X

Pre-Conference Programming

Pre-Conference Programming

WEDNESDAY, MARCH 13, 2019 | 8:00 AM – 5:00 PM

Co-Sponsors: ASCPT, IQ Consortium, and the International Society of Pharmacometrics (ISoP)
Chairs: Cynthia J. Musante, PhD, Jane Bai, PhD, and Suzana Petanceska, PhD

Overview: 
Quantitative Systems Pharmacology (QSP) is an emerging field with increasing utilization in recent years. This full-day Pre-Conference will focus on applications of QSP in drug discovery, development, and regulatory reviews. Through presentations and panel discussions, this session aims to raise awareness amongst scientists and decision-makers in academia, the pharmaceutical and biotech industries, and regulatory/funding agencies on: 

  • The potential value of QSP in drug discovery, development, and review, as illustrated by recent case study examples; 
  • Real and perceived technical and operational challenges to implementing a QSP approach; and
  • Roadblocks and opportunities for greater adoption and acceptance. 
This session is aimed for a broad audience; if you are a clinician, executive, scientist, or part of a drug discovery or development team, please join us to find out how QSP can improve decision-making from targets to treatments.

8:00 AM – 8:15 AM
Opening Remarks

Jane Bai, PhD, US Food and Drug Administration, Silver Spring, MD
Cynthia J. Musante, PhD, Pfizer, Cambridge, MA 
Suzana Petanceska, PhD, National Institutes of Aging/National Institutes of Health, Bethesda, MD

8:15 AM – 10:15 AM
SESSION 1: INTRODUCTION AND CURRENT STATUS OF QSP

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 of Aging/National Institutes of Health, Bethesda, MD

Trends towards the Industrialization of Quantitative Systems Pharmacology in Drug Research & Development 
Vikram P. Sinha, PhD, Merck Research Laboratories, Merck & Co, Upper Gwynedd, PA

Quantitative Systems Pharmacology at the US Food and Drug Administration: From Aspiration to Translation
Issam Zineh, PharmD, US Food and Drug Administration, Silver Spring, MD

10:15 AM – 10:45 AM
BREAK

10:45 AM – 12:00 PM   
SESSION 2: RECENT QSP APPLICATIONS IN DRUG DISCOVERY AND DEVELOPMENT & DECISION-MAKING

An Integrative Deep Learning Approach for De Novo Drug Discovery
Joel Dudley, PhD, Mount Sinai, New York, NY 

Recent Applications of Quantitative Systems Pharmacology in IQ Consortium: From Data to Decisions
Mindy Magee, PharmD, GlaxoSmithKline, Collegeville, PA 

Regulatory Perspectives on QSP
Yaning Wang, PhD, US Food and Drug Administration, Silver Spring, MD 

12:00 PM – 12:45 PM  
NETWORKING LUNCH 

12:45 PM – 2:00 PM  
POSTER SESSION

2:00 PM – 3:00 PM  
SESSION 3: QSP MODEL ASSESSMENT IN DRUG DISCOVERY, DEVELOPMENT & DECISION-MAKING

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 

3:00 PM - 4:30 PM 
POINT-COUNTERPOINT AND PANEL DISCUSSION: THE PATH FORWARD 
Point-Counterpoint and panel discussion with audience participation to discuss topics of interest, which may include: the potential value of QSP in drug discovery, development, and review; real and perceived technical and operational challenges to implementing a QSP approach; and roadblocks and opportunities for greater adoption and acceptance. 

4:30 PM – 4:35 PM  
QSP POSTER PRESENTATION AWARD 
Presented by Piet H. van der Graaf, PhD, PharmD; Editor-in-Chief, PSP

4:35 PM – 4:50 PM
Concluding Remarks 
Jane Bai, PhD, US Food and Drug Administration, Silver Spring, MD 
Cynthia J. Musante, PhD, Pfizer, Cambridge, MA 
Suzana Petanceska, PhD, National Institutes of Aging/National Institutes of Health, Bethesda, MD 

 

WEDNESDAY, MARCH 13, 2019 | 8:00 AM – 5:00 PM
This Pre-Conference will address challenges in developing physiologically-based pharmacokinetic (PBPK) models for locally acting drug products and using them during drug development and demonstration of bioequivalence (BE). The Pre-Conference will update the community with the latest progress in understanding drug distribution and delivery of locally acting drug products by PBPK modeling, stimulate discussion, and foster collaborations, especially with a focus on the following routes of delivery: inhalation, topical, ophthalmic, and other non-oral routes. The recent advancement of PBPK models offers a great opportunity to address the existing scientific challenges and regulatory needs across the product lifecycle.

