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Preclinical Development
Bioanalytics
Clinical Pharmacology
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Bioprocessing
Formulation and Quality
Rapid Fire Preclinical
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Preclinical Development
Preclinical Development
Preclinical Development
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Sunday, Nov 3
9:00 am
Workshop: Advanced Drug Delivery Strategies for Nucleotide-based Therapeutics: Addressing Intracellular Trafficking (ticketed event)
Location: 217 AB
Stephen T. Buckley, Ph.D. – Novo Nordisk A/S; Annette Bak, Ph.D. – AstraZeneca
Sunday, Nov 3
12:30 pm
Welcome and Overview
Location: 225 CD
Bart Hens, Pharm.D., Ph.D. – n/a
Sunday, Nov 3
12:30 pm
Short Course: Introduction to Mechanistic Modeling and Simulation in Physiologically-based Pharmacokinetic (PBPK) Modeling Programs: Industrial and Regulatory (ticketed event)
Location: 225 CD
Bart Hens, Pharm.D., Ph.D. – n/a
Sunday, Nov 3
12:45 pm
PBPK: Introduction and State-of-the-Art
Location: 225 CD
Amin Rostami, Pharm.D., PhD – University of Manchester & Certara USA Inc
Sunday, Nov 3
1:15 pm
Mechanistic Modeling of Enabling Formulations in Pharmaceutical Industry
Location: 225 CD
Michael B. Bolger, PhD – Simulations Plus, Inc.
Sunday, Nov 3
1:45 pm
Mechanistic Modeling of Enabling Formulations: an academic perspective
Location: 225 CD
Bart Hens, Pharm.D., Ph.D. – n/a
Sunday, Nov 3
2:30 pm
Regulatory Requirements for a PBPK model: Perspective from the EMA
Location: 225 CD
Anders Lindahl, Ph.D. – Swedish Medical Products Agency
Sunday, Nov 3
3:00 pm
Regulatory Requirements for Physiologically Based Pharmacokinetic- Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: Perspective from the US FDA
Location: 225 CD
Sandra Suarez, Ph.D. – U.S. Food and Drug Administration
Sunday, Nov 3
4:00 pm
Closing Remarks
Location: 225 CD
Bart Hens, Pharm.D., Ph.D. – n/a
Monday, Nov 4
8:30 am
Prologue: Advancements in Antibody Engineering and Applications
Location: 225 AB
Paul W.H.I Parren, Ph.D. – Lava Therapeutics; Andrea Hooper, PhD – Pfizer Inc.
Monday, Nov 4
8:30 am
Prologue: Simple and Interpretable Signatures to Revolutionize Drug Development in the World of AI and ML
Location: 225 CD
Viswanath Devanarayan, PhD, FAAPS – GlaxoSmithKline
Monday, Nov 4
9:00 am
Mechanism of Action and Target Selection for Antisense Oligonucleotide Therapies
Location: 303
Peter H. Hagedorn, MSc, Ph.D. – Roche Innovation Center Copenhagen
Monday, Nov 4
9:00 am
Nucleic Acid-Based Therapeutics: Discovery, Development, & Delivery - Preclinical Development
Location: 303
Charvi Nanavati, PhD – Ionis Pharmaceuticals
Monday, Nov 4
9:30 am
Nonclinical ADME and Translational PK/PD in Antisense Oligonucleotide Drug Development
Location: 303
Charvi Nanavati, PhD – Ionis Pharmaceuticals
Monday, Nov 4
10:00 am
ADME and PK Properties of GalNAc-conjugated siRNAs in Nonclinical Species
Location: 303
Saeho Chong, PhD – Alnylam Pharmaceuticals Inc.
Monday, Nov 4
10:30 am
QSP Model for a Messenger RNA Therapy
Location: 303
Pratap Singh, PhD – Alexion Pharmaceuticals
Monday, Nov 4
9:00 am
Maximizing Therapeutic Potential by Affinity and Avidity Engineering
Location: 225 AB
Gregory L. Moore, PhD – Xencor, Inc.
