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Clinical Pharmocology
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Sunday, Nov 3
9:00 am
Welcome and Overview
Location: 214 AB
Hao Cai, PhD – Genentech, Inc.
Sunday, Nov 3
9:00 am
Short Course: Translational PKPD and First-in-Human Studies for Novel Modalities (ticketed event)
Location: 214 AB
Hao Cai, PhD – Genentech, Inc.; Chunze Li, Ph.D. – Genentech, Inc.; Shraddha Sadekar
Sunday, Nov 3
9:15 am
Preclinical Safety Assessment for IND/CTA: risk identification and translational considerations for NME with novel mechanisms
Location: 214 AB
Rodney Prell, PhD – Genentech, Inc.
Sunday, Nov 3
9:55 am
Safety Consideration for a First-in-human Clinical Trial in Oncology Patients
Location: 214 AB
Hong Xie, M.D., M.S., MBA – Janssen Research & Development LLC
Sunday, Nov 3
10:50 am
Industrial Practice of using MABEL: result from a recent IQ cross pharmaceutical industry survey on MABEL staring dose
Location: 214 AB
Sherri L. Dudal, Ph.D. – F. Hoffmann - La Roche
Sunday, Nov 3
11:30 am
Regulatory Consideration on FIH Starting Dose Selection with a Focus on Immuno-oncology and Novel Drug Modalities
Location: 214 AB
Michael L. Manning, Ph.D. – U.S. Food and Drug Administration
Sunday, Nov 3
1:15 pm
Mechanistic Projection of First-in-Human Dose for T-Cell Bispecific Antibodies: A Case Study for P-cadherin LP-DART
Location: 214 AB
Xiaoying Chen, Ph.D. – Pfizer Inc.
Sunday, Nov 3
1:45 pm
Translational PKPD and First-in-human Studies for Antisense Oligonucleotides
Location: 214 AB
DANIEL A. Norris, PhD – Ionis Pharmaceuticals
Sunday, Nov 3
2:30 pm
A Preclinical Systems Pharmacology Model of Individualized NeoAntigen Specific Immunotherapy (iNeST)
Location: 214 AB
Iraj Hosseini, Ph.D. – Genentech, Inc.
Sunday, Nov 3
3:00 pm
Application of Translational Modeling and Simulation in CAR-T Therapy Development (tentative)
Location: 214 AB
Weirong Wang, PhD – Clinical Pharmacology and Pharmacometrics, Quantitative Sciences, Janssen R&D
Sunday, Nov 3
3:30 pm
Closing Remarks
Location: 214 AB
Chunze Li, Ph.D. – Genentech, Inc.
Monday, Nov 4
8:30 am
Prologue: Dosing in an Era of Personalized Medicine – Chemical
Location: 302
Vikram Sinha, PhD – Merck & Co., Inc.
Monday, Nov 4
8:30 am
Prologue: Model-informed Dose Selection and Optimization of Novel Biotherapeutics – Biomolecular
Location: 301
Chunze Li, Ph.D. – Genentech, Inc.; Elimika Fletcher, PharmDPhD – U.S. Food and Drug Administration
Monday, Nov 4
9:00 am
FIH Starting Dose Selection for Novel Therapeutics – Learning from IQ MABEL Survey Results
Location: 301
Chao Han, Ph.D. – Janssen Research & Development LLC
Monday, Nov 4
9:00 am
Symposium: Role of Modeling and Simulation in Dose and Dosing Regimen Selection – Biomolecular
Location: 301
Elimika Fletcher, PharmDPhD – U.S. Food and Drug Administration; Chunze Li, Ph.D. – Genentech, Inc.
Monday, Nov 4
9:30 am
Clinical Pharmacology Considerations for Bispecifics
Location: 301
Chandra Udata, Ph.D. – Pfizer Inc.
Monday, Nov 4
10:00 am
Dosing Approaches for Novel Therapeutic Modalities - CAR-T Therapies
Location: 301
Edward Waldron, BSc, MScPhD – Novartis Pharmaceutical Corporation
Monday, Nov 4
10:30 am
Regulatory Perspective on Dosing Approaches for Novel Therapeutic Modalities
Location: 301
Yuching Yang, PhD – U.S. Food and Drug Administration
Monday, Nov 4
9:00 am
QSP: How to Avoid “Going up the Down Staircase”
Location: 302
Balaji Agoram, PhD – Forty Seven, Inc.
Monday, Nov 4
9:00 am
Symposium: Role of Modeling and Simulation in Dose and Dosing Regimen Selection – Chemical
Location: 302
Yvonne Y. Lau, Ph.D. – Janssen Pharmaceuticals
Monday, Nov 4
9:30 am
Different Perspectives - Informing Drug Development Decision Making through Complementary M&S Approaches
Location: 302
Yogesh Patel, Ph.D. – Cognigen Corp.
