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

5:00Dinner 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

8:00Breakfast and poster session
SESSION 1: CONFERENCE WELCOME AND KEYNOTE
8:30Conference overview and welcome
Dr. Vadim J. Gurvich, Executive Director, NIPTE
8:45What do we see when we look at NIPTE as a Community of Knowledge?
Dr. Ajaz Hussain, President, NIPTE
9:15Advancing Drug Product Quality
Dr. Susan Rosencrance, Director, OPQ’s Office of Lifecycle Drug Products (OLDP), FDA
9:45Driving Innovation in Biomanufacturing Through Measurement Science
Dr. Michael Tarlov, Chief, Biomolecular Measurement Division, NIST
10:15Refreshments and poster session
SESSION 2: BIOLOGICS AND BIOSIMILARS
11:00Session and speaker introductions
Dr. Bruce Yu, University of Maryland
11:10Advanced Manufacturing of Complex Biologics: A CBER Perspective
Dr. Manuel Osorio, Senior Scientist for Emerging Technologies and Medical Countermeasures, FDA/CBER
11:30Analytical Comparability Strategies for Biosimilars
Dr. Anna Schwendeman, University of Michigan
11:50Multiscale 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
12:10Panel introductions and moderator
Dr. Anna Schwendeman, University of Michigan
12:20Panel / Q&A
12:50Lunch and poster session
NEW INITIATIVE — TRANSLATIONAL BIOMARKERS
1:50Emerging 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
2:20Break
SESSION 3: NANOTECHNOLOGY
2:40Session and speaker introductions
Dr. Aliasger Salem, University of Iowa
2:50Regulatory 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
3:10Nanotechnology Standards for Medical Products
Dr. Anil Patri, Director, Nanotechnology Core Facility, Office of Scientific Coordination, FDA
3:30Synthetically lethal nanoparticles that treat endometrial cancer
Dr. Aliasger Salem, University of Iowa
3:50Panel introductions and moderator
Dr. Xiuling Lu, University of Connecticut
4:00Panel / Q&A
4:30Networking and poster session
5:00Adjourn
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
8:00Intellectual Property in Pharma: General Principles for the Research Scientist
Eyal H. Barash, Barash Law LLC
SESSION 4: ADVANCED MANUFACTURING
8:45Session and speaker introductions
Dr. Ira Buckner, Duquesne University
8:55Advances in Regulatory Science and Emerging Technologies
Dr. Jason Rodriquez,Laboratory Branch Chief, St. Louis, MO, US FDA
9:15Advanced Manufacturing Technologies for Sustained Release Implants
Dr. Athanas Koynov, Merck
9:35Implications of Industry 4.0 for Continuous Pharmaceutical Manufacturing
Dr. Gintaras V. (Rex) Reklaitis, Edward W. Comings Professor of Chemical Engineering, Purdue University
9:55Panel introductions and moderator
Dr. Michael Repka, University of Mississippi
Special guest panelist
Dr. Fernando Muzzio, Rutgers University
10:05Panel / Q&A
10:35Refreshments and poster session
SESSION 5: ABUSE DETERRENT FORMULATIONS
11:00Session and speaker introductions
Dr. Stephen Hoag, Charles B. Jordan Professor of Medicinal Chemistry, Purdue University
11:10Regulatory 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
11:30Transdermal Patch Design for Fixed-Dose Combination Drug Delivery
Dr. Zachary Warnken, University of Texas at Austin
11:50Experimental Considerations in the Evaluation of Abuse Deterrent Formulations (ADF)
Dr. Stephen Hoag, University of Maryland
12:10Panel introductions and moderator
Dr. Stephen Hoag, University of Maryland
12:20Panel / Q&A
CLOSING SESSION: PHARMACEUTICAL INNOVATIONS LUNCH & LEARN
1:00Lunch and closing remarks
Dr. Ajaz Hussain, President, NIPTE
2:00Adjourn