Monday, Nov 4
9:00 am
Symposium: Next Generation Technologies in Preclinical Development – Biomolecular
Location: 225 AB
Andrea Hooper, PhD – Pfizer Inc.
Monday, Nov 4
9:30 am
A Cell-based Assay for Predicting Non-specific Clearance of Therapeutic Antibodies
Location: 225 AB
Shan Chung, Ph.D. – Genentech, Inc.
Monday, Nov 4
10:00 am
Drug Discovery Driven by Antibody Engineering Technologies
Location: 225 AB
Tomoyuki Igawa, Ph.D. – Chugai Pharmabody Research Pte.,Ltd.
Monday, Nov 4
10:30 am
Panel Discussion: T-Cell Redirectors (CD3-Bispecifics) - Engineering Towards Success
Location: 225 AB
Paul W.H.I Parren, Ph.D. – Lava Therapeutics; Gregory L. Moore, PhD – Xencor, Inc.; Shan Chung, Ph.D. – Genentech, Inc.; Tomoyuki Igawa, Ph.D. – Chugai Pharmabody Research Pte.,Ltd.; Paul A. Moore, PhD – MacroGenics, Inc.
Monday, Nov 4
9:00 am
Science-Driven Design of the Preclinical Package: Case by Case
Location: 225 CD
Ruth Roberts, PhD – ApconiX
Monday, Nov 4
9:00 am
Symposium: Next Generation Technologies in Preclinical Development – Chemical
Location: 225 CD
Viswanath Devanarayan, PhD, FAAPS – GlaxoSmithKline; Shraddha Thakkar, Ph.D. – National Center for Toxicological Research, US Food and Drug Administration
Monday, Nov 4
9:30 am
Computational Toxicology Strategies for Drug Discovery—Present and Future
Location: 225 CD
Thomas Hartung, M.D., Ph.D. – Johns Hopkins University
Monday, Nov 4
10:00 am
Choose The Right Cancer Cell Line For Your Research: A Genomics-guide Prioritize System (CCL-GPS)
Location: 225 CD
Xiaohui Fan, PhD – Zhejiang University
Monday, Nov 4
10:30 am
FAIR Principles and Implementations in the Pharmaceutical Industry
Location: 225 CD
Susanna-Assunta Sansone, PhD – University of Oxford
Monday, Nov 4
1:30 pm
Keynote: Applying Bispecific Antibodies To Enhance Immune Responses for Therapeutic Intervention
Location: 225 AB
Paul A. Moore, PhD – MacroGenics, Inc.; Prathap Nagaraja Shastri, PhD – Janssen Research and Development, LLC
Monday, Nov 4
1:30 pm
Keynote: Bridging the Gap in Reproducibility of AI in Predictive Medicine: lessons from the FDA projects – Chemical
Location: 225 CD
Weida Tong, PhD – US Food and Drug Administration; Shraddha Thakkar, Ph.D. – National Center for Toxicological Research, US Food and Drug Administration
Tuesday, Nov 5
8:30 am
Prologue: Emerging Research Tools for High Quality Candidate Selection – Chemical
Location: 225 CD
Brendan T. Griffin, Ph.D. – University College Cork; John Burke, Ph.D. – Applied BioMath
Tuesday, Nov 5
8:30 am
Prologue: Pre-clinical and Translational Science Considerations of Emerging Novel Therapies – Biomolecular
Location: 225 AB
Arunan Kaliyaperumal, Ph.D. – Eli Lilly and Company; Swati Gupta, PhD – Allergan
Tuesday, Nov 5
9:00 am
Considerations for Immunogenicity Risk Assessment and Mitigation and Bioanalytical Strategies for the Next Generation of Biologics
Location: 225 AB
Vibha Jawa, Ph.D. – Merck / Predictive and Clinical Immunogenicity / QP2, PPDM
Tuesday, Nov 5
9:00 am
Symposium: Emerging Research Tools for High Quality Candidate Selection – Biomolecular
Location: 225 AB
Swati Gupta, PhD – Allergan
Tuesday, Nov 5
9:30 am
Applications of Computation Tools in Cell Therapy
Location: 225 AB
Cindy Xia, PhD – Takeda Pharmaceuticals International Co.
