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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 jinkÅ: 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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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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12:00 PM
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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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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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Modeling Delays in Pharmacokinetics and Pharmacodynamics using NONMEM.
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University at Buffalo
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8:00 AM
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5:00 PM
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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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Effective Simulation with mrgsolve for Model-Informed Drug Development
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Metrum RG
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8:00 AM
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5:00 PM
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An introduction to probabilistic decisions support in drug development
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Pharmetheus
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8:00 AM
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5:00 PM
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Simcyp Designer PBPK-QSP Focused Workshop
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Certara
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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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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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Cynthia J. Musante - Pfizer
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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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Sihem Bihorel - Merck & Co, Eric Sobie - Metrum RG (ACoP14 Planning Committee), Nadia Noormohamed - GSK, Florencio Serrano Castillo - Amgen (ISoP DE&I Committee)
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Strengthening Pharmacometrics in Africa: a long-term commitment
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Pillai Goonaseelan (Colin) - 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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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, Inc.
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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 Greets - 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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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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1:00 PM
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2:30 PM
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JPKPD Meeting (by invitation only)
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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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Anna Mc Laughlin - Pharmtheus AB & Cassian Yee - Univ of TX, MD Anderson Cancer Center
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Opportunities for Model-Informed-Drug-Development (MIDD) for cell therapies
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Anna Mc Laughlin - Pharmtheus AB
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Can we apply AI for identification of optimal candidates for cellular therapy?
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Loretta Nastoupil - 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
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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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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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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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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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Christian Maass - 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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Communication Challenge: ISoP Trainee Talks
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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, BMS
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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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Insights from Spatiotemporal Modeling: Sickle Cell Disease Case Study - MCS SIG
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Nessy Tania, Pfizer
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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, Marc Dresser Gilead Sciences
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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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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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Alumni Receptions
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Tao Niu - Vertex (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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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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Jaehee Shim - Certara
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Mechanistic models defining and supporting optimal doses
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Christina Santini - Roche
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To be selected from Abstracts
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TBD
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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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Eric Sobie - Metrum RG
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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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Strategy And Applications Of PBPK Modeling For Simultaneous Dose Predictions And Adjustments For Early Inclusion Of Diverse Ethnic-Patient Populations
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Kunal Taskar - GSK
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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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How the bone ecosystem facilitates multiple myeloma relapse and the evolution of heterogeneous proteasome inhibitor resistant disease.
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Anna Miller - Certara
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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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To be selected from Abstracts
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TBD
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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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Kayla (Yi Ting) Lien - Genentech
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Prediction of human dose for gene replacement therapies
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Sergey Aksenov - Arvinas
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Combining agent-based modeling with experiments to predict novel therapeutic approaches for fibrotic disease.
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Shayn Peirce-Cottler - University of Virginia
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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 RG
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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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To be selected from Abstracts
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TBD
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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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Hao Zhu - FDA
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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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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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Madhav Channavazzala - Vantage Research Inc & Substitute (TBD)
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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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Devineni Damayanthi - Janssen & Substitute (TBD)
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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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Jian Liu - FDA & Substitute (TBD)
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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 - Univ of Sidney
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Model-informed precision dosing of anti-infectives: challenges and potential solutions
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Sebastien Wicha - Univ 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
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5:00 PM
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Trainee Tutorial: Soft Skills- Talks about Diversity in Clinical development
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Vincent Lowe & Jessica Barry, ISoP Trainee Community Hosts
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2:00 PM
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3:30 PM
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Model-Informed Drug Development of Novel Neonatal Fc Receptor (FcRn) Inhibitors Using Immunoglobulin G (IgG) as a Key Biomarker and Drug Development Tool
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Mahesh N. Samtani - Janssen & Ekatarina Gibiansky - QantPharm LLC
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Total IgG modeling and simulation to guide efgartigimod development across indications.
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Stefaan Rossenu - Argenx
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PopPK/PD Model of Nipocalimab for PK/Receptor-Occupancy/IgG as a Drug Development Bridging Tool
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Yuan Xiong - Janssen
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MIDD approaches to support new drug development for FcRn inhibitors
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Atul Bhattaram - FDA
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To be selected from Abstracts
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TBD
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3:30 PM
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4:00 PM
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Closing General Session
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Sihem Bihorel - Merck & Co
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4:30 PM
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6:00 PM
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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
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Speakers
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7:00 AM
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8:00 AM
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Coffee Service for tutorial attendees
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8:00 AM
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12:00 PM
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Tutorial - The Art of Writing Beautiful Code
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Pete Bonate - Astellas & Andreas Krause - Idorsia Pharmaceuticals
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1:00 PM
|
5:00 PM
|
TBD
|
TBD |
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1:00 PM
|
5:00 PM
|
Hands-On Tutorial: Introduction to Immuno-Oncology (IO) Quantitative Systems Pharmacology (QSP) Modeling Using the Open-Source Julia Computing Language
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Metrum RG
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1:00 PM
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5:00 PM
|
Pharmacometrics modeling & simulations using MonolixSuite: from introductory to advanced concepts and applications."
|
Lixoft/Simulations Plus
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|
1:00 PM
|
5:00 PM
|
Advanced Clinical Trial Simulations to Support MIDD
|
Pumas AI
|
|
3:00 PM
|
3:30 PM
|
Coffee Break for post ACoP14 Workshop Attendees
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|
Friday, November 10, 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
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Coffee Service for Post ACoP14 Workshop Attendees
|
|
|
8:00 AM
|
5:00 PM
|
Hands-On Tutorial: Introduction to Immuno-Oncology (IO) Quantitative Systems Pharmacology (QSP) Modeling Using the Open-Source Julia Computing Language
|
Metrum RG
|
|
8:00 AM
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5:00 PM
|
Pharmacometrics modeling & simulations using MonolixSuite: from introductory to advanced concepts and applications."
|
Lixoft/Simulations Plus
|
|
8:00 AM
|
5:00 PM
|
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 Workshops Attendees
|
