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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
Background:
The FDA and ASCPT have expressed a willingness to leverage their combined strengths for the joint development of the substantive actions of this pre -conference to raise awareness amongst scientists and decision-makers in academia, the pharmaceutical/biotech industry, and federal regulatory/funding agencies.

Goals and Objectives:

  • To provide a forum for open discussion on the challenges and critical role of PBPK for locally acting drug products in regulatory decisions. 
  • Recognize challenges and opportunities for PBPK with inhalation drug products, dermal drug delivery and ophthalmic drug products.   
  • Discuss challenges and opportunities for the community in enhancing PBPK models. 

Who Should Attend:
This ASCPT 2019 PBPK Modeling for the Development and Approval of Locally Acting Drug Products is intended for a diverse group of scientists from academia, industry, consulting, and regulatory agencies committed to improving drug discovery, development, and review who can benefit from an understanding of PBPK modeling for locally acting drug products. .

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






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