Tuesday, Nov 5
10:00 am
Analysis of T-cell Vector Integration Sites for a Murine Gamma-Retroviral Vector encoding the Anti-CD19 Chimeric Antigen Receptor used in the Production of Axicabtagene Ciloleucel
Location: 225 AB
Joe Benoun
Tuesday, Nov 5
10:30 am
Making Sense of Deep Sequencing: FDA Perspective
Location: 225 AB
Joshua Xu, PhD – U.S. Food and Drug Administration
Tuesday, Nov 5
9:00 am
Adoption and Impact of Microphysiological Systems in Pharmaceutical Development
Location: 225 CD
John Burke, Ph.D. – Applied BioMath
Tuesday, Nov 5
9:00 am
Symposium: Emerging Research Tools for High Quality Candidate Selection – Chemical
Location: 225 CD
John Burke, Ph.D. – Applied BioMath
Tuesday, Nov 5
9:30 am
Leveraging Scalable Organ Chips to Gauge Inflammatory Responses in Preclinical Drug Development
Location: 225 CD
Michael Bscheider, MD – Roche pRED, Pharmaceutical Sciences
Tuesday, Nov 5
10:00 am
3D Intestinal Tissues for Lead Optimization, Safety, and Permeability
Location: 225 CD
Seyoum Ayehunie, PhD – MatTek Corporation
Tuesday, Nov 5
10:30 am
Microbiome Contributions to Drug Metabolism
Location: 225 CD
Andrew L. Goodman, PhD – Yale University School of Medicine
Tuesday, Nov 5
1:30 pm
Keynote: Emerging Technologies for Regulatory Science: How Can FDA Help? – Biomolecular
Location: 225 AB
William Slikker, Jr., Ph.D. – U.S. Food and Drug Administration; Shraddha Thakkar, Ph.D. – National Center for Toxicological Research, US Food and Drug Administration
Tuesday, Nov 5
1:30 pm
Keynote: Fit for Purpose Models for Formulation Optimization and Performance Evaluation in ADME
Location: 225 CD
Christel A. S Bergstrom, Ph.D. – Uppsala University; Nikoletta Fotaki, PhD – University of Bath
Wednesday, Nov 6
8:30 am
Prologue: Critical Insights and Methods from Modeling Mechanisms to Support Discovery through Early Clinical Development – Biomolecular
Location: 225 AB
Brian Schmidt, Ph.D. – Bristol-Myers Squibb; Fei Hua, Ph.D. – Applied BioMath
Wednesday, Nov 6
8:30 am
Prologue: Quantitative Systems Pharmacology and Toxicology Modeling in Preclinical to Clinical Translation – Chemical
Location: 225 CD
Jane P.F Bai, PhD – U.S. Food and Drug Administration; Abhishek Gulati, Ph.D. – Astellas Pharma Global Development
Wednesday, Nov 6
9:00 am
Discovery and Development of Emicizumab, an Antibody for Hemophilia A
Location: 225 AB
Mika Sato – Chugai Pharmaceutical Co., Ltd.
