2019 Research Conference

Collaborative Innovations in Pharmaceutical Product Development

October 2 – 4, 2019

Hyatt Regency Crystal City at Reagan National Airport

SCHEDULE

October 2 | 5 – 8 PM | Potomac V, VI – Ballroom Level

5:00 Dinner reception and NIPTE Awards presentation

October 3 | 8 AM – 4 PM | Potomac Foyer and Conference Theater – Ballroom Level

| | Poster sessions will be in the Regency E. Foyer

8:00 Breakfast and poster session
SESSION 1: CONFERENCE WELCOME AND KEYNOTE
8:30 Conference overview and welcome
Dr. Vadim J. Gurvich, Executive Director, NIPTE
8:45 What do we see when we look at NIPTE as a Community of Knowledge?
Dr. Ajaz Hussain, President, NIPTE
9:15 Advancing Drug Product Quality
Dr. Susan Rosencrance, Director, OPQ’s Office of Lifecycle Drug Products (OLDP), FDA
9:45 Driving Innovation in Biomanufacturing Through Measurement Science
Dr. Michael Tarlov, Chief, Biomolecular Measurement Division, NIST
10:15 Refreshments and poster session
SESSION 2: BIOLOGICS AND BIOSIMILARS
11:00 Session and speaker introductions
Dr. Bruce Yu, University of Maryland
11:10 Advanced Manufacturing of Complex Biologics: A CBER Perspective
Dr. Manuel Osorio, Senior Scientist for Emerging Technologies and Medical Countermeasures, FDA/CBER
11:30 Analytical Comparability Strategies for Biosimilars
Dr. Anna Schwendeman, University of Michigan
11:50 Multiscale PK Modeling of Local Absorption and Systemic Exposure of Biotherapeutic Formulations Injected in Human Subcutaneous (SC) Tissue
Dr. Tonglei Li, Allen Chao Chair and Professor of Industrial and Physical Pharmacy, Purdue University
12:10 Panel introductions and moderator
Dr. Anna Schwendeman, University of Michigan
12:20 Panel / Q&A
12:50 Lunch and poster session
NEW INITIATIVE — TRANSLATIONAL BIOMARKERS
1:50 Emerging ideas, latest innovations, and the new Translational Biomarkers focus group
Dr. Jeff Idle, Director and Endowed Professor, Arthur G. Zupko’s Systems Pharmacology and Pharmacogenomics, Long Island University
2:20 Break
SESSION 3: NANOTECHNOLOGY
2:40 Session and speaker introductions
Dr. Aliasger Salem, University of Iowa
2:50 Regulatory Research Supporting the Development of Drug Products Containing Nanomaterials — a US FDA Perspective
Dr. Katherine Tyner, Associate Director for Science (acting), Office of Pharmaceutical Quality, CDER/FDA
3:10 Nanotechnology Standards for Medical Products
Dr. Anil Patri, Director, Nanotechnology Core Facility, Office of Scientific Coordination, FDA
3:30 Synthetically lethal nanoparticles that treat endometrial cancer
Dr. Aliasger Salem, University of Iowa
3:50 Panel introductions and moderator
Dr. Xiuling Lu, University of Connecticut
4:00 Panel / Q&A
4:30 Networking and poster session
5:00 Adjourn
October 4 | 8 AM – 2 PM | Potomac Foyer and Conference Theater – Ballroom Level

| | Poster sessions will be in the Regency E. Foyer

BREAKFAST SPECIAL SESSION
8:00 Intellectual Property in Pharma: General Principles for the Research Scientist
Eyal H. Barash, Barash Law LLC
SESSION 4: ADVANCED MANUFACTURING
8:45 Session and speaker introductions
Dr. Ira Buckner, Duquesne University
8:55 Advances in Regulatory Science and Emerging Technologies
Dr. Jason Rodriquez,Laboratory Branch Chief, St. Louis, MO, US FDA
9:15 Advanced Manufacturing Technologies for Sustained Release Implants
Dr. Athanas Koynov, Merck
9:35 Implications of Industry 4.0 for Continuous Pharmaceutical Manufacturing
Dr. Gintaras V. (Rex) Reklaitis, Edward W. Comings Professor of Chemical Engineering, Purdue University
9:55 Panel introductions and moderator
Dr. Michael Repka, University of Mississippi
Special guest panelist
Dr. Fernando Muzzio, Rutgers University
10:05 Panel / Q&A
10:35 Refreshments and poster session
SESSION 5: ABUSE DETERRENT FORMULATIONS
11:00 Session and speaker introductions
Dr. Stephen Hoag, Charles B. Jordan Professor of Medicinal Chemistry, Purdue University
11:10 Regulatory Consideration and Research to Evaluate Abuse Deterrence (AD) Properties of Opioid Drug Products
Dr. Xiaoming Xu, Senior Staff Fellow, Office of Testing and Research/Office of Pharmaceutical Quality, CDER
11:30 Transdermal Patch Design for Fixed-Dose Combination Drug Delivery
Dr. Zachary Warnken, University of Texas at Austin
11:50 Experimental Considerations in the Evaluation of Abuse Deterrent Formulations (ADF)
Dr. Stephen Hoag, University of Maryland
12:10 Panel introductions and moderator
Dr. Stephen Hoag, University of Maryland
12:20 Panel / Q&A
CLOSING SESSION: PHARMACEUTICAL INNOVATIONS LUNCH & LEARN
1:00 Lunch and closing remarks
Dr. Ajaz Hussain, President, NIPTE
2:00 Adjourn