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Saturday, November 4, 2023
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Start
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End
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Event
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Vendors
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7:00 AM
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8:00 AM
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Registration & Coffee Service -Workshop Attendees
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8:00 AM
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5:00 PM
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Pre-Meeting Workshop ( 1 day) - Model-Based Meta-Analysis (MBMA): Concepts, Methodologies, and Hands-on Workshop
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Certara
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8:00 AM
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5:00 PM
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Pre-Meeting Workshop (1 day) - Finch Studio NONMEM Workbench with Case Studies in Target-Mediated Drug Disposition
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Enhanced Pharmacodynamics
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8:00 AM
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5:00 PM
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Pre-Meeting Workshop (1 day) - Applying PBBM/PBPK Modeling to Predict Absorption-Related Drug-Drug Interactions: Approaches, Special Considerations, and link toward population PK"
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Simulations Plus
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8:00 AM
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5:00 PM
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Pre-Meeting Workshop (2 day) - Scientific Modeling Augmented by Machine-Learning with DeepPumasTM
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Pumas AI
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8:00 AM
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5:00 PM
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Pre-Meeting Workshop - Introduction and use of jinko: the first end-to-end in silico trial platform to translate biomedical knowledge into actionable QSP models
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Novadiscovery
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8:00 AM
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5:00 PM
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Pre-Meeting Workshop (1 day) - Reporting Pharmacometrics Analyses Introduction to Quarto
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Gilead Sciences
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8:00 AM
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5:00 PM
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Pre-Meeting Workshop (1 day) - Hands-On Tutorial: Introduction to Immuno-Oncology (IO) Quantitative Systems Pharmacology (QSP) Modeling Using the Open Source Julia Progamming Language
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Metrum Research Group
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12:00 PM
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1:00 PM
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Lunch for pre ACoP14 Workshops Attendees
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3:00 PM
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3:30 PM
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Coffee Break for pre ACoP14 Workshops Attendees
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Sunday, November 5, 2003
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Start
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End
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Event
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Vendors
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7:00 AM
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8:00 AM
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Registration & Coffee Service - Workshop Attendees
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8:00 AM
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5:00 PM
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Pre Meeting Workshop (1 Day) Simcyp Designer PBPK-QSP Focused Workshop
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Certara
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8:00 AM
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12:00 PM
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Pre Meeting Workshop (1/2 day) - Global Sensitivity Analysis with SimBiology
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Mathworks
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8:00 AM
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5:00 PM
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Pre Meeting Workshop (1 Day) - New and Advanced Methods of NONMEM7
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ICON
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8:00 AM
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5:00 PM
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Pre Meeting Workshop (1 Day) - Modeling Delays in Pharmacokinetics and Pharmacodynamics using NONMEM.
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ISoP MCS SIG
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8:00 AM
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5:00 PM
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Pre Meeting Workshop (2 Day) Scientific Modeling Augmented by Machine-Learning with Deep PumasTM
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Pumas AI
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8:00 AM
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5:00 PM
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Pre Meeting Workshop (1 Day) Effective Simulation with mrgsolve for Model-Informed Drug Development
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Metrum Research Group
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8:00 AM
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5:00 PM
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Pre Meeting Workshop (1 Day) An introduction to probabilistic decisions support in drug development
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Pharmetheus
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12:00 PM
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1:00 PM
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Lunch for pre ACoP14 Workshops Attendees
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12:00 PM
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7:30 PM
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ACoP14 Conference Registration
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1:00 PM
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5:00 PM
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Pre Meeting Workshop (1/2 Day)Practical application of MID3 to inform Early Drug Discovery Decisions using Applied BioMath Assess™
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Applied BioMath LLC
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3:00 PM
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3:30 PM
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Coffee Break for pre ACoP14 Workshops Attendees
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5:00 PM
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5:30 PM
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ISoP Awards & Fellows Reception (by invitation only)