Chairs: Liang Zhao, PhD, and Ping Zhao, PhD

8:00 AM – 8:05 AM
Introduction and Objectives 
Liang Zhao, PhD, US Food and Drug Administration, Silver Spring, MD 
Ping Zhao, PhD, Bill & Melinda Gates Foundation, Seattle, WA

8:05 AM – 8:20 AM
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, and Robin O’Connor-Semmes, PhD

8:20 AM – 8:40 AM
Using PBPK to Link Systemic PK to Local Delivery in the Lung
Guenther Hochhaus, PhD, University of Florida, Gainesville, FL

8:40 AM – 9:00 AM  
CFD Lung Models for Drug Delivery
Ching-Long Lin, PhD, University of Iowa, Iowa City, IA

9:00 AM – 9:20 AM
Application of PBPK Modeling for Inhalativa: Potential and Challenges 
Michael Block, PhD, Bayer, Leverkusen, Germany
 
9:20 AM – 9:40 AM
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

9:40 AM – 10:05 AM
PANEL DISCUSSION

10:05 AM – 10:20 AM
BREAK

Session 2:  Dermal Drug Delivery 
Moderators: Min Li, PhD, and Lakshmi Vasist, PharmD

10:20 AM – 10:40 AM
Skin Physiology and Clinical Considerations for PBPK Models of the Skin
Howard Maibach, MD, University of California, San Francisco, San Francisco, CA

10:40 AM – 11:00 AM
PBPK Models of the Skin (Considering Dosage Form Properties)
Michael Roberts, PhD, DSc, University of South Australia and The University of Queensland
Australia, Queensland, Australia

11:00 AM – 11:20 AM  
PBPK Modeling of Dermally Applied Drug Products to Support Clinical Development and Regulatory Assessment
Nikunjkumar Patel, PhD, Simcyp (A Certara Company), Sheffield, United Kingdom

11:20 AM – 11:40 AM
PBPK Modeling for the Development of Dermatological Drug Products and its Regulatory Impact
Eleftheria Tsakalozou, PhD, US Food and Drug Administration, Silver Spring, MD

11:40 AM – 12:05 PM
PANEL DISCUSSION

12:05 PM – 1:30 PM
NETWORKING LUNCH, AND POSTER SESSION 
POSTER PRESENTATIONS

Session 3: Ophthalmic Drug Products 
Moderators: Xinyuan Zhang, PhD, and David Wesche, MD, PhD

1:30 PM – 1:50 PM
An Integrated Multiscale-Multiphysics Modeling of Ocular Drug Delivery and Pharmacokinetics 
Andrzej Przekwas, PhD, CFD Research Corporation, Huntsville, AL

1:50 PM – 2:10 PM
Developing PBPK for Ocular Delivery
Michael B. Bolger, PhD, Simulations Plus, Lancaster, CA

2:10 PM – 2:30 PM
Use of 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

2:30 PM – 2:55 PM
PANEL DISCUSSION

2:55 PM – 3:15 PM
BREAK AND POSTER SESSION

Session 4: Methods and Implementation Challenges 
Moderators: Ping Zhao, PhD, and Lei Zhang, PhD

3:15 PM – 3:30 PM
European Experience of Biopharmaceutical Applications of PBPK Models
Susan Cole, PhD, Medicines & Healthcare Products Regulatory Agency, London, United Kingdom

3:30 PM – 3:50 PM
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

3:50 PM – 4:50 PM
PANEL DISCUSSION

4:50 PM – 5:00 PM
CONCLUDING REMARKS






Photo Gallery
Recent News
Contact Us