Wednesday, Nov 6
9:00 am
Symposium: PK and PD Modeling in Effective Preclinical to Clinical Translation – Biomolecular
Location: 225 AB
Fei Hua, Ph.D. – Applied BioMath; Brian Schmidt, Ph.D. – Bristol-Myers Squibb
Wednesday, Nov 6
9:30 am
QSP Model of Agonist-mediated T-cell Dynamics in Mouse Tumor Micro Environment
Location: 225 AB
Yan Ji, PhD – Novartis
Wednesday, Nov 6
10:00 am
Virtual Population Approaches using Prior Clinical Data for Immuno-oncology Development
Location: 225 AB
Yougan Cheng, Ph.D. – Bristol-Myers Squibb
Wednesday, Nov 6
10:30 am
QSP for Efficacy and Safety Decisions in Bi-specific Antibody Development
Location: 225 AB
Iraj Hosseini, Ph.D. – Genentech, Inc.
Wednesday, Nov 6
9:00 am
QSP Can Improve Hypothesis Generation and Testing in Pharmaceutical R&D
Location: 225 CD
Tarek Leil, M.S., Ph.D. – Bristol-Myers Squibb
Wednesday, Nov 6
9:00 am
Symposium: PK and PD Modeling in Effective Preclinical to Clinical Translation – Chemical
Location: 225 CD
Abhishek Gulati, Ph.D. – Astellas Pharma Global Development; Tarek Leil, M.S., Ph.D. – Bristol-Myers Squibb
Wednesday, Nov 6
9:30 am
How does QSP Modeling Support R&D Decisions? Case examples of modeling impact in central nervous system and inflammatory diseases
Location: 225 CD
Christina M. Friedrich, Ph.D. – Rosa & Co
Wednesday, Nov 6
10:00 am
Mechanistic Insights into Drug-Induced Liver Injury for Macrolide Antibiotics using Quantitative Systems Toxicology Modeling
Location: 225 CD
Kyunghee Yang, Ph.D. – DILIsym Services Inc.
Wednesday, Nov 6
10:30 am
Towards Bridging Translational Gap in Cardiotoxicity Prediction: Progressive Cardiac Risk Assessment Strategy for Moxiflox
Location: 225 CD
Nikunjkumar Patel, Ph.D. – Certara UK Limited, Simcyp Division
Wednesday, Nov 6
9:00 am
Assessing Tissue Specific Exposure with Microdialysis
Location: 304
Hartmut Derendorf, Ph.D., FAAPS – University of Florida
Wednesday, Nov 6
9:00 am
The Journey to Developing Tissue and Organ Specific Therapies - Preclinical Development
Location: 304
Reina Bendayan, Pharm.D., FAAPS – University of Toronto
Wednesday, Nov 6
9:30 am
Establishing Preclinical Safety and Efficacy of Novel Ocular Delivery Systems
Location: 304
Susan R. Crowell, Ph.D. – Genentech, Inc.
Wednesday, Nov 6
10:00 am
Preclinical Models for Pulmonary Delivery
Location: 304
Guenther Hochhaus, Ph.D. – University of Florida
Wednesday, Nov 6
10:30 am
Challenges and Applications in Quantitative Systems Pharmacology for Heart Failure
Location: 304
Limei Cheng, Ph.D. – Bristol-Myers Squibb
Wednesday, Nov 6
1:30 pm
Keynote: Integrating Novel Predictive Approaches to Translation
Location: 225 AB
Paul J. Fielder, Ph.D. – Genentech, Inc; Saileta Prabhu, Ph.D. – Genentech, Inc.
Wednesday, Nov 6
1:30 pm
Keynote: Quantitative Biopharmaceutics - Translation from Preclinical to Clinical
Location: 225 CD
Filippos Kesisoglou, MSc, Ph.D., FAAPS – Merck & Co., Inc.; Nikoletta Fotaki, PhD – University of Bath
Wednesday, Nov 6
4:00 pm
Panel Discussion: AI Driven Alternative Methods for Drug Safety and Efficacy
Location: Presentation Room 4, Exhibit Hall 4
Weida Tong, PhD – US Food and Drug Administration; Ruth Roberts, PhD – ApconiX; Thomas Hartung, M.D., Ph.D. – Johns Hopkins University
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