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5:30 PM
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7:30 PM
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ACoP14 Opening Session: Welcome/Conference Highlights
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Sihem Bihorel - Merck & Co, ACoP14 Conference Chair
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Presentation of ISoP Awards & Induction of Fellows
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Navin Goyal - Janssen, ISoP Awards Committee Chair
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Lewis B. Sheiner Award Lecture
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TBD
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7:30 PM
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10:00 PM
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Opening Reception
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Monday, November 6, 2023
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Start
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End
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Event
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Chairs & Speakers & Panelists
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7:00 AM
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9:00 AM
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Exhibits/Posters/Coffee Service
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9:00 AM
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10:00 AM
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General Session: President's Address
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President: Cynthia J. Musante - Pfizer
President-Elect: Vijay Ivaturi - Pumas AI
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10:00 AM
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11:00 AM
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State-of-the-Art Lecture: Utility of multi-scale modeling of multi-organ systems in understanding and decision-making in drug development
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Dr. Melissa Hallow - University of Georgia
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11:15 AM
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1:00 PM
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Innovation & Diversity: Redefining Pharmacometrics
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Chairs: Sihem Bihorel - Merck & Co, Eric Sobie - Ichan School of Medicine at Mount Sinai, Florencio Serrano Castillo - Amgen
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Strengthening Pharmacometrics in Africa: a long-term commitment
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Goonaseelan (Colin) Pillai - Pharmacometrics Africa NPC
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DEI in digital health & analytics: the promise and the pitfalls
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Saroja Ramanujan - Generate Biomedicines
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Leveraging Diversity to further Innovation: Developing Drugs for a Representative US population
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Lanre Okusanya - FDA
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11:15 AM
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1:00 PM
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The present and future of MIDD: focusing on drug development and human health
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Chairs: Emmanuel Chigutsa - Eli Lilly & Ye Xiong - FDA
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The Use of MIDD Approaches to Enhance New Drug Development and Patient Care
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Jiang Liu - FDA
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Novel applications of MIDD: current and next steps
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Amitava Mitra - Kura Oncology
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Diverse and innovative applications of pharmacometrics in global health
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Rada Savic - UCSF
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Moving Boundaries: Towards Virtual Twin Patients in Clinical Trials and Precision Medicine for CNS Disorders.
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Hugo Geerts - Certara
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11:15 AM
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1:00 PM
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Redefining Pharmacometrics: Is machine learning need-to-have or nice-to-have?
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Chairs: Lyndsey Meyer - Pfizer & Peter Bloomingdale - Boehringer Ingelheim
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Generative Adversarial Networks for Modeling the Race/Ethnicity, Age, and Disease Dependence of Physiological Determinants of Dosing
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Murali Ramanathan - SUNY at Buffalo
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Are ML methods superior to Cox proportional-hazards model for survival analysis? The answer may surprise you!
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Antari Khot - Takeda
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Advantages of Data-Centric Large Language Models for the field of Bio-NLP
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Abhishek Jha - Elucidata
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An Artificial Intelligence Framework for Optimal Drug Design
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Grace Ramey - UCSF
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1:00 PM
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2:30 PM
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Exhibits/Posters
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1:00 PM
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2:30 PM
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Lunch
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1:00 PM
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2:30 PM
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Trainee Lunch - A Speed Mentoring Event for Trainees to Talk with Professionals from all different walks of life, disciplines, and experiences
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Vincent Lowe & Jessica Barry, ISoP Trainee Community Hosts
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2:30 PM
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4:00 PM
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Model-based optimization for (CAR-T) Cell Therapies - The current state of affairs and a way forward
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Chairs: Anna Mc Laughlin - Pharmetheus AB & Cassian Yee - Univ of TX, MD Anderson Cancer Center
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Pharmacodynamic Analysis and QSP modeling for Phase-1 trial of TAK-102: a GPC3 Targeted CAR-T cell armored with IL-7 and CCL19 in Cancer patients
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Aman Singh - Takeda Pharmaceuticals
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Can we apply AI for identification of optimal candidates for cellular therapy?
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Loretta Nastoupil - University of TX, MD Anderson Cancer Center
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Mechanistic modeling of the lymphodepleting regimen to improve allogeneic CAR-T cell kinetics.
