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Pre-Conference Programming

Pre-Conference Programming

Please note that all Pre-Conferences are taking place at the Marriott Wardman Park Hotel.
WEDNESDAY, MARCH 13, 2019 | 8:00 AM – 5:00 PM Click here for a printable agenda.

Co-Sponsors: ASCPT, Innovation & Quality Consortium, the International Society of Pharmacometrics (ISoP), and the US Food and Drug Administration, in collaboration with the National Institute on Aging at the National Institutes of Health.
Chairs: Cynthia J. Musante, PhD; Jane Bai, PhD; and Suzana Petanceska, PhD
FDA Organizing Committee: David Strauss, MD, PhD; Rajnikanth Madabushi, PhD; Justin Earp, PhD; Elimika Pfuma Fletcher, PharmD, PhD; and Jane Bai, PhD
NIH Organizing Committee: Mary Ann Pelleymounter, PhD; and Suzana Petanceska, PhD
IQ Consortium Organizing Committee: Gerald Galluppi, PhD; Mindy Magee, PharmD; and Cynthia J. Musante, 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
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 

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 
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 

12:00 PM – 1:00 PM  
NETWORKING LUNCH 
Vouchers for hotel food outlets, include Harry’s, Stone's Throw, Lobby Lounge & Woodley Pantry

1:00 PM – 2:00 PM  
POSTER SESSION

2:00 PM – 3:15 PM

QSP POSTER PRESENTATION AWARD 
Presented by Piet H. van der Graaf, PhD, PharmD; Former Editor-in-Chief, CPT: Pharmacometrics & Systems Pharmacology
   
SESSION 3: 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 

3:15 PM – 4:35 PM 
POINT-COUNTERPOINT AND PANEL DISCUSSIONS: THE PATH FORWARD 

3:15-3:30 PM POINT-COUNTERPOINT DISCUSSION
Moderator: Rajnikanth Madabushi, PhD, US Food and Drug Administration, Silver Spring, MD 
PANELISTS: Stephan Schmidt, PhD, University of Florida, Orlando, FL; and Vikram Sinha, Merck &Co. Kenilworth, NJ

3:30 PM– 3:55 PM PANEL DISCUSSION: QSP MODEL EVALUATION
Moderator: Justin Earp, PhD, US Food and Drug Administration, Silver Spring, MD
PANELISTS: Saroja Ramanujan, PhD, Genentech, South San Francisco, CA; Stephan Schmidt, PhD, University of Florida, Orlando, FL; Yaning Wang, PhD, US Food and Drug Administration, Silver Spring, MD

3:55 PM - 4:35 PM PANEL DISCUSSION: THE PATH FORWARD
Moderator: Mindy Magee, PharmD, GlaxoSmithKline, Collegeville, PA 
PANELISTS: Suzana Petanceska, PhD, National Institute on Aging/National Institutes of Health, Bethesda, MD; Vikram Sinha, PhD, Merck & Co., Kenilworth, NJ; David Strauss, MD, PhD, US Food and Drug Administration, Silver Spring, MD; Piet H. van der Graaf, PhD, PharmD, Certara, Canterbury, United Kingdom; Issam Zineh, PharmD, MPH, US Food and Drug Administration, Silver Spring, MD

4:35PM – 4:45 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 Institute on Aging/National Institutes of Health, Bethesda, MD 

WEDNESDAY, MARCH 13, 2019 | 8:00 AM – 5:00 PM Click here for a printable agenda.

Co-Sponsor: ASCPT and the US Food and Drug Administration
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. This workshop will be especially valuable to industry developing products that need to demonstrate bioequivalence to a locally acting drug product.

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

8:00 AM – 8:05 AM
Welcome 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, US Food and Drug Administration, Silver Spring, MD, and Donald L. Heald, PhD, Janssen - Johnson and Johnson, Spring House, PA

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

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

10:05 AM – 10:20 AM
BEVERAGE BREAK 

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

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

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

12:05 PM – 1:00 PM
NETWORKING LUNCH 
Vouchers for hotel food outlets, include Harry’s, Stone's Throw, Lobby Lounge & Woodley Pantry

12:45 – 1:30 PM
POSTER PRESENTATIONS (Poster authors will be available to discuss their work)

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

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 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

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

2:55 PM – 3:15 PM
BEVERAGE BREAK AND POSTER VIEWING

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

3:15 PM – 3:30 PM
European Experience of Biopharmaceutical Applications of PBPK Models
Susan Cole, BSc, 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

3:50-4:20 PM
Session 1: Model verification for regulatory use
  1. Guenther Hochhaus, PhD, University of Florida, Gainesville, FL 
  2. Ching-Long Lin, PhD, University of Iowa, Iowa City, IA 
  3. Michael Roberts, PhD, DSc, University of South Australia and The University of Queensland 
  4. Andrzej Przekwas, PhD, CFD Research Corporation, Huntsville, AL 
  5. Nikunjkumar Patel, PhD, Simcyp (A Certara Company), Sheffield, United Kingdom
  6. Michael B. Bolger, PhD, Simulations Plus, Lancaster, CA
  7. Michael Block, PhD, Bayer, Leverkusen, Germany
  8. Liang Zhao, PhD, US Food and Drug Administration, Silver Spring, MD
4:20-4:50 PM
Session 2: Model application to support regulatory submission
  1. Howard Maibach, MD, University of California, San Francisco, San Francisco, CA
  2. Lakshmi Vasist, PharmD, GlaxoSmithKline, Research Triangle Park, NC 
  3. Gary D. Novack, PhD, PharmaLogic, San Rafael, CA 
  4. Susan Cole, BSc, Medicines & Healthcare Products Regulatory Agency, London, United Kingdom 
  5. Shinichi Kijima, PhD, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
  6. Xinyuan Zhang, PhD, US Food and Drug Administration, Silver Spring, MD
  7. Paul Seo, PhD, US Food and Drug Administration, Silver Spring, MD
  8. Robert Lionberger, PhD, US Food and Drug Administration, Silver Spring, MD
4:50 PM – 5:00 PM
Concluding Remarks
Liang Zhao, PhD, US Food and Drug Administration, Silver Spring, MD
Ping Zhao, PhD, Bill & Melinda Gates Foundation, Seattle, WA
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