Monday, Nov 4
10:00 am
Challenges of Time-varying Exposure in Oncology Exposure-response Analysis and Solutions to Overcome it: A Case Study of Ceritinib in NSCLC
Location: 302
Xinrui Zhang, PhD – Novartis Pharmaceuticals Corporation
Monday, Nov 4
10:30 am
Machine-Learning and Network Pharmacology Modeling of Chemotherapy-Induced Peripheral Neuropathy
Location: 302
Donald E. Mager, Pharm.D., PhD, FAAPS – University at Buffalo, SUNY
Monday, Nov 4
1:30 pm
Keynote: Role of Modeling and Simulation in Dose and Dosing Regimen Selection and Optimization
Location: 301
mats O. karlsson, PhD – Uppsala University; Amitava Mitra, Ph.D. – Sandoz, USA
Tuesday, Nov 5
8:30 am
Prologue: Applications of Non-Linear Mixed Effect Models to Define Systems: Shifting Focus Away from Single Drug – Chemical
Location: 302
Amin Rostami, Pharm.D., PhD – University of Manchester & Certara USA Inc; Mohamad Shebley, PhD, FCP – AbbVie
Tuesday, Nov 5
8:30 am
Prologue: Utilizing the Clinical Pharmacology Storehouse to Inform Drug Development in Special Populations and Rare Disease – Biomolecular
Location: 301
Susan M. Richards, PhD – Sanofi
Tuesday, Nov 5
9:00 am
Clinical Pharmacology of Small Interfering Ribonucleic Acid
Location: 303
BAHRU Habtemariam, Pharm.D. – Alnylam Pharmaceuticals -
Tuesday, Nov 5
9:00 am
Nucleic Acid-Based Therapeutics: Discovery, Development, & Delivery - Clinical Pharmacology
Location: 303
Charvi Nanavati, PhD – Ionis Pharmaceuticals
Tuesday, Nov 5
9:30 am
Antisense Oligonucleotide Drug Development: Some Lessons Learned and Progress from Clinical Pharmacology Perspectives
Location: 303
Yanfeng Wang, Ph.D. – Ionis Pharmaceuticals
Tuesday, Nov 5
10:00 am
Dosing Approaches for Novel Therapeutic Modalities - Nucleic Acid-Based Therapies
Location: 303
Varun Goel, MS, PhD – Alnylam Pharmaceuticals
Tuesday, Nov 5
10:30 am
Assessment of Clinical Stage Oligonucleotide: A Clinical Pharmacology Reviewer's Perspective
Location: 303
Hobart Rogers, Pharm.D., Ph.D. – U.S. Food and Drug Administration
Tuesday, Nov 5
9:00 am
Leveraging Preclinical and Historic Clinical Data to Obtain Approval of G-CSF Treatments for Acute Radiation Syndrome Under the Animal Rule
Location: 301
John Harrold, PhD – Amgen Inc.
Tuesday, Nov 5
9:00 am
Symposium: Clinical Pharmacology Paths for Small Populations – Biomolecular
Location: 301
Susan M. Richards, PhD – Sanofi
Sponsored By:
Tuesday, Nov 5
9:30 am
Clinical Perspective on Immune Tolerance and ADA Mitigation Strategies for Rare Populations
Location: 301
Ankit Desai, MBBS – Duke University Health System
Tuesday, Nov 5
10:00 am
How can Electronic Health Records be More Useful as Real-World-Data?
Location: 301
Leena Choi, Ph.D. – Vanderbilt University Medical Center
Tuesday, Nov 5
10:30 am
How to Expedite Pediatric Drug Development in Inflammatory Bowel Disease
Location: 301
Wenhui Zhang, Ph.D – Genentech, Inc.
Tuesday, Nov 5
9:00 am
Reverse Translational Assessment of CYP450- and OATP-Mediated Clearance in Chronic Kidney Disease: from Clinical Data to PBPK Modelling
Location: 302
Ming-Liang Tan, Ph.D. – U.S. Food and Drug Administration
Tuesday, Nov 5
9:00 am
Symposium: Clinical Pharmacology Paths for Small Populations – Chemical
Location: 302
Mohamad Shebley, PhD, FCP – AbbVie
Tuesday, Nov 5
9:30 am
Reverse Translation for UGTs: Leveraging clinical data to obtain UGT-mediated intrinsic clearances for IVIVE-PBPK
Location: 302
Matthew D. Harwood, Ph.D. – Certara UK Ltd - Simcyp Division
Tuesday, Nov 5
10:00 am
Assessing the Impact of Birth and Maturation on Renal Function and Drug Metabolism
Location: 302
Nick Holford, MBChB, MSc, FRACP, FAAPS – University of Auckland
Tuesday, Nov 5
10:30 am
Understanding Inflammatory Disease-Mediated Drug Interactions in Cancer Patients
Location: 302
David E. Coutant, PhD, RAC – Eli Lilly and Company
Tuesday, Nov 5
1:30 pm
Keynote: Clinical Pharmacology Paths for Small Populations
Location: 302
Danny H. Howard, Jr., Ph.D. – Novartis Institutes for Biomedical Research; Kevin Litwiler, Ph.D. – Array BioPharma
Tuesday, Nov 5
1:30 pm
Keynote: From Big to Small: Clinical Pharmacology Challenges and Opportunities, particularly in Rare Diseases
Location: 301
John D. Davis, PHD – REGENERON PHARMACEUTICALS
Tuesday, Nov 5
3:00 pm
Current Status of Drug Delivery to Tumors: Determinants, Challenges, and Opportunities
Location: 304
Clinton Stewart, Pharm.D., FAAPS – St. Jude Children's Research Hospital
Tuesday, Nov 5
3:00 pm
The Journey to Developing Tissue and Organ Specific Therapies - Clinical Pharmacology
Location: 304
Amit Desai, Ph.D. – Astellas Pharma
Tuesday, Nov 5
3:30 pm
PBPK Model Based Drug Development to Support Formulation and Dose Regimen Selections for Cutaneous Topical Drugs
Location: 304
Laurence Del Frari, Pharm.D. – Pierre Fabre Laboratories
Tuesday, Nov 5
4:00 pm
Challenges in the Development of Pharmacotherapies for NAFLD/NASH
Location: 304
Kyunghee Yang, Ph.D. – DILIsym Services Inc.