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Thibaud Derippe - AstraZeneca
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Clinical Pharmacology Considerations for the Development of CAR-T cell products
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Xiaofei Wang - FDA
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Unlocking the potential of pharmacometrics in cell therapy development and application
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Panel Discussion – Session’s speakers and chairs
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2:30 PM
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4:00 PM
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Emerging use of non-traditional healthcare data sources to enhance the impact of MIDD in advancing drug development program
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Chairs: Malidi Ahamadi - Sanofi & Flora Musuamba Tshinanu - EMA
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Deconvoluting data sharing and integration beyond Randomized controlled trials
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Klaus Romero - C-Path Institute
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Data, Code and Model Coexistence in a Digital Research Environment (DRE): Accelerating MIDD via Diverse Data in a Secure, Regulated Environment
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Jeffrey Barrett - Aridhia Digital Research Environment
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AI and Cloud: Power of Modern Trial Infrastructure for Accelerated Drug Development
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Olga Kubassova - Image Analysis Group
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Regulatory perspective on non-traditional healthcare data sources
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Flora Musuamba Tshinanu - EMA
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2:30 PM
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4:00 PM
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Prediction of target-site drug exposure and receptor occupancy in oncology
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Chairs: David Busse - Boehringer Ingelheim & Eric Jodie - Metrum RG
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Minimal Quantitative Systems Pharmacology (QSP) approach for early estimation of target engagement for different modalities
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Lourdes Curcull-Sanchez - GSK
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The Use of Minimal Physiology-based Pharmacokinetics Models and Biodistribution Studies to Predict Tumor Penetration and Receptor Occupancy
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Robin Michelet - qPharmetra
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Whole-body PBK model application to predict target occupancy in tumors from imaging data
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Wilbert de Witte - esqLABS GmbH
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To be selected from Abstracts
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TBD
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4:00 PM
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5:00 PM
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Exhibits/Posters/Coffee Service
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5:00 PM
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6:30 PM
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ISoP Trainee Communication Challenge
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Hosts: Vincent Lowe & Jessica Barry, ISoP Trainee Community
Mentor: Stacey Tannenbaum – Metrum RG
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7:00 PM
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11:00 PM
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Social Dinner Event
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Janelle Lennie - GSK & Sonoko Kawakatsu - Metrum RG (ACoP14 Social Committee Co-Chairs)
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Tuesday, November 7, 2023
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Start
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End
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Event
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Chairs & Speakers & Panelists
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7:30 AM
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9:30 AM
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Exhibits/Posters/Coffee Service
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9:30 AM
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10:45 AM
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Keynote Speaker: Enabling Patient-Centric Drug Development: an opportunity for clinical pharmacology and pharmacometrics to leverage innovation and advance diversity and inclusion
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Dr. Lisa Benincosa - Allucent
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11:00 AM
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12:30 PM
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Quality & Trainee Awards
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12:30 PM
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2:00 PM
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Exhibits/Posters
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12:30 PM
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2:00 PM
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Lunch
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12:30 PM
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2:00 PM
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SIG Lunch - QSP
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12:30 PM
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2:00 PM
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SIG Lunch - SxP
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2:00 PM
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3:30 PM
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Integration of PMx approaches to model-informed decision making: Across SIG Perspectives
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Chairs: Luke Fostvedt - pfizer (SxP SIG), Iannis Androulakis - Univ Rutgers (QSP SIG), Sean Avedissian - UNMC (Clin PMx SIG), Tongli Zhang - Univ Cincinati (MCS SIG).
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Panelists: Phyllis Chan - Genentech (SxP SIG), Meghan McCabe Pryor - Janssen (QSP SIG), Ada Zhuang - BMS (Clin PMx SIG), Helen Moore - Univ Florifda (MCS SIG)
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Integrating statistics and PMx techniques for model-informed decision making in SLE - SxP SIG
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Jonathan French - Metrum RG, Kosalaram Goteti - EMD Serono
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The need for virtual patients and how QSP can provide an integrative framework - QSP SIG
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Anna Kondic, Bristol Myers Squibb
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Integration of a Bayesian software for model-informed Vancomycin precision dosing in an academic medical center - Clin PMx SIG
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Sean N Avedissian -UNMC (College of Pharmacy), Jeremy Tigh - UNMC
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Needs for mathematical and computational methods in model-informed drug development - MCS SIG
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Jeroen Elassaiss-Schaap - PD-value B.V.
