PBPK MODELING FOR THE DEVELOPMENT AND APPROVAL OF LOCALLY ACTING PRODUCTS

Welcome and Objectives 
Liang Zhao, PhD, US Food and Drug Administration, Silver Spring, MD 
Ping Zhao, PhD, Bill & Melinda Gates Foundation, Seattle, WA

Opening Remarks: Challenges and Critical Role of PBPK for Locally Acting Drug Products in Regulatory Decisions
Robert Lionberger, PhD, US Food and Drug Administration, Silver Spring, MD

Session 1: Orally Inhaled and Nasal Drug Products 
Moderators: Myong-Jin Kim, PharmD, US Food and Drug Administration, Silver Spring, MD, and Donald L. Heald, PhD, Janssen - Johnson and Johnson, Spring House, PA

Using PBPK to Link Systemic PK to Local Delivery in the Lung
Guenther Hochhaus, PhD, University of Florida, Gainesville, FL

CFD Lung Models for Drug Delivery
Ching-Long Lin, PhD, University of Iowa, Iowa City, IA

Application of PBPK Modeling for Inhalativa: Potential and Challenges 
Michael Block, PhD, Bayer, Leverkusen, Germany

Impact of Orally Inhaled and Nasal Drug Product PBPK Models on Product Development and Regulatory Decision Making  
Ross Walenga, PhD, US Food and Drug Administration, Silver Spring, MD

PANEL DISCUSSION
Guenther Hochhaus, PhD, University of Florida, Gainesville, FL
Ching-Long Lin, PhD, University of Iowa, Iowa City, IA
Michael Block, PhD, Bayer, Leverkusen, Germany 
Ross Walenga, PhD, US Food and Drug Administration, Silver Spring, MD

Session 2:  Dermal Drug Delivery 
Moderators: Min Li, PhD, US Food and Drug Administration, Silver Spring, MD, and Lakshmi Vasist, PharmD, GlaxoSmithKline, Research Triangle Park, NC

Skin Physiology and Clinical Considerations for PBPK Models of the Skin
Howard Maibach, MD, University of California, San Francisco, San Francisco, CA
 
PBPK Modeling of Dermally Applied Drug Products to Support Clinical Development and Regulatory Assessment
Nikunjkumar Patel, PhD, Simcyp (A Certara Company), Sheffield, United Kingdom

PBPK Modeling for the Development of Dermatological Drug Products and its Regulatory Impact
Eleftheria Tsakalozou, PhD, US Food and Drug Administration, Silver Spring, MD

PANEL DISCUSSION
Howard Maibach, MD, University of California, San Francisco, San Francisco, CA
Michael Roberts, PhD, DSc, University of South Australia and The University of Queensland Australia, Queensland, Australia
Nikunjkumar Patel, PhD, Simcyp (A Certara Company), Sheffield, United Kingdom 
Eleftheria Tsakalozou, PhD, US Food and Drug Administration, Silver Spring, MD

Session 3: Ophthalmic Drug Products 

Moderators: Xinyuan Zhang, PhD, US Food and Drug Administration, Silver Spring, MD, and David Wesche, MD, PhD, Certara Strategic Consulting, Princeton, NJ

An Integrated Multiscale-Multiphysics Modeling of Ocular Drug Delivery and Pharmacokinetics 
Andrzej Przekwas, PhD, CFD Research Corporation, Huntsville, AL

Developing PBPK for Ocular Delivery
Michael B. Bolger, PhD, Simulations Plus, Lancaster, CA

Use PBPK Model to Evaluate Impact of Ophthalmic Drug Product’s Critical Quality Attributes on BA/BE Assessment 
Andrew Babiskin, PhD, US Food and Drug Administration, Silver Spring, MD

PANEL DISCUSSION
Andrzej Przekwas, PhD, CFD Research Corporation, Huntsville, AL
Michael B. Bolger, PhD, Simulations Plus, Lancaster, CA 
Andrew H. Babiskin, PhD, US Food and Drug Administration, Silver Spring, MD

Session 4: Methods and Implementation Challenges 
Moderators: Ping Zhao, PhD, Bill & Melinda Gates Foundation, Seattle, WA, and Lei Zhang, PhD, Silver Spring, MD

European Experience of Biopharmaceutical Applications of PBPK Models
Susan Cole, BSc, Medicines & Healthcare Products Regulatory Agency, London, United Kingdom

Challenges in Using PBPK Models for Locally Acting Drug Products to Inform Regulatory Decision Makings
Liang Zhao, PhD, US Food and Drug Administration, Silver Spring, MD

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Advancing QSP Toward Predictive Drug Development: From Targets to Treatments

OPENING REMARKS
Suzana Petanceska, PhD, National Institute on Aging/National Institutes of Health, Bethesda, MD

SESSION 1: INTRODUCTION AND CURRENT STATUS OF QSP
Session Co-Chairs: Cynthia J. Musante, PhD, Pfizer; and Jane Bai, PhD, US Food and Drug Administration

Introduction to QSP in Drug Discovery and Development: a Historical, Current and Future Perspective
Piet H. van der Graaf, PhD, PharmD, Certara, Canterbury, United Kingdom
Developing a Knowledge Base and Infrastructure to Enable QSP for Alzheimer’s Disease Research and Drug Development
Suzana Petanceska, PhD, National Institute on Aging/National Institutes of Health, Bethesda, MD
Trends Towards the Industrialization of Quantitative Systems Pharmacology in Drug Research & Development
Vikram P. Sinha, PhD, Merck & Co. Kenilworth, NJ
Quantitative Systems Pharmacology at the US Food and Drug Administration: From Aspiration to Translation
Issam Zineh, PharmD, MPH, US Food and Drug Administration, Silver Spring, MD 

SESSION 2: RECENT QSP APPLICATIONS IN DRUG DISCOVERY AND DEVELOPMENT & DECISION-MAKING 
Session Chair: Gerald Galluppi, PhD, Sunovion Pharmaceuticals, Marlborough, MA

An Integrative Deep Learning Approach for De Novo Drug Discovery
Joel Dudley, PhD, Institute for Next Generation Healthcare at the Icahn School of Medicine at Mount Sinai, New York, NY 
Recent Applications of Quantitative Systems Pharmacology in IQ Consortium: From Data to Decision
Mindy Magee, PharmD, GlaxoSmithKline, Collegeville, PA 
Regulatory Perspectives on QSP
Yaning Wang, PhD, US Food and Drug Administration, Silver Spring, MD 
   
QSP MODEL ASSESSMENT IN DRUG DISCOVERY, DEVELOPMENT & DECISION-MAKING 
Session Chair: David Strauss, MD, PhD, US Food and Drug Administration, Silver Spring, MD

Challenges in Model Qualification: When One Size Does Not Fit All 
Stephan Schmidt, PhD, University of Florida, Orlando, FL
Needs and Approaches for Model Assessment & Qualification: A Pharma Perspective
Saroja Ramanujan, PhD, Genentech, South San Francisco, CA 
Development and Validation of a Quantitative Systems Pharmacology Model for In Silico Cardiac Safety Assessment under the CiPA Initiative
Zhihua Li, PhD, US Food and Drug Administration, Silver Spring, MD