Tuesday, Nov 5
4:30 pm
Drug Properties + CNS PBPK Model = Prediction of Drug PK Profiles in Multiple CNS Compartments
Location: 304
Elizabeth C. de Lange, PhD, FAAPS – Division of Systems Biomedicine and Pharmacology, Leiden Academic Centre for Drug Research, Leiden U
Wednesday, Nov 6
8:30 am
Prologue: The Regulatory Impact of PBPK Modelling and How We Got There – Chemical
Location: 302
Tycho H. Heimbach, PhD – Novartis Institutes for Biomedical Research; Masoud Jamei, Ph.D. – Certara UK Limited, Simcyp Division
Wednesday, Nov 6
8:30 am
Prologue: Clinical Pharmacology Lessons Learned in Biotherapeutics Development – Biomolecular
Location: 301
Anas M. Fathallah, PhD – Biogen
Wednesday, Nov 6
9:00 am
Industry learnings on The Impact of Prognostic Factors on Time-Dependent Pharmacokinetics and Exposure-Response Analyses in Oncology
Location: 301
Benjamin Wu, Ph.D. – Genentech, Inc.
Wednesday, Nov 6
9:00 am
Symposium: Lessons Learned from Regulatory Interactions in Clinical Pharmacology for Innovative New Chemical Entities, Complex Generics, and Biosimilars – Biomolecular
Location: 301
John Diep, Pharm.D., M.S. – Halozyme
Wednesday, Nov 6
9:30 am
Considerations for Exposure-Response Analyses in Biotherapeutics Development
Location: 301
Hao Zhu, Ph.D. – U.S. Food and Drug Administration
Wednesday, Nov 6
10:00 am
Novel Approaches on Minimizing Residual Uncertainty in Biosimilar Product Development
Location: 301
Andrej Skerjanec, PhD – Sandoz, Novartis Company
Wednesday, Nov 6
10:30 am
Challenges and Opportunities in Development of Subcutaneously Administered Biotherapeutics
Location: 301
Beate Bittner, Ph.D. – F. Hoffmann - La Roche
Wednesday, Nov 6
9:00 am
Practical Challenges in Conducting Quantitative DDI Analysis for Regulatory Interactions: Case Examples
Location: 302
Venkatesh Pilla Reddy, Ph.D. – AstraZeneca
Wednesday, Nov 6
9:00 am
Symposium: Lessons Learned from Regulatory Interactions in Clinical Pharmacology for Innovative New Chemical Entities, Complex Generics, and Biosimilars – Chemical
Location: 302
Masoud Jamei, Ph.D. – Certara UK Limited, Simcyp Division
Wednesday, Nov 6
9:30 am
Regulatory Interactions on PBPK Modelling: A Case of PPIs not DDIs
Location: 302
Karen Rowland Yeo, Ph.D. – Certara
Wednesday, Nov 6
10:00 am
Application of PBPK Modeling in Regulatory Submission: FDA Experience
Location: 302
Yuching Yang, PhD – U.S. Food and Drug Administration; Fang Wu, PhD – US Food and Drug Administration
Wednesday, Nov 6
10:30 am
Application of PBPK Modeling in Regulatory Submission: EMA Experience
Location: 302
Anders Lindahl, Ph.D. – Swedish Medical Products Agency
Wednesday, Nov 6
1:30 pm
Keynote: Regulatory Perspectives on Clinical Pharmacology Strategy for Development of Biosimilars
Location: 301
Yow Ming C. Wang, Ph.D. – U.S. Food and Drug Administration
Wednesday, Nov 6
1:30 pm
Keynote: Regulatory Perspectives on Clinical Pharmacology Strategy for Development of New Chemical Entities
Location: 302
Shiew-Mei Huang, PhD, FAAPS – U.S. Food and Drug Administration; Kevin Litwiler, Ph.D. – Array BioPharma
Wednesday, Nov 6
4:00 pm
Panel Discussion: Clinical Pharmacology
Location: Presentation Room 2, Exhibit Hall 4
Shiew-Mei Huang, PhD, FAAPS – U.S. Food and Drug Administration; Karen Rowland Yeo, Ph.D. – Certara; Richard Graham; Mohamed Elmeliegy, PhD – Pfizer Inc.
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