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2:00 PM
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3:30 PM
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Many Roads Traveled: Diverse Journeys in Pharmacometrics
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Chairs: Michelle Johnson - Metrum RG & Songmao (Ben) Zheng - Adagene
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Speakers/Panelists: Emmanuel Chigusta- Eli Lilly, Sara Quinney - Indiana University, Mark Dresser- Gilead Sciences, Angela James – MacroGenics, Jeff Kearns - Novartis
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2:00 PM
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3:30 PM
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PBPK Model for Therapeutic Protein-Drug Interactions (TP-DIs): Present and Future
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Chairs: Weirong Wang - Janssen & Chunze Li - Genentech
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Clinical pharmacology considerations for TP-DI
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Xiling Jiang - FDA
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Application of PBPK model in predicting TP-DI with cytokine modulators
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Xian Pan - Certara
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PBPK model of ADCs and its impact on clinical DDI strategy and label negotiation
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Chunze Li - Genentech
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Pharmacodynamics (PD)-mediated drug-drug interactions (DDI) for anti-FcRn agents and Fc-based therapeutic proteins
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Jia Zhou - Janssen
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3:30 PM
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4:30 PM
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Exhibits/Posters/Coffee Service
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5:00 PM
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6:00 PM
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Universities' Receptions
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Tao Niu - Vertex Pharmaceuticals - ACoP14 Alumni Committee Chair
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6:00 PM
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7:30 PM
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President's Reception (by invitation only)
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Wednesday, November 8, 2023
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Start
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End
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Event
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Chairs & Speakers & Panelists
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7:00 AM
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9:00 AM
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Exhibits/Posters/Coffee Service
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|
9:00 AM
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10:30 AM
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Innovative Clinical Study Decision Making Using Quantitative Systems Pharmacology/Toxicology: An MIDD Tool
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Chiars: Holly Kimko - AstraZeneca & Lourdes Cucurull-Sanchez - GSK
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Combining Microphysiological System with AI and in silico Applications in Drug Development
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Carmen Pin - AstraZeneca
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Predicting Disease Activity Scores in Inflammatory Bowel Disease by Connecting Simulated Tissue Biomarkers of a Virtual Population to Clinical Biomarkers and Outcomes Using a Novel Algorithm
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Douglas Chung - Certara
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Mechanistic models defining and supporting optimal doses
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Antoine Soubret - Roche
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Engineering to Balance Efficacy and Safety – Optimizing Trimer Formation in T Cell Redirecting Bispecific Antibodies
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Shalla Hanson - Janssen
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9:00 AM
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11:00 AM
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Roller Coaster 1
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Chairs: Eric Sobie - Chairs: Anna Sher – GSK & Piet van der Graaf - Certara
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Pharmacometabolomic-guided precision dosing in clinical care of hematopoietic cell transplantation (HCT) recipients
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Jeannine S. McCune - City of Hope
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Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers: a Regulatory Perspective
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David Strauss - FDA
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Metabolomics-based Clinical Translation of Drug-induced Nephrotoxicity and Reno-protection With a Multiscale Modeling Approach
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Sihem Bihorel - Merck & Co
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Mapping lesion-specific response and progression dynamics in metastatic colorectal cancer
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Jiawei Zhou - Pfizer
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|
UDE Know It If UDE Saw It: Leveraging Deep Machine Learning for QSP Model Development and Evaluation
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Ahmed Elmokadem - Metrum Research Group
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Exploration of multiple AI search algorithms for nonlinear mixed effects model identification
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Robert Bies - SUNY at Buffalo
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9:00 AM
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11:00 AM
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Roller Coaster 2
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Chairs: Kayla (Yi Ting) Lien – Genentech & Eric Sobie – Icahn School of Medicine at Mount Sinai
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QSP Modelers: Take Your Data Seriously, Not Literally!
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Christina Friedrich - Rosa & Co
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Modelling pharmacometrics data with Neural ODEs including inter-individual variability
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Dominic Braem - University of Basel
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Open Problems in Generating Virtual Populations
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Richard Allen - Pfizer
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Prediction of human dose for gene replacement therapies
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Sergey Aksenov - Arvinas
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A Novel Bayesian Statistical Approach for Estimating Tumor Dynamics from Published Progression Free Survival Studies In the Presence of Response and Nontarget Progression
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Arya Pourzanjani - Amgen
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Minding your P’s and Q’s: how PMx and QSP coexist and integrate for MIDD
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Daniela Conrado - Regeneron
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11:00 AM
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12:30 PM
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Towards global harmonization – a new international council for guideline of model-informed drug development (MIDD)
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Chair: Hao Zhu - FDA
Panel Moderator: Erin Green - Pfizer
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FDA Perspectives
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Million Tegenge - FDA
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Health Canada Perspectives
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Sarem Sarem - Health Canada
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BIO and Industry perspectives
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Mark Peterson - Vertex Pharmaceuticals
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PhRMA and Industry perspectives
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Jenny Chien - Eli Lilly
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12:00 PM
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1:30 PM
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Exhibits/Posters
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|
12:00 PM
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1:30 PM
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Lunch
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|
12:00 PM
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1:30 PM
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SIG Lunch – Clin PMx
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|
12:00 PM
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1:30 PM
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SIG Lunch - MCS
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12:30 PM
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2:00 PM
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JPKPD Meeting (by invitation only)
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1:30 PM
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3:00 PM
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May the odds be ever in your favor: Innovative Approaches to improve Go/No-Go (GNG) decision making in Oncology
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Chairs: Madhav Channavazzala - Vantage Research Inc & Tarek Leil – Daiishi Sankyo
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May the odds be ever in your favor: Less so without dose finding
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Kapil Mayawala - Generate Biomedicines
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Leveraging historic data for generating a rigorous Synthetic Control Arm that accounts for patient covariates
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Shu-wen Teng - Cstone Pharmaceuticals
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Limitations of RECIST-based decision-making in Early Oncology
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Brian Topp - Merck & Co
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Improving the odds of selecting the winners by choosing the right outcome
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Kristian Thorlund - McMaster University
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1:30 PM
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3:00 PM
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Ocular Drug Development: How MIDD Can Brighten Our Vision
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Chairs: Devineni Damayanthi - Janssen & Fernando Olinto Carreno - GSK
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Current status of MIDD in ocular drug development
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Eleni Karatza - Janssen
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Translational consideration and first in human dose finding in retina gene therapy
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Hardik Mody - Genentech
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Physiologically-based PK/PD investigation to support the development of ocular gene therapies
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Carter Cao - UNC at Chapel Hill
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Regulatory Experiences and Considerations for Model-Informed Approaches in Ocular Drug Development
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Ping Ji - FDA
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1:30 PM
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3:00 PM
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Latest Innovations in Model-Informed Precision Dosing Around the World
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Chairs:Amparo de la Peña - Simulation Plus, Cognigen Division & Ana Ruiz - Gilead Sciences
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Panelist: Ron Keizer - InsightRX
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Implementation of model-informed precision dosing into routine practice
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Sophie Stocker - University of Sidney
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Model-informed precision dosing of anti-infectives: challenges and potential solutions
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Sebastien Wicha - University of Hamburg
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Model-informed precision dosing and clearance monitoring of monoclonal antibodies in patients with chronic immune-mediated inflammatory diseases.
