads projects from discovery to submission to regulatory agencies with an extensive experience of innovative translational (PBPK) and pharmacometrics (population PK/PD) strategies. She had experience of FDA and EMEA regulatory interactions for oncology (solid tumour and haematology) and neurodegenerative diseases indications. Iva is proficient at managing board/governance committees, complex multinational and interdisciplinary teams, consultants, contractors and CROs. Her therapeutic expertise is in the files of oncology, including heme and immuno-oncology, Alzheimer’s disease, neuroscience and pain. Iva has a proven scientific track record with 100+ publications in peer reviewed journals; extensive teaching/mentoring experience in clinical pharmacology and pharmacometrics. Iva enjoys developing strong and lasting collaborations with academia and scientific bodies.
Seth Robey, PhD
Director, Quant. Pharmacology & Pharmacometrics
Merck & Co., Inc.
Seth Robey, PhD, is a Director of Quantitative Pharmacology and Pharmacometrics at Merck & Co., Inc. Over nearly 8 years, Seth has gained experience in PKPD modeling, time to event modeling, and disease progression modeling across a range of therapeutic areas. Prior to joining Merck, Seth received his PhD in Pharmacology and Molecular Signaling from Columbia University and Bachelors of Science in Biochemistry from Brandeis University.
Stephen Duffull, PhD
Senior Scientific Advisor
Certara
Stephen Duffull is a Senior Scientific Advisor at Certara and Professor at the Universities of Otago and Queensland. He has been working in the area of pharmacometrics and PKPD for more than 25 years during which time he has been active in research, model informed drug development, leadership roles and training.
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Open to view video. | 91 minutes
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Slides - Julie Stone
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