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Erwin Dreesen - KU Leuven
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|
Model-informed precision dosing and clearance monitoring of monoclonal antibodies in patients with chronic immune-mediated inflammatory diseases
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Manuel Ibarra - Universidad de la República de Uruguay
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|
2:00 PM
|
5:00 PM
|
Trainee Workshop: Transitioning from Us to Them: A Soft Skills Workshop for Successfully Navigating Diverse Teams
|
Vincent Lowe & Jessica Barry, ISoP Trainee Community Hosts
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|
3:15 PM
|
3:45 PM
|
Closing ACoP14
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Sihem Bihorel - Merck & Co
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|
4:30 PM
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6:00 PM
|
ACoP 14 Meets ACoP 15 (by invitation only)
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|
Thursday, November 9, 2023
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|
Start
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End
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Event
|
Speakers
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7:00 AM
|
8:00 AM
|
Coffee Service for tutorial attendees
|
|
9:00 AM
|
12:00 PM
|
Tutorial - The Art of Writing Beautiful Code
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Instructors: Pete Bonate - Astellas & Andreas Krause - Idorsia Pharmaceuticals
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|
10:00 AM
|
5:00 PM
|
Post ACoP14 Satellite Meeting focused on Oncology
|
|
12:00 PM
|
1:00 PM
|
Lunch for Oncology Workshop Attendees
|
|
12:00 PM
|
1:00 PM
|
Registration & Lunch for Post ACoP14 Workshops Attendees
|
|
1:00 PM
|
5:00 PM
|
Post Workshop (1 1/2 day) - PBPK-PD/QSP modeling with the OSPSuite (PK-Sim®, MoBi®)
|
Pharmetheus
|
|
1:00 PM
|
5:00 PM
|
Post Workshop (1 1/2 day) - Pharmacometrics modeling & simulations using MonolixSuite: from introductory to advanced concepts and applications."
|
Lixoft/Simulations Plus
|
|
1:00 PM
|
5:00 PM
|
Post Workshop (1 1/2 day) - Advanced Clinical Trial Simulations to Support MIDD
|
Pumas AI
|
|
3:00 PM
|
3:30 PM
|
Coffee Break for post ACoP14 Workshop Attendees
|
|
Friday, November 10, 2023
|
|
Start
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End
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Event
|
Speakers
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|
7:00 AM
|
8:00 AM
|
Coffee Service for Post ACoP14 Workshop Attendees
|
|
|
8:00 AM
|
5:00 PM
|
Post Workshop (1 1/2 day) -PBPK-PD/QSP modeling with the OSPSuite (PK-Sim®, MoBi®)
|
Pharmetheus
|
|
8:00 AM
|
5:00 PM
|
Post Workshop (1 1/2 day) -Pharmacometrics modeling & simulations using MonolixSuite: from introductory to advanced concepts and applications."
|
Lixoft/Simulations Plus
|
|
8:00 AM
|
5:00 PM
|
Post Workshop (1 1/2 day) -Advanced Clinical Trial Simulations to Support MIDD
|
Pumas AI
|
|
12:00 PM
|
1:00 PM
|
Lunch for post ACoP14 Workshops Attendees
|
|
3:00 PM
|
3:30 PM
|
Coffee Break for Workshop Attendees
|
